CStone Pharmaceuticals announced that the application for extended indications of the selective RET inhibitor Pugeta® (Platinib Capsules) has been accepted by the National Medical Products Administration and included in the priority review-for the treatment of advanced or metastatic RET variants Patients with thyroid cancer

CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616), a leading biopharmaceutical company focused on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs, today announced that the selective RET inhibitor Pugeta® (Platin) The application for extended indications of Ni capsules has been accepted by the National Medical Products Administration (NMPA) of China and has been included in priority review.
The extended indications include late or metastatic transfection rearrangement (RET) gene mutations that require systemic treatment Medullary thyroid carcinoma (MTC), and advanced or metastatic RET fusion-positive thyroid cancer (TC) that requires systemic treatment and is refractory to radioactive iodine (if radioactive iodine is appropriate).
In March of this year, NMPA approved pratinib to be marketed under the trade name Pugeta® for the treatment of locally advanced or metastatic non-small cell lung cancer patients who have previously received platinum-containing chemotherapy for the treatment of RET gene fusion-positive adult patients.
Phuket Hua ® is China's first approved selective RET inhibitor, developed by Blueprint Medicines, a partner of CStone Pharmaceuticals.

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The acceptance of the extended indications of Pugeta® is based on a global phase I/II ARROW clinical study, which aims to evaluate the presence of pratinib in RET fusion-positive non-small cell lung cancer, thyroid cancer, and other RET variants.

In September 2020, at the Virtual Conference of the European Society of Medical Oncology (ESMO), the ARROW study of RET-mutant MTC patients was announced.

Pugeta® is a potent and selective RET inhibitor developed by Blueprint Medicines, a partner of CStone Pharmaceuticals.

Thyroid cancer is the most common endocrine malignant tumor, and its incidence has increased significantly in recent years.

RET fusion and activating mutations are key disease drivers in many cancer types, including NSCLC and many types of thyroid cancer.

About Pugeta® (Platinib Capsules)

Pratinib is an oral, once-a-day, potent and highly selective RET inhibitor.

The US Food and Drug Administration approved it to be marketed under the trade name GAVRETO™, which are used to treat adult patients with metastatic RET fusion-positive NSCLC confirmed by FDA-approved testing methods, and advanced or metastatic RET that requires systemic treatment Adults with mutant medullary thyroid cancer and children 12 years and older, as well as adults with advanced or metastatic RET fusion-positive thyroid cancer and children 12 years and older who require systemic treatment and are refractory to radioiodine (if applicable).

Pratinib has not been approved for other indications in China or the United States, or medical regulatory agencies in other regions have not made an approval decision for any indication of pratinib.

Pratinib is designed to selectively and effectively target oncogenic RET mutations, including secondary RET mutations that may lead to treatment resistance.

Globally, the clinical development of pratinib for the treatment of RET-fused NSCLC, various types of thyroid cancer and other solid tumor patients is underway.

Forward-looking statements

The forward-looking statements made in this article only relate to events or information as of the date the statement is made in this article.