Junshi Bio: Junshi Bio voluntarily disclosed the announcement of the notice of approval of the drug clinical trial of JS401 injection.
DATE:  Apr 14 2023

Stock code: 688180 Stock abbreviation: Junshi Biological Announcement No.: Pro 2023-027.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Voluntary Disclosure About JS401 Injection Obtaining Drug Clinical Trials

ANNOUNCEMENT OF NOTICE OF APPROVAL

the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.

Recently, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") and its holding subsidiary Wuxi Runmin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Wuxi Runmin") received the "Drug Clinical Trial Approval Notice", the clinical trial application of JS401 injection (project code "JS401") was approved. The company and Runjia (Shanghai) Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Runjia Shanghai") respectively own 50% of the equity of Wuxi Runmin. Due to the long R & D cycle and many approval links of drugs, they are easily affected by some uncertain factors. Investors are requested to make cautious decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:

Basic information of 1. drugs

Drug Name: JS401 Injection

Application: Domestic production of drug registration clinical trials

Acceptance number: CXHL2300136

Applicant: Shanghai Junshi Biomedical Technology Co., Ltd. and Wuxi Runmin Pharmaceutical Technology Co., Ltd.

Approval conclusion: According to the the People's Republic of China and Drug Administration Law and relevant provisions, after examination, 2023

The JS401 injection clinical trial application accepted on January 30, 2002 met the relevant requirements for drug registration and agreed.

This product carries out clinical trials of hyperlipidemia.

Other information related to 2. drugs

JS401 is a targeted angiopoietin-like protein 3 jointly developed by the company and its partner Runjia Shanghai.

(hereinafter referred to as "ANGPTL3") messenger RNA (hereinafter referred to as "mRNA") of small interfering RNA (hereinafter referred to as "siRNA") drugs, intended mainly for the treatment of hyperlipidemia. ANGPTL3 is a member of the angiopoietin-like protein family expressed by the liver, which inhibits lipoprotein lipase (LPL) and endothelial fat

Enzymes (EL) play a role in regulating lipid metabolism. Loss or inhibition of ANGPTL3 function can significantly reduce levels of triglycerides and other atherogenic lipoproteins. JS401 is delivered to liver cells by N-acetylgalactosamine (GalNac), specifically degrades ANGPTL3 mRNA in liver cells, and continuously inhibits the expression of ANGPTL3 protein, thus exerting its lipid-lowering (triglyceride and cholesterol) effect. As of the disclosure date of this announcement, only one ANGPTL3-targeted monoclonal antibody drug Evkeeza (Evinacumab-dgnb, a product of Regenera Pharmaceutical Company) has been approved for the treatment of homozygous familial hypercholesterolemia (HoFH) in children or adults aged 12 years and above, and no similar target siRNA drug has been approved for marketing in the world.

3. Risk Alert

Because pharmaceutical products have the characteristics of high technology, high risk and high added value, the early research and development of drugs and the long cycle and many links from development, clinical trial approval to production of products are vulnerable to some uncertain factors. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.

The company will actively promote the above research and development projects, and in strict accordance with the relevant provisions of the follow-up progress of the project to fulfill the obligation of information disclosure. For company information, please refer to the announcements published in the company's designated disclosure media "China Securities Journal", "Shanghai Securities News", "Securities Times", "Securities Daily" and the Shanghai Stock Exchange website.

It is hereby announced.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Board of Directors

April 14, 2023

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