NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus

The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks the Chinese firm’s fourth Category 1 drug approval.

Vorolanib: A Multi-Targeted RTK Inhibitor for Various Tumors
Vorolanib is a next-generation multi-targeted receptor tyrosine kinase (RTKs) inhibitor that is under development for a range of tumor types. It has shown significant anti-angiogenic effects by targeting VEGFR, PDGFR, c-Kit, Flt-3, CSF1R, and other key receptors involved in tumor growth and angiogenesis.

Global Rights and Clinical Development of Vorolanib
Betta Pharma holds the overseas rights to vorolanib for ophthalmic indications through its subsidiary Equinox, and for oncology indications through Xcovery Holdings, Inc. In China, all rights to all indications are held by another subsidiary, Canaanji Medical Science And Technology (Shanghai) Co., Ltd. Vorolanib has been the subject of 13 clinical studies in China, covering both oncology indications such as RCC, gastric cancer, and acute myeloid leukemia, as well as ophthalmic indications like wet age-related macular degeneration (w-AMD) and choroidal neovascularization (mCNV).-Fineline Info & Tech

Insight, China's Pharmaceutical Industry