Zai Lab’s Repotrectinib on Track for Priority Review by China’s CDE for ROS1+ NSCLC
The Center for Drug Evaluation (CDE) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB)...
Sichuan Kelun Pharmaceutical’s A166 Anti-HER2 ADC NDA Accepted for Review by NMPA
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has announced that the...
Suzhou Porton Biologics and Synbio Technologies Partner to Advance Cell and Gene Therapy in China
China-based Contract Development and Manufacturing Organization (CDMO) Suzhou Porton Biologics Ltd has entered into a...
Mabwell Bioscience’s 9MW3911 Receives NMPA Approval for Clinical Trial in Advanced Tumors
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical...
Akeso Biopharma Initiates Phase III Study for Ivonescimab in Non-Small Cell Lung Cancer
China-based Akeso Biopharma (HKG: 9926) has announced the initiation of a Phase III clinical study...
Zai Lab Limited Reports Q1 2023 Financial Results and Product Highlights
China-based Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) has announced its financial results for the...
Yifan Pharmaceutical’s F-627 Receives NMPA Approval for Neutropenia Treatment in Cancer Patients
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has announced receiving market approval...
Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it...
Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA)...
China’s NHC Releases Draft Guidelines for Somatic Cell Clinical Research, Seeks Public Input
The National Health Commission (NHC) has released the “Somatic Cell Clinical Research Guidelines (draft proposal)”...
Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has...
Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug...
Neuro3 Therapeutics Secures Exclusive License Deal with Lundbeck for KCNQ2 Activator Programs
Neuro3 Therapeutics (Neuro3), a biotechnology company specializing in central nervous system (CNS) diseases with operations...
Organon Reports Q1 2023 Revenue Growth, Highlights Women’s Health and Biosimilars Progress
Organon (NYSE: OGN) has released its financial report for the first quarter of 2023, announcing...
US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi
China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone...
Acorda Therapeutics Strikes Deal with Hangzhou Chance for Inbrija Distribution in China
US-based Acorda Therapeutics Inc., (Nasdaq: ACOR) has announced a distribution and supply agreement with Hangzhou...
RemeGen Ltd Receives Approval for Phase I Clinical Study of RC198 in Solid Tumors
RemeGen Ltd (HKG: 9995) has announced that it has received approval from the Human Research...
Grand Pharmaceutical Group Completes Enrollment in Phase III Study for Ryaltris Nasal Spray
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the completion of all subject enrollment...
Alphamab Oncology and CSPC Pharma Get Green Light for KN026 Phase III Study in Breast Cancer
China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced receiving...
Eyenovia, Inc. Receives FDA Approval for Mydcombi, a First-of-Its-Kind Ophthalmic Spray
US-based Eyenovia, Inc. (NASDAQ: EYEN) has announced obtaining market approval from the US Food and...