Huadong Medicine’s Lidocaine-Containing Hyaluronic Acid Gel Accepted for NMPA Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration...
Market approval filings
Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical...
Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong...
China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration...
Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application...
Joincare Pharmaceutical’s TG-1000 Shows Promise in Phase III Flu Treatment Trial
Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the...
Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has...
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO:...
Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval...
RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD)...
Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval...
FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication...
Genor Biopharma’s Lerociclib Accepted for Review by China’s NMPA for Breast Cancer Treatment
China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the market filing for its...
Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center...
Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced...
Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an...
FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
An advisory committee to the US Food and Drug Administration (FDA) has recommended the use...
Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA)...
Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market...
J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson...