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Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma…
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Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Japan firm Takeda’s (TYO: 4502) Vyvanse (lisdexamfetamine). Vyvanse is a medication used to treat attention-deficit hyperactivity disorder (ADHD). Lisdexamfetamine’s…
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Antengene’s Xpovio Price Reduced by 37% in China, Aiding Patient Access
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Antengene Corp., Ltd (HKG: 6996) has announced a significant price reduction for its drug Xpovio (selinexor) in China, cutting the cost by 37%. The new pricing for the 20mg*12 tablet box is RMB 14,135, and for the 20mg*16 tablet/box, it is RMB 18,649.67, down from the previous prices of RMB…
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China’s 9th National VBP Tender Round Targets CNS Drugs and Includes Oncology Therapies
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The National Allied Procurement Office has released a notification initiating the information filing process for drugs selected for the 9th national volume-based procurement (VBP) tender round. A total of 44 chemical drugs across 195 different specifications have been selected, with hospitals required to provide details of volume-usage for the affected…
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NMPA Revises Drug Conditional Approval Procedures: Streamlined Processes and Requirements
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The National Medical Products Administration (NMPA) has released the “Drug Conditional Approval Filing Review and Approval Procedures (trial)(revised draft proposal)”. This revised draft optimizes and adjusts the working procedures and requirements for conditional approvals compared to the trial version implemented since 2020. Enhanced Communication and Conditional Approval RequirementsThe revised draft…
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GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies
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China-based GenFleet Therapeutics has entered into an exclusive licensing and early development agreement with US firm Verastem Oncology (NASDAQ: VSTM). Under the agreement, Verastem will obtain development and commercialization rights to GenFleet’s three oncology discovery programs targeting RAS pathway-driven cancers, excluding Greater China. Financial Terms and Potential Deal SizeThe agreement…
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Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China
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Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings for regulatory Phase III global multi-center studies in China for its novel glucagon receptor/GLP-1 receptor dual agonist, survodutide. The drug is co-developed with Zealand Pharma, marking a significant step in advancing the drug’s clinical development.…
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Harbour BioMed Reports First Profitable Half-Year in H1 2023 Financial Results
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China-based Harbour BioMed (HKG: 2142) has released its interim financial report for the first half of 2023, recording revenues of USD 40 million and nearly USD 3 million in profits, marking the company’s first profitable half-year. This financial success is attributed to a licensing agreement focused on batoclimab (HBM9161) and…
