Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor)

2022-08-25 Download

SHANGHAI, China, August 25, 2022 (GLOBE NEWSWIRE) – Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that Suzhou Junjing Biomedical Technology Co., Ltd., a company jointly invested by Junshi Biosciences and Wigen Biomedicine Technology (Shanghai) Co., Ltd., has received a notice from the U.S. Food and Drug Administration (the “FDA”) concerning the approval of the investigational new drug (“IND”) application for XPO1 inhibitor WJ01024 tablets (product code: “JS110”) by the FDA. So far, 6 innovative drugs in Junshi Biosciences’ pipeline have obtained IND approval from the FDA, and with this newest addition, there are now 7.

About JS110

JS110 is a small molecule inhibitor of the nuclear export protein XPO1, which is clinically intended for the treatment of patients with advanced tumors. According to the results of pre-clinical studies, JS110 specifically blocks the function of XPO1, inhibits the nuclear export of various tumor suppressor proteins including p53, and strengthens the functions of tumor suppressor proteins. In vitro, JS110 inhibits the growth and induces death of various tumor cells; in animal tumor models, JS110 monotherapy and combination therapy can both inhibit the growth of various blood and solid tumors. Due to its unique mechanism of action, the development of JS110 may potentially bring new treatment options to patients with advanced tumors.

In April 2021, the IND application for JS110 was approved by the National Medical Products Administration. At present, the Phase I clinical trial of JS110 is in progress in the People’s Republic of China (NCT04991129).

Junshi Biosciences currently owns the world-wide exclusive production rights, licensed production rights and sales rights for JS110.

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