Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
Drug
Innovent’s Parsaclisib Filed for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics...
Proheal Pharmaceuticals Initiates Clinical Study for PHP1003 in Thyroid-Associated Ophthalmopathy
Proheal Pharmaceuticals, a Suzhou-based developer of drugs for ophthalmology and autoimmune diseases, announced the first...
HutchMed Initiates Phase II/III Study for Elunate and Tyvyt in Renal Cell Carcinoma
China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase...
Recbio’s Neoadjuvant HPV Vaccine Accepted for Review by NMPA
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced that a clinical trial...
Kintor Completes Enrollment for GT20029 Phase I Study in US
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced the completion of enrollment for a Phase I...
Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial
Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products...
WinHealth’s Ravicti Receives Orphan Drug Designation in Taiwan
China-based Hong Kong WinHealth Pharma Group Ltd announced that its Swiss partner Immedica Pharma AB’s...
Lee’s Pharmaceutical’s NVK-002 Shows Strong Results in Phase III CHAMP Study
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced that...
CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from...
Ausper Biopharma’s COVID-19 Nasal Spray Antibody Gets NMPA Approval
Ausper Biopharma Inc., a Hangzhou-based developer of hepatitis B virus (HBV) drugs, announced that its...
Ocumension Initiates Second Phase III Denali Study for OT-301 in US
China-based Ocumension Therapeutics (HKG: 1477) announced the initiation of a second Phase III Denali study...
BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals...
Zhaoke Ophthalmology Completes Enrollment for Intrarosa Phase III Trial
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed...
Ascletis Pharma Files IND for Monkeypox Antiviral ASC10 with FDA
China-based Ascletis Pharma Inc. (HKG: 1672) announced the submission of an Investigational New Drug (IND)...
Simcere Receives FDA Clearance for Clinical Study of SIM0237
China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US...
United Labs Gains NMPA Approval for Ozempic Biosimilar IND
Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products...
OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor...
Ascentage Pharma Files for Phase Ib/II Study of Bcl-2 Inhibitor in Systemic Lupus Erythematosus
Suzhou-based Ascentage Pharma (HKG: 6855) has announced the submission of a clinical filing with the...
Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to...