Sino Biopharmaceutical Submits Market Approval Application for Recombinant Coagulation Factor VIIa
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the...
Market approval filings
Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony...
Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed...
Sisram Medical’s Profhilo Accepted for Review by China’s NMPA
Sisram Medical Ltd (HKG: 1696), an Israel-based company within the Fosun Pharmaceutical Group (SHA: 600196),...
Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan...
Keymed Biosciences’ Stapokibart Filing Accepted for Priority Review in China for Atopic Dermatitis
Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a...
Trinomab’s TNM002 Antitetanus Monoclonal Antibody Filing Accepted for Review in China
China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing...
Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent...
Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), based in China, has announced that its market...
Akeso Biopharma Files New Indication for Penpulimab in First-Line NPC Treatment
Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1)...
Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods...
Asieris Pharmaceuticals’ Hexvix for Bladder Cancer Accepted for Review by China’s NMPA
Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that...
Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval...
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in South Korea
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application...
AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the...
AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK...
Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension...
Fosun Pharmaceutical’s FCN-437c filing Accepted for Review by China’s NMPA
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National...
Beijing Balance Medical Technology’s Transcatheter Aortic Valve System Accepted for NMPA Review
China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical...
Fujian Cosunter’s COVID-19 Therapy GST-HG171/Ritonavir NDA Accepted by NMPA
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its...