Stock code: 688180 Stock abbreviation: Junshi Biosciences Announcement No.: Pro 2025-003

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure of Deuterium Remidevir Hydrobromide Tablets

Announcement of routine approval from the National Medical Products Administration

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Recently, Shanghai Wangshi Biomedical Technology Co., Ltd., a holding subsidiary of Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company"), received the "Notice of Approval of Drug Supplementary Application" approved and issued by the State Medical Products Administration (hereinafter referred to as the "State Food and Drug Administration"). , product code: VV116/JT001) for the treatment of adult patients with mild to moderate novel coronavirus infection (hereinafter referred to as "COVID-19") has been approved by the State Food and Drug Administration, and the indication has been changed from conditional approval to routine approval. The relevant information is hereby announced as follows:

First, the basic situation of drugs

Name of drug: Deuterium hydrobromide tablets

Application matters: The application for conditional approval is converted into regular approval for listing

Acceptance number: CYHB2401370

Notice No.: 2025B00098

Marketing authorization holder: Shanghai Wangshi Biomedical Technology Co., Ltd

Examination and approval conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after review, this product meets the relevant requirements of drug registration, and the following supplementary application items for this product are approved: 1. Agree that the research data submitted by the applicant for the conditions attached to the listing of this product meet the requirements; 2. Agree that this product will be changed from conditional approval to conventional approval for marketing.

2. Other relevant conditions of drugs

January 28, 2023, based on one mild-to-moderate disease with or without a risk factor for progression to severe disease

A multicenter, double-blind, randomized, placebo-controlled, phase III clinical study in COVID-19 patients (JT001-015 study, NCT05582629), Mindwei? Obtained conditional marketing approval from the State Food and Drug Administration.

This time, Mindwei? Routine approval is based on multiple clinical and non-clinical studies, including the JT001-015 study and a real-world study of nearly 8,000 patients. The results of the study showed that in patients with mild and moderate COVID-19, Mindway? It can significantly accelerate symptom remission and disappearance, shorten the course of illness, accelerate the conversion of the virus to negative, reduce the incidence of severe COVID-19 or all-cause death, and have a more significant effect on older and high-risk patients. In patients with mild to moderate hepatic renal insufficiency, Mindewei? It is well safe and well tolerated, and patients do not need to adjust the dose of the drug with little or no need during the course of the medication. At the same time, pharmacological studies have shown that Mindwei? There is basically no drug-drug interaction, which greatly reduces drug contraindications, effectively protects patients' concomitant medications, and provides a safer and more effective choice for special populations.

Mindewei? is an oral nucleoside antiviral drug that inhibits SARS-CoV-2 replication. Relevant studies have shown that Mindway? It exhibits significant antiviral effects against the original and mutant strains of SARS-CoV-2, including Omicron XBB.1.16, EG.5, JN.1, and is non-genotoxic. Mindewei? It is jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, Central Asia Drug R&D Center of Chinese Academy of Sciences/Sino-Ukrainian Medical Science and Technology City ("Belt and Road" Joint Laboratory of the Ministry of Science and Technology), Lingang Laboratory, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the company. Mindewei?

It will be temporarily included in the scope of medical insurance payment from January 2023 and officially included in the national medical insurance program from January 2024

Record.

3. Risk Warning

Since pharmaceutical products have the characteristics of high technology, high risk and high added value, and the commercialization of drugs is also susceptible to some uncertain factors, investors are advised to make prudent decisions and pay attention to preventing investment risks.

The company will actively promote the above projects, and in strict accordance with the relevant regulations to fulfill the information disclosure obligations on the follow-up progress of the project in a timely manner. The relevant company information is subject to the announcements published on the company's designated disclosure media, "China Securities Journal", "Shanghai Securities News", "Securities Times" and the website of the Shanghai Stock Exchange.

The announcement is hereby made.

Shanghai Junshi Biomedical Technology Co., Ltd

board of directors

January 13, 2025