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

DRUG REGISTRATION APPROVAL OF THE GROUP'S

"METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS"

The board of directors (the "Board") of CSPC Pharmaceutical Group Limited (the "Company", together with its subsidiaries, the "Group") is pleased to announce that the "Metformin Hydrochloride Extended-Release Tablets (0.75g, 0.5g)" (the "Product") developed by CSPC Ouyi Pharmaceutical Co., Ltd.*(石藥集團歐意藥業有限公司), a subsidiary of the Group, has been granted drug registration approval by the National Medical Products Administration of the People's Republic of China. Both dose strengths are deemed to have passed the Consistency of Quality and Efficacy Evaluation for Generic Drugs, while the 0.75g dose strength is an exclusive product in China. Approval application of the Product has been filed in both China and the U.S., with approval already granted by the U.S. FDA in May 2016.

Metformin is a hypoglycemic agent which is mainly used to improve glucose tolerance of type 2 diabetic patients, lowering not only basal blood glucose but also postprandial blood glucose. The Product can be used alone or in combination with sulfonylurea or insulin to control the blood glucose of type 2 diabetic patients. Metformin hydrochloride extended-release tablet is a high-endextended-release formulation which shall be taken once daily, having notable advantage in terms of doses per day as compared to regular immediate-release formulation and enhancing administration convenience.

- 1 -

Metformin hydrochloride extended-release tablet is one of the key anti-diabetic drugs of the Group. Due to genetic and environmental factors, the population of diabetic patients has been growing year by year, providing the Product with broad market and clinical application prospects. Market launch of the Product will further enrich the Group's product portfolio and contribute to the Group's development in the anti-diabetes field.

*  for identification purpose only

By Order of the Board

CSPC Pharmaceutical Group Limited

CAI Dongchen

Chairman

Hong Kong, 26 September 2019

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. LU Hua, Dr. LI Chunlei, Dr. WANG Qingxi and Mr. CHAK Kin Man as executive directors; Mr. LEE Ka Sze, Carmelo as non-executive director; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Prof. LO Yuk Lam, Dr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.

- 2 -

Attachments

  • Original document
  • Permalink

Disclaimer

CSPC Pharmaceutical Group Ltd. published this content on 26 September 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 September 2019 04:07:01 UTC