drugset / Press release

VOLUNTARY ANNOUNCEMENT - JMT601 (CPO107) GRANTED FAST TRACK DESIGNATION BY U.S. FDA FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

2022-01-27 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

– 1 – 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 GROU P LIMITED ͩᖹණྠ Ϟʮ̡ (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT JMT601 (CPO107) GRANTED FAST TRACK DESIGNATION BY U.S. FDA FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA 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 (CPO107), a first-in-class drug candidate developed by the Group, has been granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. JMT601 (CPO107) is the world’s first bispecific SIRPα fusion protein with synergised target binding effect which has entered clinical stage of development. It effectively binds to CD20 on the lymphoma cell surface to induce the antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). CD20-binding further leads to synergised binding to CD47 expressed on lymphoma cells, thus abolishing the “don’t eat me” signal mediated by CD47 and inducing potent antibody-dependent cellular phagocytosis activity (ADCP) by the macrophages. Its enhanced efficacy as compared with conventional CD20-targeting antibodies was demonstrated in various human B-cell lymphoma models. The nonclinical toxicology studies indicated that JMT601 (CPO107) 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 100 mpk, demonstrating the satisfactory safety profile and supporting the evaluation of JMT601 (CPO107) in clinical studies. The granting of Fast Track Designation by the FDA recognizes that JMT601 (CPO107) has demonstrated the potential to treat a serious or life-threatening disease and will facilitate the development and expedite the review of JMT601 (CPO107). – 2 – Currently a multicenter, first-in-human, dose escalation and dose expansion Phase 1/2 clinical trial is underway in the U.S. to evaluate the safety, pharmacokinetics and preliminary efficacy of JMT601 (CPO107) in the treatment of patients with advanced Non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma as a subpopulation. Non-Hodgkin’s lymphoma (NHL) is a heterogeneous group of lymphoproliferative disorders originating from B lymphocytes, T lymphocytes or NK cells. B-cell lymphomas, which express CD20, make up most (about 85%) of NHLs in the U.S.. While most patients with indolent NHL can live 20 years after diagnosis, those with aggressive lymphomas can have worse prognosis with overall five-year survival rate of around 60%. The Group is also conducting a clinical trial of JMT601 in China. Clinical data from these studies will guide the global clinical development of JMT601 (CPO107). By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 27 January 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN 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, Professor WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.

The release as fetched from its publisher. irasia.com ↗