Eyebright Medical Technology’s Intraocular Lenses Earn Fast-Track Status in China
Beijing-based Eyebright Medical Technology Co., Ltd (SHE: 688050) has announced that its “intraocular lenses with...
Special review status
Beijing Balance Medical’s Transcatheter Valve System Enters China’s Innovative Device Review
China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that its transcatheter valve...
Jiangsu Recbio’s ReCOV Vaccine Receives Emergency Use Authorization in Mongolia
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced that it has...
CDE Issues Guidelines on Single-Arm Clinical Trials for Antitumor Drugs
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for the Applicability of...
Pudong New Area Grants Duty-Free Import Qualifications to Seven Companies
Seven companies have been awarded scientific and technological innovation duty-free import qualification designations by the...
Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug...
Everest Medicines’ Nefecon Included in South Korea’s GIFT Program
China-based Everest Medicines (HKG: 1952) has announced that South Korea’s Ministry of Food and Drug...
3D Medicines’ 3D185 Receives Orphan Drug Designation for Gastric Cancer
China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving orphan drug designation (ODD) status...
Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy...
Alphamab/3DMed’s Envafolimab Gains FDA Fast-Track Status for Sarcoma Treatment
Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the...
CanSino, Livzon Win China EUAs for COVID-19 Booster Vaccines
China-based vaccine makers CanSino Biologics (HKG: 6185) and Livzon Pharmaceutical Group Inc. (HKG: 1513) have...
China Passes WHO NRA Evaluation for Vaccine Regulatory System
The World Health Organization (WHO) announced that China has successfully passed the evaluation of its...
Venus Medtech’s VenusP-Valve Used Again in US Compassionate Case
Venus Medtech (Hangzhou) Inc. (HKG: 2500) announced the second US market compassionate use of its...
Takeda’s Obizur Prioritized for Review in Acquired Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd’s Obizur (susoctocog...
Hangzhou Tongee Medical Closes RMB 100 Million Series B Round for Gastric Bypass Stent
Hangzhou Tongee Medical Technology Co., Ltd, a Chinese device maker specializing in metabolic disease treatments,...