Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial...
Drug
Belief-Delivery BioMed’s BBM-H901 Granted BTD for Hemophilia B Prevention
The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable...
Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical...
I-Mab and AbbVie End CD47 Antibody Trial but Continue Collaboration
China-based biotech I-Mab (NASDAQ: IMAB) filed with the US Securities and Exchange Commission (SEC) that...
Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG:...
Ascletis Pharma’s Gannex Initiates DDI Study for ASC42 in PBC
Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has...
Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate...
CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for...
Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for...
Alphamab Oncology Doses First Patient in KN046-209 Study for NSCLC
China-based Alphamab Oncology (HKG: 9966) announced the first patient dosing in the multi-center, open-label Phase...
Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the...
Chongqing Pharscin’s Gabexate Mesylate Passes GQCE as First Generic in China
China-based Chongqing Pharscin Pharmaceutical Co., Ltd (SHE: 002907) announced that its gabexate mesylate has passed...
Sunshine Guojian’s SSGJ-608 Hits Primary Endpoint in Psoriasis Study
China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), announced...
Zelgen Biopharmaceuticals’ Donafenib Receives NMPA Approval for Thyroid Cancer
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application...
InnoCare Pharma’s Orelabrutinib sNDA Accepted for Marginal Zone Lymphoma
InnoCare Pharma (HKG: 9969) announced that a supplemental New Drug Application (sNDA) for its Bruton’s...
Arbele’s ARB202 Enters Phase I Trial for Advanced Gastrointestinal Cancer
Hong Kong-based biopharma Arbele announced that its CDH17 × CD3 bispecific T-Cell engager antibody, ARB202,...
Zhaoke Ophthalmology Enrolls First Patient in ZKY001 Phase II TPRK Study
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) announced the...
LianBio Completes Enrollment for Mavacamten Phase III Trial in oHCM
China-based biotech LianBio (OTCMKTS: LIANY) announced that enrollment has been completed in the Phase III...
Recbio Completes Enrollment for HPV Vaccine REC603 Immuno-Bridging Study
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the completion of subject...
Everest Medicines’ Xerava NDA Accepted by Taiwan’s TFDA
Everest Medicines (HKG: 1952) announced that its New Drug Application (NDA) for Xerava (eravacycline) for...