The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that, the company has received the Notice of Approval for Clinical Trial issued by the National Medical Products Administration. The application for clinical trials of the JS015 injection has been approved. Relevant information is as follows: Drug name: JS015 injection.

Application matter: Clinical Trial of Domestic Production Registration of Pharmaceutical Product. Acceptance no.: CXSL2200380 Applicant: Shanghai Junshi Biosciences Co., Ltd. Review conclusion: According to the Drug Administration Law of the People ' s Republic of China and relevant regulations, upon review, the JS015 injection accepted on 16 August 2022 meets the relevant requirements for drug registration, and clinical trials on advanced solid tumors are approved to be conducted in accordance with the submitted protocol. JS015 is a recombinant humanized anti-DKK1 monoclonal antibody injection developed independently by the Company that is mainly used for the treatment of advanced malignant solid tumor.

DKK1 (Dickkopf-1) is a secreted protein of the DKK family, which is highly expressed in multiple gastric cancer, gastroesophageal junction cancer, myeloma, liver cancer, lung cancer, ovarian cancer and other tumor cells, and can inhibit the canonical Wnt signaling pathway through negative feedback signals. JS015 binds to human DKK1 with high affinity, and can effectively block the interaction between DKK1 and its ligand LRP5/6 and activate the Wnt signaling pathway. At the same time, JS015 can inhibit the immunosuppressive effect of DKK1 in the tumor microenvironment, thereby improving the ability of immune system to kill tumor cells.

The pre-clinical in vivo pharmacodynamics showed that JS015 monotherapy, JS015 in combination with toripalimab injection, a commercialized product of the Company (trade name: TUOYI®, project code: JS001), or in combination with paclitaxel, exhibit significant anti-tumor effect. In addition, JS015 is well-tolerated by animals. As of the date of this announcement, there is no product with similar targets approved for marketing domestically and overseas.

Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, there are substantial risks and uncertainties in the process of drug research, development and commercialization. These many stages make it susceptible to uncertainties and therefore, investors are advised to make cautious decisions and pay careful attention to investment risks. The company will actively pursue the above research and development project and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict accordance with relevant regulations.