Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2024-057

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Regarding Toripalimab Acquisition

Announcement of the European Commission's approval of the listing

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") has launched a product of toripalimab (European trade name: LOQTORZI? ) was approved by the European Commission (EC) for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, inoperable or radiological, or metastatic nasopharyngeal carcinoma, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma. The approval applies to all 27 EU member states, as well as Iceland, Norway and Liechtenstein, and toripalimab is the first and only drug in Europe for the treatment of nasopharyngeal carcinoma and the only first-line treatment for advanced or transmutating esophageal squamous cell carcinoma with no restriction on PD-L1 expression. The relevant information is hereby announced as follows:

First, the basic situation of drugs

Drug name: toripalimab injection

European trade name: LOQTORZI?

Indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, inoperable or radiological, or metastatic nasopharyngeal carcinoma, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma.

2. Other relevant conditions of drugs

Nasopharyngeal carcinoma is a malignant tumor that occurs in the epithelium of the nasopharynx and is one of the common malignant tumors of the head and neck.

According to the data released by GLOBOCAN 2022, new cases of nasopharyngeal carcinoma were diagnosed worldwide in 2022

The number of cases exceeds 120,000. Because of the location of the primary tumor, surgery is rarely used. Guidelines from the European Society for Medical Oncology (ESMO) recommend immunotherapy in combination with chemotherapy for recurrent or metastatic disease

First-line treatment for nasopharyngeal carcinoma.

The approval for nasopharyngeal carcinoma is based on the results of JUPITER-02, a 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 first phase III clinical study in the world in which first-line immunotherapy combined with chemotherapy compared with chemotherapy alone presets overall survival ("OS") with a statistical test (a class of error control) and confirmed survival benefit. The findings were presented as an oral presentation at the 2021 United States Society of Clinical Oncology (ASCO) Annual Meeting General Meeting (#LBA2), subsequently featured on the cover of Nature Medicine (Impact Factor: 58.7), and United States published in full in the Journal of the American Medical Association (JAMA, Impact Factor: 63.1). 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) in the toripalimab plus chemotherapy arm pair

It was 13.2 months longer than chemotherapy alone, from 8.2 months to 21.4 months. In addition, accept the union

Patients treated with therapies achieved higher objective response rates (ORRs), longer sustained response times (DoR), and higher disease control rates (DCRs) with 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.

Esophageal cancer is one of the most common malignancies in the digestive tract. Released according to GLOBOCAN 2022

Esophageal cancer was the 11th most common malignancy and the seventh leading cause of cancer death in the world in 2022, with more than 511,000 new cases and more than 445,000 deaths. Esophageal squamous cell carcinoma and adenocarcinoma are the two main histologic subtypes of esophageal cancer. ESMO guidelines recommend PD-1 blocking antibodies in combination with chemotherapy for the first-line treatment of PD-L1-expressing advanced or metastatic esophageal squamous cell carcinoma.

The approval for esophageal squamous cell carcinoma was based on the results of JUPITER-06, a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study, NCT03829969. The study is designed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) compared to placebo plus chemotherapy in the first-line treatment of advanced esophageal squamous cell carcinoma. The results of the study were presented for the first time in an oral presentation at the European Society for Medical Oncology Annual Meeting (ESMO2021), and subsequently presented in the top international oncology journals CancerCell (Impact Factor: 48.8) and Journal of Clinical Oncology (Impact Factor: 42.1). The results of the study showed that toripalimab combined with chemotherapy can cause advanced or metastatic esophageal squamous cell carcinoma

Patients achieved better PFS and OS, with median OS prolonged by 6 months to 17 months and significantly decreased

Patients with a 42% risk of disease progression or death were associated with a significant improved survival benefit, regardless of PD-L1 expression.

Toripalimab injection is the first domestic monoclonal antibody drug targeting PD-1 approved in China, which has won the highest award in the field of national patents "China Patent Gold Award", and has carried out more than 40 clinical studies initiated by the company covering more than 15 indications around the world (including China, United States, Southeast Asia and Europe). 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 6 approved indications have been included in the National Medical Insurance Catalogue (2023), which is the only one in the National Medical Insurance Catalogue

Anti-PD-1 monoclonal antibody drugs used to treat melanoma. April 2024, Drug Office, Department of Health, Hong Kong

(DO) accepted the marketing authorization application for toripalimab in combination with cisplatin/gemcitabine as first-line treatment in adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma and as a monotherapy in adult patients with recurrent, unresectable or metastatic nasopharyngeal carcinoma whose disease has progressed during or after prior platinum-based therapy.

In terms of international layout, in October 2023, toripalimab has been used as the first nasopharyngeal carcinoma drug

Approved for marketing in the United States. In September 2024, toripalimab was approved by the European Commission for the first-line treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma. In addition, the United Kingdom Pharmaceuticals and Health Products Administration (MHRA) accepted marketing authorization applications for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma and in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma, and the Australia Drug Administration (TGA) and the Singapore Health Sciences Authority (HSA) accepted toripalimab in combination with cisplatin/ Marketing authorization application for gemcitabine as a 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

Approved for all 27 member states of the European Union, as well as Iceland, Norway and Liechtenstein, toripalimab became the first and only drug for the treatment of nasopharyngeal carcinoma in Europe and the only first-line treatment for advanced or metastatic esophageal squamous cell carcinoma with no restriction on PD-L1 expression. The European 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 performance.

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 will fulfill its information disclosure obligations 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

September 25, 2024