This week’s China healthcare and pharma roundup highlights GenFleet Therapeutics’ HKEX IPO, Sciwind’s IPO filing for enoglutide, Biocytogen’s STAR Market approval, Hengrui’s HER2 ADC licensing deal with Glenmark, and AusperBio’s US$63M Series B2 financing. Clinical updates include AbbVie’s FL filing for Epcoritamab, Ascletis’ THRβ agonist ASC47 weight loss results, Zelgen’s trispecific antibody Phase III trial for SCLC, Keymed’s BCMA/CD3 bispecific Phase III trial in MM, and Akeso’s HER3-targeting ADC clinical approval.

Transactions & BD (In/Out Licensing)

GenFleet Therapeutics (2595.HK) Completes Initial Public Offering on HKEX 18A

Key Words: IPO, HKEX 18A, oncology, immunology, KRAS inhibitor

• The News: GenFleet Therapeutics, a commercial-stage biotechnology company specializing in oncology and immunology, has successfully listed on the Hong Kong Stock Exchange (HKEX) main board on Sept 19, raising USD 233 million in gross proceeds, which could increase to USD 268 million upon exercising the over-allotment option. This marks the largest IPO fundraising under HKEX’s Chapter 18A rule since 2022.
• Key Highlights:
• Nine cornerstone investors subscribed a total of USD 100 million, including RTW Funds, OrbiMed, TruMed, and UBS Asset Management.
• GenFleet is the first biotech to enter HKEX under Chapter 18A with a commercially launched product (fulzerasib) and established licensing revenue at IPO.
• Its pipeline includes China’s first KRAS inhibitor and first-in-class combination therapies targeting pancreatic cancer, first-line NSCLC, and cachexia.
• The IPO funds will accelerate late-stage clinical trials and the development of core products, expanding GenFleet’s portfolio into major therapeutic areas.

Sciwind Files IPO under HKEX 18A Application with First-in-Class Drug

Key Words: HKEX IPO 18A, enoglutide, GLP-1 receptor agonist, obesity, type 2 diabetes

• The News: Sciwind Biosciences has submitted a HKEX IPO application to fund the commercialization of its first-in-class cAMP-biased GLP-1 receptor agonist, enoglutide, for obesity and type 2 diabetes (T2D).
• Key Highlights:
• Enoglutide achieved 15.1% placebo-adjusted weight loss in Phase III trials, outperforming semaglutide’s 8.5% reduction, with 92.8% of patients achieving clinically meaningful weight loss, compared to 54.3%-88% for competitors.
• Enoglutide’s selective cAMP activation reduces beta-arrestin recruitment, minimizing receptor desensitization and ensuring sustained efficacy.
• Sciwind’s pipeline includes XW004, an oral GLP-1 agonist with 3- to 5-fold higher bioavailability than existing oral peptides, showing 6.8% weight loss in six weeks versus 2.3% for Novo Nordisk’s oral semaglutide and 4.3% for orforglipron.

Biocytogen (2315.HK) Passes Shanghai STAR Market IPO Review

Key Words: STAR Market IPO, CRO services, RenMice platform, antibody discovery

• The News: Already listed on the HKEX under Chapter 18A, China-based Biocytogen is now set for dual listing after passing the Shanghai Stock Exchange (SSE) STAR Market listing review, seeking RMB 1.19 billion in funding to expand its pre-clinical CRO services and antibody discovery platforms.
• Key Highlights:
• Biocytogen reported revenue growth from RMB 534 million in 2022 to RMB 981 million in 2024, with a turnaround to RMB 23 million net profit, reflecting a strategic shift from internal drug development to a partnership-focused model.
• The RenMice platform generates fully human antibodies, supporting partnerships with major companies such as Merck, Gilead Sciences, and Johnson & Johnson.
• Biocytogen screens over 1,000 drug targets using its RenMab, RenLite, and RenTCR transgenic mouse platforms.

Hengrui Pharma (600276.SH & 1276.HK) and Glenmark Pharmaceuticals (BSE: 532296) Enter Exclusive License Agreement for HER2 ADC Trastuzumab Rezetecan (SHR-A1811)

Key Words: HER2 ADC, Trastuzumab Rezetecan, license agreement

• The News: Hengrui Pharma has entered into an exclusive license agreement with Glenmark Specialty S.A. (a subsidiary of Glenmark Pharmaceuticals) for its HER2-targeting ADC, Trastuzumab Rezetecan (SHR-A1811). The deal grants Glenmark exclusive rights to develop and commercialize the ADC outside of key territories, including Mainland China, USA, Canada, Europe, and Japan.
• Key Highlights:
• Glenmark will pay Hengrui an upfront payment of US$18 million, with milestone payments up to US$1.093 billion and royalties based on net sales in the licensed territories.
• Trastuzumab Rezetecan was approved in China (May 2025) for HER2-mutated NSCLC and is under priority review for breast cancer by China’s NMPA as of September 2025.
• The ADC has Breakthrough Therapy Designation for nine indications, including NSCLC, breast cancer, gastric cancer, and gynecologic malignancies, and recently gained Orphan Drug Designation from the US FDA for gastric or gastroesophageal adenocarcinoma.

AusperBio Raises US$63 Million in Series B2 Financing to Accelerate Functional Cure Therapies for Chronic Hepatitis B

Key Words: Series B2 financing, AHB-137, chronic hepatitis B (CHB), Med-Oligo™ ASO platform

• The News: AusperBio Therapeutics has closed a US$63 million Series B2 financing round to advance its functional cure therapies for chronic hepatitis B (CHB). The financing was co-led by Qiming Venture Partners and a global strategic investor, with continued support from HanKang Capital, CDH Investments, YuanBio Venture Capital, Sherpa Capital, and Genesis Capital.
• Key Highlights:
• Proceeds will support the pivotal development of AHB-137, including its Phase II/III clinical trials, expansion into global development, and combination studies.
• Funds will also advance the Med-Oligo™ ASO platform, scale commercial manufacturing, and grow the preclinical pipeline.
• AHB-137, a dual-mechanism ASO, is advancing through clinical trials, with promising data presented at EASL, AASLD, and APASL.

Clinical Development

AbbVie (NYSE: ABBV) Files FL Indication Extension for Epcoritamab in China

Key Words: Epcoritamab, follicular lymphoma (FL), CD20/CD3 BsAb, EPCORE FL-1

• The News: AbbVie has filed for Chinese approval of its bispecific antibody (BsAb) epcoritamab in combination with rituximab and lenalidomide for the treatment of relapsed/refractory follicular lymphoma (r/r FL). This follows positive Phase III EPCORE FL-1 trial results, which demonstrated a 95.7% objective response rate (ORR) and a 79% reduction in progression-free survival (PFS) risk compared to standard therapies.
• Key Highlights:
• Epcoritamab met statistical significance for both co-primary endpoints in the EPCORE FL-1 trial.
• The drug was first approved in the US in 2023 for diffuse large B-cell lymphoma (DLBCL) and expanded to FL in 2024.
• Developed using Genmab’s DuoBody technology, epcoritamab engages T-cells to kill CD20-positive B-cells by dual binding to CD3 on T-cells and CD20 on malignant cells.
• The subcutaneous formulation of epcoritamab provides enhanced administration convenience over existing CD20-directed therapies, with a manageable cytokine release syndrome (CRS) profile.

Ascletis’s (1672.HK) Muscle-Sparing Candidate Boosts Semaglutide’s Weight Loss Effects in Global Phase I Trial Conducted in the US

Key Words: ASC47, obesity, THRβ agonist, weight loss

• The News: China-based Ascletis Pharma has announced positive Phase I results from its US-based global trial for its THRβ agonist ASC47, showing a 56.2% greater weight reduction when combined with semaglutide versus semaglutide monotherapy in obese patients at a 30mg dose after 29 days. The data highlight a 30-day half-life for ASC47, enabling monthly dosing and significantly reducing weight rebound after treatment cessation.
• Key Highlights:
• At day 57 (four weeks post-dosing), the 30mg ASC47 group maintained 157.1% more weight loss than semaglutide monotherapy, with improved gastrointestinal tolerability (6.7% vomiting incidence vs. 57.1% for semaglutide alone).
• ASC47’s adipose-selective mechanism activates thyroid hormone receptors (THRβ) in fat tissue, reducing systemic exposure and minimizing muscle loss concerns.
• ASC47 significantly reduced low-density lipoprotein cholesterol (LDL-C) levels at both 30mg and 60mg doses.
• Ascletis plans Phase IIb trials combining monthly ASC47 with its GLP-1/GIP dual agonist ASC35, as well as daily oral formulations (ASC30) for obesity and metabolic dysfunction-associated steatohepatitis (MASH).

Zelgen (688266.SS) Puts First-in-Class Trispecific in Late-Stage Trial for SCLC

Key Words: alveltamig, trispecific antibody (TsAb), SCLC, DLL3/CD3, Phase III

• The News: Zelgen Biopharm has initiated a Phase III trial in China for its DLL3/CD3 TsAb, alveltamig, in relapsed small cell lung cancer (SCLC). This marks the world’s first Phase III study for a trispecific T-cell engager.
• Key Highlights:
• Alveltamig targets two distinct DLL3 epitopes on tumour cells while engaging CD3 on T-cells, achieving a 60% objective response rate (ORR) in Phase II studies with 10mg biweekly dosing in heavily pretreated patients.
• The candidate holds breakthrough therapy designation (BTD) from China’s Centre for Drug Evaluation (CDE) and orphan drug status from US health authorities.
• The open-label, multicentre trial will enrol 420 patients, comparing alveltamig against investigator’s choice of chemotherapy, with overall survival (OS) as the primary endpoint.

Keymed (2162.HK) Advances BCMA/CD3 BsAb to Phase III Trials in MM

Key Words: CM336, BCMA/CD3 bispecific antibody (BsAb), multiple myeloma (MM), Phase III

• The News: Keymed Biosciences has launched a Phase III trial for its BCMA/CD3 BsAb, CM336, in relapsed/refractory multiple myeloma (r/r MM) following promising Phase I/II results conducted in China.
• Key Highlights:
• CM336 achieved an 80% objective response rate (ORR) at higher dose levels, with a 60% complete response rate (CRR) at 80-160mg dosing and 71% response at 20-40mg levels in heavily pretreated patients with a median of three prior therapies.
• The open-label, multicentre trial will randomise 280 patients against investigator’s choice of standard therapy, with progression-free survival (PFS) as the primary endpoint.
• CM336 leverages CD3 recruitment to activate T-cells against BCMA-expressing myeloma cells, offering potential differentiation through optimised binding affinity and reduced cytokine release syndrome (CRS) incidence.

Akeso’s (9926.HK) HER3-Targeting ADC Gets Green-Light for the Clinic in China

Key Words: AK138D1, HER3, ADC, clinical trial approval

• The News: Akeso Biopharma has received clinical trial approval from China’s Centre for Drug Evaluation (CDE) for its first ADC, AK138D1, targeting HER3 in advanced solid tumours.
• Key Highlights:
• AK138D1 combines a fully humanised anti-HER3 IgG1 antibody (patritumab) with a deruxtecan payload, linked via a cleavable MC-AAA linker.
• Completed Phase I enrolment in Australia demonstrated safety, tolerability, pharmacokinetics, and preliminary efficacy in malignancies such as breast, ovarian, and lung cancers, where HER3 overexpression drives tumorigenesis and therapy resistance.
• This marks Akeso’s first ADC program entering clinical trials, building on its bispecific antibody (BsAb) platform, which includes the PD-1/CTLA-4 inhibitor cadonilimab.

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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