CSPC Pharmaceutical : INVESTIGATIONAL NEW DRUG NBL-015 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA

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CSPC PHARMACEUTICAL GROUP LIMITED

石 藥 集 團 有 限 公 司

(Incorporated in Hong Kong with limited liability)

(Stock code: 1093)

VOLUNTARY ANNOUNCEMENT

INVESTIGATIONAL NEW DRUG NBL-015

GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA

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 antibody drug NBL-015, a Claudin 18.2 eADCC antibody independently developed by Novarock Biotherapeutics Limited ("NovaRock"), a subsidiary of the Company in the United States, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer, including cancer of gastroesophageal junction. This is the second orphan-drug designation for NBL-015, the first orphan-drug designation was received in December 2020 for pancreatic cancer treatment.

Gastric cancer is a disease in which malignant (cancer) cells form in the lining of the stomach and is a rare disease in the United States. Based on World Health Organization GLOBOCAN 2020 data, gastric cancer is the third leading cause of cancer death worldwide. It has the 7th highest incidence among cancers in women and 4th highest incidence in men around the world. Gastric cancer is more prevalent in Eastern Asia, and the incidence of gastric cancer is the second highest among all malignant tumors in China.

Claudin 18.2 is a highly specific cell-surface molecule widely expressed in gastric and pancreatic tumors. In normal tissues, Claudin 18.2 expression is strictly confined to differentiated epithelial cells of the gastric mucosa, thus the development of therapeutic antibodies targeting Claudin 18.2 has high anti-cancer potential. NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC and ADCP effects. Preclinical studies of in vitro tumor cell killing and in the gastric tumor mouse model have demonstrated that NBL-015 has significant advantages over similar drugs in terms of low

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immunogenicity, good safety, high affinity and high anti-tumor activity, providing a promising prospect of becoming the best-in-class target therapy to treat gastric cancer. NBL-015 also has the potential to be combined with standard chemotherapy and PD-1 blocking immunotherapy to achieve high anti-cancer synergy.

The orphan-drug designation will allow the Group to communicate with the U.S. FDA frequently and speed up the clinical development, registration and launch of NBL-015. NovaRock plans to file clinical trial application for this investigational new drug in China and the United States in the coming months.

By Order of the Board

CSPC Pharmaceutical Group Limited

Cai Dongchen

Chairman

Hong Kong, 9 April 2021

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.

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