CSPC Pharmaceutical : VOLUNTARY ANNOUNCEMENT - JMT601 OBTAINS CLINICAL TRIAL APPROVAL IN CHINA

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CSPC PHARMACEUTICAL GROUP LIMITED ͩᖹණྠϞࠢʮ̡

(Incorporated in Hong Kong with limited liability)

(Stock code: 1093)

VOLUNTARY ANNOUNCEMENT

JMT601 OBTAINS CLINICAL TRIAL APPROVAL IN CHINA

The board of directors (the "Board") of CSPC Pharmaceutical Group Limited (the "Company", together with its subsidiaries, the "Group") is pleased to announce that JMT601, a first-in-class drug candidate developed by Shanghai JMT-BIO Technology Co., Ltd.*€ɪऎݵਟत͛ي߅ҦϞࠢʮ̡ ("Shanghai JMT-BIO"), a subsidiary of the Company, has obtained approval of its investigational new drug (IND) application from the National Medical Products Administration (NMPA) to initiate clinical trial for Non-Hodgkin lymphoma (NHL).

Non-Hodgkin lymphoma is a heterogeneous group of lymphoproliferative disorders originating from B-cell lymphocytes, T-cell lymphocytes or NK cells. While most patients with indolent NHL can live 20 years after diagnosis, the prognosis of those with aggressive lymphoma may worsen with overall five-year survival rate of around 60%. B-cell lymphoma with CD20 expression makes up most of NHL.

JMT601 is the world's first bispecific SIRPα fusion protein with synergised target binding effect which has entered clinical stage, it is a novel and rationally designed bispecific fusion protein based on the approved anti-CD20 antibody Ofatumumab by addition of a CD47 binding fragment SIRPα. It effectively binds to CD20 on the tumor cell surface to induce the antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Its subsequent synergised binding to CD47 expressed on the tumor cells serves as a "don't eat me" signal to the macrophages. JMT601's performance on blocking the interaction of CD47 with SIRPα expressed on the macrophages is significantly better as compared with SIRPα-Fc fusion protein. By disrupting the CD47/SIRPα interaction, JMT601 has enhanced antibody-dependent cellular phagocytosis activity (ADCP). Its enhanced efficacy as compared with conventional CD20-targeting antibodieswas demonstrated in various human B-cell lymphoma models. The nonclinical toxicology studies conducted indicated that JMT601 has no obvious binding with CD20-negative cells and no significant suppression of strong CD47-positive cells including erythrocytes and thrombocytes was found at a dose of 100mpk, demonstrating the satisfactory safety profile and supporting the evaluation of JMT601 in clinical studies.

The Group is also planning a Phase I clinical study in the U.S.. Clinical data from these studies will guide further development of JMT601 for the treatment of Non-Hodgkin lymphoma and other hematological malignancies.

Shanghai JMT-BIO is located in Zhangjiang Science City, Pudong New District, Shanghai. It is a fast-growing national high-tech enterprise and a foreign-funded research and development center recognized by the Shanghai Municipal Commission of Commerce in Shanghai. It is the core biopharmaceutical innovation and R&D center of the Group in Shanghai. With an established biopharmaceutical R&D technology platform, it is committed to the research and development of therapeutic macromolecule new drugs in areas such as tumor targeting, immunomodulation, and metabolism. It has over 10 new drug R&D projects ongoing, and JMT101 and JMT103, the independently developed anti-tumor patented products, have successfully entered the late clinical stage. JMT 601 is the first product of Shanghai JMT-BIO's patented technology platform for novel immuno-enhanced dual-function fusion protein.

The Group will endeavor to push forward the clinical trials and strive to launch the product as soon as possible.

By Order of the Board

CSPC Pharmaceutical Group Limited

Cai Dongchen

Chairman

Hong Kong, 25 March 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.

*

For identification purpose only