This week’s China healthcare highlights include Ribo Life Science raising over HKD 1.8 billion through its Hong Kong IPO, and Insilico Medicine signing a US$ 888 million AI-driven oncology collaboration with Servier. BioRay and Simcere Zaiming filed for Hong Kong IPOs to advance their pipelines, while Haisco secured a US$ 1 billion global licensing deal for its PDE3/4 inhibitor. Key clinical updates include MSD’s China approval for PAH drug Winrevair, breakthrough therapy designation for Doer Biologics’ DR10624, Hansoh’s aumolertinib gaining its fifth indication, and Akeso’s ivonescimab showing dual PFS/OS positive Phase III data. These developments reflect strong progress in China’s biotech innovation and partnerships.

Transactions & BD (In/Out Licensing)

Ribo Life Science (6938.HK) Lists on Hong Kong Stock Exchange, Raising Over HKD 1.8 Billion

Key Words: Ribo Life Science, 06938.HK, siRNA, RNA therapeutics, IPO, Hong Kong Stock Exchange, HKEX, RiboGalSTAR, Hong Kong listing, cornerstone investors

The News: Ribo, a leading Chinese developer of small interfering RNA (siRNA) therapeutics, has successfully listed on the Main Board under Chapter 18A of the Hong Kong Stock Exchange. The company raised gross proceeds of over HKD 1.8 billion by issuing 31,610,400 shares at an offer price of HKD 57.97 per share.

Key Highlights:

• The Hong Kong public offering was over 100x oversubscribed, and the international placing was 16.7x oversubscribed, underscoring strong global investor demand for siRNA-focused biopharmaceutical companies.
• The IPO attracted 12 cornerstone investors, including Arc Avenue, Ivy Rock, Springs Capital, China Asset Management, Dacheng and Taikang Life Insurance, reflecting long-term institutional confidence in Ribo’s pipeline and platform.
• Ribo plans to use the proceeds to advance global multicentre clinical trials for its core siRNA products, support preclinical and clinical development of its broader pipeline, and upgrade its delivery and technology platforms, including the proprietary RiboGalSTAR™ liver-targeted siRNA delivery system.
• The company operates integrated R&D centres in Suzhou, Beijing and Gothenburg (Sweden), enabling end-to-end discovery and development of siRNA therapeutics across cardiovascular, metabolic, liver and kidney diseases.

Insilico Medicine (3696.HK) Signs Up to US$ 888 Million AI-Driven Oncology Collaboration with Servier

Key Words: Insilico Medicine, Servier, AI drug discovery, Pharma.AI, oncology, research collaboration, R&D partnership, milestone payments, Hong Kong IPO

The News: Insilico has entered into a multi-year research collaboration with Servier potentially worth up to US$ 888 million, combining Insilico’s AI-driven Pharma.AI platform with Servier’s oncology development expertise. Under the agreement, Insilico is eligible to receive up to US$ 32 million in upfront and near-term R&D milestone payments. Insilico will leverage its AI platform to identify and advance potential oncology drug candidates, while Servier will co-share R&D costs and lead subsequent clinical development and global commercialisation for selected assets.

Key Highlights:

• The collaboration focuses on discovering and developing novel oncology candidates, with Insilico responsible for AI-enabled target and molecule identification. Servier will co-fund R&D and take the lead in clinical development and worldwide commercialisation of promising programmes.
• The deal structure includes upfront, near-term R&D milestones, and additional development and commercial milestones that could bring total deal value up to US$ 888 million.
• The partnership follows Insilico’s Hong Kong IPO in December 2025 and extends its strategy of monetising its AI platform through high-value alliances.
• Insilico has previously announced three pipeline out-licensing deals with a combined potential value of US$ 2.1 billion and R&D partnerships with Sanofi, Eli Lilly, and Fosun Pharma, underscoring growing industry validation of its AI-driven drug discovery model.

BioRay Files for Hong Kong IPO, Showcasing Profitable Growth and Immune-Focused Portfolio

Key Words: BioRay, Hisun Pharmaceutical, Hong Kong IPO, HKEX, immunology, autoimmune diseases, oncology, bimekizumab, zebetuximab, biologics

The News: BioRay, an integrated biopharmaceutical company spun out from the biologics division of Hisun Pharmaceutical, has applied for an initial public offering (IPO) on the Main Board of the Hong Kong Stock Exchange. The company focuses on immune-mediated and oncologic diseases and aims to leverage the listing to further expand its clinical development and commercial footprint.

Key Highlights:

• BioRay reported revenues of RMB 1.257 billion in 2023, RMB 1.623 billion in 2024, and RMB 1.379 billion in the first three quarters of 2025. Profit attributable to equity shareholders reached RMB 19.0 million in 2023, RMB 91.3 million in 2024, and RMB 122 million in the first nine months of 2025, with 2025 year-to-date profit already close to the full-year 2024 level.
• BioRay has established one of the more comprehensive immune portfolios in China, anchored by eight commercial products:
  • Bimekizumab (Bimzelx®) – an in-licensed next-generation IL‑17A/IL‑17F inhibitor for multiple immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa. The drug has strong global sales momentum, with peak worldwide annual revenue estimated at around US$8 billion, and BioRay holds mainland China marketing and promotion rights.
  • Zebetuximab (Anruixi®) – a self-developed CD20 monoclonal antibody and, as of the latest practicable date, the first and only domestically approved Class 1 CD20 mAb in China, indicated for first-line treatment of CD20‑positive diffuse large B‑cell lymphoma (DLBCL). Sales increased from RMB 10.7 million in 2023 to RMB 277 million in 2024 and reached RMB 274 million in the nine months ended 30 September 2025, supported by inclusion in the National Reimbursement Drug List (NRDL).
  • Adalimumab, infliximab and etanercept for major autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease; trastuzumab for HER2‑positive breast and gastric cancers; and tocilizumab and tofacitinib for rheumatoid arthritis and other systemic inflammatory or immune‑mediated conditions.
• BioRay is pursuing a “self-developed + in‑licensed” model to accelerate portfolio expansion in autoimmune and tumor immunology. The company is advancing an innovation pipeline that builds on its marketed assets, aiming to strengthen its position in China’s high-growth autoimmune and immuno-oncology markets while enhancing its competitiveness in global biologics.

Simcere Zaiming Files for Hong Kong Main Board IPO with Post-Money Valuation of RMB 8.57 Billion

Key Words: Simcere Zaiming, Simcere, Hong Kong IPO, HKEX, oncology, ADC, bispecific antibody, SIM0613, Ipsen, innovative drugs

The News: Simcere Zaiming, the oncology innovation arm of Simcere, has submitted a Main Board IPO application to the Hong Kong Stock Exchange, with CICC and Morgan Stanley as joint sponsors. The company’s latest private financing round implied a post-money valuation of about RMB 8.57 billion, and the IPO aims to accelerate clinical pipeline progress and commercial expansion.

Key Highlights:

• Financials: Revenue reached RMB 1.522 billion in 2023 and RMB 1.296 billion in 2024; the first three quarters of 2025 delivered RMB 1.238 billion, up around 33% year-on-year, while the company remained loss-making due to high R&D and selling expenses.
• Products and pipeline: Five launched oncology products contributed over 90% of revenue in the first nine months of 2025, with four on China’s NRDL. The pipeline combines protein engineering, ADCs and bi-/multi-specific antibodies, including SIM0613 (GPRC5D/BCMA/CD3 trispecific antibody), out-licensed overseas to Ipsen with potential milestones of US$ 1.06 billion, and SIM0610 (USP1 inhibitor) for advanced solid tumours.
• Commercial footprint: Simcere Zaiming operates a 1,200+ person commercial team, collaborates with 120+ distributors, and covers more than 2,000 hospitals across China, pursuing a “self-developed + partnered” model to scale its oncology franchise.

Haisco Pharmaceutical (002653.SZ) Signs Over US$ 1 Billion Global Licensing Deal with AirNexis, a new biotech founded by Frazier Life Sciences, for COPD PDE3/4 Inhibitor

Key Words: Haisco Pharmaceutical, AirNexis Therapeutics, HSK39004, AN01, PDE3/4 inhibitor, COPD, global licensing, milestones, royalty

The News: On 9 January, Haisco Pharmaceutical announced an exclusive license agreement with US-based AirNexis Therapeutics, granting AirNexis exclusive rights to develop, manufacture and commercialize the dual PDE3/4 inhibitor HSK39004 (AN01) outside mainland China, Hong Kong, Macau and Taiwan.

Key Highlights:

• Deal Economics: AirNexis will pay Haisco US$ 108 million upfront (US$ 40 million in cash and US$ 68 million in AirNexis shares representing 19.9% equity), up to US$ 955 million in additional milestone payments, and tiered royalties of up to 12% on future net sales. Haisco is also eligible for a share of any sublicense income AirNexis receives in its territories.
• Asset Profile – HSK39004 (AN01): HSK39004 is a dual PDE3/4 inhibitor in development as an adjunctive maintenance therapy for COPD, designed to dilate bronchi and reduce airway inflammation. It is being developed in two inhaled formulations (suspension and dry powder), both in Phase II clinical trials in China, with cumulative R&D investment of approximately RMB 70 million as of 31 December 2025.
• AirNexis, incorporated in Delaware in 2025 with support from Frazier Life Sciences, is backed by a US$ 200 million investor syndicate including FLS, OrbiMed, Goldman Sachs’ life sciences fund, SR One, Longitude and Enavate Sciences, positioning HSK39004 for late-stage global development outside Greater China.

Clinical

MSD (NYSE: MRK) Wins China Approval for First-in-Class PAH Drug Winrevair

Key Words: MSD, Merck, Winrevair, sotatercept, pulmonary arterial hypertension, PAH, activin signalling inhibitor, TGF-β, STELLAR trial, China NMPA

The News: MSD has received marketing authorisation in China for Winrevair (sotatercept), a first-in-class therapy for pulmonary arterial hypertension (PAH). Winrevair is administered via subcutaneous injection once every three weeks and is the first approved activin signalling inhibitor for PAH, targeting a key pathway involved in pulmonary vascular remodelling. The product is a fusion protein that selectively binds ligands within the TGF-β superfamily, helping restore balance between pro‑proliferative and anti‑proliferative signalling in the pulmonary vasculature.

Key Highlights:

• The approval is supported by positive Phase III STELLAR trial data, where sotatercept added to background therapy significantly improved exercise capacity versus placebo.
• At 24 weeks, patients receiving sotatercept achieved a 34.4‑metre increase in six‑minute walk distance, a key efficacy endpoint in PAH.
• Winrevair introduces a novel mechanism of action in PAH, addressing underlying vascular remodelling rather than acting solely via vasodilation like most existing therapies.
• The drug generated approximately US$ 419 million in its first year of sales following initial US approval in March 2024, underscoring strong global demand.
• With China NMPA approval, MSD expands the global footprint of Winrevair in a major PAH market, adding an innovative treatment option for patients with high unmet medical need.

Doer Biologics’ Triple Agonist DR10624 Receives Breakthrough Therapy Designation in China

Key Words: Doer Biologics, Huadong Medicine, DR10624, GLP-1R/GCGR/FGF21R, triple agonist, severe hypertriglyceridaemia, HTG, breakthrough therapy designation, BTD, CDE, metabolic disorders

The News: Doer Biologics, a subsidiary of Huadong Medicine, has received breakthrough therapy designation (BTD) from China’s Centre for Drug Evaluation (CDE) for DR10624, a first-in-class triple agonist targeting GLP-1, glucagon (GCGR) and FGF21 receptors for the treatment of severe hypertriglyceridaemia. In a Phase II study, DR10624 achieved a median reduction in fasting triglycerides of up to 74.5% after 12 weeks, versus 8.0% with placebo.

Key Highlights:

• First-in-class GLP-1R/GCGR/FGF21R triple agonist designed as a long-acting, multi-pathway metabolic therapy.
• Phase II data showed median 74.5% triglyceride reduction at Week 12 compared with 8.0% on placebo.
• Treatment led to up to 67% reduction in liver fat content, alongside weight loss and improvements in atherogenic lipids.
• In patients with baseline HbA1c ≥ 6.5%, DR10624 produced a 0.68% decrease in HbA1c, supporting its potential in broader severe metabolic disorders.

Hansoh Pharmaceutical’s (3692.HK) Aumolertinib Wins Fifth Indication with Positive AENEAS 2 Phase III Data

Key Words: Hansoh Pharmaceutical, aumolertinib, EGFR-mutated NSCLC, AENEAS 2, pemetrexed, platinum-based chemotherapy, first-line treatment, PFS, ORR

The News: Hansoh announced that aumolertinib has been approved for its fifth indication: in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or L858R substitution mutations.

Key Highlights:

• The new indication is supported by the Phase III AENEAS 2 study, which showed that aumolertinib plus chemotherapy significantly prolonged progression-free survival (PFS) versus aumolertinib monotherapy, with a hazard ratio (HR) of 0.47.
• The combination regimen achieved a median PFS (mPFS) of 28.9 months and an objective response rate (ORR) of 93.2%, without new safety signals.
• Since its initial approval in 2020, aumolertinib has expanded from a single indication to five, markedly broadening its treatment coverage for EGFR-mutated NSCLC patients.

Immunofoco Biotechnology’s CLDN18.2 CAR-T IMC-002 to Present Positive Phase I/IIa Data at 2026 ASCO GI

Key Words: Immunofoco, CLDN18.2, IMC-002, CAR-T, gastric cancer, gastroesophageal junction cancer, ASCO GI 2026, Phase I/IIa, Phase III trial

The News: Immunofoco announced that Phase I/IIa clinical data for its autologous CLDN18.2-targeting CAR-T cell therapy IMC-002 in advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) will be presented at the 2026 ASCO GI Symposium.

Key Highlights:

• The IMC-002-RT01 study is a multicenter, open-label Phase I/IIa trial evaluating the safety and preliminary efficacy of IMC-002 in heavily pre-treated, CLDN18.2-positive GC/GEJ patients.
• IMC-002 showed excellent overall tolerability, with no dose-limiting toxicities or neurotoxicity observed.
• The therapy demonstrated prominent anti-tumor activity and durable responses, indicating potential for deep remission and long-term survival benefit from a single infusion.
• A national Phase III confirmatory clinical trial of IMC-002 is currently underway.

Sanofi’s (SNY.O; SAN.PA) siRNA Therapy Plozasiran Wins China Approval for FCS

Key Words: Sanofi, plozasiran, siRNA, familial chylomicronemia syndrome, FCS, APOC3, triglycerides, acute pancreatitis, Visirna, Arrowhead

The News: Sanofi announced that plozasiran has been approved in China, making it the first and only FDA-approved siRNA therapy for familial chylomicronemia syndrome (FCS) now also available in this market.

Key Highlights:

• Plozasiran is a small interfering RNA (siRNA) therapy that inhibits apolipoprotein C‑III (APOC3), a key regulator that slows triglyceride breakdown.
• Clinical data supporting the China approval show that plozasiran significantly lowers triglyceride levels and reduces the risk of acute pancreatitis with once‑quarterly dosing, providing sustained triglyceride reduction for FCS patients.
• Sanofi obtained development and commercialization rights in Greater China for plozasiran from Visirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals, in August 2025.

HUTCHMED’s (0013.HK) Syk Inhibitor Sovleplenib Meets Phase III Primary Endpoint in wAIHA in China

Key Words: HUTCHMED, Hutchison China MediTech, sovleplenib, Syk inhibitor, warm autoimmune hemolytic anemia, wAIHA, Phase III, NDA, China NMPA

The News: HUTCHMED announced positive topline results from the Phase III part of the ESLIM‑02 trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China, with the study meeting its primary endpoint of durable hemoglobin (Hb) response rate between weeks 5 and 24.

Key Highlights:

• wAIHA is the most common form of autoimmune hemolytic anemia (AIHA), accounting for 75–80% of adult AIHA cases, and remains an area of high unmet need, particularly in patients refractory to standard therapies.
• Sovleplenib, a novel spleen tyrosine kinase (Syk) inhibitor, demonstrated rapid and durable Hb responses in patients who had failed standard treatments in the Phase III ESLIM‑02 study.
• Earlier Phase II data showed an overall response rate (ORR) of 43.8% vs 0% in the first 8 weeks and 66.7% over 24 weeks, with a favorable safety profile, supporting progression to Phase III.
• HUTCHMED plans to submit a New Drug Application (NDA) for sovleplenib in wAIHA to the China NMPA in the first half of 2026.

Akeso’s (9926.HK) Ivonescimab Label Updated in China with First Dual PFS/OS Positive Phase III Data in EGFR-TKI–Resistant nsq-NSCLC

Key Words: Akeso, ivonescimab, AK112-301, HARMONi-A, nsq-NSCLC, EGFR-TKI resistant, NMPA, PFS, OS

The News: Akeso announced that China’s NMPA has approved a major update to the ivonescimab (AK112-301) prescribing information, incorporating final HARMONi-A Phase III data in locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) that has progressed after EGFR-TKI treatment.

Key Highlights:

• HARMONi-A is the first Phase III trial in EGFR-TKI–resistant nsq-NSCLC to achieve dual positive results in both progression-free survival (PFS) and overall survival (OS).
• Ivonescimab combination therapy reduced the risk of death by 26% (OS HR=0.74; P=0.019) and lowered the risk of disease progression or death by 54% (PFS HR=0.46; P<0.001), extending median PFS from 4.8 to 7.1 months.
• The updated label also reflects ivonescimab’s favorable long-term safety profile, reinforcing its role as a new treatment option for EGFR-TKI–resistant nsq-NSCLC in China.

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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