Jiangsu Hengrui’s SHR8058 Accepted for Review by China’s NMPA for Dry Eye Disease
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its market filing for the drug...
Market approval filings
Jemincare’s Avatrombopag Market Filing Accepted for Review by China’s CDE
China-based Jiangxi Jemincare Group has announced that its market filing for avatrombopag maleate (20mg) has...
Qilu Pharmaceutical’s Biosimilar Lucentis Accepted for Review by China’s CDE
China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of...
Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...
Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE
China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its...
Junshi Biosciences’ COVID-19 Drug JT001 (VV116) Accepted for NMPA Review
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its oral nucleoside analog drug...
Daiichi Sankyo’s Mirogabalin Nears China Market Entry with CDE Review
Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE)...
Simcere’s COVID-19 Drug SIM0417 Accepted for Special Review by NMPA
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA)...
Sino Biopharma’s PD-L1 Combo with Anlotinib Accepted for Review by China’s CDE
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its New Drug Application (NDA) filing...
Dizal’s Sunvozertinib NDA Accepted for Review by China’s NMPA
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA)...
EOC Pharma’s Entinostat NDA Accepted by China’s NMPA for Breast Cancer
EOC Pharma, a biotech company operating in the US and China, has announced that its...
BeiGene’s Tislelizumab Receives NMPA Review for First-Line HCC Indication
BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that a supplementary Biologic License Application...
Legend Biotech’s Carvykti Accepted for Review by China’s CDE
The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend...
Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review
China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone...
Shanghai Pharmaceuticals Secures Exclusive Rights for Shionogi’s Ensitrelvir in China
Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced an import and distribution agreement with Japan-based...
Fosun Pharma’s Avatrombopag Receives NMPA Review for Chronic ITP Indication
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that another...
CStone’s Sugemalimab MAA Accepted by UK MHRA for NSCLC Treatment
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the Medicines and Healthcare products Regulatory Agency...
HutchMed Initiates Rolling NDA Submission for Elunate to US FDA
Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling...
Junshi Biosciences Files for EMA Approval of Tuoyi for Nasopharyngeal and Esophageal Cancers
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that a market approval filing has been...
Hansoh’s EGFR Inhibitor Ameile Filed for EMA Review by Partner EQRx
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its...