drugset / Press release

VOLUNTARY ANNOUNCEMENT - FIRST PATIENT DOSED IN PHASE III CLINICAL TRIAL OF DUOENDA (MITOXANTRONE HYDROCHLORIDE LIPOSOME INJECTION) FOR THE TREATMENT OF RECURRENT METASTATIC NASOPHARYNGEAL CARCINOMA

2023-03-02 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

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. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT FIRST PATIENT DOSED IN PHASE III CLINICAL TRIAL OF DUOENDA (多恩達 ®) (MITOXANTRONE HYDROCHLORIDE LIPOSOME INJECTION) FOR THE TREATMENT OF RECURRENT METASTATIC NASOPHARYNGEAL CARCINOMA 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 first patient has been dosed in a Phase III clinical trial conducted in China of Duoenda (多恩達 ®) (mitoxantrone hydrochloride liposome injection) developed by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.* (石藥集團中諾藥業 (石家莊) 有限公司), a subsidiary of the Company, for the treatment of patients with recurrent metastatic nasopharyngeal carcinoma who have failed platinum-based therapy. Nasopharyngeal carcinoma (NPC) is acommon head and neck malignant tumor. About 30% of NPC patients still experience recurrence or metastasis after initial treatment. The treatment of advanced recurrent metastatic NPC isdifficult, especially for patients who have failed first-line platinum-based therapy. With the limited choice and low efficacy of therapeutic drugs (including chemotherapy and immunotherapy), new drugs are urgently needed. This study is a randomized, open-label, active-controlled and multi-center Phase III clinical trial conducted in China to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent metastatic NPC. - 1 - Duoenda is a new drug of improved formulation independently developed by the Group with intellectual property rights and was approved for marketing in January 2022 for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). The active ingredient of this product is mitoxantrone hydrochloride, and its use of liposomes as drug carriers has the advantages of reducing the peak drug concentration, reducing myocardial distribution and increasing tumor tissue distribution, which can improve the efficacy and safety of mitoxantrone. Duoenda has broad-spectrum anti-tumor activity. The Group will continue to explore the application of Duoenda for various indications and provide patients with safe and effective therapies to address the unmet clinical needs. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 2 March 2023 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, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors. - 2 -

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