NMPA Revises Drug Conditional Approval Procedures: Streamlined Processes and Requirements
The National Medical Products Administration (NMPA) has released the “Drug Conditional Approval Filing Review and...
August 2023
GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies
China-based GenFleet Therapeutics has entered into an exclusive licensing and early development agreement with US...
Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China
Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings...
Harbour BioMed Reports First Profitable Half-Year in H1 2023 Financial Results
China-based Harbour BioMed (HKG: 2142) has released its interim financial report for the first half...
Allurion’s Non-Invasive Weight-Loss Balloon Debuts at Ruijin Hospital’s Hainan Subsidiary
US-based Allurion’s (NYSE: ALUR) weight-loss intragastric balloon has been first applied in Shanghai Ruijin Hospital’s...
Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review...
AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has filed a legal claim against the US...
MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental...
Henlius Biotech Expands Licensing Agreement with KGbio for PD-1 Inhibitor
Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced an update to the licensing agreement...
Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...
CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials
The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key...
Chinese Pharma Consortium Eyes Poland’s Neuca in Strategic European Market Acquisition
A consortium of China-based pharmaceutical companies, potentially including the state-owned giant Sinopharm (HKG: 1099), is...
Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National...
CanSino Biologics to Expand Southeast Asian Presence with Solution Group Berhad Stake
China-based CanSino Biologics (SHA: 688185, HKG: 6185) is poised to acquire an undisclosed amount of...
Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital...
Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril,...
Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...
CSH MEDI Secures Series A+ Funding to Advance Biomagnetic Equipment Technology
CSH MEDI, a Shanghai-based biomagnetic equipment manufacturer, has reportedly raised close to RMB 100 million...
Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)...
Luye Pharma Group’s Subsidiary Boan Biotechnology Reports 18.4% Revenue Growth in H1 2023
China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955),...