Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2025-012

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Regarding Toripalimab Acquisition

Announcement of approval of listing by the Health Sciences Authority of Singapore

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 Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") received a notice that toripalimab (Singapore trade name: LOQTORZI? ) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with relapsed, inoperable or radiotherapy, or metastatic nasopharyngeal carcinoma was approved by the Health Sciences Authority (HSA) in Singapore. Toripalimab became the first and only immuno-oncology drug approved for nasopharyngeal carcinoma in Singapore. The relevant information is hereby announced as follows:

First, the relevant situation of drugs

Nasopharyngeal carcinoma is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is a common malignant tumor of the head and neck

One. According to the data released by GLOBOCAN 2022, nasopharyngeal carcinoma in 2022 is confirmed worldwide

More than 120,000 new cases have been diagnosed. Toripalimab is the only drug of choice recommended in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Head and Neck Tumors 2025.V1 for the full treatment of recurrent/metastatic nasopharyngeal carcinoma.

The approval for nasopharyngeal carcinoma is based on JUPITER-02, a first-line treatment for nasopharyngeal carcinoma

Randomized, double-blind, placebo-controlled, international multicenter phase III clinical study, NCT03581786). The JUPITER-02 study is the first international multicenter, double-blind, randomized controlled phase III clinical study in the field of immunotherapy for nasopharyngeal carcinoma, and the world's first first-line immunotherapy combined with chemotherapy for nasopharyngeal carcinoma Chemotherapy alone presets overall survival (OS) with a statistical test (a type of error control) and confirms survival

Beneficial phase III clinical study. The results of this study were presented in an oral presentation in the 2021 U.S. Clinical Oncology

The General Assembly (#LBA2) of the Annual Meeting of the Society (ASCO) was subsequently featured on the cover of the journal Nature Medicine and published in full in the Journal of the American Medical Association (JAMA). The results of the study showed that toripalimab in combination with chemotherapy compared with chemotherapy alone resulted in:

Patients had a 48% lower risk of disease progression and a 37% lower risk of death. Toripalimab in combination with chemotherapy group

Median progression-free survival (PFS) was 13.2 months longer than chemotherapy alone, from 8.2 months to 21.4

Months. In addition, patients treated with the combination achieved higher objective response rates (ORRs) and longer duration of response (DoR), with a complete response (CR) rate of 26.7% and no new safety findings

Sexual signals. Long-term survival follow-up data will be presented at the 2024 ASCO Annual Meeting, Toripalimab Treatment Arm 5

The annual survival rate is 52%.

Toripalimab Injection is the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China, and has won the "China Patent Gold Award", the highest award in the field of national patents, and has carried out more than 40 clinical studies initiated by the company covering more than 15 indications around the world (including China, the United States, Europe and Southeast Asia). Ongoing or completed pivotal registrational clinical studies evaluating the safety and efficacy of toripalimab across multiple tumor types. As of the disclosure date of this announcement, 11 indications of toripalimab have been approved in Chinese mainland. In December 2020, toripalimab injection passed the national medical insurance negotiation for the first time, and 10 approved indications have been included in the national medical insurance catalog, and it is the only anti-PD-1 monoclonal antibody for the treatment of melanoma, non-small cell lung cancer, kidney cancer and triple negative breast cancer in the national medical insurance catalog. In October 2024, toripalimab was approved in Hong Kong, China for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

In terms of international layout, as of the disclosure date of this announcement, toripalimab has been approved for marketing in the United States, the European Union, India, the United Kingdom, Jordan, Australia, Singapore and other countries and regions, and is undergoing marketing review in many countries or regions around the world.

2. Impact on the company

The application for marketing authorization was submitted through Project Orbis. Initiated and initiated by the U.S. Food and Drug Administration's (FDA) Oncology Center of Excellence (OCE), the program provides a collaborative mechanism and framework for FDA and regulatory agencies in other countries to jointly review oncology drug registration applications. Toripalimab is the first domestic oncology drug to be included in the Orbis program, following the approval of the TGA for two marketing authorization applications for toripalimab for the nasopharyngeal carcinoma indication submitted to the Therapeutic Goods Administration of Australia ("TGA") through the Orbis program.

With the high incidence of nasopharyngeal cancer in Southeast Asia, toripalimab has become the first and only tumor immunotherapy drug approved for nasopharyngeal cancer in Singapore. The Singapore market is an important part of the company's overseas commercialization strategy, and this approval is conducive to the company's promotion of drug sales and marketing in Southeast Asia, as well as the expansion of the entire overseas market, and enhance the international influence of the company's products, which is expected to have a long-term impact on the company

Positive impact on operating results.

3. Risk Warning

Due to the high-tech, high-risk, and high value-added characteristics of pharmaceutical products, and the commercialization of drugs may be affected by local policies, changes in the market environment and other factors, there is a certain degree of uncertainty. 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

March 27, 2025