CSTONE PHARMA-B (02616): Pralsetinib Capsules (Gavreto®) Included in China's 2025 National Reimbursement Drug List

Stock News12-08

CSTONE PHARMA-B (02616) announced that its product Pralsetinib Capsules (Gavreto®, 100 mg) has been included in the latest edition of China's National Reimbursement Drug List (NRDL) released by the National Healthcare Security Administration. The updated list will take effect on January 1, 2026.

Gavreto® is an oral, once-daily targeted therapy. The National Medical Products Administration (NMPA) of China has approved Gavreto® for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy in adults and pediatric patients aged 12 and above, as well as advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and refractory to radioactive iodine (if applicable) in adults and pediatric patients aged 12 and above.

In Hong Kong, Gavreto® is approved for treating adult patients with RET fusion-positive metastatic NSCLC. In Taiwan, it is indicated for 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 refractory to radioactive iodine (if applicable) in adult patients.

The U.S. Food and Drug Administration (FDA) has approved the drug under the brand name GAVRETO® for metastatic RET fusion-positive NSCLC in adults, as well as advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and refractory to radioactive iodine (if applicable) in adults and pediatric patients aged 12 and above.

Gavreto® was developed by Blueprint Medicines, CSTONE PHARMA-B's partner (acquired by Sanofi in July 2025). CSTONE PHARMA-B holds exclusive development and commercialization rights for Gavreto® in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. In November 2023, CSTONE PHARMA-B granted Shanghai Allist Pharmaceuticals the exclusive commercialization rights for Gavreto® in mainland China.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment