Securities code: 688180 securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022-005 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure about Aurora A inhibitor js112
Announcement of obtaining the approval notice of drug clinical trial
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
Recently, Suzhou JunJing Biomedical Technology Co., Ltd., jointly invested by Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”) and Weijing biomedical technology (Shanghai) Co., Ltd., received the notice of approval of drug clinical trial approved and issued by the State Drug Administration, and the clinical trial application of Aurora A inhibitor wj05129 tablets (project code “js112”) was approved. Due to the long R & D cycle and many approval links of drugs, they are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Drug name: wj05129 tablets
Application item: clinical trial of domestic drug registration
Acceptance No.: cxhl2101685, cxhl2101686
Applicant: Suzhou JunJing Biomedical Technology Co., Ltd
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, wj05129 tablets accepted on November 24, 2021 meet the relevant requirements of drug registration, and it is agreed that the single drug of this product can be used for clinical trial in advanced malignant tumors.
2、 Other drug related information
Js112 is an oral small molecule Aurora A inhibitor. Aurora A, as a member of serine / threonine protein kinase in Aurora kinase family, plays an important role in cell mitosis. Studies have shown that the combination of Aurora A inhibitors and KRAS (G12C) inhibitors can overcome the resistance of KRAS (G12C) inhibitors, and have a synthetic lethal effect with RB1 gene deletion or inactivation, and can be used to treat RB1 deficient or inactivated malignancies such as small cell lung cancer and three negative breast cancer. As of the disclosure date of this announcement, there is no Aurora A inhibitor approved for listing in the world.
The company has the exclusive production right, entrusted production right and sales right of js112 in the world. For details, please refer to the website of Shanghai Stock Exchange (www.sse. Com. CN.) disclosed by the company on September 17, 2020 Announcement (Announcement No.: pro 2020-016).
3、 Risk tips
Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks.
The company will actively promote the above R & D projects and fulfill the obligation of information disclosure on the follow-up progress of the project in strict accordance with relevant regulations. The information about the company shall be subject to the announcements published by the designated disclosure media of the company, such as China Securities News, Shanghai Securities News, securities times, securities daily and the website of Shanghai Stock Exchange. It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors February 8, 2022
