CStone Pharmaceuticals Receives NMPA Approval for Local Manufacturing of RET Inhibitor GAVRETO in China
核心洞察
CStone Pharmaceuticals announced that China's National Medical Products Administration (搜索) has approved the manufacturing localization application for GAVRETO (pralsetinib), enabling domestic production starting in 2026.
The approval allows end-to-end domestic production from active pharmaceutical ingredient to finished drug product, significantly enhancing supply chain flexibility and resilience for the Chinese market.
GAVRETO is a once-daily oral targeted therapy approved in China for treating RET fusion-positive non-small cell lung cancer (搜索) and RET-mutant medullary thyroid carcinoma (搜索) in adults and pediatric patients.
CStone Pharmaceuticals announced that the National Medical Products Administration (搜索) (NMPA) of China has approved the manufacturing localization application for GAVRETO® (pralsetinib, 100mg), marking a significant milestone in the company's supply chain strategy. Beginning in 2026, supply for the Chinese market will transition gradually from imported to locally manufactured product.
Strategic Manufacturing Transition
Dr. Jason Yang, Chief Executive Officer, President of R&D, and Executive Director of CStone, emphasized the strategic importance of this approval: "The approval of GAVRETO®'s localized production marks another important milestone in CStone's lifecycle management strategy, particularly in establishing robust manufacturing and quality management systems. This authorization enables end-to-end domestic production—from active pharmaceutical ingredient (API) to finished drug product (DP)—significantly enhancing supply chain flexibility and resilience."
The manufacturing localization is expected to ensure sustainable product access and better serve RET (搜索)-positive patients while strengthening GAVRETO®'s market position in China. Yang noted that the company remains committed to collaborating with partners to improve treatment accessibility across China.
Current Therapeutic Applications
GAVRETO® is a once-daily oral targeted therapy that has received NMPA approval for multiple indications in China. The drug is approved for treating adults with locally advanced or metastatic RET fusion-positive Non-Small Cell Lung Cancer (搜索) (NSCLC). Additionally, it is indicated for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant Medullary Thyroid Carcinoma (搜索) (MTC) who require systemic therapy.
The therapy is also approved for adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer (搜索) who require systemic therapy and are radioactive iodine-refractory, when radioactive iodine treatment is appropriate.
Regional and International Approvals
Beyond mainland China, GAVRETO® has secured approvals across Greater China. In Hong Kong, the drug is approved for treating adult patients with RET (搜索) fusion-positive metastatic NSCLC. In Taiwan, it has received approval for adult patients with locally advanced or metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC requiring systemic therapy, and advanced or metastatic RET fusion-positive thyroid cancer (搜索) requiring systemic therapy in radioactive iodine-refractory cases.
In the United States, the FDA has approved GAVRETO® for adult patients with metastatic RET (搜索) fusion-positive NSCLC as detected by an FDA-approved test, and for adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer (搜索) who require systemic therapy and are radioactive iodine-refractory. The thyroid cancer indication received accelerated approval based on Objective Response Rate (ORR) and duration of response (DOR), with continued approval contingent upon verification of clinical benefit in confirmatory trials.
Partnership and Development Background
GAVRETO® was discovered by CStone's partner, Blueprint Medicines. CStone maintains an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of GAVRETO® in Greater China, encompassing Mainland China, Hong Kong, Macau, and Taiwan. In November 2023, CStone announced an exclusive agreement with Shanghai Allist Pharmaceuticals (搜索) Co., Ltd. to commercialize GAVRETO® in Mainland China.
The localized manufacturing approval represents a key step in CStone's comprehensive approach to ensuring reliable access to this targeted therapy for patients with RET (搜索)-positive cancers across China's healthcare system.