This week’s China healthcare highlights include Insilico Medicine’s partnership with Hengtai Biotech to co-develop an AI-discovered NLRP3 inhibitor for CNS disorders and Ellipses Pharma’s licensing of a first-in-class B7H3 ADC from Innolake Biopharm. IPO filings by Dizal Pharmaceutical, Biosun Pharma, and Fosun Adgenvax highlight the growing activity in oncology, autoimmune diseases, and vaccine innovations. Licensing deals, such as AstraZeneca acquiring full rights to AbelZeta’s GPC3 CAR-T therapy, showcase continued interest in advanced cell therapies. Clinical breakthroughs, including approvals for AbbVie’s risankizumab in ulcerative colitis and AstraZeneca’s durvalumab in endometrial cancer, reflect significant advancements in addressing unmet medical needs.

Transactions & BD (In/Out Licensing)

Insilico (3696.HK) Partners with Hengtai Biotech for AI-Driven CNS Drug Discovery

Key Words: Insilico Medicine, Hengtai Biotech, ISM8969, NLRP3 inhibitor, CNS disorders, AI drug discovery, Chemistry42, Fosun Pharma

The News: Insilico has announced a co-development agreement with Hengtai Biotech for ISM8969, a potential best-in-class NLRP3 inhibitor targeting central nervous system (CNS) disorders. Discovered and optimized using Insilico’s AI-driven Chemistry42 platform, the deal positions Insilico to receive upfront and milestone payments exceeding HKD 500 million (US$ 66 million), including an initial payment of HKD 78 million.

Key Highlights:

• Insilico will lead the IND application and Phase I trial for ISM8969, with Hengtai Biotech taking over subsequent clinical development and commercialization.
• This partnership builds on Insilico’s recent momentum, including a US$ 888 million collaboration with Servier earlier this month.
• The deal strengthens Insilico’s ties with the Fosun Pharma ecosystem, as Hengtai Biotech is supported by Shenzhen Pengfu Fund and Fosun Pharma.

Ellipses In-Licenses First-in-Class B7H3 Antibody Drug Conjugate from China

Key Words: Ellipses Pharma, Innolake Biopharm, B7H3 ADC, ILB-3101, EP0028, oncology, in-licensing, Phase 1 trials

The News: Ellipses Pharma, a clinical-stage oncology drug development company, has announced a collaboration and licence agreement with Innolake Biopharm to develop ILB-3101, a first-in-class B7H3 antibody drug conjugate (ADC). Under the agreement, Ellipses gains worldwide rights to ILB-3101, excluding Greater China.

Key Highlights:

• ILB-3101, now designated as EP0028 by Ellipses, is a B7H3-targeted ADC with an eribulin payload, designed to treat multiple tumour types and address resistance to topoisomerase-1 based ADCs.
• The candidate is currently in a Phase 1 trial in China sponsored by Innolake. Ellipses plans to initiate a Phase 1 clinical trial in the US, with plans to expand into Europe and other territories following regulatory approvals.
• About Ellipses: Ellipses is a global clinical-stage drug development company focused on first- and best-in-class oncology drugs. Its pipeline includes three clinical Phase 2 programmes, with a new Phase 1 study set to begin in 2026. Supported by a global network of over 300 oncology key opinion leaders, Ellipses prioritizes de-risking asset selection and optimizing clinical trial design.
• About Innolake: Innolake is a Hangzhou/Shanghai-based clinical-stage biotech company focused on developing innovative therapies for cancer and autoimmune diseases. Its proprietary technology platforms support a robust pipeline of ADCs, biologics, and small molecule programmes targeting unmet medical needs.

Dizal Pharmaceutical (688192.SH) Files for Hong Kong IPO

Key Words: Dizal Pharmaceutical, IPO, Hong Kong Stock Exchange, oncology, innovative therapies

The News: On January 23, 2026, Dizal Pharmaceutical, a biopharmaceutical company headquartered in Wuxi, Jiangsu, filed its prospectus with the Hong Kong Stock Exchange for a proposed IPO on the Main Board. Dizal has been listed on the Shanghai Stock Exchange since December 2021, with a market capitalization of approximately RMB 27.84 billion as of January 23.

Key Highlights:

• Founded in 2017, Dizal originated from AstraZeneca’s iMED Asia center and focuses on developing globally competitive therapies in oncology and hematology.
• The company has two approved drugs:
  • Savolitinib®: A small-molecule EGFR inhibitor for NSCLC with exon 20 insertion mutations, approved in both China and the U.S., and included in China’s National Reimbursement Drug List (NRDL).
  • Gavreto®: A selective JAK1 inhibitor and the only approved therapy for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL), also granted FDA Fast Track and Orphan Drug designations.
• Dizal’s pipeline includes a diverse portfolio of innovative candidates, such as:
  • Birelentinib (DZD8586): A dual Lyn/BTK inhibitor targeting B-cell malignancies, including CLL/SLL and DLBCL, with FDA Fast Track designation.
  • DZD6008: A fourth-generation EGFR TKI addressing resistance to third-generation EGFR TKIs.
  • GW5282: A next-generation EZH1/2 dual inhibitor for NHL and solid tumors.
  • DZD1516: A highly selective HER2 TKI for HER2-positive breast cancer.
  • DZD2269: An A2a receptor antagonist for immuno-oncology applications.
• Dizal reported revenues of RMB 91 million, RMB 360 million, and RMB 586 million in 2023, 2024, and the first nine months of 2025, respectively, with net losses of RMB 1.108 billion, RMB 940 million, and RMB 583 million over the same periods.

Biosun Pharma Files for Hong Kong IPO with a Valuation of RMB 2.387 Billion

Key Words: Biosun Pharma, Huadong Medicine, Hong Kong IPO, JAK2 inhibitor, BTK inhibitor, autoimmune diseases, oncology

The News: On January 22, 2026, Biosun Pharma, a biopharmaceutical company headquartered in Hangzhou, submitted its application for a Hong Kong IPO, with CITIC Securities serving as the sole sponsor. Biosun Pharma was spun off from parent company Huadong Medicine and is valued at RMB 2.387 billion following its recent Series C financing.

Key Highlights:

• Core Products:
  • Bazedoxib: A selective JAK2 inhibitor in the NDA stage, expected to receive regulatory approval in Q2 2026. Bazedoxib is positioned as a potential best-in-class therapy for myeloproliferative neoplasms (MPN), covering the widest range of indications and leading clinical progress. It is anticipated to be among the first three domestically developed JAK inhibitors approved in China for myelofibrosis (MF). The Chinese MF drug market was valued at US$ 300 million in 2024 and is projected to reach US$ 500 million by 2035.
  • CX1440: A selective BTK inhibitor in Phase III clinical trials, targeting autoimmune diseases such as immune thrombocytopenia (ITP), chronic urticaria (CU), and autoimmune hemolytic anemia (AIHA). CX1440 is ranked among the top three BTK inhibitors globally for ITP and the top two for CU and AIHA. An NDA for ITP is expected to be submitted by late 2027.
• Preclinical candidates include therapies targeting hematological malignancies, autoimmune diseases, and solid tumors. Notable assets include:
  • CX03: A PIM1 inhibitor intended for combination use with Bazedoxib in treating MF and JAK2-resistant hematologic malignancies.
  • CX12: A METTL3 inhibitor showing strong anti-tumor activity in preclinical models when combined with PD-1 inhibitors.
  • CX13: A PPARG inverse agonist targeting advanced urothelial carcinoma.
  • CX15: A KEAP1 degrader for NRF2-activated solid tumors.
  • CX16: A VAV1 degrader under development for autoimmune and inflammatory diseases.
• Biosun Pharma has raised a total of RMB 800 million across multiple funding rounds. In December 2025, the company completed a Series C financing of RMB 87 million, achieving a post-money valuation of RMB 2.387 billion.

Fosun Pharma’s (2196.HK) Vaccine Unit Fosun Adgenvax Plans Hong Kong IPO

Key Words: Fosun Pharma, Fosun Adgenvax, Hong Kong IPO, vaccine unit, biotech

The News: Fosun Pharma has announced plans to spin off its vaccine unit, Fosun Adgenvax (Chengdu) Biopharmaceutical, for a Hong Kong initial public offering (IPO). The proposal, approved by Fosun Pharma’s board, aims to strengthen the unit’s financing, research, and production capabilities.

Key Highlights:

• The spin-off aligns with a surge in biotech IPOs in Hong Kong, where the Chapter 18A listing rule has enabled pre-revenue biotech companies to raise over US$ 17 billion since 2018.
• Fosun Adgenvax specializes in vaccine development, with products including a 13-valent pneumococcal conjugate vaccine and pipeline candidates such as quadrivalent influenza and viral vector vaccines.
• In 2024, the unit reported a net loss of RMB 123.4 million, attributed to increased R&D spending, which rose to 245% of its revenue.

AbelZeta Announces AstraZeneca to Acquire Remaining China Rights to GPC3 Armored CAR-T Therapy

Key Words: AbelZeta, AstraZeneca, C-CAR031, GPC3 CAR-T, hepatocellular carcinoma (HCC), cell therapy, licensing, China

The News: AbelZeta Pharma, a global clinical-stage biopharmaceutical company, announced that AstraZeneca will acquire AbelZeta’s 50% share of China development and commercialization rights to C-CAR031, a GPC3-targeting CAR-T therapy. With this agreement, AstraZeneca will obtain the exclusive global rights to develop, manufacture, and commercialize C-CAR031.

Key Highlights:

• AbelZeta will receive up to US$ 630 million, including upfront, development, regulatory, and sales milestone payments for the GPC3 program in China.
• AstraZeneca already owns the development, manufacturing, and commercialization rights to C-CAR031 outside of China under a prior agreement. AbelZeta is eligible for additional milestone payments and royalties for rest-of-world development.
• C-CAR031 is an autologous CAR-T therapy targeting Glypican 3 (GPC3) using AstraZeneca’s dominant negative TGF-beta receptor II armoring platform, designed to treat hepatocellular carcinoma (HCC) and other solid tumors.
• AbelZeta is a global clinical-stage biopharmaceutical company with research centers in Rockville, Maryland, and Shanghai, China. The company specializes in developing innovative cell-based therapies targeting hematological malignancies, autoimmune diseases, and solid tumors. AbelZeta operates its own GMP facilities to advance its robust pipeline, including multiple CAR-T therapies.

Clinical

Hengrui’s (1276.HK) Lp(a) Inhibitor HRS-5346 Granted Breakthrough Therapy Designation (BTD) in China

Key Words: Hengrui Pharmaceuticals, Lp(a) inhibitor, HRS-5346, breakthrough therapy designation, cardiovascular disease, MSD, TuoJie Biotech

The News: Hengrui has received breakthrough therapy designation (BTD) from China’s Centre for Drug Evaluation (CDE) for HRS-5346, an inhibitor of lipoprotein(a) [Lp(a)], developed by its subsidiary TuoJie Biotech. The designation focuses on the treatment of elevated Lp(a) levels, an independent risk factor for atherosclerotic cardiovascular disease (ASCVD).

Key Highlights:

• Elevated Lp(a) is a significant contributor to ASCVD, a leading global cause of death, affecting 1.4 billion people worldwide. Currently, no approved therapies exist to lower Lp(a) levels.
• HRS-5346 has completed a Phase II study in a high cardiovascular risk population with elevated Lp(a), though results remain undisclosed.
• In March 2025, MSD secured exclusive global rights to HRS-5346 outside of Greater China in a deal worth up to US$ 1.97 billion, reflecting strong global interest in the candidate.

JunCell Presents Promising Phase I Data for TIL Therapy in Advanced NSCLC

Key Words: JunCell Therapeutics, GC101, TIL therapy, NSCLC, Phase I, ESMO, immuno-oncology

The News: JunCell Therapeutics, a China-based biotech company, has unveiled the first clinical data from a registrational study in China for its tumour-infiltrating lymphocyte (TIL) therapy, GC101, in advanced non-small cell lung cancer (NSCLC) at the ESMO Immuno-Oncology Congress.

Key Highlights:

• The Phase I study demonstrated an objective response rate (ORR) of 41.7% and a disease control rate (DCR) of 66.7% in 12 heavily pre-treated patients.
• GC101 uses a novel protocol that eliminates the need for high-intensity lymphodepletion chemotherapy and exogenous IL-2 administration, significantly reducing toxicity compared to traditional TIL therapies.
• After a median follow-up of 13.0 months, the median duration of response and overall survival have not yet been reached.
• These early results underscore the potential of GC101 as a new treatment option for advanced NSCLC patients who have exhausted standard therapies.

AbbVie’s (NYSE: ABBV) Risankizumab Gains Second Indication in China for Ulcerative Colitis (UC)

Key Words: AbbVie, Skyrizi, risankizumab, ulcerative colitis, UC, IL-23 inhibitor, regulatory approval, China

The News: AbbVie has announced that its IL-23 inhibitor, Skyrizi (risankizumab), has received regulatory approval in China for the treatment of adults with moderately to severely active ulcerative colitis (UC). This is Skyrizi’s second approved indication in China, following its authorization for Crohn’s disease in March 2025.

Key Highlights:

• The approval targets patients who have had an inadequate response, loss of response, or intolerance to conventional or biologic therapy.
• The decision is supported by results from two Phase III trials, INSPIRE and COMMAND, where Skyrizi showed superior clinical remission rates compared to placebo during both induction (12 weeks) and maintenance (52 weeks).
• Skyrizi works by selectively blocking IL-23 through its p19 subunit, addressing the underlying inflammation of UC.

Leads Biolabs’ (9887.HK) PD-L1/4-1BB Bispecific Antibody Opamtistomig (LBL-024) Granted EU Orphan Drug Designation

Key Words: Leads Biolabs, Opamtistomig, LBL-024, PD-L1, 4-1BB, orphan drug designation, EP-NEC, immuno-oncology

The News: Leads Biolabs announced on January 22, 2026, that its bispecific antibody Opamtistomig (LBL-024) has been granted Orphan Drug Designation (ODD) by the European Commission (EC) for extra-pulmonary neuroendocrine carcinoma (EP-NEC). This milestone strengthens the global development of Opamtistomig, which has demonstrated first- or best-in-class potential in Phase II and registrational trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC.

Key Highlights:

• Opamtistomig (LBL-024): A first-in-class bispecific antibody targeting PD-L1 and 4-1BB, designed to reverse immune suppression and selectively stimulate T-cell activation. It is the first 4-1BB-targeting bispecific antibody to advance to a pivotal trial as monotherapy.
• In addition to the EU ODD, Opamtistomig has received FDA Orphan Drug Designation (2024) and Fast Track Designation (2026) for EP-NEC, as well as Breakthrough Therapy Designation in China (2024).
• Opamtistomig has shown promising efficacy and safety in trials for EP-NEC and is advancing toward potential accelerated approval. Clinical activity has also been observed in other high-need indications, including NSCLC, SCLC, biliary tract cancer, and ovarian cancer.
• Founded in 2012, Leads Biolabs is a clinical-stage biotech company focused on developing innovative therapies for oncology and autoimmune diseases. With a pipeline of 14 drug candidates, including seven in clinical stages, Leads Biolabs has established proprietary platforms such as X-body for bispecific antibodies and LeadsBody for T-cell engagers. The company is committed to advancing next-generation immuno-oncology therapies globally.

AstraZeneca’s Durvalumab Approved in China for dMMR Endometrial Cancer

Key Words: AstraZeneca, durvalumab, dMMR endometrial cancer, DUO-E trial, China approval, immunotherapy

The News: AstraZeneca’s durvalumab has been approved in China for the treatment of primary advanced or recurrent endometrial cancer with deficient mismatch repair (dMMR). The approval is based on positive results from the DUO-E Phase III trial.

Key Highlights:

• Durvalumab is approved for use in combination with carboplatin and paclitaxel as first-line treatment, followed by durvalumab monotherapy as maintenance therapy.
• DUO-E Trial Results: In dMMR endometrial cancer patients, durvalumab plus chemotherapy reduced the risk of disease progression or death by 58% (HR 0.42; 95% CI: 0.22-0.80) compared to chemotherapy alone. The median progression-free survival (PFS) was not reached in the durvalumab group, versus 7.0 months for the control group.

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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