医药生物行业：爱德华Evoque获FDA批准，持续看好三尖瓣介入商业化前景

Investment Rating - The report maintains an "Increase" rating for the industry, indicating a positive outlook for investment opportunities in the sector [2][7]. Core Insights - Edward Lifesciences' Evoque has received FDA approval, marking it as the first transcatheter tricuspid valve replacement product for treating tricuspid regurgitation (TR) patients, which is expected to significantly improve the health of patients with severe symptoms [5]. - The demand for transcatheter interventions is robust, with projections indicating that the number of transcatheter tricuspid valve replacement surgeries could reach 453,500 by 2030, leading to a market size of approximately $13.606 billion [6]. - The report highlights that the domestic market currently lacks approved transcatheter tricuspid valve products, but several leading companies, including Jianxi Technology, Qiming Medical, and Peijia Medical, are making significant progress in their development efforts [6]. Summary by Sections Industry Overview - The industry comprises 492 listed companies with a total market capitalization of 58,477 billion and a circulating market capitalization of 50,449 billion [3]. Company Performance - Edward Lifesciences is expected to achieve high growth in its TMTT business, with projected revenues exceeding previous guidance of $280-320 million for 2024, driven by the launch of Evoque in Europe and the U.S. [5][6]. Competitive Landscape - Jianxi Technology is anticipated to be the first to receive domestic approval for its LuX-Valve products, which are currently in the NMPA approval stage, potentially granting a three-year exclusivity period [6]. - Other companies like Qiming Medical and Peijia Medical are also advancing their products through clinical trials and initial human implantations, indicating a competitive environment in the transcatheter tricuspid valve market [6].