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Business Wire India

• Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study
• Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies
• Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year

 

Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA.

 

PV is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms.

 

 

“There is an urgent need for innovative treatment options in polycythemia vera, where patients currently face limited therapeutic choices to control their hematocrit and significant symptom burden,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “The FDA’s acceptance of our NDA brings us closer to potentially offering a first-in-class therapy that could meaningfully improve clinical outcomes and quality of life. This milestone is a reflection of our successful partnership with Protagonist and Takeda’s unwavering commitment to advancing innovative treatments in hematologic cancers where significant unmet needs persist.”

 

 

The NDA for rusfertide was primarily based on the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study (NCT05210790), as well as four-year efficacy and safety data from the Phase 2 REVIVE study (NCT04057040) and long-term extension THRIVE study (NCT06033586). In the VERIFY study, rusfertide met the primary endpoint and all four key secondary endpoints. Patients receiving rusfertide plus current standard of care demonstrated a higher response rate compared to current standard of care. This included hematocrit control, a reduction in phlebotomy requirements and improvement in pre-specified patient reported outcomes of fatigue and symptom burden. Rusfertide was generally well-tolerated through 52 weeks of treatment. The most common treatment-emergent adverse events (AEs) in rusfertide-treated patients were injection site reactions (47.4%), anemia (25.6%) and fatigue (19.6%), which were mainly grade 1 or 2. Serious AEs occurred in 8.1% of overall rusfertide-treated patients.

 

 

“Rusfertide exemplifies Protagonist’s end-to-end expertise, from exploring a novel hepcidin mimetic mechanism to address unmet needs in polycythemia vera to discovering the peptide and driving its clinical development through NDA filing. We are very pleased with the FDA granting rusfertide Priority Review and look forward to its potential approval in 2026,” said Dinesh V. Patel, Ph.D., Protagonist President and CEO. “We have identified a great partner in Takeda as rusfertide progresses toward this milestone, thereby bringing a successful closure to our more than decade-long journey from concept-to-commercialization.”

 

 

In January 2024, Protagonist and Takeda entered into a worldwide license and collaboration agreement for rusfertide. Protagonist discovered rusfertide and led its development through Phase 3 studies, with Takeda responsible for implementing the regulatory strategy for the U.S. NDA filing and for leading any future global regulatory filings. Protagonist holds an option to co-commercialize in the U.S. through a 50/50 profit and loss share structure or to opt-out of this structure, providing Takeda with a worldwide license pursuant to the license and collaboration agreement.

 

 

About Rusfertide
Rusfertide is a first-in-class investigational subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, rusfertide aims to reduce excess red blood cell production and help patients achieve sustained hematocrit control. Rusfertide is administered once weekly via subcutaneous self-injection and has been generally well-tolerated in clinical trials to date.

 

 

About VERIFY
The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating rusfertide in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from rusfertide beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%.

 

 

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of rusfertide plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

 

 

About REVIVE and THRIVE
The Phase 2 REVIVE study (NCT04057040) evaluated rusfertide in adult patients with polycythemia vera and consisted of three parts, including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the blinded, placebo-controlled, randomized withdrawal Part 2 (13 weeks) and 58 patients in the Part 3 open-label expansion (52 weeks). The THRIVE study (NCT06033586) is an ongoing, open-label extension study evaluating the long-term durability of response and safety profile of rusfertide in patients with polycythemia vera. The study includes 46 patients who previously participated in REVIVE. Patients eligible to transition to the THRIVE study completed the open-label extension portion of REVIVE, ≥12 months of rusfertide therapy and had an end-of-treatment visit. THRIVE is designed to further assess the maintenance of hematocrit control, reduction in the need for therapeutic phlebotomy and overall safety of once-weekly, subcutaneous rusfertide over an additional two-year treatment period.

 

 

About Polycythemia Vera (PV)
Polycythemia vera (PV) is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus.

 

 

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

 

 

About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist’s proprietary discovery platform are currently in advanced Phase 3 clinical development, with NDAs for both ICOTYDE™ (icotrokinra) and rusfertide under review at the FDA. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor (“IL-23R”), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond.

 

 

Rusfertide is a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

 

 

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company’s website at https://www.protagonist-inc.com.

 

 

Takeda Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

 

 

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

 

 

Takeda Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

 

 

Takeda Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 

 

Protagonist Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.

 

 

 

 

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Business Wire India

• Thales has successfully demonstrated a world-first innovation that prepares 5G networks for the age of quantum computing, marking a major milestone for the global telecommunications industry.
• The collaboration with a top tier mobile operator, showed that existing 5G SIM / eSIM cards already deployed in the field can be securely upgraded to quantum-safe protection, without disrupting service or impacting the customer experience.
• This Post-Quantum Cryptographic (PQC) breakthrough proves that mobile networks can evolve their security through crypto agility to address quantum cyber threats.

 

Quantum computing has the potential to break today’s encryption methods in the future, putting mobile communications, personal data and critical infrastructure at risk. For telecom operators, this is not a distant theoretical issue: 5G networks underpin everything from smartphones and connected vehicles to emergency services, industry and national infrastructure.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301594505/en/

 

 

 

The challenge is scale. Replacing millions of devices every time security standards evolve is neither practical nor sustainable. The industry needs a new approach. With this demonstration, Thales shows that security can be upgraded remotely and instantly, directly on SIM and eSIM cards already in use. This capability, known as crypto agility, allows operators to adapt their security protections as threats and standards evolve, without waiting for new product generations.

 

Indeed, this innovation underlines how Thales can strengthen the security of SIM and eSIM already deployed, by remotely downloading post-quantum cryptographic algorithms directly onto the card. This happens seamlessly in the background, preserving existing data and services while instantly enhancing security. With Thales’ unique crypto-agile approach, operators can remotely update the device protection without replacing cards, changing devices or interrupting connectivity.

 

 

It means 5G networks can remain secure, resilient and trusted over time, even as quantum computing becomes a reality. This successful demonstration is the first of its kind and sends a strong signal to the market:

 

 

• Quantum-safe security can be introduced over the air without changing devices or interrupting service.
• Mobile networks can evolve securely over time, even as threats change.
• Telecom operators can protect long-term investments while preparing for the next era of quantum computing.

 

 

It also builds on Thales’ strong leadership in post-quantum cryptography, backed by dedicated research teams across the Group. Thales not only integrates future-proof security technologies, but it also actively develops them, with its own quantum-resistant methods submitted to international standardization efforts such as those led by the U.S. National Institute of Standards and Technology (NIST).

 

“This successful test shows that quantum-safe security is no longer a future concept, it’s something networks can start preparing for today,” said Eva Rudin, VP Mobile Connectivity solutions at Thales. “By enabling remote upgrades, we help operators protect their customers and critical services without disruption. We will continue working together to help bring quantum-ready security to commercial and private 5G networks worldwide, ensuring trust, resilience and continuity in a rapidly changing digital world.”

 

 

About Thales
Thales (Euronext Paris: HO) is a global leader in advanced technologies for the Defence, Aerospace and Cyber & Digital sectors. Its portfolio of innovative products and services addresses several major challenges: sovereignty, security, sustainability and inclusion.

 

 

The Group invests more than €4 billion per year in Research & Development in key areas, particularly for critical environments, such as Artificial Intelligence, cybersecurity, quantum and cloud technologies.

 

 

Thales has more than 83,000 employees in 68 countries. In 2024, the Group generated sales of €20.6 billion.

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260301594505/en/

 

Business Wire India

NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation; Headquarters: Chiyoda-ku, Tokyo; President and CEO: Katsushige Kojima; “NTT DOCOMO BUSINESS”) and Airlinq Inc. (Headquarters: California, USA; CEO: Sunil Kaul; “Airlinq”), a global provider of AIoT solutions and Autonomous Connectivity Management Platform (CMP)¹, have entered into a strategic partnership to expand the delivery of global IoT-connected solutions across markets with diverse and country-specific telecommunications regulatory requirements².

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301475708/en/

 

 

 

1. Background

 

Global deployment of IoT-enabled devices and services continues to accelerate, particularly across mobility industries such as automotive and construction machinery. As connected services—including connected vehicles³—expand across borders, enterprises increasingly require reliable connectivity and consistent operational models worldwide.

 

 

At the same time, telecommunications regulations and licensing frameworks differ by country and region. In some markets, long-term roaming usage such as permanent roaming or other types of permanent service delivery by foreign operators without local licenses may be constrained, creating challenges for global IoT rollouts.

 

 

Addressing these challenges often requires technical and legal coordination with multiple stakeholders—including local carriers and relevant authorities—adding operational complexity for enterprises expanding internationally.

 

 

Against this backdrop, NTT DOCOMO BUSINESS, with proven experience delivering global IoT services in the mobility sector, and Airlinq, with deep expertise and an ecosystem of platform with local carriers across diverse regulatory environments, have formed the strategic partnership to enable stable, compliant, and scalable IoT services globally.

 

 

2. Overview of the strategic partnership

 

 

By combining their platforms and expertise, the two companies will unify fragmented connectivity environments and operational models across countries and carriers, while reducing the operational complexity of global IoT services.

 

 

This will enable customers to establish a unified operational model for smooth and sustainable service delivery worldwide, without having to individually address country- or carrier-specific regulatory and connectivity requirements.

 

 

NTT DOCOMO BUSINESS and Airlinq will jointly deliver:

 

 

• unified SIM and connectivity management across countries and carriers
• flexible profile switching using eSIM/eUICC⁴
• regulatory alignment and local compliance support through collaboration with local carriers

 

These capabilities will significantly reduce the burden of managing complex, multi-country IoT connectivity operations.

 

Key Areas of Collaboration

 

 

1. Unified SIM and Connectivity Management via CMP
   By leveraging Airlinq’s CMP and, where required, integrating with local carrier CMPs, the strategic partnership will enable unified visibility and management of SIM assets and connectivity status across multiple countries and mobile networks.
2. Flexible Connectivity Using eSIM/eUICC
   Using remote SIM provisioning⁵, customers can switch to local-carrier SIM profiles without physical SIM replacement, supporting efficient operations and deployments aligned with local requirements across diverse markets.
3. Regulatory Alignment and Local Compliance Support
   The strategic partnership will support contracting and operational coordination with local carriers where required, helping customers deliver connectivity services in alignment with local legal and regulatory requirements.
4. End-to-End Support from Planning Through Operations
   NTT DOCOMO BUSINESS will provide end-to-end support—from planning and implementation through ongoing operations—so customers can deploy and run global IoT services without managing multiple providers or country-by-country adjustments.

 

3. Roles and Responsibilities

 

NTT DOCOMO BUSINESS

 

 

• Provision of the overall solution for enterprises deploying IoT devices and services
• Leading project governance and execution
• Managing the collaborative operating framework for the strategic partnership

 

Airlinq

 

• Provision of the CMP and eSIM/eUICC solutions
• Coordination with local carriers
• Support for regulatory alignment and compliance, including contracting and operational execution

 

4. Executive Comments

 

Kazuo Komine, Senior Vice President, Head of 5G & IoT Services, Platform Service Division, NTT DOCOMO BUSINESS, Inc.

 

 

“In areas such as automotive, securing stable, global connectivity has become essential for IoT-driven services and business. However, many markets require special consideration due to regulatory and operational constraints, making implementation and ongoing operations a significant challenge for customers. Through our strategic partnership with Airlinq, we will deliver effective solutions to these challenges—enabling compliant, stable, and flexible mobile IoT connectivity across diverse regulatory environments to support our customers’ global expansion and the sustainable growth of IoT industries.”

 

 

Sunil Kaul, CEO of Airlinq Inc.

 

 

“Global IoT scale is no longer limited by technology, but by regulation. Together with NTT DOCOMO BUSINESS, we are removing those barriers and enabling enterprises to deploy compliant, future-proof IoT services anywhere in the world.”

 

 

5. Future Outlook

 

 

Through the strategic partnership, NTT DOCOMO BUSINESS and Airlinq will provide connected solutions aligned with local regulatory and connectivity requirements across global markets, covering the full lifecycle from pre-deployment planning to post-deployment operations.

 

 

The two companies will support enterprises pursuing global IoT initiatives across mobility sectors such as automotive, construction machinery, and agricultural equipment, serving as partners to accelerate digital transformation and global business expansion.

 

 

1.	Autonomous Connectivity Management Platform (CMP): a system used to manage and control connectivity and SIM-related information for IoT devices in a unified manner.
2.	Markets with complex telecommunications regulatory requirements: markets that may restrict or limit long-term roaming usage or permanent connectivity services by foreign operators without local licenses.
3.	Connected vehicles: vehicles equipped with communication capabilities that connect to networks and cloud platforms to enable functions such as status monitoring, location tracking, software updates, and value-added services.
4.	eUICC (Embedded Universal Integrated Circuit Card): a SIM architecture that securely stores and manages multiple carrier profiles.
5.	Remote SIM Provisioning: a mechanism that enables remote download and switching of carrier SIM profiles on eSIM-enabled devices without physical SIM replacement.

 

About NTT DOCOMO BUSINESS

 

NTT Communications Corporation changed its name to NTT DOCOMO BUSINESS, Inc. on July 1, 2025. As an Industrial and Regional DX Platformer that drives digital transformation across industries and communities, we are enabling the development of a decentralized, autonomous, and collaborative society where businesses and communities can thrive sustainably. Our mission is to unlock new value and help create prosperity for all.

 

 

https://www.ntt.com/en/index.html

 

 

 

 

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Business Wire India

PHC Corporation’s Biomedical Division (Head Office: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereinafter “PHCbi”), a global provider of laboratory sample storage and cell cultivation solutions and subsidiary of PHC Holdings Corporation (Head Office: Chiyoda-ku, Tokyo), today announced the launch of its new cell expansion system LiCellGrow™ ^(*1) for research use in Japan and other select countries worldwide^(*2). The system is designed to improve quality and efficiency in the production of new advanced therapies by allowing therapy developers to visualize metabolic changes in cells in real time and automatically control culture conditions.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301429276/en/

 

 

 

PHCbi will exhibit LiCellGrow™ at the 25th Congress of the Japanese Society for Regenerative Medicine, March 19-20 at the Kobe International Conference Center and Kobe International Exhibition Center in Kobe, Japan.

 

Cell and gene therapies (CGT), in which cells or genetic material are used to create personalized medical treatments, are rapidly advancing as promising treatment options for hard-to-treat diseases such as genetic disorders and cancer. In the manufacturing of CGT products, however, variations in cell characteristics and complexity of manufacturing are challenges to maintaining a consistent quality product. As a result, therapy developers are faced with reduced production efficiency, lower yields, and increased manufacturing costs compared to conventional therapies. To overcome these challenges, it is essential for therapy developers to be able to identify critical process parameters (CPPs) and critical quality attributes (CQAs) in CGT product manufacturing. The ability to monitor cell status and control culture conditions based on cell status are indispensable to developing quality CGT products at scale efficiently and at a lower cost.

 

 

PHCbi developed LiCellGrow™ to address these challenges and support CGT manufacturing at scale by helping to identify optimal culture conditions during the manufacturing process development. The system is equipped with proprietary In-Line monitoring technology that continuously measures, in real time, glucose and lactate concentrations, two key indicators of cell metabolism. It also incorporates culture control technology that adjusts cell culture medium at the optimal time based on these measurements. This technology is built on PHCbi’s proprietary electrochemical measurement platform, cultivated through more than 30 years of blood glucose sensor development. By visualizing the metabolic state of cultured cells, which is traditionally difficult to assess, and enabling precise control of culture conditions, LiCellGrow™ supports improved cell quality and enhanced efficiency as well as lower costs through reduced losses in the manufacturing of CGT products.

 

 

Under PHC Group’s Value Creation Plan 2027, which includes a focus on Diagnostics and Life Sciences, PHCbi is developing solutions to enhance efficiency and reduce costs in the manufacturing of CGT products. LiCellGrow™ builds on the In-Line monitoring technology introduced in LiCellMo™ ^(*3), a live cell metabolic analyzer launched in 2024 for research use only. From late 2026 through early 2028, PHCbi plans to expand its product lineup in phases, including culture bags with filtration functions that enhance cell recovery, pH/DO (dissolved oxygen) meter units, and cGMP-compliant dedicated consumables. These enhancements will support seamless scaling of CGT from basic research to commercial manufacturing in products such as CAR-T cell therapy.

 

 

[Key Features of the Product]

 

 

1. Automated Control and Optimization of Culture Conditions Using In-Line Monitoring Technology
By utilizing In-Line monitoring technology, LiCellGrow™ continuously tracks real-time changes in culture conditions and cell status, and automates medium exchange based on the acquired metabolic data. This enables the culture environment to be consistently maintained in an optimal state, contributing not only to improved cell quality and uniformity but also enhanced manufacturing efficiency. Furthermore, this process control approach aligns with the concept of Quality by Design (QbD) ^(*4), which embeds quality scientifically at the design stage rather than relying solely on final product testing. The system therefore supports the development of scientifically robust and highly reproducible manufacturing processes.

 

 

2. Single-Use Design Ensuring Aseptic Conditions and Highly Reproducible Cell Culture
LiCellGrow™ employs easy-to-attach, single-use dedicated culture bags. With automated measurement of culture conditions using In-Line sensors, the sampling tasks previously required to check glucose and lactate concentrations are no longer necessary. This reduces the risk of cross-contamination and enables closed-system cell culture that maintains aseptic conditions. In addition, the device can be placed inside a standard CO₂ incubator commonly used in laboratories, eliminating the need for special facility investments and allowing users to easily establish a reliable and highly reproducible culture environment.

 

 

Chikara Takauo, Director of PHC Corporation and Head of the Biomedical Division, commented:
“We are excited to launch LiCellGrow™ and offer therapy developers a new way to solve common challenges in quality, cost, and delivery of cell and gene therapies. Building on the success of our research-use system LiCellMo™, LiCellGrow™ represents an important step forward in making CGT manufacturing efficient, reliable, and scalable. We are committed to expanding our PHCbi offerings to continue to contribute to the adoption of CGT and other advanced therapy options for hard-to-treat conditions.”

 

 

****************************************************************
Overview of the 25th Congress of the Japanese Society for Regenerative Medicine
Dates: March 19 – 20, 2026
Venue: Kobe International Exhibition Hall, Building No. 2, 1st Floor (PHCbi Booth No.: T31)
Official Website: The 25th Congress of the Japanese Society for Regenerative Medicine
******************************************************************

 

 

(*1) https://www.phchd.com/jp/biomedical/incubation/cell-expansion-system-en
This product is intended for research use only and not for medical or clinical purposes.
(*2) Not available for purchase in the United States. Expected U.S. launch in the summer of 2026.
(*3) Live Cell Metabolic Analyzer | PHCbi
(*4) An approach to quality assurance defined in the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines (ICH Q8–Q11) and widely adopted in the pharmaceutical field.

 

 

About the Biomedical Division of PHC Corporation

 

 

Established in 1969, PHC Corporation is a Japanese subsidiary of PHC Holdings Corporation (TSE 6523), a global healthcare company that develops, manufactures, sells, and services solutions across diabetes management, healthcare solutions, life sciences and diagnostics. The Biomedical Division supports the life sciences industry helping researchers and healthcare providers in around 110 countries and regions through its laboratory and equipment and services including CO₂ incubators and ultra-low temperature freezers.
www.phchd.com/global/phc

 

 

About PHC Holdings Corporation

 

 

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries include PHC Corporation, Ascensia Diabetes Care, Epredia, LSI Medience Corporation, Wemex Corporation, and Mediford Corporation. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, diagnostics and life sciences. The consolidated net sales in FY2024 were JPY 361.6 billion with global distribution of products and services in more than 125 countries and regions. PHC Group is a collective term referring to PHC Holdings Corporation and its subsidiaries.
www.phchd.com

 

 

 

 

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Business Wire India

House of McDowell’s Soda has always celebrated the magic of yaari – championing the joy of first-time experiences made unforgettable with friends. From everyday milestones to once-in-a-lifetime moments, the brand believes that every “first” becomes iconic when shared with your yaars.

 

This Holi, that philosophy took center stage in the most unique format. With Yaari Jam: Holi on Wheels, House of McDowell’s Soda reimagined one of India’s most celebrated festivals through the lens of friendship- creating a spectacle that’s never been done before.

 

Conceptualized by Publicis Groupe India’s ‘Team Spirit’, the activation brought together real-life friends and comedians Tanmay Bhat and Aaditya Kulshreshtha (Kullu), alongside creators Anuj Gupta and Aishwarya Mohanraj – for a Holi celebration unlike any other. Set inside a sprawling arena, two high-performance cars became unexpected protagonists in a high-octane game of colour tag.

 

What followed was a riot of movement and mischief: drifting tyres triggering paint explosions, colour bombs bursting mid-chase, dash cams capturing unfiltered reactions as clouds of colour engulfed the gang. The empty concrete expanse slowly transformed into a living, breathing canvas – not just of colour, but of shared adrenaline, laughter and the electric thrill of doing something wildly new, together, for the very first time with yaars.

 

Speaking about the activation, Aanandita Datta, Vice President Marketing & Category Head, Diageo India, said, “At House of McDowell’s Soda, we see friendship not just as an emotion, but as a cultural force that shapes how young India lives life. Building on our ‘Firsts with Friends’ philosophy launched last year, Yaari Jam: Holi on Wheels brings that spirit to life in a new way. It reimagines a deeply rooted festival through a more contemporary lens. We wanted to move beyond celebration as ritual and create celebration as a shared experience – something immersive and unforgettable. Our ambition is to build House of McDowell’s Soda into a brand that doesn’t just participate in culture, but actively shapes it by curating elevated, first-of-its-kind moments that friends can truly call their own.”

 

Aaditya Kulshreshtha (Kullu), Actor & Comedian, part of the experience, shared, “I’ve played Holi my whole life – galli wali, terrace wali, all of it. But this? This was unreal. The second the cars started drifting and colour just exploded everywhere, it felt like I was in an actual movie action sequence… except with my closest yaars roasting me in the background. The banter was non-stop, the chaos was beautiful and doing something this cool together made it genuinely special. It wasn’t just another Holi – it was our first time doing Holi like this.”

 

Kartik Smetacek, Chief Creative Officer, Saatchi & Saatchi India, added, “This is the second big campaign under our new platform idea for McDowell’s – Firsts With Friends. Holi is the perfect occasion for friends to come together and unleash some madness. This high-octane reimagining of a Holi party has just the right mix of surprise and spectacle.”

 

Catch all the drifts, colour bursts and unfiltered yaari in action – watch the Yaari Jam: Holi Edition film here.

Business Wire India

At MWC® 2026, Lenovo™ introduces a new generation of adaptive AI devices and forward-looking concepts designed for business professionals, creators, students, and gamers. Headlined by new modular PC architecture, a glasses-free 3D laptop concept, a foldable gaming handheld device, and the initial rollout of Lenovo Qira, Lenovo’s showcase reflects a broader shift in personal computing toward systems that adapt intelligently to people and their environments.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301217460/en/

 

 

Across its portfolio, Lenovo continues to focus on delivering technology that is more personalized, proactive, and protected, while building a unified AI ecosystem that works naturally across devices.

 

“The AI era will not be defined by a single device or application, but by intelligent systems that work seamlessly across everything we use,” said Luca Rossi, President, Intelligent Devices Group, Lenovo. “We are demonstrating how Lenovo and Motorola are bringing that vision to life, combining adaptive hardware innovation with a single, unified system-level AI integration that works naturally across PCs, smartphones, tablets, wearables, and beyond. From premium mobile devices and transformative form factors, to the rollout of Lenovo Qira, we are building the widest AI portfolio that delivers more connected, more intuitive personal computing experiences designed around people.”

 

Lenovo Qira: Personal Ambient Intelligence

 

Lenovo Qira is a Personal Ambient Intelligence built at the system level and integrated directly into Lenovo and Motorola devices rather than layered on as a standalone application. Operating across supported PCs, tablets, smartphones, and wearables, Lenovo Qira is designed to help maintain continuity between tasks and devices while assisting based on user intent.

 

In the coming weeks, Lenovo Qira will roll out across more than 20 devices within Lenovo’s PC portfolio, spanning Yoga™, IdeaPad™, Legion™, and ThinkPad™ families, through a combination of over-the-air updates and preloads. This includes the launch of the Idea Tab Pro Gen 2 as Lenovo’s first tablet to feature the experience. First wave support on PCs includes six languages across nine regions: English (U.S., U.K., India), Spanish (U.S./Latin America, Spain), French (France), Italian (Italy), German (Germany), and Portuguese (Brazil).

 

Lenovo Qira is designed to continuously evolve, expanding across more devices while enabling new experiences and partnerships. In 2026, that evolution will extend to additional languages and devices, including its debut on Motorola smartphones, further advancing a unified AI ecosystem across Lenovo and Motorola.

 

Breakthrough Concepts: Exploring Adaptive Form Factors

 

ThinkBook™ Modular AI PC Concept

 

Lenovo is showcasing a modular AI PC concept that explores a selectively modular approach to business computing built around the idea of “carry small, use big.”

 

The concept features a 14-inch ultra-thin base system designed to support interchangeable display configurations, detachable input components, and modular I/O elements. A secondary display can attach in multiple orientations or replace the keyboard, enabling workspace expansion to approximately 19 inches while maintaining portability. The concept illustrates how modular architecture could support evolving workflows and extended device lifecycles in AI-ready environments.

 

Yoga Book Pro 3D Concept

 

Lenovo is also presenting a glasses-free 3D laptop concept designed to enable creators to view and manipulate depth directly on screen.

 

By combining dual displays, AI-powered 2D-to-3D conversion, gesture interaction, and intuitive creative controls, the concept reduces friction in immersive content creation and highlights Lenovo’s exploration of spatial computing experiences.

 

Legion Go Fold Concept

 

A foldable gaming handheld concept further expands Lenovo’s exploration of adaptable hardware.

 

The device transitions from a compact handheld format into a larger immersive screen and supports multiple usage modes, including handheld play, split-screen multitasking, expanded display gaming, and desktop-style interaction. The concept demonstrates how flexible display technology could enable hybrid gaming and productivity experiences in a single device.

 

Commercial Portfolio: AI-Ready Platforms for Modern Work

 

Lenovo continues evolving its commercial PC portfolio to support organizations adopting AI-enabled workflows at scale.

 

The updated ThinkPad T-Series introduces enhancements focused on serviceability, usability, and AI readiness, with select models achieving class-leading iFixit repairability scores. These updates reinforce Lenovo’s commitment to lifecycle value, reduced downtime, and sustainable fleet management.

 

The ThinkPad X13 Detachable extends flexible, mobile-first productivity with integrated pen support and field-replaceable components in a lightweight design suited for frontline and hybrid professionals.

 

Lenovo is also expanding into rugged mobility with the introduction of the ThinkTab X11, a durable Android tablet designed for demanding industrial and frontline environments.

 

For small and medium-sized businesses, the ThinkBook 14 2-in-1 Gen 6 delivers multimode versatility and AI-enabled collaboration features, while the ThinkVision™ M16 portable monitor provides lightweight screen expansion to support flexible workstyles.

 

Across its commercial portfolio, Lenovo integrates security, manageability, and lifecycle services to help organizations adopt AI-enabled devices with confidence and control.

 

Consumer and Gaming Portfolio: Intelligent Experiences for Everyday Use

 

For creators, students, and gamers, Lenovo’s latest devices balance performance, portability, and intelligent features designed to simplify everyday experiences.

 

The Yoga 9i 2-in-1 Aura Edition (14”, 11) combines premium convertible design with immersive OLED visuals and intelligent features that streamline creative workflows. The Yoga Pro 7a (15”, 11) and IdeaPad Slim 5i Ultra (14”, 11) expand Lenovo’s AI-enabled laptop portfolio, balancing performance and portability for productivity and content creation.

 

In tablets, the Idea Tab Pro Gen 2 introduces intelligent learning and productivity experiences in a versatile form factor and marks Lenovo’s first tablet to feature Lenovo Qira.

 

Within gaming, Lenovo expands its lineup with the Legion 7a (15”, 11) gaming laptop and the Legion Tab (8.8”, 5), a high-performance gaming tablet featuring a 3K display and advanced cooling.

 

Advancing Smarter AI for All

 

At MWC 2026, Lenovo underscores a clear strategy towards the democratization of AI. By combining forward-looking hardware exploration with the deployment of Lenovo Qira, Lenovo continues shaping a more connected and intuitive computing future, one where intelligent systems adapt to people, not the other way around.

 

For more details about all Lenovo’s new devices, solutions, and proofs of concept announced at MWC 2026, visit the Lenovo MWC 2026 Press Kit:

 

• Lenovo Scales Trusted AI-Powered Business Computing Through Modular Innovation and Enterprise Platforms
• Lenovo Expands Mobility, Creativity, and Productivity with New Consumer AI Laptops, Tablets, and Concepts at MWC 2026

 

About Lenovo

 

Lenovo is a US$69 billion revenue global technology powerhouse, ranked #196 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver Smarter Technology for All, Lenovo has built on its success as the world’s largest PC company with a full-stack portfolio of AI-enabled, AI-ready, and AI-optimized devices (PCs, workstations, smartphones, tablets), infrastructure (server, storage, edge, high performance computing and software defined infrastructure), software, solutions, and services. Lenovo’s continued investment in world-changing innovation is building a more equitable, trustworthy, and smarter future for everyone, everywhere. Lenovo is listed on the Hong Kong stock exchange under Lenovo Group Limited (HKSE: 992) (ADR: LNVGY). To find out more visit https://www.lenovo.com, and read about the latest news via our StoryHub.

 

 

 

 

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Business Wire India

GIGABYTE Technology, a global leader known for its engineering excellence in high-performance computing and AI servers, extends its comprehensive end-to-end AI infrastructure portfolio designed specifically for the telecommunications industry at MWC 2026. GIGABYTE’s end-to-end product solutions enable operators to convert massive volumes of network data into intelligence, automation, and new revenue streams, as telecommunications networks evolve from data carriers into AI-powered digital platforms.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223386188/en/

 

 

From Network Data to AI Value: Building Telco’s AI Factory

 

At the core of the telco-to-AI transformation is the AI Factory, where network and subscriber data are converted into operational intelligence and commercialized AI services. GIGABYTE addresses this need with GB300 NVL72, a liquid-cooled rack-scale platform integrating 72 NVIDIA Blackwell Ultra GPUs and 36 NVIDIA Grace™ CPUs in a single system. Connected via NVIDIA Quantum-X800 InfiniBand or NVIDIA Spectrum-X™ Ethernet and NVIDIA ConnectX®-8 SuperNIC™s, GB300 NVL72 is optimized for large-scale AI training and inference workloads, enabling operators to automate operations, optimize network planning, and deploy AI-driven services at telecom scale.

 

Powering the Data-to-AI Pipeline with AI and HPC Supercomputing

 

To eliminate bottlenecks across the data-to-AI pipeline, GIGABYTE extends its AI and HPC portfolio into the telecom domain with platforms built on NVIDIA and AMD accelerator architectures. The G894-SD3-AAX7, powered by NVIDIA HGX™ B300, supporting workloads such as real-time traffic analytics, reasoning models, and large-scale AI training. For converged AI and HPC environments, the XN24-VC0-LA61, based on NVIDIA MGX™ architecture and NVIDIA GB200 Grace Blackwell NVL4 Superchips, uses direct liquid cooling to enable dense, energy-efficient deployment.

 

GIGABYTE also showcases G893-ZX1-AAX4, combining AMD EPYC™ 9005/9004 CPUs with AMD Instinct™ MI355X GPUs, delivering high performance-per-watt for inference, simulation, and advanced modeling while helping operators manage power and cost.

 

Digital Twins for Intelligent, AI-Driven Network Operations

 

Digital twins are becoming a critical tool for AI-driven network operations. GIGABYTE enables high-fidelity, real-time simulation with XL44-SX2-AAS1, built on NVIDIA MGX™ architecture and configured with eight NVIDIA RTX PRO™ 6000 Blackwell Server Edition GPUs. With 800 GB/s bandwidth via NVIDIA ConnectX®-8 SuperNIC™ and PCIe Gen6 connectivity, the platform enables higher throughput and better scale-out capabilities, making it the perfect choice for round-the-clock high-availability assignments.

 

Enabling Efficient Cloud Hosting at Telco Scale

 

As telecom operators expand into AI cloud and neocloud services, GIGABYTE’s high-density blade servers provide a scalable foundation for AI and HPC hosting. At MWC, GIGABYTE introduces B683-Z80-LAS1, a 6U, 10-node blade system powered by AMD EPYC™ processors with a 1:1 CPU-to-NIC configuration. Featuring full-system direct liquid cooling, the integrated piping removes over 90% of system heat, achieving sustainable green computing and optimized power usage effectiveness (PUE).

 

Extending AI from Core to Edge

 

AI transformation extends to the network edge, where low latency, data proximity and privacy are essential. GIGABYTE’s AI workstations enable local AI development, inference, and deployment across enterprise and private network environments. The W775-V10-L01, powered by the NVIDIA GB300 Grace™ Blackwell Ultra Desktop Superchip, supports up to 775 GB of coherent memory for large-scale AI workloads at the desk. Additional platforms, including AMD EPYC™-based and Intel® Xeon®-based workstations, provide flexibility for diverse edge AI and private network scenarios. The compact AI TOP ATOM, delivering up to one petaFLOP of AI compute, further enables rapid prototyping and edge AI deployment in a palm-sized form factor.

 

End-to-end Solutions from Data Center to Edge
https://www.gigabyte.com/Events/MWC
#5F60, Hall 5, Fira Gran Via

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223386188/en/

 

Business Wire India

Jabali AI today announced the Jabali AI Game Jam at GDC 2026, a global 24-hour competition running March 7–8 that challenges creators to build and publish a playable 2D or 3D game in a single day using Jabali Studio. The event is designed to showcase the shift to AI-first games—games where AI is a functional part of gameplay, not only a content generator. 

The “AI-First Games” Challenge

Many AI game jam entries look interesting, but only get to shallow games which break often. Jabali Studio is built to help creators iterate reliably—combining natural-language creation with a proprietary technology designed to keep core mechanics coherent as the game evolves.

“We’re looking for playable AI-first games—games that work on day one, and that creators can keep improving after the jam. The 24-hour format is a stress test for what can be achieved in a compressed timeline,” said Vatsal Bhardwaj, founder of Jabali AI. 

From “Crunch” to Creative Throughput

The 24-hour limit is intentional: in traditional development, a one-day deadline often means brute-force implementation and late-night debugging. In an AI-first workflow, the goal is to spend the time directing the game—while the Bali, AI Producer, accelerates iteration across code, assets, and systems integration.

Event Details & Prizes 

The jam is open to creators worldwide—from professional developers to first-time builders working with AI. Winners will receive cash prizes and have their games featured as flagship examples of Playable Media on the Jabali platform.

For details on registration, judging, prizes, and the full ruleset, visit:

https://www.jabali.ai/announcement/jabali-gdc-gamejam-2026/

Winners will not only receive cash prizes but will have their games featured as examples of Playable Media on the Jabali platform.

Business Wire India

 

New Belgium Brewing, the Kirin Group company leading its U.S. alcoholic beverage business, will launch two original flavors – KIRIN HYOKETSU STRAWBERRY and KIRIN HYOKETSU PINEAPPLE – under the KIRIN HYOKETSU (HYOKETSU) brand, manufactured and sold by Kirin Brewery Company, Limited (Kirin Brewery). The ready to drink cocktail will be available in Hawaii, Tampa, FL, and The Japan Pavilion at EPCOT theme park, operated by Mitsukoshi (U.S.A.), on March 2.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227374991/en/

 

 

 

Created with American consumers in mind, the new flavors bring HYOKETSU’s signature crisp, fruit-forward taste to two key U.S. markets. Produced and sold locally in the U.S., the beverages deliver fresh fruit flavor in a convenient, easy-to-enjoy format.

 

The U.S. is the world’s largest ready-to-drink (RTD) market, accounting for approximately half of the global market^*1. Fruit-forward flavors and convenience continue to make RTDs one of the fastest-growing segments in the category.

 

 

*1	IWSR (2024)

 

Since its launch in 2001, HYOKETSU has become one of Japan’s leading RTD brands, known for its crisp, fruit-forward profile. In Japan, the brand has sold a cumulative total of approximately 15 billion units^*2, reflecting long-term consumer demand and brand strength.

 

*2	350ml equivalent basis, as of December 31, 2025.

 

Through local manufacturing and sales in the U.S., Kirin Brewery seeks to deliver fresh fruit flavor in a convenient format while building HYOKETSU as a scalable global brand.

 

 

Product Details

 

Product

 

 

• Strawberry and Pineapple, two flavors popular with U.S. consumers were selected for the launch.
• Designed for American tastes, the RTDs deliver HYOKETSU’s signature fruit-forward profile, with fresh fruit flavor and a light, easy-to-drink finish.

 

 

Package Design

 

• Packaging features HYOKETSU’s signature blue and silver color palette, signaling freshness and fruit character.
• The “KIRIN” and HYOKETSU brand names are clearly displayed, while the “CHU-HI” description references the product’s Japanese roots.

 

About Kirin Holdings

 

Kirin Holdings Company, Limited is a global company operating across three core business domains spanning Alcoholic Beverages, Non-alcoholic Beverages & Health Science, and Pharmaceuticals. The company traces its roots to Japan Brewery, established in 1885, which later became Kirin Brewery in 1907. Since then, Kirin has expanded its business operations by leveraging fermentation and biotechnology as core strengths. The company entered the pharmaceutical field in the 1980s, which has since grown into a global business. In 2007, the company transitioned to a pure holding company structure as Kirin Holdings, and it is now strengthening its Non-alcoholic Beverages & Health Science domain.

 

 

Under its long-term vision “Innovate2035!”, the Kirin Group is focused on creating value that encourage behavioral change among consumers and patients, creating new lifestyle habits in the areas of food and health. With a unique business portfolio spanning Alcoholic Beverages, Non-alcoholic Beverages & Health Science, and Pharmaceuticals, the Group will further expand group-wide initiatives that support both mental and physical well-being.

 

 

The Kirin Group will continue to advance innovation through the combined strength of its people and technology, creating both social and economic value as a global leader in CSV*, while pursuing sustainable, long-term growth in corporate value.

 

 

*Creating Shared Value: combined added value for consumers as well as for society at large.

 

 

 

 

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Business Wire India

 

• IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in combination with IDEAYA’s PARG inhibitor IDE161.
• IDEAYA has dosed the first patient in its Phase 1 trial of IDE034, initially evaluating safety, tolerability, and PK.
• First dosing triggers a $5 million milestone payment to Biocytogen under the companies’ option and license agreement.

 

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.

 

According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

 

 

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

 

 

“Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study.”

 

 

About Biocytogen

 

 

Biocytogen (SSE: 688796; HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen has established a dual-engine platform combining a fully human antibody library with an extensive target-humanized mouse model portfolio, enabling a systematic approach to accelerating global drug discovery and development.

 

 

Biocytogen has independently developed its proprietary RenMice^® (RenMab^®/ RenLite^®/ RenNano^®/RenTCR™/ RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, hu-VHH discovery, and TCR mimic antibody discovery, and has established a sub-brand, RenSuper™ Biologics, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen, Jiangsu, Shanghai), the USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

 

 

 

 

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