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

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




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

— the 7th innovative drug in Junshi Biosciences’ pipeline to get IND approval from the US FDA

SHANGHAI, China, Aug. 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.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800