CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings
The Center for Drug Evaluation (CDE) has released a notice outlining the guidelines for “New...
CNIPA Launches Pilot for Priority Patent Review for Macau Applicants in Mainland China
The China National Intellectual Property Administration (CNIPA) has announced the commencement of a pilot program...
AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval...
Lion TCR Secures RMB 300 Million in Series B2 Financing to Advance Clinical Studies and Facility Construction
Singapore-based clinical-stage biotechnology company Lion TCR has announced the successful completion of its Series B2...
LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm...
CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from...
NMPA Releases 69th Batch of Reference Drugs for Generic Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 69th batch of reference drugs for...
BDgene Technology Secures Over RMB 200 Million in Series B Financing Led by Lapam Capital
Gene therapy specialist Shanghai BDgene Technology Co., Ltd has successfully raised over RMB 200 million...
WuXi Biologics Partners with Pharmadule Morimatsu AB for CRDMO Expansion in Singapore
China-based WuXi Biologics (HKG: 2269) has announced a strategic partnership with Sweden-headquartered Pharmadule Morimatsu AB...
CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of...
CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration...
Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National...
Chia Tai Tianqing Launches First Batch of F-627 for Neutropenia Treatment in China
China-based Chia Tai Tianqing has announced the first batch prescriptions in China for its efbemalenograstim...
Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from...
Mega Lifesciences Secures Exclusive Rights for Bio-Thera’s Bevacizumab Biosimilar in Indonesia
Thailand-based Mega Lifesciences (BKK: MEGA) has announced an in-licensing agreement with China-based Bio-Thera Solutions (SHA:...
Jiangsu Hengrui’s Dalpiciclib Approved for Initial Therapy in HR+, HER2- Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
Fosun Kite’s Yescarta Gains NMPA Approval for Refractory Large B-Cell Lymphoma
China-based Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co.,...
Ascletis Pharma’s ASC42 Showcased in Combination Therapy for Chronic Hepatitis B at EASL 2023
China-based Ascletis Pharma Inc. (HKG: 1672) announced the poster presentation of ASC42, a novel farnesoid...
Sinopharm Expands Partnership with Guizhou Government to Boost Health Industry
China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strengthened partnership with the...
Coherent Biopharma and C-Ray Therapeutics Partner to Advance Peptide-Drug Conjugate Development
China-based Coherent Biopharma and C-Ray Therapeutics have announced a strategic partnership to delve into the...