Brii Biosciences’ HBV Drug Candidates Receive NMPA’s Breakthrough Therapy Designations
Brii Biosciences Ltd (HKG: 2137) has announced that two of its hepatitis B virus (HBV)...
HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study,...
Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced...
NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in...
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced...
Subtle Medical Inc Closes USD 10 Million Series B+ Round to Accelerate Global Expansion
Subtle Medical Inc, a medical imaging specialist and Stanford University spin-off, has reportedly raised close...
Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China,...
NMPA Updates In Vitro Diagnostic Reagents Classification List for Enhanced Regulatory Oversigh
The National Medical Products Administration (NMPA) has coordinated the revision and release of the In...
Novartis Inks Deal to Acquire Mariana Oncology, Bolstering Radioligand Therapy Portfolio
Swiss pharmaceutical giant Novartis (NYSE: NVS) is poised to expand its oncology portfolio by acquiring...
China’s NMPA Revamps Medical Device Classification Rules to Improve Regulatory Efficiency
The National Medical Products Administration (NMPA) has revised the “Notice on Standardizing the Classification of...
BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors...
FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers...
BIO Survey Highlights Extensive Dependence on Chinese CDMOs in Life Sciences
The Biotechnology Innovation Organization (BIO), a US industry trade group, has completed a survey among...
Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
Yunnan Baiyao Group Co., Ltd (SHE: 000538), a traditional Chinese medicine (TCM) company based in...
Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug...
Ribobay Pharma and General Biol to Commence GMP-Grade Oligonucleotide Manufacturing Services
Shanghai-based contract research, development, and manufacturing organization (CRDMO) Ribobay Pharma has announced plans to commence...
BioSecure Act Advances in US, Aiming to Curb Ties with Chinese Bioscience Firms
US legislators are working expeditiously to finalize the BioSecure Act, legislation that, if enacted, would...
Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced that it has...
Tianjin Lisheng Pharmaceutical Co., Ltd. to Sell Stake in Mitsubishi Tanabe’s China Subsidiary
Tianjin Lisheng Pharmaceutical Co., Ltd. (SHE: 002393), a Chinese pharmaceutical company, has announced plans to...