Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the...
Market approval filings
Johnson & Johnson Pursues FDA Approval for Spravato as Monotherapy for Treatment-Resistant Depression
Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval...
Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has...
Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic...
Sino Biopharmaceutical Submits Market Approval Filing for CDK2/4/6 Inhibitor Culmerciclib in Breast Cancer
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced the submission...
Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward...
Jiangsu Simcere Pharmaceutical’s Quviviq Approval Application Accepted for Review by China’s NMPA
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals...
Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced...
Sino Biopharmaceutical’s Rovadicitinib Gets CDE Nod for Review in Myelofibrosis
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the Center for Drug Evaluation (CDE) in...
NMPA Accepts 3SBio’s Filing for Anemia Treatment SSS06, Potential Game Changer for Dialysis Patients
3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the...
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration...
Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully...
Harbour BioMed Resubmits Biological License Application for Batoclimab in China
Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands,...
Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib)...
Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that...
Suzhou Zelgen’s Recombinant Human Thyroid Stimulating Hormone Accepted for NMPA Review
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced...
Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG:...
Fosun Pharma’s FCN-159 Receives Priority Review Status from NMPA for Pediatric Neurofibromatosis
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National...
Luye Pharma Submits Market Approval Application for Rivastigmine Patch in Japan
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a...
Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the...