drugset / Press release

VOLUNTARY ANNOUNCEMENT - "DUVELISIB CAPSULES" OBTAINS DRUG REGISTRATION APPROVAL

2022-03-18 · 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 “DUVELISIB CAPSULES” OBTAINS DRUG REGISTRATION APPROV AL 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 “Duvelisib Capsules” (brand name: Copiktra) (the “Product”) of CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.* (ͩᖹණྠʕփႡ ᖹҦஔ(୿)ʮ̡), a subsidiary of the Company, has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least two prior systemic therapies. The Group has the exclusive license of the Product in China (including Hong Kong, Macau and Taiwan). The Product is the first approved orally available phosphoinositide 3-kinase PI3K-δ and PI3K-γ dual inhibitor worldwide and is also the first approved PI3K selective inhibitor in China. The abnormality of PI3K signaling pathway is considered to cause the proliferation of tumor cells and help form a tumor microenvironment conducive to the evasion of cancer cells from the monitoring of the immune system. Inhibition of PI3K-δ and -γ pathways has a significant clinical efficacy on various B-cell and T-cell lymphomas, and pre-clinical data also show a significant synergistic effect on immunotherapy of a variety of solid tumors. – 2 – In comparison with the data from the pivotal clinical study in the U.S., the Product showed significantly better efficacy in a representative group of r/r FL subjects in China. The responses occurred quickly (median TTR = 1.8 months), objective response rate (ORR) reached 95.2% with a 52.4% complete response rate, and the median progression-free survival was 15.2 months. The Product is safe and tolerable in r/r FL subjects in China, with similar safety results observed in the pivotal clinical study in the U.S. and no new potential signals of risks identified. The majority of TEAEs were low grade (grade 1-2), and no deaths due to adverse events were reported. The pulmonary infections observed in the U.S. clinical trial can also be effectively prevented and managed by safe and convenient pre-treatment. Overall, the Product demonstrated a superior benefit-risk ratio. The Product has also obtained the clinical trial approval for the treatment of advanced malignant solid tumors in combination with PD-1 antibody in China. The Group is currently conducting clinical trials on esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, gastric cancer, colorectal cancer and other solid tumors to expand the group of patients benefitting from the Product. The approval of the Product will further enrich the innovative anti-tumor product portfolio of the Group. The Group will strive to ensure the rapid launch of the Product in order to fulfill the clinical needs of patients with hematological malignancies in China. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 18 March 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, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors. * For identification purpose only

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