CStone Announces the Approval of Pujihua(R) (pratinib capsules) in China for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer

SUZHOU, March 14, 2022 /PRNewswire/ -- CStone Pharmaceuticals announced today that the expanded indication application for the selective RET inhibitor Pujihua® (pratinib capsules) has been approved by the China National Medical Products Administration (NMPA).

Dr.

Professor Gao Ming, the principal investigator of the Pujihua® ARROW study and president of Tianjin People's Hospital, said: "In recent years, the incidence of thyroid cancer has continued to rise

Dr.

Approval of the expanded indication of Pujihua® is based on a global Phase I/II ARROW clinical study to evaluate Pujihua® in RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and other RET A global clinical study of safety, tolerability, and efficacy in patients with fusions with advanced solid tumors

About Thyroid Cancer

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

Thyroid cancer is clinically divided into several subtypes such as papillary carcinoma, follicular carcinoma, anaplastic carcinoma and medullary carcinoma.

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

About Pujihua® (pratinib capsules)

Pujihua® is an oral, once-daily, potent and highly selective RET inhibitor that has been approved by the China National Medical Products Administration for the treatment of transfection rearrangement (RET) genes who have received platinum-containing chemotherapy in the past Adult patients with fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), adults with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, and children 12 years of age and older, and those requiring systemic therapy Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer (TC) who are refractory to radioactive iodine therapy (if radioactive iodine is available)

The U.

The European Commission (EC) has granted conditional marketing authorization to GAVRETO as a monotherapy for the treatment of adult patients with RET fusion-positive advanced NSCLC who have not received prior RET inhibitor therapy

Pujihua® is not yet approved for other indications in China, the United States, and Europe

Pujihua® is designed to selectively and efficiently target oncogenic RET mutations, including secondary RET mutations that may lead to treatment resistance

Pujihua® was developed by CStone partner Blueprint Medicines

Blueprint Medicines and Roche are jointly developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-mutated NSCLC, thyroid cancer and other solid tumors

Forward-Looking Statements

Forward-looking statements made herein relate only to events or information as of the date on which they are made

Disclaimer: For communication use by healthcare professionals only
.

Source: CStone Pharmaceuticals