Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2025-010

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Announcement on the Approval of the New Indication Application for Toripalimab in Combination With Bevacizumab for the First-Line Treatment of Advanced Hepatocellular Carcinoma

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major 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 the "Drug Registration Certificate" approved and issued by the National Medical Products Administration, and the listing application of toripalimab (trade name: Tuoyi) in combination with bevacizumab for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma was approved. This is the 11th indication approved for toripalimab in China. Since the commercialization of drugs after marketing approval is susceptible to some uncertainties, investors are advised to make prudent decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:

First, the basic situation of drugs

Drug name: toripalimab injection

Application: Drug registration (domestic production)

Acceptance number: CXSS2400069, CXSS2400070

Certificate No.: 2025S00778, 2025S00779

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

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 indications are approved, specifically: this product combined with bevacizumab is used for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

2. Other relevant conditions of drugs

Liver cancer is a common malignant tumor of the digestive system worldwide, and the pathological type is hepatocellular carcinoma

(about 90%). According to the data released by GLOBOCAN 2022, 2022 is the year of liver cancer worldwide

The number of new cases and deaths was 866,000 and 759,000, respectively. China is a big country with liver cancer, and liver cancer will be diagnosed in 2022

The number of new cases reached 368,000 (accounting for 42.4% of global cases), ranking fourth among malignant tumors in China, and deaths

317,000 (accounting for 41.7% of global cases), ranking second among malignant tumors in China. Due to insidious onset, about 70% to

80% of Chinese HCC patients are in the middle and advanced stages when they are first diagnosed, with a median overall survival (OS) of only about 10 months and a 5-year survival rate of about 12%.

THE APPROVAL OF THIS NEW INDICATION IS BASED ON DATA FROM THE HEPATORCH STUDY (NCT04723004). The study is an international multicenter, randomized, open-label, positive drug-controlled phase III clinical study, with Professor Fan Jia of Zhongshan Hospital, Fudan University, academician of the Chinese Academy of Sciences, as the principal investigator, and conducted in 57 clinical centers in Chinese mainland, Taiwan and Singapore, enrolling a total of 326 patients. The study is designed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab in the first-line treatment of unresectable or metastatic hepatocellular carcinoma compared to standard treatment sorafenib.

IN SEPTEMBER 2024, THE RESULTS OF THE HEPATORCH STUDY WERE PRESENTED AT THE 27TH NATIONAL CONGRESS OF CLINICAL ONCOLOGY AND 2024

First released at the annual meeting of the Chinese Society of Clinical Oncology (CSCO), the primary endpoints progression-free survival (hereinafter referred to as "PFS", based on independent imaging assessment) and OS achieved "double endpoint positive results". Compared with sorafenib, toripalimab plus bevacizumab significantly prolonged PFS and OS in patients, with median PFS of 5.8 and 4.0 months, respectively, and a 31% lower risk of disease progression or death (hazard ratio [HR]=0.69,

95% CI: 0.525-0.913; P=0.0086), with median OS of 20.0 and 14.5 months, respectively, and death

Risk was reduced by 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). The objective response rate (ORR) was significantly higher in the toripalimab plus bevacizumab arm than in the sorafenib arm, with ORRs of 25.3% and 6.1%, respectively. At the same time, the safety profile of the combination therapy in patients with advanced hepatocellular carcinoma was good, and the toxicity profile was consistent with the known single-agent toxicity profile, and no new safety signals were found.

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 and other countries and regions, and has been reviewed for marketing in many countries or regions around the world.

3. Risk Warning

Since pharmaceutical products are high-tech, high-risk, and high value-added, and the commercialization of drugs after marketing approval is also susceptible to some uncertainties, 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 22, 2025