南京传奇正式获得中国国家药品监督管理局授予的LCAR-B38M CAR-T用于自体回输的临床试验申请(IND)批件

2018年3月13日


Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
Genscript Biotech Corporation
金斯瑞生物科技股份有限公司
(Incorporated in the Cayman Islands with limited liability)
(Stock code: 1548)
*
VOLUNTARY ANNOUNCEMENT RESEARCH AND DEVELOPMENT UPDATE
Reference is made to the voluntary announcements of Genscript Biotech Corporation (the “Company”, together with its subsidiaries, the “Group”) dated 28 October 2016, 14 May 2017, 6 June 2017, 19 September 2017 and 11 December 2017 (the “Previous Announcements”) in relation to the research and development results of chimeric antigen receptor T-Cell (“CAR-T”) technology in immunotherapy for cancer cure by Nanjing Legend Biotechnology Co., Ltd.* (南京傳奇生物科技有限公司) (“Nanjing
Legend
”), a subsidiary of the Company as of the date of this announcement.

The Company is pleased to announce that, on 13 March 2018, Nanjing Legend formally received the permission of a clinical trial granted by the China Food and Drug Administration* (國家食品藥品監督管理總局) with respect to LCARB38M CAR-T for autologous infusion. Nanjing Legend will proceed to launch clinical trials of LCAR-B38M CAR-T for autologous infusion, pursuant to the Drug Registration Regulations* (藥品註冊管理辦法) and the Good Clinical Practice of Pharmaceutical Products* (藥品臨床試驗質量管理規範).

LCAR-B38M CAR-T Cells is a bispecific chimeric antigen receptor product targeting B-cell maturation antigen (BCMA) developed through a proprietary technology platform of single-domain antibody-based chimeric antigen receptors of Nanjing Legend. Substantive progress has been made in the clinical research on the LCARB38M CAR-T immunotherapy for patients with multiple myeloma. Please refer to the Previous Announcements for highlights of the clinical research results.

As of the date of this announcement, Nanjing Legend has applied for the registration of various invention patents for its technologies and products in relation to chimeric antigen receptors in the People’s Republic of China and overseas, with the aim to obtain patent protection globally.

Shareholders and potential investors of the Company are advised to pay attention to investment risks and exercise caution when they deal or contemplate to deal in the securities of the Company. Characterized by high technology and high risks, and the long cycles and complicated sessions from the research and development, clinical trials, to commercial production, the development of LCAR-B38M CAR-T Cells for autologous use might be affected by various factors including without limitation technological barriers, regulatory review requirements, and government policies. As such, there are uncertainties in the competitiveness of LCAR-B38M CAR-T Cells for autologous use in the future.
By order of the Board
Genscript Biotech Corporation
Zhang Fangliang

Chairman and Chief Executive Officer
Hong Kong, 13 March 2018
As at the date of this announcement, the executive Directors are Dr. Zhang Fangliang, Ms. Wang Ye and Mr. Meng Jiange; the non-executive Directors are Dr. Wang Luquan and Mr. Pan Yuexin; and the independent non-executive Directors are Mr. Guo Hongxin, Mr. Dai Zumian and Ms. Zhang Min.

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