Shanghai Junshi Biosciences : VOLUNTARY ANNOUNCEMENT - JS007 INJECTION RECEIVED THE ACCEPTANCE NOTICE FOR THE INVESTIGATIONAL NEW DRUG APPLICATION
April 07, 2021 at 06:38 am
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SHANGHAI JUNSHI BIOSCIENCES CO., LTD.*
上海君實生物醫藥科技股份有限公司
(a joint stock company incorporated in the People's Republic of China with limited liability)
(Stock code: 1877)
VOLUNTARY ANNOUNCEMENT -
JS007 INJECTION RECEIVED THE ACCEPTANCE NOTICE FOR
THE INVESTIGATIONAL NEW DRUG APPLICATION
This announcement is made by Shanghai Junshi Biosciences Co., Ltd.* (上海君實生物醫藥科技 股份有限公司) (the "Company") on a voluntary basis. Reference is also made to the overseas
regulatory announcement of the Company dated 7 April 2021.
The board (the "Board") of directors (the "Directors") of the Company is pleased to announce that, the Company has received the Acceptance Notice 《( 受理通知書》) issued by the National Medical Products Administration (the "NMPA"). The investigational new drug application for the JS007 injection (project code: "JS007") has been accepted. Relevant information is as follows:
ABOUT JS007
Drug name: JS007 injection
Application matter: Registration of Domestic Production of Pharmaceutical Product
Review conclusion: Accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People's Republic of China.
JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection developed independently by the Company that is mainly used for the treatment of advanced cancer. Cytotoxic
lymphocyte-associatedantigen-4(CTLA-4) is an important receptor for T cell surface modulates immune response. JS007 is able to bind to CTLA-4 specifically and block the interaction between CTLA-4 and its ligand B7 (CD80 or CD86) effectively, thereby activates T-lymphocyte and inhibits the growth of tumor. Currently, ipilimumab, a marketed drug with the same target overseas, as the first immunity checkpoint inhibitor, has been proved to have significant tumor suppressor effect in multiple tumor types including melanoma, lymphoma, renal cell cancer, urothelial carcinoma, ovarian cancer and non-small cell lung carcinoma, and has been approved for the treatment of advanced melanoma. According to the data of pre-clinical studies, compared with ipilimumab with the same target but different sequence, JS007 shows similar level of safety but better efficacy.
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RISK WARNING
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 projects and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict accordance with relevant regulations.
By order of the Board
Shanghai Junshi Biosciences Co., Ltd.*
Mr. Xiong Jun
Chairman
Shanghai, the PRC, 7 April 2021
As at the date of this announcement, the board of directors of the Company comprises Mr. Xiong Jun, Dr. Li Ning, Dr. Feng Hui, Mr. Zhang Zhuobing and Dr. Yao Sheng as executive Directors; Dr. Wu Hai, Mr. Tang Yi, Mr. Li Cong, Mr. Yi Qingqing and Mr. Lin Lijun as non-executive Directors; and Dr. Chen Lieping, Mr. Qian Zhi, Mr. Zhang Chun, Dr. Jiang Hualiang and Dr. Roy Steven Herbst as independent non-executive Directors.
For identification purpose only
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Shanghai Junshi Biosciences Co. Ltd. published this content on 07 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 April 2021 10:37:09 UTC.
Shanghai Junshi Biosciences Co Ltd is a China-based company mainly engaged in innovation-driven biopharmaceutical business. The Company's main businesses are the discovery, clinical research and development of innovative drugs. The Company's main products include teriprizumab injection, Etesevimab, adalimumab injection and other drugs, which are used to treat malignant tumors, autoimmune system diseases, chronic metabolic diseases, nervous system diseases and infectious diseases . The Company is also engaged in the clinical research and development of recombinant humanized anti-PCSK9 monoclonal antibody injection and other drugs. The Company provides its products for domestic and overseas markets.