Login/Register

New lung cancer drug cleared for marketing in China by Gongwin-KYNov 18, 2022

On 17th, Gongwin-KY announced that its new drug, PTS302, for the treatment of lung cancer, has been approved by the China Drug Administration and is expected to be officially licensed in the near future. PTS302 is the first company, after TaiGen, to obtain a drug certificate in China, which is a significant indicator. Encouraged by the positive drug certification, Gongwin's stock price celebrated on the 17th, closing at NT$414.5 and surpassing the NT$400 mark.

According to the website of the China Drug Administration, the processing status of Tianjin Chase Sun Pharmaceutical and its affiliated company was changed to completed on the afternoon of the 16th, pending the issuance of the certificate. Tianjin Chase Sun Pharmaceutical, a subsidiary of Gongwin, is responsible for the production and manufacturing of the new anti-lung cancer drug PTS302 and the sale of the drug, which means that Gongxin's new anti-lung cancer drug PTS302 has been approved.

In other words, Gongwin's new anti-lung cancer drug PTS302 has already been approved. Established in 2014, Gongxin Pharmaceuticals' subsidiary, Red Sun Health and Wellness (Tianjin), is responsible for the production, manufacturing and sales of the new anti-lung cancer drug PTS302, in addition to the group's operational headquarters and R&D base in Taiwan.

General Manager Lin Mao-yuan pointed out that for the sale of PTS302, 16 tertiary care hospitals in the clinical trial will be used as seed hospitals and 30 core hospitals will be targeted as the first phase of the market. In addition, 100 more tertiary hospitals will be selected as the second stage target market to capture the central airway obstruction treatment for lung cancer, which has an annual sales volume of more than $10 billion.

In addition to actively pursuing international licensing of drugs in non-China regions through a comprehensive patent portfolio to generate benefits, the company will also accelerate the development of new cancer indications, currently targeting common cancers such as breast cancer, head and neck squamous carcinoma and peripheral lung cancer, for which initial clinical results have been achieved.

In addition, a US clinical trial for the treatment of rare adenoid cystic carcinoma will be filed in the first half of 2023, and a clinical trial for the relief of malignant pleural effusion will be filed soon.