NMPA Issues Immediate Guidelines for NGS-Related IVD Reagent Classification
China’s National Medical Products Administration (NMPA) released the “Guidelines for Classification Definition of Next-Generation Sequencing...
China Updates Class 3 Hospital Accreditation Standards for 2025
Last month, China’s National Health Commission officially issued the Class 3 Hospital Accreditation Standards (2025...
Huadong Medicine Receives NMPA Approval for Phase III Trial of Roflumilast Foam
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that Its wholly-owned subsidiary Hangzhou Zhongmei Huadong...
China’s Sichuan Kelun-Biotech Wins BTD for Sac-TMT in Non-Squamous NSCLC
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that its core product Jiatailai (sacituzumab...
China’s CDE Seeks Feedback on Advanced Therapy Medicinal Products Guidelines
China’s Center for Drug Evaluation (CDE) released a draft guideline titled “Scope, Classification and Definitions...
Philochem Grants RayzeBio Global Rights to OncoACP3 for Prostate Cancer
Switzerland-based Philochem AG, a wholly-owned subsidiary of the Philogen Group (BIT: PHIL), announced a licensing...
Henlius Biotech Starts Global Phase II Trial for PD-L1 ADC HLX43
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a global,...
Tawada Healthcare Secures Series A+ Funding Led by Highlight Capital
Indonesian integrated medical equipment service provider Tawada Healthcare (THC) has reportedly raised “tens of millions”...
Merck’s Pimicotinib NDA Accepted for Review by China’s CDE
German pharmaceutical major Merck KGaA (ETR: MRK) announced that the New Drug Application (NDA) for...
CSPC Pharma’s SYS6040 ADC Gains FDA Clinical Trial Approval
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received clinical trial approval...
State Council Issues Opinions to Advance Shenzhen’s Healthcare Reforms
The General Office of the State Council released the “Opinions on Further Advancing Shenzhen’s Comprehensive...
Eisai’s Urece Arrives in Shanghai, Poised for Chinese Market Entry
Eisai’s (TYO: 4523) China unit announced that the first batch of its innovative drug Urece...
Sanofi to Ship Beyfortus Ahead of RSV Season, Ensuring Global Availability
France-based Sanofi (NASDAQ: SNY) announced plans to commence shipments of Beyfortus (nirsevimab) in early Q3...
Boai NKY’s LYC001 Receives Clinical Approval in China for Advanced Solid Tumors
China-based Boai NKY Medical Holdings Ltd (SHE: 300109) announced that its joint venture company, Beijing...
Sino Biopharmaceutical’s TQB2868 Approved for Phase III Trial in Metastatic Pancreatic Cancer
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the Center...
Ocumension Therapeutics Gains CDE Approval for Phase III Presbyopia Trial
Ocumension Therapeutics (HKG: 1477), a Chinese ophthalmology specialist, announced that the Center for Drug Evaluation...
Jiangxi Rimag Plans Acquisition of Changsha Zhongya Medical for RMB 29.5 Million
China-based Jiangxi Rimag Group Co., Ltd (HKG: 2522) announced plans to acquire 100% stake in...
Biogen Launches Qalsody in China for SOD1-ALS Treatment
US-based Biogen (NASDAQ: BIIB) officially launched Qalsody (tofersen) in China this week. The drug, the...
Boehringer Ingelheim and Echosens Expand Partnership to Tackle MASH
Germany-based Boehringer Ingelheim and France-based Echosens have expanded their partnership to enhance early screening, precise...
China Expands Medical Insurance Coverage in New State Council Guidelines
The General Office of the State Council released the “Guidelines on Further Safeguarding and Improving...