Zhitong Finance App News, Cornerstone Pharmaceutical-B (02616) announced that the company Pujihua ® (Platinib capsules, 100 mg) has been included in the latest “National Basic Medical Insurance, Maternity Insurance and Work Injury Insurance Drug Catalogue” published by China's National Medical Security Administration. The catalogue will be officially implemented on January 1, 2026.
Pukehua ® is an oral, once-daily targeted therapy. The China National Drug Administration (NMPA) has approved Pukehua ® for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive RET gene fusion, adults with advanced or metastatic RET mutant medullary thyroid cancer requiring systematic treatment, and advanced or metastatic RET fusion positive thyroid cancer patients who require systematic treatment and are difficult to treat with radioactive iodine (if radioactive iodine is applied) and children 12 years and older.
Pukehua ® has been approved in Hong Kong, China to treat adult patients with metastatic NSCLC positive for RET gene fusion, in Taiwan, China, to treat locally advanced or metastatic RET fusion positive NSCLC, advanced or metastatic RET mutant MTC requiring systemic treatment, and advanced or metastatic RET fusion positive thyroid cancer patients requiring systemic treatment and not being treated with radioactive iodine (if radioactive iodine therapy is applied).
The US Food and Drug Administration (FDA) approved it for marketing under the trade name GAVRETO®. The indications are: for the treatment of adult patients with NSCLC that have been tested positive for metastatic RET fusion by FDA-approved testing methods; adults with advanced or metastatic RET fusion positive thyroid cancer requiring systematic treatment and difficult to treat with radioactive iodine (if applicable), and children aged 12 and above.
Pukehua ® was developed by Cornerstone Pharmaceuticals partner Blueprint Medicines (acquired by Sanofi in July 2025). Cornerstone Pharmaceuticals has exclusive development and commercialization rights for Pukehua ® in the Greater China region (including mainland China, Hong Kong, Macau, and Taiwan). In November 2023, Cornerstone Pharmaceuticals granted exclusive commercialization promotion rights for Pujihua® in mainland China to Shanghai Alice Pharmaceutical Technology Co., Ltd.