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.

CSPC PHARMACEUTICAL GROUP LIMITED

石 藥 集 團 有 限 公 司

(Incorporated in Hong Kong with limited liability)

(Stock code: 1093)

VOLUNTARY ANNOUNCEMENT

APPLICATION FOR MARKETING APPROVAL OF "Duvelisib Capsules" ACCEPTED BY NMPA

The board of directors (the "Board") of the CSPC Pharmaceutical Group Limited (the "Company", together with its subsidiaries, the "Group") is pleased to announce that the application for marketing approval of "Duvelisib Capsules" (brand name: COPIKTRA) of CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.*(石藥集團中奇製藥技術(石家莊)有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China and granted the qualification of conditional marketing approval and priority review.

COPIKTRA was applied under class 5.1 chemical drug. It is indicated for the treatment for adult patients with relapsed/refractory follicular lymphoma after at least 2 prior systemic therapies. The product has been granted marketing approval by the U.S. Food and Drug Administration (FDA) in September 2018, being the first approved dual PI3K-δ and PI3K-γ inhibitor. The Group has obtained an exclusive license to develop and commercialize the product in China (including Hong Kong, Macau and Taiwan).

By order of the Board

CSPC Pharmaceutical Group Limited

CAI Dongchen

Chairman

Hong Kong, 19 April 2021

  • For identification purpose only

- 1 -

As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.

- 2 -

Attachments

  • Original document
  • Permalink

Disclaimer

CSPC Pharmaceutical Group Ltd. published this content on 19 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 April 2021 00:49:01 UTC.