Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2025-005

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Regarding Toripalimab Acquisition

Announcement of approval for marketing by the Therapeutic Goods Administration of Australia

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 notice that toripalimab (product code: JS001) has obtained marketing authorization approved by the Therapeutic Products Administration of Australia (hereinafter referred to as "TGA") for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, as well as as monotherapy for recurrent disease progression during or after treatment with prior platinum-containing therapy. The marketing authorization application for adult patients with unresectable or metastatic nasopharyngeal carcinoma has been approved by the TGA. Toripalimab becomes Australia's first and only immuno-oncology treatment for nasopharyngeal carcinoma. The relevant information is hereby announced as follows:

First, the basic situation of drugs

Drug name: toripalimab injection

Indications: Toripalimab in combination with cisplatin/gemcitabine as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for adult patients with recurrent, unresectable or metastatic nasopharyngeal carcinoma whose disease has progressed during or after prior platinum-based therapy.

2. Other relevant conditions 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

of the randomized, double-blind, placebo-controlled, international multicenter phase III clinical study, NCT03581786) and

Results of the POLARIS-02 study, a multicenter, open-label, Phase II pivotal registration clinical study in recurrent or metastatic nasopharyngeal carcinoma with second-line and higher lines, NCT02915432).

The JUPITER-02 study is the first international multicenter, largest, double-blind, randomized controlled phase III clinical study in the field of immunotherapy for nasopharyngeal carcinoma, and the world's first phase III clinical study in which first-line immunotherapy combined with chemotherapy combined with chemotherapy alone presets overall survival (OS) with a statistical test (a class of error control) and confirmed a survival benefit. The findings were presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting General Meeting (#LBA2), 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 showed that toripalimab plus chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37% compared with chemotherapy alone. Median progression-free survival (PFS) was 13.2 months longer with toripalimab plus chemotherapy 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 signals identified. Long-term survival follow-up data are available in:

The 2024 ASCO Annual Meeting demonstrated a 5-year survival rate of 52% in the toripalimab-treated group.

Results from the POLARIS-02 study were published online in the Journal of Clinical Oncology in January 2021

（Journal of Clinical Oncology）。 The results of the study showed that toripalimab demonstrated durable antitumor activity and a manageable safety profile in patients with recurrent/metastatic nasopharyngeal carcinoma who had failed prior chemotherapy

The ORR was 20.5%, the DoR was 12.8 months, and the median OS was 17.4 months.

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, 10 indications for toripalimab have been approved in Chinese mainland. In December 2020, toripalimab injection passed the national medical insurance negotiation for the first time, and all 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 deployed in the United States, the European Union, and India

degree, the United Kingdom, Jordan, Australia and other countries and regions have been approved for listing. In addition, Singapore's Health Sciences Authority (HSA) has accepted a marketing authorization application for toripalimab in combination with cisplatin/gemcitabine as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as a monotherapy for adult patients with recurrent, unresectable or metastatic nasopharyngeal carcinoma whose disease has progressed during or after prior platinum-based therapy.

3. 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. In addition, toripalimab for the treatment of nasopharyngeal carcinoma has also been granted orphan drug designation by the TGA, which has accelerated its local review and approval registration to a certain extent.

With this approval, toripalimab is the first and only tumor immunotherapy drug for nasopharyngeal carcinoma in Australia. The company's partner, Dr. Reddy's Laboratories Limited, will be responsible for the commercialisation of toripalimab in Australia. The Australian market is an important part of the company's overseas commercialization strategy, and this approval will help the company further promote the expansion of overseas markets, enhance the international influence of the company's products, and is expected to have a positive impact on the company's long-term operating results.

4. 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 and its partners will actively promote the above-mentioned projects, and fulfill the obligation of information disclosure on the follow-up progress of the project in a timely manner in strict accordance with the relevant regulations. 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 18, 2025