Gongwin-KY (6617) announced that its subsidiary, Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd, notified that the pharmaceutical information of "p-toluenesulfonamide injection (PTS302)", further improvement reports, instructions for use and indications, and post-launch risk control plan were delivered to the Centre for Drug Evaluation, National Medical Products Administration. Today, CDE has accepted the materials, so this case has entered the review stage.
Gongwin-KY pointed out that this means that CDE has completed the clinical review work on PTS302, hence the review on the aforementioned four materials has started. After this stage is completed, the case will be passed to the " Certification Committee for Drugs " for the final stage before the approval of drug certificate - "GMP on-site inspection", showing the application for PTS302 market launch is progressing smoothly.
Since the partner in China, Tianjin Chase Sun Pharmaceutical Co., Ltd. has many years of rich experiences in the production of PTS302, Gongwin-KY has deep confidence in its subsidiary, Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd, for its future performance in "GMP on-site inspection".
As PTS302 is a class 1 new drug item listed for priority review and approval by CDE for "having obvious therapeutic advantages compared with existing lung cancer treatments", it also has the priority to be listed for factory inspection. When it is successfully launched in the market in the near future, it will make significant contributions to the company's revenues.
Gongwin-KY stated that according to the multinational company IQVIA’s survey of the number of patients with severe lung cancer airway obstruction in China and the estimated pricing of drugs, the scale of PTS302 in China’s lung cancer airway obstruction market can reach RMB 2.4 billion. Due to the the existence of uncontrollable factors such as air pollution and smoking in China, the market potential will continue to expand.
Currently, Gongwin-KY continues to participate in the Respiratory Disease Academic Seminars held in China and other Asian countries,, expecting that, after the China lung cancer new drug certificate for PTS302 is successfully obtained, it will be quickly promoted to 300 3AAA hospitals with minimally invasive respiratory interventional treatments in China, and can expand international regional licensing activities of PTS series drugs in Asia, in order to contribute to the company's overall operational momentum.
Pierre Hsiao, Deputy General Manager of Gongwin Biopharm