This week’s China healthcare highlights include Trinomab preparing for a STAR Market IPO to raise RMB 1.5 billion for its monoclonal antibody portfolio, including first-in-class TNM002; Huadao Biopharma launching a STAR Market IPO process with its low-cost CAR-T therapy for relapsed non-Hodgkin lymphoma; and Sirius Therapeutics resubmitting a Hong Kong IPO for siRNA therapies focused on FXI anticoagulants. Maxwell Biosciences received approval for an A+H dual listing with its ADC platform targeting advanced cancers, while Earendil Labs plans a Hong Kong IPO to expand its AI-driven drug development in oncology and autoimmune diseases. Key approvals include GSK’s depemokimab for asthma and nasal polyps, Abbisko Therapeutics’ Ipagratinib gaining EMA Orphan Drug Designation for HCC, Akeso reporting strong NSCLC data for ivonescimab, and Foshan Radiopharmaceutical securing NMPA approval for its novel lung cancer diagnostic. These developments highlight China’s rapid progress in biopharma innovation.

Transactions

Trinomab Pharmaceutical Passes STAR Market IPO Review

Key Words: Trinomab Pharmaceutical, IPO, STAR Market, monoclonal antibody, tetanus, RSV

• The News: Trinomab Pharmaceutical has updated its prospectus in preparation for a listing on the STAR Market. The company plans to raise RMB 1.5 billion, allocating RMB 830 million to new drug development, RMB 330 million to expand antibody production facilities, and RMB 340 million to supplement working capital. Trinomab is an innovative biopharmaceutical company focused on fully human monoclonal antibody therapeutics.
• Key Highlights:
• Core Products:
  • Siltartoxatug Injection (TNM002):
  • Approved in China in February 2025.
  • The world’s first recombinant monoclonal antibody targeting tetanus toxin.
  • Received CDE Breakthrough Therapy Designation, Priority Review Status, and FDA Fast Track Designation.
  • Included in the National Reimbursement Drug List by the end of 2025.
• TNM001:
  • A long-acting monoclonal antibody for RSV prevention in infants.
  • NDA accepted by China’s National Medical Products Administration (NMPA).
  • Included in Priority Review procedures.
• Pipeline Overview (fully human monoclonal antibody candidates), including:
  • NGF antibody: Investigational therapy for chronic pain.
  • VZV antibody: Preventing infections such as shingles.
  • CMV antibody: For immunocompromised patients.
  • Rabies virus and HSV antibodies: Early-stage development.
• Financial Performance:
  • Revenue: RMB 0 (2023), RMB 15.06 million (2024), RMB 51.22 million (2025).
  • Net Loss: RMB 4.46 billion (2023), RMB 5.15 billion (2024), RMB 6 billion (2025).

Huadao Biopharma Launches IPO Process, Aiming to Offer Affordable CAR-T Therapy

Key Words: Huadao Biopharma, IPO, CAR-T, STAR Market, affordable therapy

• The News: Huadao Biopharma (Shanghai) has officially initiated its IPO process, submitting a counseling filing with the Shanghai Securities Regulatory Bureau. The company, headquartered in Shanghai, focuses on innovative CAR-T therapies and aims to disrupt the existing market with a groundbreaking pricing strategy. Its first CAR-T cell therapy for relapsed/refractory non-Hodgkin lymphoma is priced at around RMB 200,000—a fraction of the cost of similar domestic or international CAR-T therapies.
• Key Highlights:
• IPO Progress:
  • Submitted IPO counseling filing to the Shanghai Securities Regulatory Bureau.
  • Target listing on China’s STAR Market, with Ping An Securities as the listing counselor.
• Core Product:
  • HD001 CAR-T Therapy:
  • Proposed price: RMB 230,000–250,000.
  • Indication: Relapsed/refractory non-Hodgkin lymphoma.
  • NDA communication meeting submitted in December 2025, with approval expected in 2026.
  • Positioned as the most affordable CAR-T therapy on the market, priced far below competitors:
  • Global CAR-T therapies: US$ 400,000–500,000.
  • Domestic therapies: RMB 1 million–1.2 million.
• HD003, HD004, HD006: Clinical-stage CAR-T candidates targeting hematological malignancies and solid tumors.
• Full Industry Chain Integration:
  • Sole company in China with fully independent IP covering upstream technologies, including viral vectors, reagents, and production equipment.
  • Developed an automated, closed-loop, unmanned CAR-T production system.
  • Expected annual capacity of 9,000 doses from the Phase I production facility in Shanghai, with plans to expand nationwide.
• Pricing Power: Breakthrough cost reductions achieved through self-developed technology and local production scalability.
• Financial and Commercial Development:
  • Founded in 2017, Huadao Biopharma has raised significant capital through multiple funding rounds, supported by prominent investors such as Newcapec and Huatai Ruihe.
  • Expansion underway with five industrial bases in Shanghai, Chongqing, Xianyang, Changchun, and Zhengzhou to significantly scale production.

Sirius Therapeutics Resubmits Application for Hong Kong IPO, Targeting siRNA Therapies for Chronic Diseases

Key Words: Sirius Therapeutics, IPO, HKEX, 18A Chapter, siRNA, chronic diseases, FXI inhibitor

• The News: On March 31, 2026, Sirius Therapeutics resubmitted its Chapter 18A listing application to the Hong Kong Stock Exchange (HKEX), marking its second attempt to go public. Backed by investors including Goldman Sachs, Haitong International, and HSBC, the young siRNA-focused biotech aims to leverage its clinical pipeline, strong financial backing, and strategic positioning in chronic diseases to establish itself on the global stage.
• Key Highlights:
• IPO Progress:
  • Resubmitted Chapter 18A application to HKEX on March 31, 2026.
  • IPO proceeds to focus on R&D of three core products, advancement of extrahepatic delivery technology, and operational funding.
• SRSD107 (Core Product):
  • A first-in-class, long-acting siRNA anticoagulant targeting coagulation factor XI (FXI).
  • Mitigates high bleeding risks of existing oral anticoagulants while retaining baseline hemostatic function.
  • Phase I trial results (2025): Over 95% FXI reduction with strong safety and long-lasting efficacy.
  • Phase II trials initiated in Europe and China, key data expected in late 2026.
• Expanded portfolio:
  • SRSD216: Targets lipoprotein(a) (Lp(a)), in Phase IIa trials in the U.S. and China.
  • SRSD384: Anti-obesity therapy, IND submitted; preclinical data shows promising efficacy.
  • 18 additional preclinical assets focusing on chronic disease treatment.
• PEPR® siRNA Platform: Proprietary RNA engineering platform enabling extrahepatic delivery, extending the application of siRNA therapies beyond liver diseases.
• Global Co-Co Partnership with CRISPR Therapeutics (2025):
  • Joint development and commercialization of SRSD107 under a 50:50 profit-sharing model.
  • Initial payment: $95 million, milestone payments exceeding $800 million.
  • CRISPR oversees U.S. commercialization; Sirius retains Greater China rights.
  • Collaboration accelerates clinical timeline while minimizing overseas market entry costs.
• Financial Overview:
  • Cash and equivalents: RMB 1.173 billion as of March 2026, providing sufficient operating runway for 37 months.
  • 2024-2025 R&D expenditure: Over 30% allocated to SRSD107, accumulating a net loss of approximately RMB 6 billion.

Maxwell Biosciences’ (688062.SH) Hong Kong IPO Approved, Advancing A+H Dual Listing

Key Words: Maxwell Biosciences, HKEX, IPO, A+H listing, ADC therapies

• The News: On April 2, 2026, Maxwell Biosciences received approval for its IPO application on the Hong Kong Stock Exchange (HKEX), marking its transition to an A+H dual listing platform. Founded in 2017, Maxwell Biosciences is known for its innovative drug development capabilities and fully integrated end-to-end operations, from drug discovery to commercialization. The company, which went public on the STAR Market in January 2022, now plans to use its Hong Kong listing to accelerate its international expansion.
• Key Highlights:
• Core Product – 9MW2821 (Nectin-4 ADC Therapy):
  • Phase III trials for single-agent treatment of urothelial carcinoma (UC) and combination with PD-1 antibodies in first-line UC therapy. Both indications have been granted Breakthrough Therapy Designation.
  • Phase III trial for monotherapy in cervical cancer also underway.
  • Interim analyses for all three indications expected in 2026, with plans to submit pre-BLA meetings based on the results.
• Other Clinical Programs:
  • Phase II for cervical and endometrial cancers (combination therapies) to conclude in 2026, with key Phase III trials to follow.
  • Phase III for triple-negative breast cancer (TNBC) monotherapy to begin this year.
• ADC Platforms:
  • DARfinity – Site-specific conjugation for enhanced stability and efficacy.
  • IDconnect – Optimized linker designs.
  • Mtoxin – Novel camptothecin-based payloads.
  • LysOnly – Conditional toxin release technology for increased safety.
• Other Platforms:
  • Next-generation TCE (bispecific/trispecific T-cell engagers) using steric hindrance designs for improved efficacy and safety.
  • siRNA platform targeting dual pathways to tackle chronic diseases.

AI-Driven Biotech Startup Earendil Labs Reportedly Eyeing Hong Kong IPO to Raise US$ 500 Million

Key Words: Earendil Labs, AI-powered drug discovery, IPO, Hong Kong, autoimmune diseases, oncology

• The News: AI-based biotech startup Earendil Labs is reportedly planning an IPO in Hong Kong, aiming to raise as much as US$ 500 million (HK$3.9 billion), according to Bloomberg sources. The company is said to be working with China International Capital Corporation (CICC) and Morgan Stanley to arrange the offering.

Headquartered in Delaware, Earendil Labs is an associated company of Beijing-based HuaShen Bio. Combining machine learning, generative protein engineering, and high-throughput experimental techniques, the firm focuses on biologic drug development, particularly in autoimmune diseases and oncology.

• Key Highlights:
• In January, Earendil formed a notable partnership with French pharmaceutical giant Sanofi to advance treatments for autoimmune and inflammatory diseases.
• Last month, the company reached a collaboration agreement with WuXi AppTec (HKEX: 02268) for cancer therapy technologies.
• Most recently, on Thursday, Earendil announced another collaboration with WuXi Biologics (HKEX: 02269), expanding its oncology development initiatives.
• Core Product: HXN-1001 (Anti-TL1A Monoclonal Antibody)
  • Long-acting monoclonal antibody targeting TL1A.
  • Completed Phase I trials; Phase II trials are set to commence.
  • Target indications include ulcerative colitis, Crohn’s disease, asthma, and atopic dermatitis.
• Sanofi-Licensed Assets:
  • HXN-1002 (α4β7/TL1A Bispecific Antibody) for inflammatory bowel disease and skin inflammation.
  • HXN-1003 (TL1A/IL-23 Bispecific Antibody) addressing similar indications.
• Other Pipeline Programs:
  • Targeted therapies for autoimmune diseases like asthma, COPD, atopic dermatitis, and B-cell-related conditions.
  • Oncology assets include candidates targeting DLL3, B7-H3, TROP2/PD-L1, EGFR/PD-L1, and Claudin 18.2. These therapies leverage bispecific antibodies (BsAbs), trispecific T-cell engagers, and ADCs to address key cancers such as colorectal cancer and small cell lung cancer.
  • Over 10 undisclosed preclinical candidates are expected to enter IND submissions by 2026–2027.

Clinical

GSK’s (LON.GSK) Ultra-Long-Acting IL-5 Monoclonal Antibody Depemokimab Secures 2nd Approval in China for CRSwNP

Key Words: GSK, Depemokimab, IL-5 monoclonal antibody, CRSwNP, SEA, NMPA, ANCHOR study

• The News: On April 3, the National Medical Products Administration (NMPA) of China approved GSK’s depemokimab for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the second approved indication for depemokimab in China within a week, following its March 27 approval for severe eosinophilic asthma (SEA).
• Key Highlights:
• Product Overview:
  • Depemokimab is GSK’s next-generation, ultra-long-acting anti-IL-5 monoclonal antibody with a highly potent binding affinity and extended half-life.
  • Unlike its predecessor mepolizumab (monthly subcutaneous injection, approved in 2015), depemokimab requires only one injection every six months.
• Clinical Studies Supporting CRSwNP Approval:
  • The approval is supported by two Phase III studies, ANCHOR-1 and ANCHOR-2, completed in October 2024.
  • Both trials were 52-week, randomized, multicenter, double-blind, placebo-controlled studies on 271 and 257 adult CRSwNP patients, respectively.
• Efficacy Results (Both studies met their co-primary endpoints):
  • Significant reduction in total nasal endoscopic polyp score (0-8 scale) from baseline at Week 52:

ANCHOR-1: Reduction by 0.7 vs placebo.

ANCHOR-2: Reduction by 0.6 vs placebo.

• Significant improvement in nasal congestion VRS (verbal rating scale) score from baseline during Weeks 49-52:

ANCHOR-1: Reduction by 0.23 vs placebo.

ANCHOR-2: Reduction by 0.25 vs placebo.

• Safety Profile: Treatment-emergent adverse events (TEAEs) were comparable between depemokimab and placebo groups, with no significant differences in severity during the trials.

Innovent Biologics (1801.HK) Presents Phase 3 Subgroup Analysis of Picankibart at AAD 2026, Demonstrating Consistent Efficacy Across BMI and Weight Groups

Key Words: Innovent Biologics, picankibart, IL-23p19 inhibitor, psoriasis, CLEAR-1, BMI, body weight, PASI 90, AAD 2026

• The News: Innovent Biologics announced subgroup analysis results from the Phase 3 CLEAR-1 study for picankibart, an IL-23p19 inhibitor, at the American Academy of Dermatology (AAD) 2026 meeting. The study evaluated the efficacy of picankibart in Chinese adults with moderate-to-severe plaque psoriasis, focusing on body mass index (BMI) and body weight subgroups.
• Key Highlights:
• BMI and Body Weight Analysis:
• By Week 16, nearly 80% of patients receiving picankibart achieved PASI 90 response, consistently observed across:
  • Body weight subgroups:

Lower weight (<73.55 kg): 80% PASI 90 response.

Higher weight (≥73.55 kg): 79.8% PASI 90 response.

• BMI categories:

Normal BMI (18.5–24.9): 82% PASI 90 response.

Overweight BMI (25–29.9): 80% PASI 90 response.

Obese BMI (≥30): 78.7% PASI 90 response.

• Efficacy was sustained through Week 52 in all subgroups.

• The consistent efficacy across BMI and weight subgroups addresses a treatment challenge for psoriasis patients, particularly those with obesity, where biologic therapies often see reduced effectiveness.

Abbisko Therapeutics’ (2256.HK) FGFR4 Inhibitor Ipagratinib Granted Orphan Drug Designation by EMA for Hepatocellular Carcinoma

Key Words: Abbisko Therapeutics, Ipagratinib, FGFR4 inhibitor, hepatocellular carcinoma, orphan drug designation, EMA, FGF19, advanced HCC

• The News: Abbisko Therapeutics announced that its highly selective FGFR4 inhibitor, Ipagratinib (ABSK-011), has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC). This recognition supports the clinical development, regulatory filings, and commercialization of Ipagratinib in Europe.
• Key Highlights:
• Mechanism of Action of Ipagratinib:
  • Ipagratinib is a highly selective, oral FGFR4 inhibitor designed to target the FGFR4/FGF19 signaling pathway, a key driver in FGF19-overexpressing HCC.
  • In prior clinical studies, Ipagratinib demonstrated strong anti-tumor activity, favorable safety, and tolerability as both monotherapy and in combination with other therapies in this patient population.
• Global Development Progress:
  • In addition to EMA’s ODD, Ipagratinib has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), and Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA).
  • A pivotal Phase 2 study for FGFR4/FGF19-overexpressing advanced HCC is ongoing globally, with sites in over 50 centers and first patient dosing completed in June 2025.
• Unmet Needs in Hepatocellular Carcinoma (HCC):
  • HCC accounts for 75-85% of primary liver cancer cases and is the third leading cause of cancer-related deaths globally.
  • Roughly 30% of HCC patients overexpress FGF19. These patients often have limited benefit from current first-line immune checkpoint inhibitor (ICI) therapies combined with anti-angiogenic agents, leaving a gap in effective second- and later-line options for FGF19-overexpressing HCC.

Akeso (9926.HK) Presents Preliminary Data from Neo-RISE Lung Study at ELCC 2026, Highlighting Promising Results for Ivonescimab in Neoadjuvant NSCLC Treatment

Key Words: Akeso, Ivonescimab, Neo-RISE Lung, NSCLC, neoadjuvant therapy, ELCC 2026, pathological complete response, major pathological response

• The News: Akeso, Inc. announced preliminary results from the Neo-RISE Lung study at the 2026 European Lung Cancer Congress (ELCC), evaluating ivonescimab in combination with immunogenic radiotherapy and chemotherapy as a neoadjuvant treatment for stage II-III non-small cell lung cancer (NSCLC).
• Key Highlights:
• Efficacy Results:
  • 100% objective response rate (ORR).
  • 1% pathological complete response (pCR).
  • 3% major pathological response (MPR).
  • 2% preoperative downstaging rate.
  • All surgically treated patients achieved R0 resection (no residual tumor).
• Safety Profile: Favorable safety profile with a manageable incidence of treatment-related adverse events (TRAEs) grade ≥3 (28.5%), predominantly hematological toxicities.
• The Neo-RISE Lung study demonstrates a highly promising therapeutic paradigm for perioperative NSCLC treatment, combining radiotherapy, ivonescimab, and chemotherapy to achieve high efficacy and favorable surgical outcomes.

Foshan Radiopharmaceutical Co., Ltd. Receives NMPA Approval for Technetium Tc-99M Hydrazino Nicotinamide Polyethyleneglycol Injection for Lung Cancer Diagnosis

Key Words: Foshan Radiopharmaceutical, Technetium Tc-99M, integrin αvβ3, SPECT/CT, lung cancer, diagnostic imaging, NMPA

• The News: Foshan Radiopharmaceutical announced that its Technetium Tc-99M Hydrazino Nicotinamide Polyethyleneglycol injection and its preparation kit have been approved for marketing by the National Medical Products Administration (NMPA) of China. The approval was granted under the NMPA’s priority review and approval procedure.
• Key Highlights:
• Product Details:
  • Class 1 innovative radioactive diagnostic agent targeting integrin αvβ3.
  • Indicated for SPECT/CT imaging in patients with suspected lung cancer as an auxiliary tool for evaluating regional lymph node metastasis.
• Clinical Impact:
  • Provides a new diagnostic option to improve the accuracy of diagnosing regional lymph node involvement in lung cancer.
  • Enhances subsequent clinical management strategies for patients.

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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