CStone Pharmaceuticals’ Gavreto Wins Hong Kong Approval for RET Fusion NSCLC
CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval...
Product approvals
NMPA Approves RocketHeart’s LV Assist System and Our United Group’s Radiation Therapy Device
The National Medical Products Administration (NMPA) has approved marketing for two innovative medical devices: RocketHeart’s...
BeiGene’s Tislelizumab Faces FDA Delay Due to Inspection Hurdles
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision...
Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products...
Venus Medtech’s Transcatheter Prosthetic Pulmonary Valve Approved by NMPA
The National Medical Products Administration (NMPA) has approved Venus Medtech (Hangzhou) Inc’s (HKG: 2500) transcatheter...
Hansoh Pharmaceutical’s Generic Ibrance Approved by NMPA
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that it has received market approval...
Hengrui Medicine’s Generic Tacrolimus Wins NMPA Approval for Transplant Rejection Prevention
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received market approval...
Bayer’s Kerendia Approved by China’s NMPA for Diabetic Kidney Disease
The National Medical Products Administration (NMPA) has approved Bayer’s (ETR: BAYN) Category 1 drug Kerendia...
Hengrui Medicine’s SHR3680 Approved for High Burden Metastatic Prostate Cancer
China’s Hengrui Medicine Co., Ltd. (SHA: 600276) announced that its Category 1 drug SHR3680 has...
Akeso Biopharma’s Cadonilimab Approved for Cervical Cancer Treatment
China-based biotech company Akeso Biopharma (HKG: 9926) announced that its self-discovered bispecific antibody (BsAb) cadonilimab...
BrightGene Bio-Medical Technology Gains NMPA Approval for Oseltamivir Dry Suspension
China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced receiving market approval from the...
Lee’s Pharmaceutical Wins NMPA Approval for ALS Drug Teglutik
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has announced receiving market approval from the National...
Merck KGaA’s Erbitux Approved in China for Head and Neck Cancer Treatment
Germany-based pharmaceutical firm Merck KGaA announced that China’s National Medical Products Administration (NMPA) has issued...
Ocumension Therapeutics’ OT-401 Approved for Chronic Non-Infectious Uveitis in China
China-based Ocumension Therapeutics (HKG: 1477) has received approval from the National Medical Products Administration (NMPA)...
Qingdao HuaRen Pharmaceutical Gains CE Marks for Monkeypox and COVID-19 Detection Kits
China-based Qingdao HuaRen Pharmaceutical Co., Ltd (SHE: 300110) has announced receiving CE marks in the...
SSY Group’s Blonanserin and Paracetamol Approved by China’s NMPA
China-based SSY Group Limited (HKG: 2005) has announced receiving market approvals from the National Medical...
Innovent Biologics’ Tyvyt Approved for First-Line Esophageal Squamous Cell Carcinoma
The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801)...
Boston Scientific Launches Expect Airway Ultrasound Needle in China for Lung Cancer Diagnosis
US-based Boston Scientific Corporation (NYSE: BSX) has announced the official market launch of its Expect...
BeiGene’s Brukinsa Faces Three-Month FDA Approval Delay for CLL/SLL Indication
China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit...
Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas...