Qihan-Biotech’s QT-019B Universal CAR-T Wins Implied NMPA Approval
Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for...
Drug
Junshi’s JS001sc Subcutaneous PD-1 Meets Phase 3 Endpoint in NSCLC
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that its Phase 3 trial JS001sc-002-III-NSCLC...
CStone’s Sugemalimab Wins EU Approval for Stage III NSCLC, Expanding European Indication
CStone Pharmaceuticals (HKG: 2616) announced that the European Commission (EC) has approved a new indication...
Salubris’ SAL0139 Wins NMPA Nod for Hyperlipidemia Clinical Trial
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that its independently developed innovative small molecule...
Zhongsheng’s Onradivir Granules Enroll First Phase 3 Pediatric Influenza Patient
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced the enrollment and dosing of the first...
Kelun-Biotech’s Sac-TMT Achieves First ADC-IO NSCLC Success
Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that sacituzumab tirumotecan (sac-TMT), its proprietary TROP2 ADC,...
Luye’s LY03017 Wins FDA Nod for Psychosis Trials in Alzheimer’s and Parkinson’s
Luye Pharma Group Limited (HKG: 2186) announced that its independently developed LY03017 received U.S. FDA...
Biokin’s iza-bren NDA Accepted for Nasopharyngeal Carcinoma, Advancing Bispecific ADC
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its New Drug Application (NDA) for...
Bayer’s HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer
Bayer AG (ETR: BAYN) announced that sevabertinib (trade name HYRNUO) received U.S. FDA approval for...
Pien Tze Huang’s PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436) announced the enrollment of the first...
Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its anti‑PD‑1 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly...
Pfizer’s Hympavzi Wins China Approval as First Weekly Non‑Factor Hemophilia Therapy
Pfizer Inc. (NYSE: PFE) announced that Hympavzi (marstacimab), the world’s first non‑factor hemophilia therapy requiring...
Kelun-Biotech’s Trastuzumab Botidotin HER2 ADC Launches in China After Phase 3 Win vs T-DM1
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced the official China launch of trastuzumab botidotin,...
Regeneron’s Libtayo Wins EC Approval for Adjuvant CSCC, 68% Risk Reduction
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the European Commission (EC) approved Libtayo (cemiplimab) as adjuvant...
Lynk’s LNK01004 Pan-JAK Inhibitor Shows EASI-75 Win in Phase 2 Atopic Dermatitis Trial
Lynk Pharmaceuticals Co., Ltd. announced positive Phase II data for its self‑developed Class 1 innovative drug LNK01004,...
Sino Biopharm’s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials
Sino Biopharmaceutical Limited (HKG: 1177) announced that its self‑developed LM‑350, a CDH17‑targeting Antibody‑Drug Conjugate (ADC),...
Cutia’s CU-40105 Topical Finasteride Spray NDA Accepted by NMPA, a China First
Cutia Therapeutics (HKG: 2487) announced that the National Medical Products Administration (NMPA) has accepted its...
Roche’s Lunsumio SC Wins EU Conditional Approval for Follicular Lymphoma
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) announced that the European Commission (EC) has granted...
Roche’s giredestrant SERD Achieves iDFS Win in Phase 3 lidERA Breast Cancer Trial
Roche (SWX: ROG, OTCMKTS: RHHBY) announced its investigational oral SERD giredestrant met the primary endpoint...
Hengrui’s HRS-6209 CDK4 Inhibitor Wins NMPA Nod for Breast Cancer Combo Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑6209 capsules, a novel...