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...
Product approvals
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...
AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its...
CSPC Receives CDE Approval for Generic Version of Pfizer’s Xeljanz
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market...
Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the...
Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan...
Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s...
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:...
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)...