This week’s China healthcare highlights include Adcoris signing a global licensing deal with K2 Therapeutics for ACR246, a first-in-class 5T4 ADC, leveraging a NewCo model to grant K2 global development and commercialization rights alongside equity and up to US$ 730M in milestones. BeOne Medicines licensed a trispecific antibody HH160 from Huahui Health in a deal worth up to US$ 2.02B, while Argo Biopharma’s siRNA candidate BW-50218 entered Phase I, triggering a milestone payment from Novartis. Henlius Biotech gained EU approval for POHERDY® (HLX11), a pertuzumab biosimilar for HER2-positive breast cancer. Other updates include Jiangsu Lianhuan’s positive Phase III results for LH-1801 in type 2 diabetes, Insilico Medicine’s IND approval for inhalable Rentosertib, and InnoCare enrolling the first patient in a Phase III trial of orelabrutinib for SLE.

Transactions

Adcoris Signs Global Licensing Deal with K2 Therapeutics for 5T4 ADC ACR246

Key Words: Adcoris, K2 Therapeutics, ACR246, 5T4 ADC, NewCo, licensing deal, TopI payload, solid tumors

• The News: China-based Adcoris entered an exclusive strategic partnership with Singapore’s K2 Therapeutics for ACR246, a first-in-class 5T4-targeting ADC. The NewCo-based deal grants K2 global rights to ACR246 and another bispecific ADC program, with Adcoris receiving upfront cash, equity, up to US$ 730 million in milestones, and double-digit tiered royalties.
• Key Highlights:
• Deal Details:
  • Equity in the newly formed entity.
  • Up to US$ 730 million in milestone payments.
  • K2 receives global development and commercialization rights to ACR246 and another bispecific ADC program through a NewCo model.
• ACR246 is a first-in-class 5T4 ADC using a novel TopI inhibitor payload and targeting the 5T4-positive solid tumors.
• Clinical Status: Phase I/IIa ongoing in China to assesses the safety and efficacy; global Phase Ib planned in 2027.
• Adcoris is a China-based biotechnology company developing next-generation antibody-drug conjugates and other innovative oncology therapies.
• K2 Therapeutics is a Singapore-based biotech company backed by MPM BioImpact and focused on advancing ADC and oncology drug development globally.

BeOne Medicines (688235.SH) Licenses PD-1×CTLA-4×VEGF-A Trispecific Antibody from Huahui Health

Key Words: BeOne Medicines, Huahui Health, HH160, trispecific antibody, PD-1, CTLA-4, VEGF-A, oncology, licensing deal

• The News: BeOne Medicines has entered into an exclusive option and license agreement with Huahui Health for a trispecific antibody targeting PD-1, CTLA-4 and VEGF-A, potentially HH160. Under the agreement, BeOne will pay a US$ 20 million upfront fee. If BeOne exercises its option within the specified period, Huahui will receive an additional US$100 million option exercise payment, and may receive up to US$ 374 million in development and regulatory milestones, up to US$1.53 billion in sales milestones, plus tiered royalties on future sales. Upon option exercise, BeOne will gain exclusive global rights to develop, manufacture and commercialize the selected candidate.
• Key Highlights:
• Deal Details:
  • Total deal value: Up to US$ 2.02 billion.
  • Upfront Payment: US$ 20 million.
  • Additional Payment: Up to US$ 2.004 billion, including US$ 100 million option exercise payment, up to US$ 374 million in development and regulatory milestones, and up to US$ 1.53 billion in sales milestones.
  • Exclusive option and license agreement; BeOne gains global rights after option exercise.
• HH160: Trispecific antibody targeting PD-1, CTLA-4, and VEGF-A and designed to simultaneously modulate three key pathways in the tumour micro-environment.
• Huahui Health is a China-based biotechnology company focused on developing innovative multi-specific antibody therapies for oncology and other diseases.

Clinical

Argo Biopharma’s BW-50218 Enters Phase I, Triggering Novartis Milestone Payment

Key Words: Argo Biopharmaceutical, BW-50218, Novartis, siRNA, TTR, Phase I, milestone payment, RNAi

• The News: Argo Biopharma announced that its TTR-targeting siRNA candidate BW-50218 has completed first subject dosing in a Phase I clinical trial in Australia. As the molecule has entered the clinical stage, Argo Biopharma will receive a milestone payment under its exclusive license and collaboration agreement with Novartis. The payment will be used to support continued development of the company’s liver-targeted and extrahepatic siRNA pipeline. BW-50218 is an siRNA therapeutic developed based on Argo Biopharma RADS™ platform and is designed to achieve potent and durable gene silencing through liver-targeted delivery.
• Key Highlights:
• Drug Profile – BW-50218:
  • BW-50218: a TTR-targeting siRNA developed using Argo’s RADS™ platform with liver-targeted delivery.
  • Phase I trial in Australia evaluating safety, tolerability, PK, and PD.
• BW-50218 is covered by Argo’s exclusive license and collaboration agreement with Novartis.
• Milestone Trigger: First-in-human dosing triggers a milestone payment from Novartis.
• Argo Biopharma is a clinical-stage biotechnology company focused on developing next-generation RNAi therapeutics using liver-targeted and extrahepatic siRNA delivery platforms.

Henlius Biotech (2696.HK) POHERDY® Gains EU Approval, Supporting Organon Commercialization Partnership

Key Words: Henlius Biotech, Organon, HLX11, POHERDY, pertuzumab biosimilar, EU approval, HER2 breast cancer, commercialization

• The News: Shanghai Henlius announced that the European Commission approved HLX11, a pertuzumab biosimilar marketed as POHERDY®, for HER2-positive early and metastatic breast cancer. Henlius plans to commercialize the product in agreed regions with Organon.
• Key Highlights:
• Regulatory Progress:
  • The European Commission has approved POHERDY® / HLX11 in the EU.
  • The EU approval follows POHERDY®’s prior approval in the US, further expanding its global regulatory footprint.
• HLX11 is a pertuzumab biosimilar referencing PERJETA® and approved as a 420 mg/14 mL injection for intravenous use.
• Indications:
  • HER2-positive early breast cancer including neoadjuvant and adjuvant treatment for patients at high risk of recurrence.
  • HER2-positive metastatic or unresectable recurrent breast cancer.
• Henlius will commercialize HLX11 with Organon in agreed regions.

Jiangsu Lianhuan (600513.SH) Reports Positive Phase III Results for LH-1801 in Type 2 Diabetes

Key Words: Jiangsu Lianhuan, LH-1801, SGLT-2 inhibitor, metformin, type 2 diabetes, Phase III, NDA

• The News: Jiangsu Lianhuan announced topline Phase III results for LH-1801 combined with metformin in Chinese adults with inadequately controlled type 2 diabetes. The study met its primary endpoint and will support a future NDA submission.
• Key Highlights:
• Study Design:
  • Multicenter, randomized, double-blind, dapagliflozin-controlled Phase III trial.
  • 615 Chinese adults with type 2 diabetes inadequately controlled on stable metformin.
• Drug Profile – LH-1801:
  • LH-1801: a novel SGLT-2 inhibitor co-developed with the Chinese Academy of Sciences Shanghai Institute of Materia Medica.
  • Developed for Type 2 Diabetes and has independent intellectual property rights in China.
• Regulatory Pathway:
  • Further analysis ongoing; NDA planned after results from the second pivotal monotherapy study.
  • Pending favorable results from the second monotherapy study, Jiangsu Lianhuan plans to submit a new drug application.

Insilico Medicine (3696.HK)’s Inhaled Rentosertib Receives CDE IND Approval

Key Words: Insilico Medicine, Rentosertib, ISM001-055, IPF, inhaled formulation, AI drug discovery, CDE, IND

• The News: Insilico Medicine announced that the nebulized inhalation formulation of Rentosertib, also known as ISM001-055, has received IND approval from China’s CDE and is expected to enter clinical development. The inhaled formulation is designed for direct lung delivery, aiming to improve local exposure and reduce systemic exposure, following positive Phase IIa results for the oral formulation in IPF.
• Key Highlights:
• Rentosertib is an AI-discovered and AI-designed drug candidate for idiopathic pulmonary fibrosis, with both oral and nebulized inhalation formulations under development.
• Formulation: Inhaled delivery aims to increase lung exposure, reduce dose, accelerate onset, and lower systemic exposure.
• Clinical Plan:
  • Phase I study in healthy volunteers and IPF patients.
  • Includes SAD/MAD cohorts and open-label patient evaluation.
  • Expected enrollment: around 80 subjects.
• Pipeline Relevance: Rentosertib nebulized inhalation formulation is the 13th program from Insilico Medicine’s AI-driven R&D pipeline to receive IND approval.

InnoCare Pharma 09969.HK) Enrolls First Patient in Phase III Trial of Orelabrutinib for SLE

Key Words: InnoCare, orelabrutinib, BTK inhibitor, SLE, systemic lupus erythematosus, Phase III, SRI-4

• The News: InnoCare Pharma announced the first patient enrollment in the Phase III registration clinical trial of orelabrutinib, its investigational BTK inhibitor, for the treatment of Systemic Lupus Erythematosus. The Phase III trial follows positive Phase IIb results, in which orelabrutinib became the first BTK inhibitor to demonstrate efficacy in SLE. The ongoing Phase III study will further evaluate the efficacy and safety of orelabrutinib in SLE.
• Key Highlights:
• Orelabrutinib is an investigational BTK inhibitor and is the first BTK inhibitor to demonstrate efficacy in SLE.
• Phase IIb Data:
  • At Week 48, the 75mg QD orelabrutinib group achieved a significantly higher SRI-4 response rate than placebo: 57.1% vs. 34.4%, p < 0.05.
  • In the high disease activity subgroup, the SRI-4 response rate reached 68%, representing a 43% improvement.
  • In the 75mg group, 71.1% of patients reduced steroid dosage to ≤7.5mg.
• Phase III will further evaluate efficacy and safety in SLE.

Shanxi Micot Completes Phase I Database Lock for Anticoagulant Reversal Agent MT1011
Key Words: Shanxi Micot, MT1011, anticoagulant reversal, factor Xa inhibitors, Phase I, bleeding risk

• The News: Shanxi Micot Technology announced that its broad-spectrum anticoagulant reversal agent MT1011 completed Phase I clinical study database lock on April 17, 2026. MT1011 is a novel synthetic small-molecule drug designed to address severe bleeding risks associated with anticoagulant therapy. In the single-center Phase I study, MT1011 showed a favorable safety profile, with no drug-related serious adverse events reported across five dose groups. The company plans to accelerate the initiation of Phase II clinical trials.
• Key Highlights:
• Product Profile – MT1011:
  • MT1011 is a synthetic small-molecule anticoagulant reversal agent and is designed to address severe bleeding risks associated with anticoagulant therapy.
  • The initial target use is reversal of Factor Xa inhibitors, including rivaroxaban and apixaban.
• Clinical Progress:
  • Phase I clinical study database lock was completed on April 17, 2026, following a single-center study across five dose groups.
  • MT1011 showed a favorable safety profile with no drug-related SAEs reported, and the company plans to accelerate Phase II initiation.
• Shanxi Micot Technology is a China-based biopharmaceutical company focused on developing innovative therapies in thrombosis, hemostasis and anticoagulation-related indications.

Allist Pharmaceuticals (688578.SS)’s GlecirAsib + Sitneprotafib Combination Proposed for Breakthrough Therapy Designation

Key Words: Allist, glecirasib, sitneprotafib, KRAS G12C, SHP2 inhibitor, NSCLC, Breakthrough Therapy Designation

• The News: Shanghai Allist Pharmaceuticals announced that its oral dual-target combination of glecirasib plus sitneprotafib has been included in the proposed Breakthrough Therapy Designation list for first-line KRAS G12C-mutated, PD-L1<50% locally advanced or metastatic non-squamous NSCLC. Early clinical data showed a confirmed ORR of 71% and median PFS of 12.2 months, with controllable safety.
• Key Highlights:
• Product Profile:
  • GlecirAsib is a KRAS G12C inhibitor
  • Sitneprotafib is a highly selective SHP2 inhibitor.
  • The combination is an oral dual-target regimen designed to provide synergistic anti-tumor effects.
• Clinical Data:
  • Confirmed ORR: 71%.
  • Median PFS: 12.2 months.
  • Median follow-up: 14.4 months.
• Clinical Significance:
  • The proposed designation reflects the potential of the combination as a first-line targeted therapy option for KRAS G12C-mutated NSCLC patients with PD-L1<50%.
  • The regimen is intended to address an unmet need in a patient population currently treated mainly with immune-chemotherapy-based first-line regimens.

Hutchmed (0013.HK)’s Sovleplenib NDA Accepted in China for wAIHA

Key Words: Hutchmed, sovleplenib, Syk inhibitor, wAIHA, NDA, Priority Review, Breakthrough Therapy Designation

• The News: HUTCHMED announced that China’s NMPA has accepted its New Drug Application for sovleplenib in patients with warm antibody autoimmune hemolytic anemia. The NDA also received Priority Review and Breakthrough Therapy Designation. The submission is supported by data from the randomized, double-blind, placebo-controlled China Phase II/III ESLIM-02 study, in which the Phase III stage met the primary endpoint of durable hemoglobin response between Weeks 5 and 24. Sovleplenib is a novel, highly selective oral Syk inhibitor, and this marks its second NDA submission.
• Key Highlights:
• Sovleplenib is a novel, highly selective oral Syk inhibitor and is developed for patients with warm antibody autoimmune hemolytic anemia.
• Regulatory Status: China’s NMPA accepted the NDA for sovleplenib in wAIHA with Priority Review and Breakthrough Therapy Designation.
• Clinical Data:
  • The NDA is supported by the randomized, double-blind, placebo-controlled China Phase II/III ESLIM-02 study.
  • The Phase III stage met the primary endpoint of durable hemoglobin response between Weeks 5 and 24.
  • Earlier Phase II results showed an overall response rate of 43.8% versus 0% for placebo during the first 8 weeks.
  • Over 24 weeks, the overall response rate was 66.7%.
• Upcoming Step: Phase III data to be presented at EHA 2026.

Bayer (ETR: BAYN)’s Asundexian NDA Accepted in China for Secondary Stroke Prevention

Key Words: Bayer, asundexian, FXIa inhibitor, ischemic stroke, TIA, NMPA, CDE, OCEANIC-STROKE

• The News: Bayer announced that the marketing application for asundexian, also known as has been accepted by China’s NMPA Center for Drug Evaluation. The application is for reducing the risk of recurrent stroke in adult patients with ischemic stroke or transient ischemic attack, excluding patients with cardioembolic stroke. Asundexian is a direct inhibitor of activated coagulation factor XI. In the Phase III OCEANIC-STROKE study, asundexian plus antiplatelet therapy significantly reduced the risk of ischemic stroke by 26% versus placebo without increasing the risk of ISTH-defined major bleeding.
• Key Highlights:
• High ischemic stroke recurrence and bleeding limitations with current antithrombotics highlight the need for safer secondary prevention options.
• Product Profile – Asundexian:
  • Asundexian is a direct inhibitor of activated coagulation factor XI and FXIa plays different roles in hemostasis and thrombosis.
  • Evaluated as a potential option for secondary prevention after non-cardioembolic ischemic stroke or high-risk TIA
• Clinical Data:
  • In the Phase III OCEANIC-STROKE study, Asundexian was evaluated in patients after non-cardioembolic ischemic stroke or high-risk TIA.
  • Compared with placebo, asundexian plus antiplatelet therapy significantly reduced the risk of ischemic stroke by 26% in Phase III stage.
  • The treatment did not increase the risk of ISTH-defined major bleeding.
  • The results were consistent across subgroups including age, sex, qualifying event, stroke subtype, NIHSS score, acute stroke treatment, and secondary prevention strategy.

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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