Kelun‑Biotech’s SKB103 Wins NMPA Approval – Novel TAA‑PD‑L1 Bispecific ADC Enters Clinical Trials for Advanced Solid Tumors
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its SKB103, a novel TAA‑PD‑L1 bispecific...
Clinical trial approval / initiation
Alphamab Oncology Doses First Patient in Phase III KN026 Study – Bispecific HER2 Antibody Targets Adjuvant Breast Cancer
Alphamab Oncology (HKG: 9966) announced first patient dosing in a Phase III clinical study of...
Shenzhen Salubris Wins NMPA Approval for SAL0150 – Oral Long-Acting Diabetes/Obesity Drug Targets Weekly Dosing Regimen
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced clinical trial approval from China’s National Medical...
Qilu Pharma’s QLS1317 Wins NMPA Approval – First‑in‑Class MSI‑H Targeted Therapy Enters Solid Tumor Clinical Trials
Qilu Pharmaceutical Co., Ltd. announced that its self‑developed Category 1 innovative drug, QLS1317 tablets, has...
Henlius Biotech’s HLX18 Wins NMPA Approval – Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX18, a recombinant humanized anti‑PD‑1 monoclonal antibody...
Lepu Biopharma Wins NMPA Approval for Perioperative HNSCC Trial – First‑in‑World EGFR ADC + PD‑1 Combination Advances to Clinic
Lepu Biopharma Co., Ltd. (HKG: 2157) announced NMPA IND approval for a groundbreaking Phase II/III...
Biokin Pharma’s BL‑ARC002 Wins NMPA Approval – First‑in‑Class Antibody‑Radionuclide Conjugate Enters Solid Tumor Trials
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its BL‑ARC002 injection, a Category 1...
Hansoh Pharma Wins NMPA Approval for Two Category 1 Drugs – HS‑20152 and HS‑10587 Enter Clinical Trials in Rare Disease and Oncology
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that two Category 1 innovative drugs have...
Hengrui Pharma’s SHR-3836 Wins NMPA Approval for Multiple Myeloma – First-in-Class Anti-Tumor Agent Enters Clinical Development
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its independently developed drug...
Innovent Biologics Doses First Patient in Phase 3 Tigulixostat Study – Next‑Gen Xanthine Oxidase Inhibitor Targets Gout Market
Innovent Biologics, Inc. (HKG: 1801) announced that the first subject has been dosed in the...
CSPC Pharma’s SYH2082 Wins NMPA Approval – Long‑Acting GLP‑1/GIP Dual‑Biased Agonist Enters Obesity Clinical Trials
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its self‑developed SYH2082, a long‑acting injectable GLP‑1/GIP...
Alphamab Oncology Doses First Patient in JSKN016 Phase III – HER3/TROP2 ADC Targets Heavily Pretreated Triple Negative Breast Cancer
Alphamab Oncology (HKG: 9966) announced first patient dosing in a Phase III clinical study for...
Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced the initiation of a Phase III clinical...
Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) received National Medical Products Administration (NMPA) approval to initiate...
InventisBio’s D-2570 Wins FDA Phase II Clearance – Oral TYK2 Inhibitor Targets Moderate-to-Severe Plaque Psoriasis
InventisBio (Shanghai) Co., Ltd. (SHA: 688382) announced FDA clearance to initiate a Phase II clinical...
TransThera Sciences Doses First Patient in Phase II Tinengotinib Combination Study – Multi-Kinase Inhibitor Plus Fulvestrant Targets HR+/HER2- Breast Cancer
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced first patient dosing in a Phase II clinical...
Jiuyuan Gene Engineering Secures NMPA Approval for JY47 – SIRPα Antibody Enters MASH Clinical Development
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced receiving tacit clinical approval from China’s...
UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
CSPC Pharma Secures Dual NMPA‑FDA Approval for PDE4B Inhaler SYH2059 – First‑in‑Class ILD Candidate Enters Global Clinical Development
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its highly selective PDE4B inhibitor SYH2059 powder...