CStone Pharmaceuticals announces that China’s first selective RET inhibitor Pugeta® (Platinib Capsules) has been approved, providing new treatment options for lung cancer patients

(Suzhou, China, March 24, 2021) CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616), a leading biopharmaceutical company focused on the development and commercialization of innovative tumor immunotherapies and precision therapeutic drugs, today announced that China National The Drug Administration (NMPA) approved Phuket Hua? (Platinib Capsules) As a national first-class new drug, it is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients who have previously received platinum-containing chemotherapy for transfection rearrangement (RET) gene fusion positive treatment.

Dr.

Professor Wu Yilong from Guangdong Provincial People’s Hospital, the main investigator of the ARROW study, said: “In the field of precision treatment of lung cancer, the research and development of RET targets is a huge breakthrough.

The ARROW study is a global clinical study aimed at evaluating the safety, tolerability and effectiveness of pratinib in patients with RET fusion-positive NSCLC, RET mutant medullary thyroid carcinoma and other advanced solid tumors with RET fusion.

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

About RET fusion-positive non-small cell lung cancer

The incidence of lung cancer has continued to increase in China in recent years.

In the field of lung cancer, EGFR, ALK, ROS1 and other driver gene mutations have been widely popularized, and targeted drugs targeting these driver genes have been approved for marketing.

About Phuket Hua (Platinib Capsules)

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

The U.

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, clinical development for pratinib for the treatment of patients with RET fusion-positive NSCLC, various types of thyroid cancer and other solid tumors is ongoing.