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...
Drug
Clover Bio Reports Positive SCB‑1019 Phase I Data – RSV PreF Vaccine Demonstrates Superior Booster Response vs. GSK’s Arexvy
Clover Biopharmaceuticals Ltd. (HKG: 2197) announced additional positive Phase I data from its US clinical...
Henlius Biotech Wins Health Canada Approval for Denosumab Biosimilars – Bildyos and Tuzemty Expand Organon Partnership to Canada
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced marketing approval from Health Canada for Bildyos (denosumab...
Qilu Pharma’s QLS31905 Wins FDA Orphan Drug Designation – First‑in‑Class Claudin18.2/CD3 Bispecific Enters Phase III for Pancreatic Cancer
Qilu Pharmaceutical Co., Ltd. announced that QLS31905, its Claudin18.2/CD3 bispecific T‑cell engager (BsAb), has received...
Bayer/Regeneron’s Eylea HD Wins Japan Approval for RVO – Third Indication Nod with Extended Dosing Demonstrates 3 Fewer Injections
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Eylea HD (aflibercept) injection 8...
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...
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...
GSK’s Risvutatug Rezetecan Wins Japan ODD – B7-H3 ADC Targets Small-Cell Lung Cancer with Phase 1 Durable Responses
GlaxoSmithKline (GSK; NYSE: GSK) announced that risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate (ADC), received...
Belief BioMed Partners with Grand Life Sciences on BBM-H803 – AAV Gene Therapy for Hemophilia A Targets Greater China Market
Belief BioMed (“BBM”) and Grand Life Sciences Group Co., Ltd. (HKG: 0512) announced an exclusive...
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...
Innovent’s IBI302 Hits STAR Trial Primary Endpoint – Dual VEGF/Complement Inhibitor Shows 16‑Week Dosing and 50% Macular Atrophy Reduction in nAMD
Innovent Biologics, Inc. (HKG: 1801) announced that its Phase III STAR study (NCT05972473) evaluating efdamrofusp...
RemeGen Secures Fourth NMPA Approval for Disitamab Vedotin – HER2‑Low Breast Cancer with Liver Metastases Indication Expands ADC Franchise
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced NMPA approval for a new indication of...
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...