China News Service, March 24th (Reporter Chen Jing) The reporter was informed on the 24th that the National Medical Products Administration (NMPA) of China has approved Pujihua® (Platinib Capsules) as a national first-class new drug listing application.

  The drug will benefit adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received platinum-containing chemotherapy for the RET gene (that is, the rearranged gene during transfection, which is a lung cancer driver gene) fusion-positive.

According to investigations, there has been no report before the selective RET inhibitors have been approved for marketing in China.

  In recent years, the incidence of lung cancer has continued to increase in China.

There are many new cases of lung cancer and deaths caused by lung cancer each year.

Non-small cell lung cancer accounts for the majority of lung cancers.

RET fusion is a newly discovered lung cancer driver gene. In non-small cell lung cancer, RET fusion patients are common among young people who do not smoke.

  The main researcher of ARROW research and Professor Wu Yilong of Guangdong Provincial People’s Hospital told reporters: “In the field of precision treatment of lung cancer, the research and development of RET targets is a huge breakthrough. The data results of ARROW research strongly support the approval of Phuket Hua® in China. , And is expected to change the treatment standard for RET fusion-positive non-small cell lung cancer patients in China."

  The reporter learned that the ARROW study is a global clinical study aimed at evaluating the safety, tolerability and effectiveness of pratinib in patients with related advanced solid tumors.

  ARROW research data shows that pratinib has shown long-lasting anti-tumor activity in Chinese patients with related NSCLC, with an overall response rate (ORR) of 56%, and its safety and tolerance are good. Treatment termination or death caused by adverse events related to tinib.

  As a potent and selective RET inhibitor, the clinical development of pratinib for the treatment of RET fusion-positive NSCLC, various types of thyroid cancer, and other solid tumor patients is ongoing worldwide.

In an interview, Dr. Jiang Ningjun, Chairman and CEO of the relevant pharmaceutical company, said: “We will continue to fully promote the development of Pugeta® in China, and evaluate its use in patients with first-line NSCLC, thyroid cancer and other solid tumors more widely. The curative effect will benefit more patients as soon as possible.” (End)