This week, biotech highlights include Dizal’s US$ 1.5B AstraZeneca deal (EGFR TKI, NSCLC), Hansoh’s US$ 2.3B IL-23 licensing (autoimmune), Innovent’s US$ 1.1B CD40L antibody deal, Jasper’s Kira acquisition with US$ 132M financing, and Insilico’s US$ 2.5B AI drug alliance.

Transactions & BD (In/Out Licensing)

Dizal (688192.SH) Licenses Sunvozertinib to AstraZeneca in US$ 1.5 Billion Global Deal

Key Words: sunvozertinib, EGFR TKI, NSCLC, exon20ins, Dizal, AstraZeneca, licensing, WU-KONG28

• The News: Dizal Pharmaceutical has granted AstraZeneca exclusive global rights to develop and commercialize sunvozertinib, an oral, irreversible, highly selective EGFR TKI targeting multiple EGFR mutation subtypes. The deal includes a US$ 600 million non-refundable upfront payment, up to US$ 400 million in clinical development milestones, up to US$ 500 million in sales milestones.
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 1.5 billion plus tiered royalties.
  • Upfront Payment: US$ 600 million, non-refundable.
  • Milestone Payments: up to US$ 400 million clinical, up to US$ 500 million sales.
• Product Profile – Sunvozertinib:
  • Sunvozertinib: an oral, irreversible, highly selective EGFR TKI targeting multiple EGFR mutation subtypes.
  • Mechanism: covalently inhibits mutant EGFR signaling, including EGFR exon 20 insertion and other activating or resistance-associated EGFR mutations.
  • Indication Focus: EGFR-mutant NSCLC, particularly EGFR exon 20 insertion-positive disease, with broader potential across multiple EGFR-driven mutation subtypes.
  • Development Stage: approved in China for previously treated EGFR exon 20 insertion NSCLC.

Hansoh Pharmaceutical (3692.HK) Licenses Oral IL-23 Receptor Antagonist to Avere Therapeutics Amid NextCure (NXTC.O) Merger

Key Words: IL-23, oral cyclic peptide, licensing, M&A, reverse merger, autoimmune, Siglec-15, NextCure, Avere Therapeutics

• The News: Hansoh Pharmaceutical granted Avere Therapeutics exclusive rights to develop, manufacture, and commercialize AVR-001 / HS-20118, an oral cyclic peptide IL-23 receptor antagonist, in markets outside Mainland China, Hong Kong, Macau, and Taiwan. Avere simultaneously entered into a reverse merger agreement with NextCure, with the combined company expected to operate as Avere Therapeutics upon completion of the transaction, which is expected in H2 2026.
• Key Highlights:
• Deal Details:
  • Total Deal Value: approximately US$ 2.3 billion, includes US$120 million upfront and up to US$ 2.18 billion in milestones, plus tiered royalties on net sales.
  • The Avere-NextCure merger is expected to close in H2 2026; pre-merger NextCure shareholders will hold approximately 1.21% of the combined company, while Avere shareholders will hold approximately 98.79%.
  • The US$ 320 million private investment includes US$ 251 million in convertible notes that convert to common stock upon merger close.
• Product Profile -AVR-001 / HS-20118:
  • AVR-001 / HS-20118: an oral cyclic peptide IL-23 receptor antagonist discovered by Hansoh Pharmaceutical and licensed to Avere Therapeutics for global development in autoimmune and inflammatory diseases.
  • Mechanism: designed to block IL-23 signaling by inhibiting IL-23 pathway activation, thereby reducing Th17-driven inflammation and downstream inflammatory cytokines such as IL-17.
  • Indication Focus: IL-23-mediated autoimmune diseases, including psoriasis, psoriatic arthritis, inflammatory bowel disease and other chronic inflammatory conditions.
  • Development Stage: clinical-stage oral IL-23 program.
• Avere Therapeutics is a privately held biotechnology company developing oral therapies for IL-23-driven inflammatory diseases, led by its once-weekly oral IL-23 program AVR-001.

Innovent Biologics (1801.HK) and Spero Therapeutics (SPRO.O) Enter US$ 1.1 Billion Exclusive License for IBI355

Key Words: Innovent, Spero, IBI355, CD40L, IgG4-RD, SjD, license, Phase I, Phase II

• The News: Innovent Biologics granted Spero Therapeutics exclusive global rights outside Greater China to develop, manufacture and commercialize IBI355, a third-generation anti-CD40L monoclonal antibody. The deal totals approximately US$ 1.1 billion including upfront, development, regulatory and sales milestones plus tiered royalties on net sales.
• Key Highlights:
• Total Deal Value: approximately US$ 1.1 billion.
• Product Profile – IBI355:
  • IBI355: A third-generation anti-CD40L monoclonal antibody developed by Innovent Biologics for autoimmune and inflammatory diseases.
  • Mechanism: Blocks the CD40L–CD40 co-stimulatory pathway, reducing abnormal B-cell activation, T-cell–B-cell interaction, autoantibody production and inflammatory immune responses.
  • Indication Focus: IgG4-related disease, Sjögren’s disease and other CD40L-driven autoimmune diseases.
  • Development Stage: Phase I completed / early clinical development.

Jasper Therapeutics (JSPR.O) Acquires Kira Pharmaceuticals and Raises US$132 Million to Advance Immunology Pipeline

Key Words: Jasper Therapeutics, Kira Pharmaceuticals, merger, financing, complement, immunology, KP-104, KP-701, briquilimab, autoimmune diseases

• The News: Jasper Therapeutics completed an all-stock acquisition of Kira Pharmaceuticals; a privately held biotechnology company focused on complement and immune-mediated disease therapies. Following the transaction, the combined company will continue operating under Jasper Therapeutics. Concurrently, Jasper raised approximately US$132 million in net proceeds through a private placement of convertible preferred stock.
• Key Highlights:
• Deal Details:
  • Total Deal Value: US$ 132 million private placement net proceeds, plus all-stock merger consideration.
  • Combined company retains KP-104, and KP-701; Kira out-licensed KP-301 and KP-402 to Mirador Therapeutics for US$ 12 million upfront plus development and sales milestones
• Product Profile – KP-104 (Vensobafusp alfa):
  • KP-104: A potential best-in-class dual complement inhibitor targeting both the alternative and terminal complement pathways, in Phase 2/3-ready development for paroxysmal nocturnal hemoglobinuria (PNH) and rare kidney diseases.
  • Mechanism: Bifunctional biologic simultaneously blocking the alternative and terminal complement pathways.
  • Indication Focus: PNH and rare kidney diseases; Phase 2 basket trial interim data expected Q4 2026 for kidney indication, with updated data in Q2 2027; Phase 2 end-of-meeting with FDA planned for PNH, with update in H1 2027.
• Product Profile – KP-701:
  • KP-701: A preclinical novel dual-action anti-CD79BxCD32B monoclonal antibody for autoantibody-mediated diseases.
  • Mechanism: Dual-action antibody targeting B-cell receptor components CD79B and CD32B.
  • Indication Focus: Autoantibody-mediated diseases; CTA/IND submission expected Q1 2027, first-in-human data planned Q3 2027.

Insilico Medicine (3696.HK) and Bora Pharmaceuticals (TPE: 6472) Form Strategic AI Drug Development Alliance Worth Over US$ 2.5 Billion

Key Words: Insilico Medicine, Bora Pharmaceuticals, Pharma.AI, AI drug discovery, strategic collaboration, automation, drug development

• The News: Insilico Medicine and Bora Pharmaceuticals announced a strategic collaboration alliance to integrate Insilico’s AI-powered Pharma.AI platform with Bora’s global capabilities. The partnership has a potential total value exceeding US$ 2.5 billion if fully implemented, aiming to establish an AI-driven end-to-end drug development and manufacturing ecosystem.
• Key Highlights:
• Deal Details:
  • Total Deal Value: over US$ 2.5 billion.
  • Collaboration Scope: AI-enabled target discovery, molecular design, drug optimization, development planning, manufacturing, quality systems, and commercialization.
• Product Profile – AI Platform:
  • AI: an AI-powered drug discovery platform developed by Insilico Medicine that integrates artificial intelligence, machine learning, and automation technologies.
  • Target Identification & Validation: uses multi-omics data and AI models to discover and prioritize disease-associated targets.
  • Mechanism:AI-driven target identification, generative chemistry, and molecular optimization to analyze biological data, identify novel disease targets, generate new molecular structures, and optimize drug candidates for potency, selectivity, safety, and pharmacokinetic properties.
  • Clinical Validation:supported the discovery and development of Rentosertib (ISM001-055), an AI-discovered small molecule targeting TNIK for idiopathic pulmonary fibrosis (IPF), which has advanced into Phase III clinical development.

Clinical

Kelun-Biotech (6990.HK) Reports SKB264 Plus Keytruda Hits Primary Endpoint in First-Line PD-L1 Negative NSCLC Phase III Study

Key Words: Kelun-Biotech, SKB264, sac-TMT, TROP2 ADC, Keytruda, pembrolizumab, PD-L1 negative, non-squamous NSCLC, Phase III, OptiTROP-Lung06, PFS

• The News: Kelun-Biotech announced that its TROP2 ADC sac-TMT combined with pembrolizumab met the primary endpoint of progression-free survival (PFS) in a pre-specified interim analysis of the Phase III OptiTROP-Lung06 study for first-line treatment of PD-L1 negative locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
• Key Highlights:
• Clinical Data – OptiTROP-Lung06:
  • Study Design: randomized, open-label, multicenter Phase III evaluating sac-TMT plus pembrolizumab versus chemotherapy plus pembrolizumab in PD-L1 TPS <1% locally advanced or metastatic non-squamous NSCLC.
  • Efficacy: sac-TMT plus pembrolizumab showed statistically significant and clinically meaningful PFS improvement versus pembrolizumab plus pemetrexed and platinum chemotherapy, with a favorable overall survival trend observed.
  • Safety: safety profile consistent with prior reports, no new safety signals identified.
• Product Profile – Sac-TMT (SKB264/MK-2870):
  • Sac-TMT: a TROP2-targeting antibody-drug conjugate with a novel topoisomerase I inhibitor payload, developed by Kelun-Biotech and co-developed with Merck (MK-2870).
  • Mechanism: binds TROP2-expressing tumor cells and delivers a belotecan-derived topoisomerase I inhibitor payload through ADC-mediated internalization, inducing DNA damage and tumor-cell death.
  • Indication Focus: first-line PD-L1 negative non-squamous NSCLC; prior Phase III OptiTROP-Lung05 in PD-L1 positive NSCLC also met primary endpoint, with a supplemental NDA submitted to CDE.
  • Development Stage: Phase III clinical development; OptiTROP-Lung06 met its primary PFS endpoint in first-line PD-L1-negative locally advanced or metastatic non-squamous NSCLC.

MediLink Therapeutics’s B7-H3 ADC YL201 Files for Marketing Approval in China

Key Words: B7-H3, ADC, YL201, MediLink Therapeutics, Roche, nasopharyngeal carcinoma, TMALIN, NMPA, FDA

• The News: MediLink Therapeutics’s B7-H3-targeting ADC YL201 (tam-peli) has submitted a New Drug Application to the CDE for relapsed/metastatic nasopharyngeal carcinoma after prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
• Key Highlights:
• Clinical Data – TAISHAN-301:
  • Phase III study in relapsed/metastatic nasopharyngeal carcinoma met one co-primary endpoint of BICR-assessed ORR at a pre-specified interim analysis in May 2025; the other co-primary endpoint of OS is not yet mature.
  • The first positive Phase III results globally for a B7-H3 ADC.
• Product Profile – YL201:
  • YL201: aB7-H3-targeting antibody-drug conjugate developed by MediLink Therapeutics for advanced solid tumors, with an NDA submitted in China for relapsed / metastatic nasopharyngeal carcinoma after prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
  • Mechanism: Binds B7-H3-expressing tumor cells and delivers a cytotoxic payload through ADC-mediated internalization, leading to intracellular payload release, DNA damage and tumor-cell death.
  • Indication Focus: relapsed / metastatic nasopharyngeal carcinoma, with broader potential across B7-H3-expressing solid tumors.
  • Development Stage: NDA submitted to China CDE for nasopharyngeal carcinoma; partnered with Roche for global development.

China’s State Council Prioritises Innovation in 15th Five-Year Health Plan

Key Words: China, State Council, innovation, drugs, devices, clinical evaluation, AI, cell therapy, gene therapy, radiopharmaceuticals

• The News: China’s State Council released the National Health 15th Five-Year Plan, elevating support for innovative drugs and medical devices to a top-level strategic priority. The plan introduces a comprehensive clinical evaluation system for innovative drugs to address hospital access barriers, where average tertiary hospital adoption rates for negotiated innovative drugs were only ~10.7% between 2010 and mid-2024.
• Key Highlights:
• Clinical Data:
  • Average tertiary hospital adoption rate for negotiated innovative drugs was ~10.7% from 2010 to mid-2024, limiting clinical accessibility.
  • Unified evaluation framework aims to provide institutional support for evidence-based formulary inclusion and clinical uptake.
• Product Profile – Frontier Modalities:
  • Cell and gene therapies, novel antibodies, vaccines, nucleic acid drugs, and radiopharmaceuticals named as specific priority modalities.
  • AI integration mandated across the health-industrial chain, including a national pilot base for medical AI applications.
• Regulatory and Policy Framework:
  • Revised Drug Administration Law Implementation Regulations (effective May 2026) formalise four accelerated pathways: breakthrough, conditional approval, priority review, special approval.
  • Overseas data reciprocity and paediatric/rare disease market exclusivity included in the regulations.
  • Drug Trial Data Protection Measures (June 2026) grant up to six years’ data protection for imported originators.
  • Pricing reforms allow self-assessed innovative drug pricing and a new commercial health insurance innovative drug catalogue.

Hengrui Medicine (600276.SH) Reports Positive Phase III Data for First-in-Class FXI Antibody SHR-2004 in VTE Prophylaxis

Key Words: Hengrui Medicine, SHR-2004, Factor XI, antibody, VTE prophylaxis, Phase III, total knee arthroplasty, enoxaparin, superiority, NDA

• The News: Hengrui Medicine announced positive top-line results from a Phase III confirmatory trial of SHR-2004, a first-in-class humanised monoclonal antibody targeting Factor XI/XIa, for venous thromboembolism prophylaxis after total knee arthroplasty.
• Key Highlights:
• Clinical Data:
  • Study Design: randomised, double-blind, 111-centre trial in 1,165 patients comparing single-dose intravenous SHR-2004 (90 mg) or subcutaneous SHR-2004 (120 mg) 4–8 hours post-TKA versus daily subcutaneous enoxaparin (40 mg).
  • Efficacy: VTE rates at day 12 were 10.6% (IV), 16.1% (SC), and 21.9% (enoxaparin); IV arm achieved superiority with p<0.0001.
  • Safety: composite bleeding rates of 1.9% (IV), 2.1% (SC), and 1.9% (enoxaparin); no new safety signals observed.
• Product Profile – SHR-2004:
  • SHR-2004: a first-in-class humanised monoclonal antibody targeting coagulation Factor XI and activated FXIa, designed to block the intrinsic thrombotic amplification pathway while preserving haemostatic function.
  • Mechanism: inhibits FXI/FXIa to reduce thrombosis without increasing bleeding risk associated with current anticoagulants.
  • Indication Focus: venous thromboembolism prophylaxis after total knee arthroplasty.
  • Development Stage: Phase III confirmatory trial completed; NDA submission planned in China in 2026.

Hansoh Pharmaceutical and GSK-Partnered B7-H3 ADC Achieves Phase III OS Benefit in SCLC

Key Words: B7-H3, ADC, SCLC, Phase III, OS, Hansoh, GSK, ARTEMIS-008

• The News: Hansoh Pharmaceutical announced that risvutatug rezetecan, a B7-H3-targeted ADC, met the primary overall survival endpoint in the Phase III ARTEMIS-008 trial for small cell lung cancer. The result marks the first Phase III confirmation of an OS benefit for a B7-H3 ADC in any tumor type.
• Key Highlights:
• Clinical Data – ARTEMIS-008:
  • Study Design: Phase III, randomized, comparing risvutatug rezetecan versus topotecan in SCLC patients.
  • Primary Endpoint: statistically significant and clinically meaningful OS improvement at prespecified interim analysis.
  • Secondary Endpoints: consistent gains in PFS and no new safety signals observed.
• Product Profile – Risvutatug Rezetecan:
  • Risvutatug Rezetecan: a B7-H3-targeted antibody-drug conjugate developed by Hansoh Pharmaceutical and partnered with GSK, being advanced for small cell lung cancer and other B7-H3-expressing solid tumors.
  • Mechanism: binds B7-H3 on tumor cells and delivers a rezetecan-based topoisomerase I inhibitor payload through ADC-mediated internalization, causing DNA damage and tumor-cell death.
  • Indication Focus: Small cell lung cancer, addressing unmet need after rapid relapse on platinum-based therapy.
  • Development Stage: Phase III completed; NMPA BLA submission planned; global Phase I and Phase III ongoing under GSK partnership

Hengrui Medicine (600276.SH) Addresses FDA Delay in US BLA for Camrelizumab Plus Rivoceranib in HCC

Key Words: Hengrui, camrelizumab, rivoceranib, FDA, CRL, HCC, CARES-310, cGMP

• The News: Hengrui Medicine received a Complete Response Letter from the FDA for the BLA of camrelizumab plus rivoceranib in first-line unresectable or metastatic HCC, citing cGMP observations at the rivoceranib manufacturing site from an April 2026 inspection.
• Key Highlights:
• Clinical Data – CARES-310:
  • Study Design: Global, randomized, open-label Phase III study evaluating camrelizumab plus rivoceranib versus sorafenib as first-line treatment for unresectable or metastatic HCC.
  • Patient Population: patients with unresectable or metastatic HCC who had not received prior systemic therapy.
  • Efficacy Results:combination significantly improved both PFS and OS versus sorafenib. In the primary analysis, median PFS was 5.6 months versus 3.7 months, while interim OS was 22.1 months versus 15.2 months.
  • Response:achieved a higher objective response rate versus sorafenib, supporting improved tumor control in first-line HCC.
• Product Profile – Camrelizumab plus Rivoceranib:
  • Camrelizumab plus Rivoceranib: A combination regimen pairing Hengrui’s anti-PD-1 antibody camrelizumab with rivoceranib, an oral VEGFR2 tyrosine kinase inhibitor, for first-line unresectable or metastatic hepatocellular carcinoma.
  • Mechanism: Camrelizumab restores T-cell-mediated antitumor immunity by blocking PD-1 signaling, while rivoceranib inhibits VEGFR2-driven angiogenesis and may improve the tumor microenvironment to enhance immune response.
  • Indication Focus: first-line unresectable or metastatic hepatocellular carcinoma.
  • The CARES-310 Phase III study showed improved overall survival and progression-free survival versus sorafenib in first-line unresectable or metastatic HCC.
  • Development Stage: approved in China and under U.S. regulatory review; the FDA issued a Complete Response Letter citing cGMP observations at the rivoceranib manufacturing site rather than new clinical efficacy or safety concerns.

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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