Avistone’s Vebreltinib Wins NMPA Approval for MET-Amplified NSCLC
Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd. announced that its subsidiary Pearl Bio’s c-MET inhibitor vebreltinib...
Cancer
BMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration...
GenFleet Therapeutics Files for Hong Kong IPO Amid KRAS Inhibitor Success
China-based GenFleet Therapeutics (Shanghai) Inc. has submitted its initial public offering (IPO) application to the...
Mabwell Bioscience Partners With Calico Life Sciences on 9MW3811 Development
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) is set to enter into a licensing...
Sino Biopharmaceutical’s LM-108 Gains CDE BTD for Gastric Adenocarcinoma
Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has obtained Breakthrough Therapy Designation (BTD) from...
Mabwell Bioscience Grants Qilu Pharma Exclusive Rights to Mailisheng in Greater China
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced a licensing agreement with compatriot firm...
Fosun Pharma’s Serplulimab Approved for ES-SCLC in the UK and India
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai...
Bio-Thera Solutions Initiates Phase III Trial of BAT8006 for Platinum-Resistant Ovarian Cancer
Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced the successful first patient dosing in its Phase III...
EMA Panel Recommends Brukinsa Tablet Formulation for Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
CARsgen’s Satri-cel NDA Accepted by China’s NMPA for Gastric Adenocarcinoma
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the National Medical Products Administration (NMPA)...
Immvira Bioscience Files for Hong Kong IPO to Advance Oncolytic Immunotherapy Pipeline
Shenzhen-based Immvira Bioscience Inc. has filed for an initial public offering (IPO) with the Hong...
Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing...
BeOne Medicines Launches Ziihera for HER2-High Biliary Tract Cancer in China
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced the official commercial availability...
Medilink Therapeutics’ YL201 Wins FDA Breakthrough Therapy Designation for SCLC
Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
TransThera Sciences’ Tinengotinib Gains FDA Fast Track for mCRPC Treatment
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced...
Broncus Medical Wins NMPA Approval for BroncAblate RFA System Console
Shanghai and Hangzhou (China), and San Jose and Seattle (United States)-based Broncus Medical (HKG: 2216)...
Hengrui Pharmaceuticals Wins NMPA Approval for Six Novel Solid Tumor Drugs
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approvals from the...
J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Johnson & Johnson’s Imbruvica Secures CHMP Recommendation for Expanded MCL Use
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products...