This week’s China healthcare highlights showcase strong innovation and global ambitions through major licensing deals, IPO activity, and clinical advancements. Notable transactions include Shimai Pharma’s Hong Kong IPO for its next-gen TCE platform, Mindray Medical’s IPO for global expansion, and transformative deals like Third Arc Bio-Adagene’s US$840M pact for tumor-specific T-cell engagers and SanegeneBio-Lilly’s US$1.2B RNAi collaboration. Clinical breakthroughs feature GenFleet’s Phase III KRAS G12D trial, Lepu Biopharma’s 75% ORR in r/r DLBCL, and AusperBio’s chronic hepatitis B success. Beijing Mabworks and Hygieia also delivered major milestones in PMN and cardiovascular therapies, further solidifying China’s leadership in innovative therapeutics and global biotech growth.

Transactions & BD (In/Out Licensing)

Zhejiang Shimai Pharmaceutical Files for Hong Kong IPO

Key Words: Shimai Pharma, T-cell Engager, IPO, Hong Kong Stock Exchange, Oncology

The News: Shimai Pharma, a Hangzhou-based biotech company, filed its prospectus with the Hong Kong Stock Exchange on November 12, 2025, seeking a Main Board IPO listing. Founded in 2017, Shimai Pharma is a global leader in next-generation T-cell engager (TCE) therapies, utilizing its innovative cloaked TCE technology to selectively activate treatments within tumors for the treatment of solid tumors.

Key Highlights:

• Core Products:
  • DNV3: A potential best-in-class LAG3-targeting TCM, completed Phase I in 2022 for advanced tumors and lymphomas. It ranks second globally and in China for melanoma treatment among anti-LAG3 antibodies.
  • SMET12: A first-in-class EGFR×CD3 TCE in Phase IIa for EGFR-positive advanced solid tumors, including esophageal cancer. It received FDA IND approval in 2021 and is ranked first globally and in China by development stage.
  • CMD011: A GPC3×CD3 TCE in Phase I for liver cancer, showcasing Shimai’s modular TCE platform. It ranks among the top two globally for its class.
  • CMDE005: A next-generation cloaked EGFR×CD3 TCE in Phase I, designed to reduce immune-related risks like cytokine release syndrome (CRS).
• Preclinical Pipeline: Shimai is also advancing two tri-specific cloaked TCE candidates, CMDE101 (FOLR1×PD-L1×CD3) and CMDE102 (PSMA×PD-L1×CD3), aimed at delivering multifunctional therapies for solid tumors.

Mindray Medical (300760.SZ) Files for Hong Kong IPO, Expanding Global Strategy

Key Words: Mindray Medical, Hong Kong IPO, Globalization, Medical Devices

The News: On November 10, 2025, Mindray Medical, a leading Chinese medical device company, officially filed its IPO application with the Hong Kong Stock Exchange. The IPO will combine a Hong Kong public offering with an international placement, with proceeds to be used for R&D investment, global M&A, and strengthening its global sales and supply chain capabilities.

Key Highlights:

• Global Leadership: Mindray is among the global top 30 medical device companies, with several product lines ranked in the global top three by market share. Its international revenue accounts for over 50% of total revenue, and its comprehensive product portfolio spans diagnostics, imaging, life support, and surgical solutions.
• Strong R&D and Strategic M&A: As of June 2025, Mindray invested RMB 12.8 billion in R&D, with 5,200 researchers across 12 global centers and 12,240 patents filed. Strategic acquisitions, such as Finland’s HyTest and Germany’s DiaSys, have strengthened its supply chain and expanded its IVD business.
• Global Expansion: Mindray operates in 14 countries, with 64 overseas subsidiaries and localized production in 11 countries. In 2024, international revenue reached RMB 16.4 billion, and its major product lines rank top three globally.

Genuine Biotech Submits Prospectus for Proposed IPO on Hong Kong Stock Exchange, Exclusively Sponsored by CICC

Key Words: Genuine Biotech, IPO, Hong Kong Stock Exchange, Azvudine, CICC

The News: On November 9, 2025, Genuine, a biotechnology company based in Pingdingshan, Henan Province, officially filed its prospectus with the Hong Kong Stock Exchange for a proposed IPO on the Main Board. This submission follows previous filings that expired on August 4, 2022, and February 18, 2025. The IPO is exclusively sponsored by China International Capital Corporation (CICC).

Key Highlights:

• Core Business: Established in 2012, Genuine Biotech focuses on the development, manufacturing, and commercialization of innovative drugs targeting viral infections, cancer, and cardiovascular and cerebrovascular diseases.
• Drug Portfolio:
• Azvudine: The company’s flagship product, conditionally approved in China for HIV and COVID-19, is under development for monotherapy in multiple myeloma, lymphoma, and acute leukemia, as well as four combination therapies, including Azvudine/Anti-PD-1 for liver and colorectal cancers.
• CL-197: Designed for long-acting HIV treatment.
• Doravirine: Targeted therapy for non-small cell lung cancer.
• ZSSW-136: Developed for malignant tumors.
• MTB-1806: Aimed at acute ischemic stroke treatment.

Third Arc Bio Pens Back-Loaded US$ 840 Million Pact for Adagene’s Masking T-Cell Engager Tech

Key Words: Third Arc Bio, Adagene, Safebody, T-Cell Engagers, Immunotherapy, Licensing Deal

The News: Third Arc Bio has entered a licensing agreement with Adagene to leverage the biotech’s Safebody precision antibody masking platform for the development of two new CD3 T-cell engagers targeting tumor-associated antigens. The deal includes a US$ 5 million upfront payment to Adagene, with the potential for up to US$ 840 million in development and commercial milestones, plus royalties, according to a Nov. 13 announcement.

Key Highlights:

• Innovative Technology: Adagene’s Safebody platform enables the activation of antigens exclusively within the tumor microenvironment, improving safety and expanding the therapeutic index of T-cell engagers.
• Global Development Rights: Third Arc Bio will receive worldwide rights to research, develop, and market two candidates derived from the collaboration. Adagene retains a no-cost option to develop and commercialize the products in specific parts of Asia.
• Strategic Fit: Third Arc Bio aims to integrate Safebody technology into its portfolio of CD3- and CD28-targeting T-cell engagers. The company’s lead program, ARC101, a bispecific T-cell engager targeting CLDN6, is currently in Phase 1 trials for solid tumors.
• Adagene’s Track Record: Adagene’s masking technology has attracted partnerships with major players like Sanofi, which extended its collaboration with Adagene in July 2025, investing US$ 25 million and sponsoring a trial for the biotech’s lead candidate, ADG126 (muzastotug), an anti-CTLA-4 therapy in Phase 1b/2 and Phase 2 trials.

SanegeneBio and Lilly (NYSE.O) Ink RNAi Licensing Deal for Metabolic Diseases

Key Words: SanegeneBio, Eli Lilly, RNAi, Metabolic Diseases, LEAD™ Platform, Licensing Deal

The News: SanegeneBio, a clinical-stage biotechnology company specializing in RNAi therapeutics, has entered into a global research and licensing collaboration with Eli Lilly and Company (Lilly) to develop RNAi therapeutics for metabolic diseases. The agreement leverages SanegeneBio’s proprietary tissue-selective delivery technology, LEAD™ (Ligand and Enhancer Assisted Delivery), and marks a significant step forward in creating innovative, disease-modifying therapies.

Key Highlights:

• Collaboration Details: SanegeneBio will lead the discovery and optimization of RNAi molecules using its LEAD™ platform, while Lilly will handle IND-enabling studies, clinical development, and global commercialization. This partnership combines SanegeneBio’s expertise in RNAi delivery technology with Lilly’s strengths in drug development and commercialization.
• Innovative Technology: The LEAD™ platform enables tissue-selective delivery of RNAi therapies, allowing for subcutaneous administration as infrequently as twice per year. This breakthrough technology offers improved efficacy, safety, and durability, providing a transformative approach to treating metabolic diseases.
• Financial Terms: SanegeneBio will receive an upfront payment, equity investment, and near-term milestones, with the potential for up to US$1.2 billion in total milestones and tiered royalties on future sales.
• About SanegeneBio: Founded in 2021, SanegeneBio is a biotechnology company focusing on RNAi-based therapeutics. With R&D operations in Boston, Shanghai, and Suzhou, the company is advancing a pipeline of experimental medicines targeting autoimmune nephropathies, obesity, and cardiometabolic diseases using its proprietary LEAD™ platform.

AI Biotech Pioneer Insilico Medicine Reapplies for Hong Kong IPO

Key Words: Insilico Medicine, Hong Kong IPO, AI Drug Discovery, Pharma.AI, Generative AI

The News: On November 4, 2025, Insilico Medicine, a globally recognized leader in AI-driven drug discovery, officially reapplied for a Hong Kong IPO. Founded in 2014, the company leverages its proprietary Pharma.AI platform to revolutionize drug discovery and development, with a clinical pipeline that includes a Phase II candidate, positioning it as an industry frontrunner.

Key Highlights:

• Innovative AI Platform: Insilico’s Pharma.AI platform provides end-to-end solutions, from target identification to small molecule generation and clinical outcome prediction. As of November 2025, it has generated over 20 clinical or IND-stage assets, with three licensed to global pharmaceutical companies, securing contracts worth over US$ 2 billion.
• Efficiency in Drug Discovery: Insilico’s AI-powered approach significantly reduces discovery timelines, identifying drug candidates in 12–18 months versus the industry average of 4.5 years.
• Broadening Applications: Beyond pharmaceuticals, Insilico is expanding Pharma.AI’s use to advanced materials, agriculture, nutritional products, and veterinary medicine, demonstrating the platform’s versatility.
• Patents and Revenue Growth: Insilico has 739 patents and patent applications, with revenue primarily driven by licensing deals, collaborations, and its in-house drug pipeline.

Clinical Development

Simcere Pharmaceutical (2096.HK) Initiates Phase II Trial for Treg-Selective IL-2 Mutant Fusion Protein

Key Words: Simcere, SIM0278, Treg, IL-2 Mutant, Atopic Dermatitis, Autoimmune Diseases

The News: Simcere has initiated a Phase II clinical trial for its Treg-selective IL-2 mutant fusion protein, SIM0278, targeting moderate-to-severe atopic dermatitis. This follows promising Phase I results demonstrating a favorable pharmacokinetic and safety profile. The randomized, double-blind, placebo-controlled multicenter trial will evaluate the subcutaneous injection’s ability to restore immune balance by preferentially activating regulatory T-cells (Tregs) over effector T-cells and natural killer (NK) cells.

Key Highlights:

• Innovative Mechanism: SIM0278 employs protein engineering to reduce effector T-cell affinity while maintaining Treg binding, leveraging the Treg peripheral tolerance mechanism to address immune dysregulation in autoimmune conditions.
• Strategic Partnerships: Simcere partnered with Almirall in 2022, granting Almirall ex-China rights for dermatology indications. The candidate has already completed Phase I trials in the US, with Phase II studies planned for additional skin diseases.
• Best-in-Class Potential: SIM0278 demonstrates durable efficacy, an optimized dosing regimen, and broad therapeutic potential across multiple immune-mediated disorders, including atopic dermatitis.

GenFleet Therapeutics ‘s (2595.HK) KRAS G12D Inhibitor Becomes Second Globally to Enter Phase III

Key Words: GenFleet, KRAS G12D, GFH375, Pancreatic Cancer, Phase III, RAS Pathway

The News: GenFleet, a China-based biotech company, has initiated a Phase III clinical trial for its oral KRAS G12D inhibitor, GFH375, in 320 patients with pretreated metastatic pancreatic cancer. This follows positive Phase I/II results, which showed a 41% objective response rate (ORR) and a 97% disease control rate (DCR). The global, multicenter open-label randomized trial will compare GFH375 monotherapy against investigator’s choice chemotherapy, with co-primary endpoints of progression-free survival (PFS) and overall survival (OS), paving the way for potential regulatory approval.

Key Highlights:

• Innovative Mechanism: GFH375 is a small-molecule inhibitor that non-covalently binds to both active and inactive KRAS G12D conformations, preventing downstream pathway activation. The drug demonstrated a low off-target risk in kinase selectivity profiling.
• Partnership Expansion: GenFleet signed a 2023 agreement with Verastem Oncology covering three RAS pathway targets. Verastem exercised an option for ex-China rights to GFH375 in January 2025, following encouraging early clinical data.
• Global Competitive Landscape: GFH375 is the second KRAS G12D inhibitor to reach Phase III globally, following Hengrui’s HRS-4642.
• Safety Profile: In a safety analysis of 66 patients, 30% experienced grade-3 treatment-related adverse events, with manageable gastrointestinal and hematological toxicities supporting further development for advanced pancreatic ductal adenocarcinoma.

Lepu Biopharma (2157.HK) Flaunts 75% ORR for CD20 ADC Plus Orelabrutinib in r/r DLBCL

Key Words: Lepu Biopharma, MRG001, Orelabrutinib, CD20 ADC, DLBCL, Phase II

The News: Lepu has unveiled promising Phase II data for its CD20 antibody-drug conjugate (ADC), MRG001, combined with the BTK inhibitor orelabrutinib, in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). The combination achieved a 75% objective response rate (ORR), including 25% complete responses (CR), across 16 evaluable patients, with a 93.8% disease control rate (DCR). Notably, 100% of patients previously treated with CD3/CD20 bispecific antibodies (BsAb) responded, and the regimen showed an 87.5% response in the triple-class exposed population, including patients with bulky lesions over 7.5 cm.

Key Highlights:

• Innovative Mechanism: MRG001 features a valine-citrulline linker that conjugates a chimeric anti-CD20 antibody to an MMAE payload. Its mechanism complements orelabrutinib’s inhibition of B-cell receptor signaling while preserving natural killer cell-mediated antibody-dependent cellular cytotoxicity (ADCC).
• Safety Profile: The combination therapy demonstrated a manageable safety profile with no dose-limiting toxicities, supporting its potential as a novel treatment for chemotherapy-resistant B-cell malignancies.
• Market Opportunity: With approximately 190,000 new DLBCL cases annually in China and a global market projected to exceed US$ 11.5 billion by 2034, the combination therapy could address a significant unmet need.

AusperBio Announces Late-Breaking 48-Week Phase II Data of AHB-137 in Chronic Hepatitis B at AASLD 2025

Key Words: AusperBio, AHB-137, Chronic Hepatitis B, Antisense Oligonucleotide, Phase II, AASLD

The News: AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio) presented late-breaking 48-week data from two Phase II studies of AHB-137 at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 in Washington D.C. The pooled data from two multicenter, randomized Phase II trials (NCT06115993; NCT06550128) in HBeAg-negative chronic hepatitis B (CHB) patients on nucleos(t)ide analog (NA) therapy demonstrated sustained antiviral responses and a favorable safety profile.

Key Highlights:

• Efficacy Results: AHB-137 treatment achieved robust antiviral responses 24 weeks after the end of treatment (Week 48), with the 300 mg, 24-week regimen delivering the highest response rates. Key outcomes included:
  • Complete Response: HBsAg < 0.05 IU/mL and HBV DNA < LLOQ.
  • Partial Response: HBsAg < 10 IU/mL and HBV DNA < LLOQ.
• Safety Profile: AHB-137 was well tolerated, with no new safety signals identified during the off-treatment phase.
• Consistent Efficacy: Response rates were consistent across baseline HBsAg levels, supporting the potential for broad utility in CHB patients.
• About AHB-137: AHB-137 is an investigational unconjugated antisense oligonucleotide (ASO) developed using AusperBio’s proprietary Med-Oligo™ ASO technology. Designed to achieve a functional cure for chronic hepatitis B, AHB-137 employs a novel dual mechanism and has shown promise in preclinical and clinical settings. It has completed a global Phase I study and is now being evaluated in multiple Phase II trials and a Phase III trial in China as part of a coordinated global development strategy.

Beijing Mabworks Biotechnology Presents Positive Phase III Results for MIL62 in Primary Membranous Nephropathy at ASN 2025

Key Words: Beijing Mabworks, MIL62, Primary Membranous Nephropathy, Phase III, ASN, Clinical Remission

The News: Mabworks announced that Phase III clinical trial results for MIL62 in primary membranous nephropathy (PMN) were presented as a “High-Impact Clinical Trial” oral report at the 2025 American Society of Nephrology (ASN) Annual Meeting. This marks the first global Phase III study in PMN to meet its primary endpoint, demonstrating significant efficacy and safety for MIL62 monotherapy.

Key Highlights:

• Efficacy Achievements:
  • Clinical Remission: MIL62 achieved a 49.4% complete clinical remission rate at 76 weeks, compared to 3.9% in the control group (P<0.0001).
  • Overall Remission: 4% of MIL62-treated patients achieved clinical remission by 76 weeks.
  • Rapid Response: Median immunological remission time was 5 weeks, and median clinical remission time was 16 weeks. Immunological complete remission (based on PLA2R antibody levels) reached 90.6% at 52 weeks.
• Renal Function Protection: MIL62 demonstrated renal protection, with a mean change in eGFR at 76 weeks of +3.9 ml/min/1.73m² compared to -10.4 ml/min/1.73m² in the control group.
• Safety Profile: The overall safety profile of MIL62 was favorable, supporting its use as a monotherapy in PMN.
• Regulatory Progress: The New Drug Application (NDA) for MIL62 in PMN was accepted by the China National Medical Products Administration (NMPA) in September 2025 and granted priority review.

Hangzhou Hygieia Pharmaceuticals Presents Positive Phase 1 Data for Kylo-11 in Elevated Lp(a) at AHA 2025

Key Words: Hangzhou Hygieia, Kylo-11, Lp(a), Phase 1, AHA, Cardiovascular Disease

The News: Hygieia presented Phase 1 clinical trial data for Kylo-11 at the 2025 American Heart Association (AHA) Scientific Sessions. The randomized, double-blind, placebo-controlled, single ascending dose study in Chinese healthy subjects with elevated lipoprotein(a) [Lp(a)] demonstrated significant and durable reductions in serum Lp(a) levels, positioning Kylo-11 as a potential ultra-long-acting therapy for cardiovascular risk reduction.

Key Highlights:

• Efficacy Results:
  • Lp(a) Reduction: A single dose of Kylo-11 achieved Lp(a) reductions ranging from 83.5% to 98.4% across six dose cohorts (9 mg to 600 mg) and an exploratory 225 mg cohort in subjects with baseline Lp(a) > 200 nmol/L.
  • Sustained Efficacy: 30 mg group: 77.6% reduction maintained at Week 48; 225 mg group: 96.7% reduction maintained at Week 40.
  • Rapid and Durable Effects: Doses ≥ 30 mg reduced Lp(a) levels below 75 nmol/L starting at Week 4 and sustained the reduction throughout the study.
• Safety Profile: Kylo-11 was well tolerated across all dose groups, with no serious adverse events or injection site reactions reported.
• Innovative Potential: The data support Kylo-11’s promise as an ultra-long-acting therapy, with the potential for once-a-year dosing, offering a convenient and effective treatment for patients with elevated Lp(a).

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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