China Healthcare Weekly – 23rd September 2025

This week’s China healthcare and pharma roundup highlights Atom Bioscience’s HKEX IPO, Ark Biosciences’ pipeline funding, Mabwell’s USD 1 billion siRNA deal, HiDiamond Bio’s Pre-Series A, and Enrui Kainuo’s CAR-NK cell therapy financing, alongside updates on IASO Bio’s CAR-T long-term data, Fosun’s breast cancer drug approval, Hengrui’s hepatitis B siRNA breakthrough, Ascletis’ GLP-1 advances, and Innovent’s diabetes therapy approval.

Transactions & BD (In/Out Licensing)

Atom Files for HKEX IPO with RMB 3.05 Billion Post-Series D Valuation

Key Words: Atom Bioscience, HKEX IPO, gout, ABP-671

• The News: Atom Bioscience has filed for a HKEX IPO following its Series D funding round, which valued the company at RMB 3.05 billion (USD 430 million).
• Key Highlights:
• Lead candidate ABP-671 (URAT1 inhibitor) is in Phase IIb/III trials in China and the US, targeting gout and hyperuricaemia.
• ABP-671 eliminates hepatotoxicity risks of benzbromarone while offering superior uric acid reduction.
• Atom reported losses of RMB 97.4M (2023) and RMB 434.1M (2024).

Ark Bio Eyes Hong Kong IPO to Advance Pipeline

Key Words: Ark Biosciences, HKEX IPO, RSV treatment, ziresovir

• The News: Ark Biosciences has applied for a HKEX IPO, backed by J.P. Morgan and CITIC Securities, to fund its respiratory and paediatric pipeline.
• Key Highlights:
• Lead candidate ziresovir, an RSV treatment for infants aged 1 to 24 months, is under review by China’s NMPA.
• Pipeline includes AK0610 (RSV prevention) and AK3280 (IPF treatment).
• Ark raised funds in 2022 at a RMB 4.69 billion valuation but reported losses of RMB 270M (2023) and RMB 197M (2024).

Mabwell (688062.SH) Signs USD 1 Billion Licensing Deal with Kalexo Bio for Dual-Target siRNA

Key Words: Mabwell Bioscience, Kalexo Bio, siRNA, USD 1 billion, dyslipidaemia, cardiovascular

• The News: Mabwell Bioscience has entered an exclusive global licensing agreement with Kalexo Bio, a new company formed together with US-based Aditum Bio, for its dual-target siRNA candidate 2MW7141, targeting dyslipidaemia and cardiovascular risk reduction. The deal is valued at USD 1 billion, including USD 12 million upfront and a double-digit equity stake in Kalexo’s Series A round.
• Key Highlights:
• 2MW7141 uses a novel non-lipid nanoparticle delivery system, enabling dual inhibition of two lipid metabolism targets.
• The deal reflects rising interest in cardiovascular siRNA therapies, following Argo Bio’s recent USD 5.36 billion collaboration with Novartis.
• Mabwell’s AI-powered R&D platform enables rapid identification of multi-target nucleic acid therapies, improving development efficiency.

HiDiamond Completes Pre-Series A Funding for Oncology Pipeline

Key Words: HiDiamond Bio, Pre-Series A, oncology, AI-powered organoid platforms

• The News: HiDiamond Bio has raised nearly RMB 100 million in Pre-Series A funding led by Northern Light Venture Capital. The funds will advance clinical proof-of-concept studies and develop AI-powered organoid platforms for target validation and molecule design.
• Key Highlights:
• HiDiamond uses a hub-and-spoke model leveraging founder expertise and industry resources to develop high-value assets. Its lead candidate, the HiD21 series, targets haematological malignancies, solid tumours, and autoimmune diseases, currently in Phase I trials.
• Northern Light praised HiDiamond’s innovative R&D model, emphasizing mid-stage asset development with cost-efficiency advantages.
• HiDiamond exemplifies China’s shift from quantity to quality in biopharma innovation, integrating global resources and flexible business models.

Enrui Kainuo Completes Series A Financing for CAR-NK Cell Therapies

Key Words: Enrui Kainuo, CAR-NK, Series A, cell therapy, autoimmune diseases

• The News: Enrui Kainuo Biotech raised over RMB 200 million in Series A funding led by SCGC Capital, Hengqin Financial Investment, and Green Pine Capital Partners. Proceeds will advance clinical development of its CAR-NK cell therapies and expand its proprietary platforms covering CAR-T and T-cell engager (TCE) bispecific antibodies.
• Key Highlights:
• The lead CAR-NK candidate targets systemic lupus erythematosus (SLE), focusing on autoimmune and inflammatory diseases.
• Founded in 2021, the company has established R&D, manufacturing, and clinical capabilities with proprietary technology platforms.
• Investors emphasized the innovative off-the-shelf approach addressing unmet needs in immunology beyond oncology applications.

Clinical Development

IASO Bio Highlights Three-Year Follow-Up Data of CAR-T Cell Therapy Fucaso for Multiple Myeloma

Key Words: IASO Bio, Fucaso, CAR-T, BCMA, multiple myeloma, long-term follow-up

• The News: IASO Biotherapeutics presented three-year follow-up data from the FUMANBA-1 study of its fully human anti-BCMA CAR-T therapy, Fucaso (Equecabtagene Autoleucel, Eque-cel), at the 2025 International Myeloma Society Annual Meeting. The findings demonstrate deep, durable efficacy and manageable long-term safety in relapsed/refractory multiple myeloma (R/R MM) patients, including those with high-risk features.
• Key Highlights:
• The FUMANBA-1 trial enrolled 109 heavily pretreated relapsed/refractory multiple myeloma (R/R MM) patients across 14 sites in China, including 12.8% with extramedullary disease and 11% with prior anti-BCMA CAR-T exposure. Patients received lymphodepletion followed by a single infusion of Fucaso (Equecabtagene Autoleucel, Eque-cel) at 1×10⁶ cells/kg.
• Overall response rate (ORR) was 96.3%, with 83.2% achieving complete or stringent complete response (CR/sCR). In CAR-T–naïve patients, ORR and CR/sCR were 98.9% and 88.4%, respectively. Median progression-free survival (PFS) was 30.5 months, extending to 35.9 months in CAR-T–naïve patients.
• Minimal residual disease (MRD) negativity was achieved in 95.3% of evaluable patients, lasting a median of 36.5 months.
• Cytokine release syndrome (CRS) occurred in 93.6% of patients (one grade ≥3 case), with no late neurotoxicity or secondary malignancies.
• Fucaso demonstrated rapid tumor clearance, prolonged persistence, and sustained antitumor activity, significantly improving quality of life with extended treatment-free intervals.

Fosun’s (600196.SH) CDK4/6 Inhibitor Gains Second Breast Cancer Approval in China

Key Words: Fosun Pharma, CDK4/6 inhibitor, HR-positive breast cancer, FCN-437c

• The News: Fosun Pharma received approval for its CDK4/6 inhibitor FCN-437c as a first-line endocrine therapy for HR-positive, HER2-negative advanced breast cancer. This expands its earlier approval for second-line treatment with fulvestrant.
• Key Highlights:
• FCN-437c was developed under China’s National Major New Drug Innovation program and features a novel chemical structure. The expanded indication includes premenopausal, perimenopausal, and postmenopausal patients.
• Breast cancer, the most common female malignancy in China, sees HR-positive subtypes in approximately 70% of cases.
• Fosun’s subsidiary, Ahon Pharma, will lead commercialization efforts, enhancing Fosun’s oncology portfolio.

Hengrui’s (1276.HK) siRNA Candidate Receives Breakthrough Therapy Designation for Chronic Hepatitis B

Key Words: Hengrui Pharma, siRNA, chronic hepatitis B, breakthrough therapy designation

• The News: Hengrui Pharma secured breakthrough therapy designation (BTD) from China’s Centre for Drug Evaluation (CDE) for its siRNA therapeutic HRS-5635 targeting chronic hepatitis B (CHB).
• Key Highlights:
• HRS-5635 demonstrates potent antiviral activity and sustained viral suppression with favourable safety profiles.
• It aims for functional cure through hepatitis B surface antigen clearance, addressing unmet needs among China’s estimated 75 million HBV carriers.
• The candidate is in Phase II trials and offers enhanced liver targeting and durability of response compared to earlier siRNA therapies.

Ascletis (1672.HK) Announces Quarterly Dosing GLP-1 Candidate ASC30 With 75-Day Half-Life

Key Words: Ascletis Pharma, China-based, GLP-1 agonist, ASC30, weight management

• The News: China-based Ascletis Pharma has announced Phase Ib data for its small molecule GLP-1R biased agonist ASC30, which demonstrates a 75-day half-life, enabling quarterly subcutaneous dosing for weight management maintenance therapy.
• Key Highlights:
• ASC30 offers daily oral tablets, monthly injections (46-day half-life) for weight loss, and quarterly subcutaneous injections for maintenance. The quarterly formulation shows excellent GI tolerability (0% nausea/vomiting vs. 12.5% for placebo) and a median peak concentration at 17 days.
• As the first oral, long-acting GLP-1 agonist with patent protection through 2044, ASC30 addresses limitations of therapies like semaglutide.
• Phase IIa data for the monthly formulation is expected in Q1 2026, positioning ASC30 as a next-gen weight management solution.

Innovent (1801.HK) Announces Mazdutide Received Approval from China’s NMPA for Glycemic Control in Adults with Type 2 Diabetes

Key Words: Mazdutide, dual GCG/GLP-1 receptor agonist, glycemic control, type 2 diabetes, NMPA approval

• The News: China’s National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for glycemic control in adults with type 2 diabetes (T2D). This approval marks mazdutide as the world’s first dual GCG/GLP-1 receptor agonist for glycemic control, offering comprehensive benefits in glucose management, weight reduction, and metabolic health.
• Key Highlights:
• Mazdutide addresses two core mechanisms of diabetes—insufficient insulin secretion and insulin resistance—delivering superior glycemic control, weight loss, and metabolic improvements for cardiovascular, hepatic, and renal health.
• The approval is based on results from two Phase 3 clinical trials, DREAMS-1 and DREAMS-2, which demonstrated mazdutide’s significant efficacy over placebo and dulaglutide in glycemic control and weight reduction, with a favorable safety profile.
• Mazdutide aligns with the “Healthy China 2030” vision by addressing the critical needs of long-term glucose management and complication prevention in China’s vast T2D population.

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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