China-based CStone Pharmaceuticals (HKG: 2616) has announced a licensing agreement with Allist Pharmaceuticals Co., Ltd, granting the Shanghai-based biotech exclusive commercial promotion rights to Gavreto (pralsetinib) in mainland China. CStone retains development, regulatory filing, and other rights excluding promotion in mainland China. Under the agreement, CStone will receive an undisclosed upfront fee, research and development milestone payments, and sales revenues, while Allist will charge service fees.
Gavreto’s Profile and Market Approvals
Gavreto, an oral, once-daily, highly selective RET inhibitor, was in-licensed from US-based biotech Blueprint Medicines in June 2018. It has been approved in China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with RET gene fusion-positive who have previously received platinum-containing chemotherapy. Additionally, it treats adults with advanced or metastatic RET mutant medullary thyroid cancer (MTC), children aged 12 and above requiring systematic treatment, and adults with advanced or metastatic RET fusion-positive thyroid cancer and children aged 12 and above who need systematic treatment and are refractory to radioactive iodine (if applicable). The drug is also registered in Hong Kong, Taiwan, the US, and the EU, among other markets.
CStone’s Recent Out-License Deal
This agreement marks CStone’s second out-license deal this month. Previously, CStone handed over China market development, registration, manufacturing, and commercialization rights for the PD-1 inhibitor nofazinlimab to 3SBio in a deal worth RMB 160 million.- Flcube.com
