Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the "Company"), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the "State Drug Administration"). Ltd. has received the "Notice of Approval for Clinical Trial" from the State Drug Administration (hereinafter referred to as "SDA") for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows:

I. Basic information of the drug
Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to carry out clinical trial. Specifically, it is an open, multi-center phase II clinical study of adebelizumab combined with simultaneous radiotherapy for the treatment of locally advanced cervical cancer.

II. Other information of the drug
Adebelizumab is a humanized anti-PD-L1 monoclonal antibody independently developed by the Company, which can specifically bind PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to immune tolerance of tumors, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of treating tumors. Similar products, Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio) and Durvalumab (trade name: Imfinzi), have been approved for marketing in the U.S., among which Atezolizumab and Durvalumab have been approved for marketing in China. Atezolizumab and Durvalumab have been approved for sale in China. In China, similar products, Envolizumab (trade name: Envidia) of Kangning Jieri/Sidi Pharmaceuticals and Sugilizumab (trade name: Zetimibe) of Cornerstone Pharmaceuticals, have been approved for sale by the State Administration of Drug Administration (SADA). The Company's adebelizumab injection (trade name: Aireli) was approved for marketing in March 2023, with the approved indication of being used in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small-cell lung cancer. The combined global sales of Atezolizumab, Avelumab and Durvalumab were quoted at approximately $7,346 million in 2022. Up to now, approximately RMB564.37 million has been invested in research and development expenses for the project related to Adebelizumab Injection.

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