Zhifei Bio Initiates Phase I Study for DTaP-Hib Quadrivalent Vaccine – Component Combination Targets Pediatric Immunization Compliance
Chongqing Zhifei Biological Co., Ltd. (SHE: 300122) announced the initiation of a Phase I clinical...
Clinical trial approval / initiation
Gan & Lee’s Bonfaglutide Wins NMPA Approval for OSA Study – Biweekly GLP‑1 Expands to Sleep Apnea Indication
Gan & Lee Pharmaceuticals (SHA: 603087) announced NMPA clinical trial approval to initiate a study...
Haixi Pharma Advances HXP056 to Phase II – Oral Multi‑Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced the initiation of a Phase II clinical...
IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced receiving tacit clinical approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...
Hope Medicine Doses First Patient in HMI-115 Phase III – First-in-Class Non-Hormonal Endometriosis Therapy Advances in China
Hope Medicine Inc. announced first patient dosing in a Phase III clinical study evaluating HMI-115,...
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...
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...