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...
Drug
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...
HutchMed and AstraZeneca’s Tagrisso-Orpathys Combo Shows Promise in NSCLC Study
Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) and AstraZeneca (AZ, NASDAQ: AZN) announced the...
NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review
The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted...
Kintor Pharma Completes GT20029 Phase I Study for Hair Loss and Acne
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced the completion of dosing all 92 subjects in...
Inmagene and HutchMed Dose First Subject in IMG-004 Phase I Study
China-based Inmagene Biopharmaceuticals and Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the...
BeiGene’s Tislelizumab Meets Primary Endpoint in Global HCC Study
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the global Phase III RATIONALE 301...
Innovent Biologics’ IBI-112 Achieves Primary Endpoints in Psoriasis Phase II Trial
China-based Innovent Biologics Inc. (HKG: 1801) announced that its interleukin-23 subunit p19 (IL-23p19) monoclonal antibody...
Sciwind’s XW003 Shows Positive Weight Loss Results in Phase Ic/IIa Study
Hangzhou-based Sciwind announced positive interim topline results from a 26-week Phase Ic/IIa clinical study of...