This week’s China healthcare updates highlight a US$15.2B global collaboration between Hengrui and Bristol Myers Squibb across 13 early-stage oncology, hematology, and immunology programs. DualityBio exercised its U.S. profit-sharing option for B7-H3 ADC DB-1311, positioning it for potential best-in-class status in mCRPC. Allogene restructured its Overland partnership, reducing Asia exposure for its CAR-T portfolio. Huajian Future filed for a Hong Kong IPO, advancing autoimmune, metabolic, and oncology pipelines. Impact Therapeutics launched its HK$910M IPO on HKEX, driven by its synthetic lethality oncology platform. Additional highlights include Fosun Pharma’s global option deal for AR1001 Alzheimer’s therapy, METiS TechBio’s US$2.1B IPO debut as the first AI nano-delivery company, and GSK teaming up with Sino Biopharm to commercialize hepatitis B therapy bepirovirsen in China. These developments underline China’s growing role in biopharma innovation, strategic expansion, and global partnerships.

Transactions

Hengrui (600276.SH) and BMS (BMY.N) Sign US$ 15.2 Billion Strategic Collaboration Across 13 Early-Stage Programs

Key Words: Hengrui, Bristol Myers Squibb, global strategic collaboration, licensing, oncology, hematology, immunology, early-stage pipeline

• The News: Hengrui Pharma and BMS entered into a global strategic collaboration and licensing agreement covering 13 early-stage programs across oncology, hematology and immunology. The package includes four Hengrui oncology / hematology programs, four BMS immunology programs, and five jointly developed programs based on Hengrui’s R&D engine and technology platforms.
• Key Highlights:
• Deal Details:
  • Total deal value: Up to US$ 2 billion.
  • Upfront / Near-term payments: Up to US$ 950 million, including US$ 600 million upfront, US$ 175 million first anniversary payment, and a conditional US$ 175 million second anniversary payment in 2028.
  • Royalties: Hengrui is eligible to receive tiered royalties on net sales outside mainland China, Hong Kong and Macau.
  • Closing timeline: Transaction expected to close in Q3 2026, subject to HSR antitrust clearance and customary closing conditions.
  • Programs covered: 13 early-stage programs, including four Hengrui oncology / hematology assets, four BMS immunology assets and five jointly discovered / developed programs.

DualityBio (9606.HK) Exercises U.S. Profit-Sharing Option for B7-H3 ADC DB-1311

Key Words: DualityBio, BioNTech, DB-1311, BNT324, B7-H3 ADC, mCRPC, profit-sharing option, global co-development

• The News: DualityBio has exercised its exclusive U.S. cost- and profit/loss-sharing option for DB-1311 / BNT324, a B7-H3-targeting antibody-drug conjugate co-developed with BioNTech. The decision follows encouraging Phase I/II data in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). By retaining U.S. economic participation instead of fully out-licensing the asset, DualityBio is positioning DB-1311 as a potential global best-in-class ADC.
• Key Highlights:
• Deal Details:
  • Option exercised: U.S. cost- and profit/loss-sharing option for DB-1311 / BNT324.
  • Allowed DualityBio to share potential U.S. upside rather than only receiving upfront and milestone payments.
  • Development stage: DB-1311 is advancing toward a global Phase III mCRPC trial, with rPFS and OS as dual primary endpoints.
• Product Profile – DB-1311 / BNT324:
  • DB-1311 / BNT324: A B3-H7 targeting ADC and received received FDA Fast Track Designation for prostate cancer.
  • Indication focus: Metastatic castration-resistant prostate cancer, with potential expansion into earlier-line prostate cancer settings.
  • B7-H3 is highly expressed in solid tumors, including prostate cancer, making it an attractive ADC target in treatment-resistant disease.
• Clinical Data:
  • Study design: Global multicenter Phase I/II study in heavily pretreated mCRPC patients.
  • Efficacy: Among 129 evaluable patients, median rPFS was 11.3 months and median OS was 22.5 months.
  • Safety: No new safety signals were observed; common TRAEs were mainly nausea and hematologic events, mostly Grade 1-2.

Allogene (ALLO.O) Terminates Overland Partnership, Reshaping Asia Strategy for Allogeneic CAR-T

Key Words: Allogene Therapeutics, Overland Therapeutics, allogeneic CAR-T, Asia rights, collaboration termination, cell therapy

• The News: Allogene Therapeutics has terminated its cell therapy collaboration with Overland Therapeutics for selected Asian territories, marking a major reset of its allogeneic CAR-T strategy in the region. The original partnership, established in 2020, granted the joint venture exclusive rights to develop, manufacture and commercialize four Allogene allogeneic CAR-T programs. As part of the restructuring, Allogene will reduce its equity exposure to Overland and transition from a strategic partner to a minority financial investor.
• Key Highlights:
• Deal Details:
  • Termination date: On May 12, 2026.
  • Original agreement: Granted Asian rights to four allogeneic CAR-T programs targeting BCMA, CD70, FLT3 and DLL3.
  • Original financial terms: Overland committed approximately US$ 117 million to the joint venture, including a US$ 40 million upfront payment to Allogene.
  • Equity adjustment: Allogene will forfeit part of its Overland equity for no consideration and is expected to hold approximately 3% of Overland on a fully diluted basis after the restructuring.
• Allogene Therapeutics is a U.S.-based clinical-stage biotech focused on developing off-the-shelf allogeneic CAR-T therapies for cancer.
• Overland Therapeutics is a China/U.S. based biotech backed by Hillhouse, focused on developing innovative therapies across oncology, autoimmune diseases and advanced modalities including cell therapy, ADC and RNAi.

Huajian Future Files for Hong Kong IPO with Autoimmune, Metabolic and Oncology Pipeline

Key Words: Huajian Future, IPO, HKEX, HJ787, TYK2 inhibitor, HJ178, GLP-1/GIP agonist, HJ891, KRAS G12C inhibitor

• The News: Huajian Future has filed for a Hong Kong Main Board IPO, with CITIC Securities acting as the sole sponsor. The Chengdu-based clinical-stage biotech focuses on small-molecule Class 1 innovative drugs across autoimmune, metabolic and oncology diseases. Following its Series C2 financing, the company reached a post-money valuation of approximately RMB 2.7 billion.
• Key Highlights:
• Deal Details:
  • Sole sponsor: CITIC Securities.
  • Latest valuation: Post-money valuation reached approximately RMB 2.7 billion after the Series C2 financing.
• Product Profile – HJ787 / HJ178 / HJ891:
  • HJ787: A selective TYK2 inhibitor with topical and oral formulations, prioritized for mild-to-moderate atopic dermatitis and acne and currently in Phase II.
  • HJ178: An oral small-molecule GLP-1/GIP dual agonist being developed for type 2 diabetes and overweight/obesity and currently in Phase II.
  • HJ891: An oral KRAS G12C inhibitor for KRAS G12C-mutant NSCLC, designed with lung-targeted enrichment in Phase IIb.
• Huajian Future is a Chengdu-based clinical-stage biotech focused on developing differentiated small-molecule innovative drugs across autoimmune, metabolic and oncology diseases.

Impact Therapeutics (7630.HK) Lists on HKEX with Synthetic Lethality Oncology Pipeline

Key Words: Impact Therapeutics, IPO, HKEX, synthetic lethality, senaparib, PARP inhibitor, IMP1734, IMP9064

• The News: Impact Therapeutics listed on the Hong Kong Stock Exchange, marking a new public-market milestone for a China-based synthetic lethality oncology biotech. Founded in 2009, Impact is focused on precision oncology drugs based on synthetic lethality, led by its commercial PARP1/2 inhibitor senaparib and a broader pipeline covering PARP1, ATR, WEE1, PKMYT1, DHX9, ATM and USP1 targets.
• Key Highlights:
• Deal Detail:
  • Offering size: 41.977 million H shares were offered globally.
  • Offer price: HK$ 20.10 per share.
  • Trading debut: Shares opened at HK$ 34.20, up 70.15% from the offer price, implying a market capitalization of approximately HK$ 9.45 billion at open.
• Drug Profile – Senaparib:
  • Senaparib: An oral PARP1/2 inhibitor approved in China in January 2025 for first-line maintenance treatment of ovarian cancer in an all-comer population.
  • Mechanism: Blocked PARP-dependent single-strand DNA repair and can trap PARP on damaged DNA, causing replication stress and tumor cell death.
  • Commercial performance: Generated RMB 20 million in sales revenue in its first commercial year, with gross margin of 92.2%.
• Impact Therapeutics is an oncology biotech focused on synthetic lethality-based cancer therapies, with a marketed PARP inhibitor and a pipeline spanning PARP1, ATR, WEE1 and other DNA damage response targets.

METiS TechBio (7666.HK) Lists on HKEX as First AI Nano-Delivery Company

Key Words: METiS TechBio, IPO, HKEX, AI nano-delivery, NanoForge, AiTEM, AiLNP, AiRNA, MTS-004

• The News: METiS TechBio listed on the Hong Kong Stock Exchange, positioning itself as the world’s first listed AI-driven nano-delivery company and Hong Kong’s first AI biologics-related biopharma listing. The company issued 201.229 million H shares at HK$ 10.50 per share, raising more than HK$ 2.1 billion before any over-allotment option, implying a market capitalization of approximately HK$ 12.1 billion at the offer price.
• Key Highlights:
• Deal Detail:
  • Offering size: 201.229 million H shares were issued globally.
  • Offer price: HK$ 10.50 per share.
  • Implied Market Cap: Approximately HK$ 12.1 billion at the offer price.
  • 18 cornerstone investors subscribed for US$ 148 million, led by BlackRock with US$ 50 million.
• Platform Profile:
  • NanoForge: Proprietary AI nano-delivery platform integrating a large lipid library, AI modeling and validation capabilities for nano-material and payload design.
  • AI-enabled design platform: AiTEM / AiLNP / AiRNA
  • Delivery scope: Generated delivery systems targeting eight organs or tissues, including liver, lung, immune organs, heart, muscle, tumor, CNS and GI tract.
• Product Profile – MTS-004:
  • MTS-004: Lead AiTEM-derived formulation oral candidate for pseudobulbar affect (PBA), a neurological condition characterized by involuntary and inappropriate episodes of laughing or crying.
  • Clinical stage: Completed Phase III clinical trials in China for PBA in 38 months.
  • China’s first AI-enabled formulation new drug to complete Phase III trials and the first PBA drug candidate in China to complete clinical testing.
• METiS TechBio is an AI-driven drug delivery company focused on nano-material design, formulation optimization, LNP delivery and RNA therapeutics.

GSK (GSK.N) Partners with Sino Biopharm (1177.HK) to Commercialize Bepirovirsen in China

Key Words: GSK, Sino Biopharm, Chia Tai Tianqing, bepirovirsen, antisense oligonucleotide, chronic hepatitis B, functional cure, China commercialization

• The News: GSK has entered into a commercialization partnership with Sino Biopharm for bepirovirsen, its investigational antisense oligonucleotide therapy for chronic hepatitis B in mainland China. Under the agreement, Sino Biopharm’s subsidiary Chia Tai Tianqing / CTTQ will purchase and supply bepirovirsen for an initial term of 5.5 years, while GSK will retain product ownership and book sales revenue.
• Key Highlights:
• CTTQ will purchase and supply bepirovirsen for an initial 5.5-year term; GSK remains the product owner and records sales revenue.
• Product Profile – Bepirovirsen:
  • Bepirovirsen: An antisense oligonucleotide / small nucleic acid therapy for chronic hepatitis B.
  • Mechanism: Designed to block HBV DNA replication, reduce hepatitis B surface antigen levels and enhance immune response.
  • Administration: Monthly injection, offering better dosing convenience than weekly pegylated interferon.
• Clinical Data:
  • Phase III B-WELL 1/2: Met the primary endpoint in two pivotal Phase III studies.
  • The trials assessed sustained reductions in HBV DNA and hepatitis B surface antigen, with undetectable levels maintained for at least 6 months.
  • B-Together IIb: Followed by pegylated interferon achieved a 15% primary endpoint rate at 24 weeks after treatment discontinuation, with no relapse reported in responders.
• Sino Biopharm is a Hong Kong-listed Chinese pharmaceutical group with strong commercial and R&D capabilities across liver diseases, oncology, respiratory diseases and other major therapeutic areas.

Kexing Biopharm (688136.SH) Refiles for Hong Kong IPO with Recombinant Protein Franchise and Global Expansion

Key Words: Kexing Biopharm, HKEX IPO, recombinant protein, A+H listing, interferon, erythropoietin, overseas revenue, 3KX platform

• The News: Kexing Biopharm has refiled for a Hong Kong Main Board IPO, with China Securities International as the sole sponsor. The company is a commercial-stage recombinant protein biopharma with mature cash-flow products, including Sinogen / Sai Ruojin, EPIAO / Yipuding, Baitexi and Changlekang, while expanding into oncology, autoimmune diseases, ophthalmology and antiviral therapies through its 3KX technology platform.
• Key Highlights:
• Deal Details:
  • IPO status: Refiled for Hong Kong Main Board listing.
  • Sole sponsor: China Securities International.
  • Build an A+H capital structure to support innovation pipeline development, biosimilar expansion, product in-licensing and overseas commercialization.
• Financial Profile:
  • Revenue: RMB 1.26 billion in 2023, RMB 1.41 billion in 2024 and RMB1.53 billion in 2025.
  • Net Profit: Turned profitable in 2024 with RMB 27 million net profit, then increased to RMB 153 million in 2025, representing 466% YoY growth.
  • Overseas revenue: Overseas pharmaceutical product revenue reached RMB 366 million in 2025, accounting for 23.9% of total revenue.
  • R&D expenses: RMB 345 million in 2023, RMB 168 million in 2024 and RMB 200 million in 2025, supporting 3KX platform development and clinical pipeline advancement.
• Product Profile – GB-K02:
  • GB-K02: Lead late-stage biologic candidate, a PEGylated long-acting recombinant human granulocyte colony-stimulating factor.
  • Indication: Prevention or treatment of chemotherapy-induced neutropenia, especially in cancer patients receiving myelosuppressive chemotherapy.
  • Clinical Stage: Completed Phase III clinical development and is expected to move toward NDA filing.
• Kexing Biopharm is a commercial-stage Chinese recombinant protein biopharma company with marketed biologics, global sales coverage and an innovation pipeline built around its 3KX platform.

Fosun Pharma (600196.SH, 2196.HK) and AriBio Sign Exclusive Global Option Agreement for AR1001 for the Treatment of Alzheimer’s Disease

Key Words: Fosun Pharma, AriBio, AR1001, Alzheimer’s disease, Phase 3 clinical trial, global partnership

• The News: Fosun Pharma and AriBio, a South Korea-based biopharmaceutical company, announced the signing of an exclusive global option agreement for AR1001, an innovative drug candidate for the treatment of Alzheimer’s disease (AD). Under the agreement, Fosun Pharma will pay AriBio a US$ 60 million option fee. If the option is exercised, Fosun Pharma will provide up to US$ 180 million in upfront and regulatory milestone payments, with additional sales milestone payments triggered if net sales exceed US$ 2.5 billion annually.
• Key Highlights:
• AR1001 Overview:
  • AR1001 (mirodenafil) is a once-daily, clinical-stage oral phosphodiesterase-5 inhibitor with disease-modifying potential for early Alzheimer’s disease, targeting patients with mild cognitive impairment to mild dementia. The drug demonstrates strong blood-brain barrier penetration and an excellent safety profile.
  • Currently in the global Phase 3 POLARIS-AD trial (NCT05531526) with over 1,500 patients enrolled across the U.S., Europe, China, and other regions.
• Deal Details:
  • Fosun Pharma will manage global development, registration, manufacturing, and commercialization.
  • The global option agreement expands the previous regional partnership covering Chinese mainland, Hong Kong, Macao, and ASEAN countries.

Clinical

Chinese Biotechs Spotlight Dual-Payload ADCs at AACR 2026

Key Words: AACR 2026, dual-payload ADC, bispecific ADC, HER2, EGFR/B7-H3, ITGB6/B7-H3, FRα, TA-MUC1, Chinese biotech

• The News: At AACR 2026, Chinese biotech companies presented multiple next-generation dual-payload ADC programs, highlighting a broader shift from conventional single-payload ADCs toward more complex designs aimed at addressing tumor heterogeneity and drug resistance. Dual-payload ADCs combine two cytotoxic payloads with different mechanisms of action on the same antibody backbone.
• Key Highlights:
• Technology Trend:
  • Dual-Payload ADC design: used two mechanistically distinct payloads, such as Topo I inhibitors and microtubule inhibitors, to create synergistic tumor killing.
  • China angle: Chinese companies showed broad participation at AACR 2026, with multiple preclinical dual-payload or bispecific ADC programs targeting solid tumors.
• Selected Preclinical Programs:
  • TJ106: A HER2-targeting bispecific dual-payload ADC designed to address resistance to existing HER2 ADCs such as Enhertu, with preclinical activity reported across HER2-expression models, including Enhertu-resistant models.
  • LUA006: Qilu’s EGFR/B7-H3 bispecific dual-payload ADC, designed to improve tumor selectivity by balancing EGFR binding and B7-H3-driven internalization.
  • BCG048: Biocytogen’s ITGB6/B7-H3 bispecific dual-payload ADC, designed to improve internalization and activity in heterogeneous solid tumors.
• Other Notable Programs:
  • IMD2146: A TME-activated EGFR/TROP2 bispecific dual-payload ADC carrying a pan-RAS inhibitor and DXd payload, designed for RAS-driven tumors.
  • DB-1326: DualityBio’s dual-payload TA-MUC1-directed ADC, reported to show strong preclinical antitumor activity.
• Additional Platforms: Henlius’ Hanjugator camptothecin ADC platform and RemeGen’s payload-recycling ADC platform also reflect broader Chinese innovation around payload, linker and therapeutic-index optimization.

BeOne’s (6160.HK) BEQALZI^TM Becomes First BCL2 Inhibitor Approved for R/R Mantle Cell Lymphoma

Key Words: BeOne Medicines, BEQALZI, sonrotoclax, BCL2 inhibitor, FDA approval, R/R MCL, mantle cell lymphoma

• The News: BeOne Medicines announced that the U.S. FDA granted accelerated approval to BEQALZI™(sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor. The approval makes BEQALZI the first and only BCL2 inhibitor approved for MCL in the U.S. and marks the first new BCL2 inhibitor approval in the U.S. in about a decade.
• Key Highlights:
• BEQALZI^TM received U.S. FDA accelerated approval for R/R MCL after at least two prior systemic therapies, including a BTK inhibitor.
• First-in-Class in MCL: First and only BCL2 inhibitor approved for mantle cell lymphoma.
• Clinical Data:
  • Approval was supported by the Phase I/II BGB-11417-201 study in R/R MCL.
  • Efficacy: ORR was 52%, with CR rate of 16%.
  • Response Kinetics: Median time to response was 1.9 months.
  • Durability: Median duration of response was 15.8 months at a median response follow-up of 11.9 months.
• Drug Profile – BEQALZI™(sonrotoclax):
  • BEQALZI™: A next-generation oral BCL2 inhibitor designed for improved potency and selectivity.
  • Mechanism: Blocked BCL2, a key survival protein that helps cancer cells avoid apoptosis.
  • Differentiation: Compared with earlier BCL2 inhibitors, sonrotoclax is designed to improve efficacy, tolerability and convenience through greater potency, selectivity and a shorter half-life profile.

Therorna Advances circRNA-Based in vivo CAR-T TI-0032 into First-in-Human Study

Key Words: Therorna, circular RNA, in vivo CAR-T, TI-0032, CD19, autoimmune diseases, ASGCT 2026, TI-0093

• The News: Therorna announced that it will present three posters at the 2026 ASGCT Annual Meeting, highlighting progress across its circular RNA platform. The key program is TI-0032, a circRNA-based, CD19-targeted in vivo CAR-T therapy for relapsed / refractory autoimmune diseases, whose first-in-human investigator-initiated trial has already started.
• Key Highlights:
• Clinical Progress:
  • First-in-Human study: TI-0032 has initiated an investigator-initiated trial for relapsed / refractory autoimmune diseases.
  • IND plan: China and U.S. IND submissions for TI-0032 are under planned advancement.
• Drug Profile – TI-0032:
  • TI-0032: A circRNA-based in vivo CAR-T therapy targeting CD19, designed to reprogram patients’ T cells in vivo and enable an off-the-shelf, repeat-dose treatment approach.
  • Delivery system: Uses T-cell-targeted LNPs carrying circular RNA payloads generated by Therorna’s splint-free circularization technology.
  • Clinical focus: Relapsed / refractory autoimmune diseases, with potential application in deep B-cell depletion.
• Preclinical Data:
  • Human Immune Cells: Achieved durable CAR expression for ≥14 days, with >90% CD8+ cell selectivity.
  • B-cell Killing: At low doses ≥01 µg, TI-0032 achieved >95% B-cell killing and efficiently depleted B cells in SLE patient PBMCs.
  • NHP Data: Complete B-cell depletion was observed in peripheral blood, spleen, bone marrow and mesenteric lymph nodes by IHC confirmation.
• Therorna is a clinical-stage biotech focused on developing circular RNA therapeutics and vaccines across infectious diseases, oncology and autoimmune diseases.

Pfizer’s (PFE.N) Ultra-Long-Acting GLP-1 Agonist PF-08653944 Cleared for Clinical Trial in China

Key Words: Pfizer, PF-08653944, MET-097i, GLP-1 receptor agonist, obesity, weight management, China IND, Metsera

• The News: Pfizer’s Class 1 new drug PF-08653944 injection has received clinical trial approval from China’s CDE for long-term weight management in adults with obesity or overweight plus at least one weight-related comorbidity. This marks the first clinical approval for PF-08653944 in China. The asset, also known as MET-097i, was originally developed by Metsera and became part of Pfizer’s obesity portfolio following its acquisition of Metsera.
• Key Highlights:
• Regulatory Milestone:
  • China CTA approval: PF-08653944 injection was approved for clinical development in China.
  • Indication: Long-term weight management in adults with BMI ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity.
• Clinical Data:
  • VESPER-3 design: A 64-week randomized, double-blind, placebo-controlled Phase IIb study in adults with obesity or overweight without type 2 diabetes.
  • Dosing design: Patients received weekly dose escalation followed by monthly maintenance dosing across several dose regimens.
  • Weight loss: At Week 28, selected monthly maintenance regimens achieved placebo-adjusted weight loss of 10.0% and 12.3%, with no plateau observed.
  • Weight benefit: Achieved greater body-weight reduction than dulaglutide, with LS mean treatment differences of -3.78% for 4mg and -5.76% for 6mg.
• Drug Profile – PF-08653944 / MET-097i:
  • PF-08653944 / MET-097i: an ultra-long-acting, biased GLP-1 receptor agonist.
  • Administration: Subcutaneous injection; being developed as both once-weekly and once-monthly dosing regimens.
  • Designed for obesity and overweight management, with potential use as monotherapy and in peptide-based combination regimens.

Zhongsheng’s (002317.SZ) ZSP1601 Hits Phase IIb Endpoint in MASH

Key Words: Zhongsheng Pharmaceutical, ZSP1601, MASH, NASH, pan-PDE inhibitor, fibrosis, Phase IIb

• The News: Zhongsheng Pharmaceutical announced that its first-in-class MASH candidate ZSP1601 met the primary endpoint in a Phase IIb study. The oral pan-phosphodiesterase inhibitor showed statistically significant efficacy versus placebo, with signals across MASH response, liver fibrosis improvement, liver fat reduction, liver enzyme improvement and tolerability.
• Key Highlights:
• Clinical Data:
  • Study design: Phase IIb study enrolled 181 biopsy-confirmed MASH patients, randomized to ZSP1601 50mg BID, 100mg BID or placebo for 48 weeks.
  • Primary endpoint: At Week 48, response rates were 64.9% for ZSP1601 100mg, 57.6% for 50mg and 32.5% for placebo.
  • Fibrosis improvement: In the 100mg group, rate differences v placebo were 29.5% for ≥ 1-stage fibrosis improvement without MASH worsening and 10.6% for ≥ 2-stage fibrosis improvement without MASH worsening, both statistically significant.
  • Liver fat reduction: 1% of patients in the 100mg group achieved ≥50% relative liver fat reduction at Week 48.
• Drug Profile – ZSP1601:
  • ZSP1601: An oral pan-phosphodiesterase inhibitor.
  • Mechanism: Designed to increase intracellular cAMP signaling and suppress inflammatory and fibrotic pathways, targeting the inflammation-fibrosis axis in MASH.
  • Indication: Metabolic dysfunction-associated steatohepatitis, especially patients where liver inflammation and fibrosis progression drive long-term risk.
• Zhongsheng Pharmaceutical is a pharmaceutical company developing and commercializing medicines across liver/metabolic diseases, respiratory diseases, ophthalmology and other therapeutic areas.

Haisco’s (002653.SZ) Oral Factor B Inhibitor HSK39297 Beats Eculizumab in Phase III PNH Trial

Key Words: Haisco, HSK39297, Factor B inhibitor, PNH, eculizumab, Phase III, oral complement inhibitor

• The News: Haisco will present first Phase III head-to-head data for HSK39297, an oral Factor B inhibitor, versus eculizumab in complement inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria at EHA 2026. The study showed a significantly higher hemoglobin response rate for HSK39297 than eculizumab.
• Key Highlights:
• Clinical Data:
  • Study design: Multicenter, randomized, open-label, active-controlled Phase III trial comparing HSK39297 with eculizumab in complement inhibitor-naïve PNH patients.
  • Patient population: 73 PNH patients enrolled; 37 received HSK39297 and 36 received eculizumab.
  • Primary endpoint: Proportion of patients achieving Hb ≥120g/L in at least 3 of 4 assessments during Weeks 18-24, without red blood cell transfusion after Week 2.
  • Efficacy: Primary endpoint response rate was 59.5% for HSK39297 versus 8.3% for eculizumab.
• Drug Profile – HSK39297:
  • HSK39297: A highly selective oral Factor B inhibitor targeting the alternative complement pathway.
  • Mechanism: Factor B inhibition blocks alternative complement pathway activation and downstream complement amplification.
  • Indication: Paroxysmal nocturnal hemoglobinuria, a rare complement-mediated blood disorder characterized by intravascular hemolysis, anemia and transfusion burden.
  • China NDA: Haisco submitted the PNH NDA to CDE in December 2025.
• Haisco Pharmaceutical Group is a pharmaceutical company focused on developing and commercializing differentiated therapies across anesthesia, pain management, metabolic, autoimmune and rare disease areas.

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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