Junshi Biological: JS105 Clinical Test Application to get FDA approval

On July 4, Capital State learned that Junshi (01877.HK/688180.SH) disclosed a announcement on the FDA approval of the JS105 clinical trial application.

According to the announcement, the company and partner Runjia Medicine recently received a notice from the US Drug Administration. Human epidermal growth factor receptor-2 (HER-2) negative, PIK3CA mutation advanced or metastatic breast cancer (postmenopausal) women (postmenopausal) and clinical trial applications of male patients obtained FDA approval.

Pre -clinical studies have shown that JS105 has a significant effect on breast cancer animal models, and has better medicinal effects on cervical cancer, kidney cancer, colorectal cancer, esophageal cancer and other physical tumors. At the same time, JS105 has good security.

It is reported that as early as February 2019, the company signed the "Technical Transfer and Cooperation Agreement" with Runjia Medicine.

In April 2021, the company established a joint venture contract with Runjia Medicine to jointly invest in the establishment of Jun Shi Runjia, and was responsible for the research and development, clinical application, production and commercialization of Jun Shijiajia in the joint venture area. The company and Runjia Medicine have 50%of Junshi Runjia.

In March 2022, the clinical trial application of JS105 was accepted by the State Drug Administration, and was approved by the State Drug Administration in May 2022.

Up to now, there is only one PI3K-α inhibitor in the world, Piqray® (ALPELISIB, Novartis) has been approved to treat HR-positive, HER-2 negative, PIK3CA mutations for advanced breast cancer. Listing.

As of press time, the company's H shares rose 3.55%to HK $ 43.75; A -shares rose 3.89%to 76.88 yuan.

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