This week’s China healthcare highlights include Gan & Lee’s US$ 81.1M licensing deal with JW Pharmaceutical for Bofanglutide, a biweekly GLP-1 agonist in Phase III trials for diabetes and obesity, and OriCell’s US$ 110M pre-IPO funding to advance its CAR-T program Ori-C101 targeting HCC. Bristol Myers Squibb inaugurated its first China Innovation Centre in Beijing to drive partnerships under its China 2030 Strategy. Xuanzhu Biopharma secured a US$ 100M licensing deal with Boston Oncology to expand its CDK and ALK inhibitors into MENA markets. Everest Medicines announced a US$ 250M acquisition of Hasten Biopharma to commercialize 14 chronic disease products across Asia. These deals and expansions showcase China’s growing role in biopharma innovation, licensing, and commercialization.

Transactions

Gan & Lee (603087.SS) Grants Exclusive License for Biweekly GLP-1 Agonist to JW Pharmaceutical in Korea

Key Words: Gan & Lee, JW Pharmaceutical, GLP-1RA, GZR18, Bofanglutide, diabetes, obesity, licensing agreement

The News: On April 8, Gan & Lee Pharmaceuticals announced an exclusive licensing agreement with Korea-based JW Pharmaceutical for the development and commercialization of Bofanglutide injection (GZR18) in Korea. This marks the third overseas licensing deal for Bofanglutide, following agreements in Latin America and India.

Key Highlights:

• Bofanglutide (GZR18):
  • A biweekly glucagon-like peptide-1 receptor agonist (GLP-1RA) developed by Gan & Lee for the treatment of type 2 diabetes and obesity/overweight.
  • Phase III clinical trials are underway, with Bofanglutide positioned to become the world’s first marketed biweekly GLP-1RA.
  • Offers a reduced dosing frequency of once every two weeks, compared to the mainstream weekly GLP-1RAs, potentially improving patient adherence and enabling long-term management of metabolic diseases.
• Deal Terms:
  • JW Pharmaceutical gains exclusive rights to develop, register, and commercialize Bofanglutide in Korea.
  • Gan & Lee will receive a one-time, non-refundable upfront payment of US$ 5 million.
  • The company is also eligible for up to US$ 76.1 million in milestone payments, depending on clinical progress, regulatory approval, and commercialization, with total deal value reaching US$ 81.1 million (excluding royalties).
  • Additional tiered royalties will be paid based on product sales in Korea.

OriCell Secures US$ 110 Million to Advance Global Cell Therapy Development

Key Words: OriCell, CAR-T, cell therapy, hepatocellular carcinoma, Ori-C101, GPC3, pre-IPO financing, clinical trials

The News: OriCell Therapeutics, a China-based biotechnology company, has closed a US$ 110 million pre-IPO financing round to support the global advancement of its cell therapy pipeline. The round was co-led by Vivo Capital, the Beijing Medical and Health Industry Investment Fund, Qiming Venture Partners, and a leading global healthcare fund, with participation from several other institutional investors.

Key Highlights:

• The pre-IPO financing will be used to accelerate international multi-centre clinical trials for the company’s core assets, strengthen its technology platform, and prepare for a future IPO.
• Core Candidate – Ori-C101:
  • An autologous CAR-T therapy targeting GPC3, developed for the treatment of advanced hepatocellular carcinoma (HCC). Having completed Phase I studies, Ori-C101 is preparing to enter pivotal trials and holds the potential to become the first CAR-T therapy approved for liver cancer.
• Pipeline Development:
  • OriCell is advancing next-generation CAR-T candidates, including in vivo CAR-T programs, leveraging its proprietary antibody discovery and cell engineering platforms to create cutting-edge cell therapy solutions.

BMS (NYSE: BMY) Opens First Innovation Centre in China to Drive Biopharma Collaboration

Key Words: Bristol Myers Squibb, BMS, innovation centre, BioPark, Beijing, oncology, haematology, immunology, cardiovascular disease, neuroscience, China 2030 Strategy

The News: Bristol Myers Squibb (BMS) has inaugurated its first Innovation Centre in China, located in Beijing’s Economic-Technological Development Area (BioPark). The centre is designed to foster strategic partnerships across the biopharmaceutical value chain, with a focus on key therapeutic areas such as oncology, haematology, immunology, cardiovascular disease (CVD), neuroscience, and novel therapeutic modalities.

Key Highlights:

• Strategic Role of the Centre:
  • The centre aims to accelerate the introduction of global first-in-class and best-in-class therapies into China while facilitating the global development of innovations originating within the country.
  • It will complement BMS’s existing R&D centre in Shanghai, strengthening the company’s research and development capabilities within China.
• China 2030 Strategy Initiatives:
  • The launch took place during BMS’s third annual China Partnership Week, which included an innovation forum and the signing of multiple strategic collaboration memoranda.
  • These initiatives align with BMS’s China 2030 Strategy to deepen integration into China’s innovation ecosystem.
• China’s Role in Global R&D: BMS highlighted that China now participates in nearly 100% of the company’s highest-priority global clinical trials, emphasizing the growing importance of China in BMS’s global research and development network.

Xuanzhu Biopharmaceutical (2575.HK) Announces Over US$ 100 Million Licensing Deal for Cancer Drugs in the Middle East

Key Words: Xuanzhu Biopharmaceutical, Boston Oncology, licensing agreement, Bireociclib, Dirozalkib, CDK2/4/6 inhibitor, ALK inhibitor, breast cancer, NSCLC, MENA

The News: On April 9, Xuanzhu announced an exclusive licensing and supply agreement with Boston Oncology CGT Holding Co. Limited, headquartered in Cambridge, Massachusetts, with a regional hub in Riyadh, Saudi Arabia. The deal gives Boston Oncology exclusive rights to develop, register, and commercialize Xuanzhu’s two innovative cancer drugs—Bireociclib Tablet (brand name: Xuanyuening®) and Dirozalkib Tablet (brand name: Xuanfeining®)—in over 20 countries in the Middle East and North Africa (MENA) region.

Key Highlights:

• Deal Structure:
  • Xuanzhu Biopharmaceutical will receive upfront and milestone payments totaling more than USD 100 million.
  • Xuanzhu will also earn royalties on net sales in the licensed territories.
  • The agreement includes product supply at an agreed price to support Boston Oncology’s commercialization activities in the region.
• Bireociclib (Xuanyuening®):
  • China’s first approved CDK2/4/6 inhibitor, offering a unique multi-target synergy to suppress tumor cell proliferation while minimizing hematological toxicities seen with traditional CDK4/6 inhibitors.
  • Approved by China’s National Medical Products Administration (NMPA) for various indications in advanced or metastatic HR+/HER2- breast cancer, including:
    • Combination with fulvestrant for patients progressing after prior endocrine therapy.
    • Monotherapy for patients progressing after two prior endocrine therapies and one chemotherapy in the metastatic setting.
    • Combination with aromatase inhibitors as a first-line therapy for HR+/HER2- advanced breast cancer.
  • Dirozalkib (Xuanfeining®):
    • A next-generation ALK inhibitor with strong affinity for ATP-binding points in the ALK kinase domain, demonstrating potent activity against resistance mutations such as G1202R and I1171N, common with earlier-generation ALK inhibitors.
    • Proven to effectively penetrate the blood-brain barrier, leading to significant anti-tumor effects within the central nervous system.
    • Approved by China’s NMPA in August 2025 as a monotherapy for ALK-positive locally advanced or metastatic NSCLC in patients who have not been treated with ALK inhibitors previously.

Everest Medicines to Acquire Hasten Biopharma for US$ 250 Million

Key Words: Everest Medicines, Hasten Biopharma, acquisition, chronic diseases, Asia-Pacific, commercialisation, market access, drug development

The News: Everest Medicines has signed a share purchase agreement to acquire Hasten Biopharma for a total consideration of US$ 250 million. The acquisition will be paid in three tranches, enabling Everest to commercialize 14 chronic disease products across multiple Asia-Pacific (APAC) markets.

Key Highlights:

• The deal includes 14 chronic disease products, establishing Everest as a major player in the APAC chronic disease market. Hasten Biopharma reported normalised revenue of US$ 82.2 million and an EBITDA of US$ 27.3 million for the fiscal year ending 31 December 2025.
• The acquisition brings Hasten’s 120-person sales and commercial team under Everest, creating a pan-Asia commercialisation platform.
• This move aligns with Everest’s strategy to strengthen its chronic disease portfolio and leverage its platform for introducing innovative global assets to China and Asia.
• A refundable deposit of RMB 200 million, previously paid by Everest under a letter of intent, will be returned upon deal closure.

RA Capital Forms New SPAC to Target Biotech Opportunities in China

Key Words: RA Capital, SPAC, biotechnology, China, IPO, drug licensing, Research Alliance III

The News: RA Capital Management has launched a new special purpose acquisition company (SPAC), named Research Alliance III, with plans to go public and pursue a merger or acquisition with a biotechnology or healthcare company based in China.

Key Highlights:

• SPAC Offering:
  • Research Alliance III plans to sell 5 million shares at $10 each, raising $50 million to fund its acquisition efforts.
  • RA Capital aims to capitalize on China’s growing biotech ecosystem, which has produced a significant number of promising drug assets and licensing deals.
• Strategic Focus:
  • The initiative comes amid a slow IPO market for biotech, which the SPAC believes may enhance its ability to find attractive merger targets.
  • RA Capital sees strong investor interest in drug company IPOs, despite recent market challenges.
• Track Record:
  • RA Capital has a history of successful SPACs, including one that merged with Point Biopharma, later acquired by Eli Lilly, and another which was liquidated.
  • Past investments in Chinese biotech assets include Aiolos Bio, Metsera (acquired by Pfizer for $10 billion), and Candid Therapeutics.

Clinical

Adagene (ADAG.O) Enters Collaboration with Incyte on MSS Colorectal Cancer Therapy

Key Words: Adagene, Incyte, immuno-oncology, IO, CTLA-4, SAFEbody, ADG126, INCA33890, MSS CRC, drug development, collaboration

The News: Adagene, a China-based biotechnology company, has entered into a clinical collaboration with the US-based firm Incyte to evaluate a novel immuno-oncology (IO) combination therapy targeting microsatellite stable colorectal cancer (MSS CRC).

Key Highlights:

• Core Collaboration:
  • The clinical trial will combine Adagene’s masked CTLA-4 SAFEbody antibody, muzastotug (ADG126), with Incyte’s bispecific TGFβR2×PD-1 antibody (INCA33890). The trial, funded and conducted by Incyte, will study the combination in MSS CRC patients, both with and without liver metastases. Adagene will provide the investigational drug, muzastotug.
  • Trial Design: The initial dose-escalation phase will evaluate safety, followed by an efficacy expansion phase for later-line MSS CRC patients.
• Clinical Background of Key Products:
  • Muzastotug (ADG126): A masked CTLA-4 SAFEbody antibody that has demonstrated encouraging response rates in a Phase Ib/II trial for MSS CRC in combination with pembrolizumab.
  • INCA33890: A TGFβR2×PD-1 bispecific antibody showing clinical activity across checkpoint-sensitive and insensitive tumors, including MSS CRC. It is currently in a separate Phase III trial for first-line treatment.

Bayer’s (ETR: BAYN) HER2 Inhibitor Sevabertinib Recommended for Priority Review in China

Key Words: Bayer, HER2 inhibitor, sevabertinib, NSCLC, HER2 activating mutations, CDE, priority review, SOHO-01

The News: Bayer’s first-in-class oral HER2 inhibitor, sevabertinib, has been recommended for priority review by China’s Centre for Drug Evaluation (CDE) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations.

Key Highlights:

• Core Product:
  • Sevabertinib: A non-covalent, reversible tyrosine kinase inhibitor (TKI) designed to target EGFR and HER2 mutations, including HER2 exon 20 insertions.
  • US approval was granted in November 2025 for a later-line treatment indication.
• Supporting Clinical Data:
  • Data from the Phase I/II SOHO-01 study supported the CDE’s recommendation:
  • In treatment-naive patients, sevabertinib achieved an objective response rate (ORR) of 71% and a median duration of response (mDOR) of 11.0 months.
  • In patients who had received prior systemic therapy, including HER2-targeted agents, the ORR was 38%.
• Regulatory Pathway: Bayer submitted a new drug application (NDA) in China in July 2025 for the second-line treatment of NSCLC patients with HER2 (ERBB2) mutations, further expanding treatment options for this population.

Duality Biotherapeutics (9606.HK) Submits First ADC Drug for Approval in China

Key Words: Duality Biotherapeutics, ADC, DB-1303, BNT323, HER2, breast cancer, regulatory submission

The News: On April 9, China’s Center for Drug Evaluation (CDE) announced that Duality Biotherapeutics has submitted a marketing application for its first antibody-drug conjugate (ADC), DB-1303 (BNT323). This represents the company’s first submission of an innovative drug for approval.

Key Highlights:

• DB-1303 (BNT323):
  • A HER2-targeting ADC with a stable, cleavable linker and a proprietary topoisomerase inhibitor payload designed to reduce off-target toxicity and enhance antitumor efficacy, including a bystander killing effect.
  • Positioned as a potential new therapy for HER2-expressing advanced solid tumors, including both high and low HER2-expressing cancers.
• Clinical Achievements:
  • Phase III Clinical Trial (DYNASTY Breast02):
  • In September 2025, DB-1303 achieved its primary endpoint of significantly improving progression-free survival (PFS) compared to T-DM1 in HER2-positive, unresectable, or metastatic breast cancer patients previously treated with trastuzumab and taxanes.
• Regulatory Designations:
  • Awarded Fast Track and Breakthrough Therapy designations by the U.S. FDA.
  • Designated as Breakthrough Therapy by NMPA for HER2-positive advanced endometrial cancer patients who progress on or after immune checkpoint inhibitors.
• Broad Clinical Activity:
  • Clinical benefits have been observed across various tumors, including breast, endometrial, ovarian, colorectal, and esophageal cancers.
  • Duality Biotherapeutics’ development program includes global clinical data from patients in the U.S., China, Australia, and other regions.
• Collaboration with BioNTech: Duality’s partner, BioNTech, plans to submit a separate marketing application for DB-1303 to treat HER2-expressing advanced endometrial cancer as a second-line or later therapy.

BeOne Medicines (6160.HK, ONC.O, 688235.SH) Announces Conditional Approval of Tarlatamab in China for Extensive-Stage SCLC

Key Words: BeOne Medicines, tarlatamab, SCLC, DLL3, CD3, bispecific antibody, conditional approval

The News: BeOne Medicines announced that China’s NMPA has granted conditional marketing approval for tarlatamab to treat adult patients with extensive-stage small cell lung cancer (SCLC) who have received at least two prior systemic therapies.

Key Highlights:

• Tarlatamab is a bispecific T-cell engager antibody targeting DLL3 and CD3. It is the first and only approved therapy of its kind, offering a novel treatment approach for extensive-stage SCLC.
• Approval Basis:
  • The conditional approval is supported by data from the DeLLphi-301 and DeLLphi-307 studies:
  • DeLLphi-301 Study: Reported an objective response rate (ORR) of 40% (95% CI: 31, 51) and a median duration of response (DoR) of 9.7 months (95% CI: 2.7, 20.7+).
  • DeLLphi-307 Study: Conducted in Chinese patients, demonstrated consistent efficacy, reinforcing clinical benefit in local populations.
• A new drug application for an additional indication based on data from the DeLLphi-304 study was accepted by the NMPA’s Center for Drug Evaluation (CDE) in July 2025.

AbbVie (NYSE: ABBV) Secures NMPA Approval for Expanded Upadacitinib Indication in UC and CD

Key Words: AbbVie, upadacitinib, ulcerative colitis, Crohn’s disease, NMPA, inflammatory bowel disease

The News: AbbVie announced that China’s NMPA has approved an expanded indication for upadacitinib, allowing its use in adult patients with moderate-to-severe active ulcerative colitis (UC) and Crohn’s disease (CD).

Key Highlights:

• Updated Indication:
  • The approval broadens eligibility to include patients who have shown inadequate response, loss of response, or intolerance to at least one conventional therapy or biologic treatment.
  • The update applies to cases where TNF inhibitors are not clinically recommended, addressing a wider range of patient needs.
• Previous Restriction: Upadacitinib was previously limited to patients who were intolerant of or did not respond to one or more TNF inhibitors.
• Alignment with FDA: The regulatory update aligns with a similar approval granted by the U.S. FDA, ensuring flexibility in therapeutic options for managing inflammatory bowel disease.

AstraZeneca (LON: AZN) Receives NMPA Approval for Tremelimumab and Durvalumab Combination in First-Line NSCLC

Key Words: AstraZeneca, tremelimumab, durvalumab, NSCLC, chemotherapy, NMPA, POSEIDON trial

The News: AstraZeneca plc has received approval from China’s NMPA for the combination of tremelimumab and durvalumab with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in patients without EGFR or ALK mutations.

Key Highlights:

• The approval is supported by results from the Phase 3 POSEIDON trial, where the combination regimen demonstrated the following:
  • A 23% reduction in the risk of death compared to chemotherapy alone (HR 0.77).
  • Median overall survival (OS) of 14.0 months, compared to 11.7 months for chemotherapy alone.
  • A 2-year OS rate of 33%, versus 22% for chemotherapy alone.
  • The combination also reduced the risk of disease progression or death by 28% (HR 0.72).
• Safety Profile: The regimen maintained a consistent safety profile with no new safety signals observed, reinforcing its clinical benefit and tolerability.

RemeGen (9995.HK) Secures Approval for Disitamab Vedotin and Toripalimab Combination in First-Line Urothelial Carcinoma

Key Words: RemeGen, disitamab vedotin, toripalimab, urothelial carcinoma, HER2, NMPA approval, RC48-C016 trial

The News: RemeGen announced the approval of its New Drug Application (NDA) for disitamab vedotin in combination with toripalimab as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma.

Key Highlights:

• The approval is based on results from the RC48-C016 Phase III clinical trial, which demonstrated the following key outcomes:
  • Progression-free survival (PFS) improved to 13.1 months, compared to platinum-containing chemotherapy.
  • Overall survival (OS) extended to 31.5 months.
  • Objective response rate (ORR) of 76.1%.
  • Disease control rate (DCR) of 91.4%.
• Safety Profile: The combination therapy showed a favorable safety profile, with grade ≥3 treatment-related adverse events reported at a rate of 55.1%.
• Clinical Significance: This marks the fifth approved indication for disitamab vedotin in China, highlighting its growing impact in oncology.

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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