CDE Releases Draft Guidelines for Extrapolating Adult Drug Data to Pediatric Use
The Center for Drug Evaluation (CDE) has released the “Guidelines on Quantitative Methodology for Extrapolating...
RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD)...
Jacobio Partners with Merck KGaA for KRAS G12C Inhibitor Clinical Study
China-based Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has announced a clinical study collaboration partnership...
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...
BeiGene’s Brukinsa Outperforms Imbruvica in Phase III ALPINE Study
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its Bruton’s...
Hengrui Medicine’s Deputy GM Tao Weikang Resigns, Joins Qilu Pharma
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its deputy general manager...
Proxinse Medtech Raises Series A Funding for Endoscope Camera System
Shenzhen Proxinse Medical Technology Co., Ltd, a provider of minimally invasive surgery endoscope camera systems...
AlphaLife Sciences Raises Series A+ Funding for Clinical Research SaaS
China-based clinical research SaaS service provider AlphaLife Sciences has reportedly raised “tens of millions” of...
Aosaikang’s Neratinib Maleate API Market Filing Accepted by NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its...
Azvudine Included in China’s COVID-19 Treatment Protocol
The National Healthcare Commission and the National Administration of Traditional Chinese Medicine have released a...
NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting...
WuXi Biologics Partners with Toregem BioPharma on Anti-USAG-1 Monoclonal Antibody
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into...
BeiGene Partners with Amoy Diagnostics for Companion Diagnostics Development
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a partnership...
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...
Aier Eye Hospital Group Plans IPO on ChiNext Board
China-based ophthalmic medical services provider Aier Eye Hospital Group Co., Ltd (SHE: 300015) is set...
BeiGene Partners with Immune-Onc for Clinical Development of Myeloid Checkpoint Inhibitors
China-based biotech BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a clinical study...
Cyagen Biosciences Partners with Neurophth for Ophthalmology AAV Capsid Development
Cyagen Biosciences, a provider of custom-engineered mouse and rat models with operations in the US...
IASO Biotherapeutics Licenses CD19 Binder to Cabaletta Bio for Autoimmune Diseases
China-based IASO Biotherapeutics has announced a licensing agreement with US firm Cabaletta Bio Inc. (NASDAQ:...
Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Shanghai Launches High-Quality Development Pilot for Public Hospitals
The Shanghai Municipal Health Commission (SHC) has released a notification regarding the public hospital high-quality...