SINOMED(SH:688108) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-27 02:51Core Viewpoint - The company, Sainuo Medical Technology Co., Ltd., has received approval from the Drug Regulatory Authority of Pakistan (DRAP) for its HT Supreme™ drug-eluting stent system, marking a significant step in its overseas business expansion [1][3]. Group 1: Product Registration Details - The HT Supreme™ drug-eluting stent system is a combination product consisting of a cobalt-chromium alloy stent and a balloon delivery system, featuring a non-corrosive polymer layer and a biodegradable polymer layer for drug release [1][2]. - The product is designed for patients with symptomatic coronary artery disease due to primary coronary artery lesions (length ≤ 40 mm) and is applicable for reference vessel diameters ranging from 2.25 mm to 5.00 mm [2]. Group 2: Historical Context and Certifications - The HT Supreme™ stent is the first heart stent product developed by a Chinese manufacturer to undergo pre-market clinical studies simultaneously in China, the USA, Japan, and Europe, receiving CE certification in December 2019 and registration from the National Medical Products Administration of China in December 2020 [2]. - The product has also obtained medical device registration certificates in multiple countries, including Thailand, Uzbekistan, Singapore, and others, from 2022 to 2025 [2]. Group 3: Impact on Company Operations - The approval of the product in Pakistan is expected to enhance the company's sales in international markets, contributing positively to its overseas business development [3]. - The company acknowledges that international market sales may be influenced by regulatory policies, market environment changes, and exchange rate fluctuations, which could impact future performance [3].