China Approves GSK’s Juluca for HIV-1 Infection
The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE:...
Product approvals
Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from...
YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval
China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house...
Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Jemincare’s Sonidegib Receives First Prescriptions in China for Basal Cell Carcinoma
China-based Jiangxi Jemincare Group has announced the first prescriptions in China for its sonidegib, a...
BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion...
Hotgen Biotech Gains Regulatory Approvals in Saudi Arabia and India
China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving one certificate from the Saudi...
NMPA Approves Beijing Union Strong’s Intracranial Aneurysm Surgical Planning Software
The National Medical Products Administration (NMPA) has approved the marketing of Beijing Union Strong Technology...
Pfizer’s Zavicefta Approved in China for Pediatric Complex Intra-Abdominal Infections
US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from...
NMPA Approves JW Therapeutics’ Carteyva for Recurrent Follicular Lymphoma
The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’...
Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for...
Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China...
Merck’s Keytruda Gains 9th Indication Approval in China for Hepatocellular Carcinoma
US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab)...
Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo...
Hua Medicine’s Dorzagliatin Approved in China for Type 2 Diabetes
China-based Hua Medicine (HKG: 2552) has announced that its Category 1 drug dorzagliatin has been...
Everest Medicines’ Xerava Approved in Hong Kong for Complicated Intra-Abdominal Infections
Everest Medicines Limited (HKG: 1952), a China-based biopharmaceutical company, has announced that it has received...
Humanwell Healthcare’s Remimazolam Receives NMPA Approval for Bronchoscopy Use
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another...
Rainmed Medical’s caFFR System Receives TGA Approval for Coronary Disease Diagnosis
China-based Rainmed Medical Limited has announced that it has received market approval from Australia’s Therapeutic...
Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication...
Legend Biotech’s Carvykti Approved in Japan for Relapsed Multiple Myeloma
China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan’s Ministry of Health, Labour and...