drugset / Press release

VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR VALSARTAN AND LEVAMLODIPINE MALEATE TABLETS (SYH9056 TABLETS)

2026-06-16 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

Hong Kong Exchanges and Clearing Limited and The Stock Excha nge 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 whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR VALSARTAN AND LEVAMLODIPINE MALEATE TABLETS (SYH9056 TABL ETS) 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 marketing authorisation application for Valsartan and Levamlodipine Maleate Table ts (SYH9056 Tablets) (the ‘‘Product ’’) developed by the Group has been accepted by the National Medi cal Products Administration (the ‘‘NMPA ’’) of the People ’s Republic of China. The indication for this application is t he treatment of mild-to-moderate essential hypertension inadequately co ntrolled by monotherapy. The Product is a single-pill combination of valsartan and levamlodipine ma leate (strength: 80mg/2.5mg) and has been submitted for registration as a Class 2.3 new drug under the r egistration classification of chemical drugs, offering distinct clinical therapeutic advantages . Currently, this combination is not marketed in China or overseas. Levamlodipine Maleate (Xuanning) is the first domesticall y developed innovative drug from China to receive full approval from the U.S. Food and Drug Administra tion (FDA) (U.S. brand name: CONJUPRI). It is the first new hypertension drug from China t o be marketed in the United States, representing a new height for the overseas expansion of Chin ese pharmaceuticals. The Group has achieved breakthroughs in key core technologies and pionee red the preparation method of levamlodipine maleate. Meanwhile, leveraging its proprie tary PCT-patented separation technology, the Group separates the active ingredient — levamlodipine maleate — from amlodipine maleate. It achieves the same antihypertensive effect at only 50% of the dose of imported amlodipine, while effectively reducing adverse reactions associated with am lodipine such as peripheral oedema and headache, thereby improving medication safety for patient s. The mechanisms of action of valsartan and levamlodipine maleate in this combination are complementa ry, offering stronger antihypertensive efficacy and a better safety profile when used together. Fur thermore, the single-pill combination enhances dosing convenience and significantly improves pa tient medication adherence, leading to more effective blood pressure control. – 1 – This application is based on the results of a bioequivalence study conducted in healthy subjects and a Phase III clinical study conducted in hypertensive patient s. The Phase III clinical study results demonstrated that, in patients with mild-to-moderate esse ntial hypertension inadequately controlled by monotherapy, the antihypertensive efficacy of the Product was significantly superior to that of levamlodipine maleate or valsartan monotherapies. Signif icant efficacy was observed after 4 weeks of treatment, with the therapeutic effect stabilising after 8 weeks, and no efficacy rebound was observed after 24 weeks of continuous administration. In addition, c ompared with monotherapies, the Product presented no new safety risks, and the incidence rates of per ipheral oedema, headache and dizziness were significantly lower than historical research data for amlodipine monotherapy. Therefore, the Product demonstrated remarkable antihypertensive effica cy and distinct advantages in medication safety. Based on its comprehensive advantages in efficacy, safety a nd compliance, the Product has significant clinical application value and is expected to become a new tr eatment option for hypertension. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 16 June 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors. – 2 –

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