ePTFE心包膜
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佰仁医疗(688198.SH):ePTFE心包膜产品获批注册
Ge Long Hui A P P· 2025-12-03 09:17
该产品为0.1mm的膨体聚四氟乙烯(ePTFE)膜,用于心脏外科手术中心包膜的修复或重建。人体的心 脏表面有一层薄膜包裹着整个心脏,这层薄膜被称为心包或心包膜,对心脏表面组织,特别是对冠状动 脉血管具有保护作用。每当需要进行心外手术时,都不可避免地要切开心包膜,由于心包的外科损伤所 致术后永久失去原有心包膜,以致导致心脏表面裸露与胸骨组织粘连,使得再行开胸手术时面临出血等 严重并发症的风险,致使手术难度增加,特别是小儿复杂先心病患者,很多都需要再次开胸。因此,开 心手术常规需要植用心包膜(ePTFE)修复或重建破损心包以保护心脏。目前国内市场所用的心包膜为 外企垄断,长期以来依赖进口,该产品的注册和上市将结束心外ePTFE心包膜依赖进口的历史。 格隆汇12月3日丨佰仁医疗(688198.SH)公布,近日,经国家药品监督管理局审查,公司研发的心包膜 (ePTFE)产品获批注册。 ...
佰仁医疗(688198):业绩亮眼 研发成果有序落地
Xin Lang Cai Jing· 2025-09-24 10:30
Core Insights - The company successfully launched its TAVR product, achieving revenue of 250 million yuan in H1 2025, a year-on-year increase of 30.1%, and a net profit attributable to shareholders of 70 million yuan, up 102.9% year-on-year, with a 64.7% increase after excluding share-based payment impacts [1] - The TAVR product has received broad market recognition and has been patented in Japan and registered in Indonesia, laying a solid foundation for international expansion [1] - The company maintains a high gross margin of 90.5% in Q2 2025, attributed to the new product launch, while actively promoting academic initiatives to enhance market presence [1] Financial Performance - In H1 2025, the company reported a gross margin of 90.5%, an increase of 1.2 percentage points year-on-year and 4.7 percentage points quarter-on-quarter [1] - The sales expense ratio, excluding share-based payment costs, remained stable at 24.0% in H1 2025 [1] Research and Development - The company invested 70 million yuan in R&D in H1 2025, accounting for 30.0% of revenue, with plans for 12 products to enter the registration review process by 2025, marking the highest number of products in review since its establishment [2] - Several products, including ophthalmic biological patches and ePTFE pericardium, have received feedback on their registration reviews, while others are in the clinical trial phase [2] Future Outlook - The company has adjusted its earnings per share forecasts for 2025-2027 to 1.43, 1.94, and 2.51 yuan respectively, with a target price of 119.45 yuan based on DCF valuation, maintaining a "buy" rating [2]