赛诺医疗(688108.SH):公司冠脉支架产品在海外获得注册证

Core Viewpoint - The approval of the HT Supreme™ drug-eluting stent system by the Drug Regulatory Authority of Pakistan (DRAP) marks a significant milestone for the company in expanding its overseas business and is expected to boost sales in international markets [1][2] Group 1: Product Registration and Development - The company submitted the registration application for the HT Supreme™ drug-eluting stent system to the Drug Regulatory Authority of Pakistan in October 2023 and has received approval [1] - The HT Supreme™ stent is the first product developed by a Chinese stent manufacturer to conduct pre-market clinical studies simultaneously in China, the United States, Japan, and Europe, receiving CE certification in December 2019 and medical device registration in China in December 2020 [1] - The product has also obtained medical device registrations in multiple countries including Thailand, Uzbekistan, Singapore, Indonesia, Turkey, Taiwan, Malaysia, India, Bangladesh, Hong Kong, South Korea, Egypt, Belarus, Mexico, Kyrgyzstan, Morocco, Peru, Saudi Arabia, Ecuador, Argentina, and Vietnam from 2022 to 2025 [1] Group 2: Impact on Overseas Business - The registration of the product in Pakistan is a crucial part of the company's strategy to expand its overseas business, which is anticipated to enhance the sales of its products in international markets [2]