{"id":12059,"date":"2024-11-11T13:21:36","date_gmt":"2024-11-11T05:21:36","guid":{"rendered":"https:\/\/flcube.com\/?p=12059"},"modified":"2024-11-11T13:21:37","modified_gmt":"2024-11-11T05:21:37","slug":"sino-biopharmaceutical-ltd-receives-nmpa-approval-for-kras-g12c-inhibitor-garsorasib","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12059","title":{"rendered":"Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib"},"content":{"rendered":"\n

Sino Biopharmaceutical Ltd (HKG: 1177<\/a>), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) that harbors the KRAS G12C mutation and has received at least one prior systemic treatment.<\/p>\n\n\n\n

Phase II Study Results<\/strong>
The conditional approval is supported by the results of a multi-center, single-arm, open-label pivotal Phase II study for garsorasib in KRAS G12C mutant locally advanced or metastatic NSCLC. Among the 123 patients treated with garsorasib 600mg twice daily, with a median follow-up time of 12.3 months, the objective response rate (ORR) was 52.0%, the disease control rate (DCR) was 88.6%, the median progression-free survival (PFS) was 9.1 months, and the median overall survival (OS) was 14.1 months.<\/p>\n\n\n\n

Partnership and Licensing Agreement<\/strong>
Sino Bio\u2019s subsidiary, Chia Tai Tianqing, signed a licensing deal with InventisBio in August of the previous year, securing exclusive rights for development, regulatory approval, manufacturing, and commercialization of the drug in mainland China. Chia Tai Tianqing is also set to receive a proportion of profits outside of Chinese Mainland based on potential future data sharing cooperation.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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