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Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement Number: Pro 2024-070

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure Announcement on Toripalimab Approved by the UK Medicines and Healthcare Products Agency

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, TopAlliance Biosciences Inc., a wholly-owned subsidiary of Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company"), has obtained marketing authorization from the United Kingdom Medicines and Healthcare products Regulatory Agency (hereinafter referred to as "MHRA") for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for relapsed, inoperable or radiotherapy. or first-line treatment of adult patients with metastatic nasopharyngeal carcinoma, and toripalimab in combination with cisplatin and paclitaxel for first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma. Toripalimab became the first and only drug for the treatment of nasopharyngeal carcinoma in the UK, and the only first-line treatment for advanced or metastatic esophageal squamous cell carcinoma with no restriction on PD-L1 expression. The relevant situation is hereby announced as follows:

First, the basic situation of drugs

Drug name: toripalimab injection

UK TRADE NAME: LOQTORZI?

Indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with relapsed, inoperable or radiotherapy, 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 mucosal 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, the number of new cases of nasopharyngeal carcinoma diagnosed worldwide in 2022 exceeded 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 the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

The approval for the indication of nasopharyngeal carcinoma is mainly 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 multi-center, largest, 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 type of error control) and confirms a survival benefit. The results of this study were presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting General Meeting (#LBA2), and then appeared on the cover of Nature Medicine (impact factor: 58.7) and was 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) was extended by 13.2 months to 21.4 months in the toripalimab plus chemotherapy arm compared with chemotherapy alone. In addition, patients treated with the combination achieved a higher objective response rate (ORR) and a 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 will be presented at the 2024 ASCO Annual Meeting, with a 5-year survival rate of 52% in the toripalimab treatment group.

Esophageal cancer is one of the most common malignancies in the digestive tract. According to the data released by GLOBOCAN 2022, esophageal cancer is the 11th most common malignant tumor 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 is 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 orally for the first time at the Annual Meeting of the European Society for Medical Oncology (ESMO 2021) and subsequently published in the top international oncology journals Cancer Cell (Impact Factor: 48.8) and Journal of Clinical Oncology (Impact Factor: 42.1). The results of the study showed that toripalimab in combination with chemotherapy resulted in better PFS and OS in patients with advanced or metastatic esophageal squamous cell carcinoma, with a median OS extension of 6 months to 17 months, and a significant reduction in the risk of disease progression or death by 42%, significantly improving survival and benefit, regardless of PD-L1 expression.

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, 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 of 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 anti-PD-1 monoclonal antibody drug for the treatment of melanoma in the National Medical Insurance Catalogue. 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 and other countries and regions. In addition, the Therapeutic Goods Administration (TGA) of Australia and the Health Sciences Authority (HSA) of Singapore have accepted marketing authorization applications for 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, respectively.

3. Impact on the company

With this approval, toripalimab has become the first and only drug for the treatment of nasopharyngeal carcinoma in the UK, and the only first-line treatment for advanced or metastatic esophageal squamous cell carcinoma with no restriction on PD-L1 expression. The UK 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 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

November

18, 2024