Core Viewpoint - The company, Yuan Da Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration of China for Neffy, the world's first epinephrine nasal spray for treating severe allergic reactions, which is expected to enhance accessibility for patients in China [1][4]. Group 1: Product Overview - Neffy is the first non-injection treatment product approved by the FDA for type I allergic reactions, designed for easy and quick administration during emergencies [2]. - The product has a shelf life of 30 months, reducing waste and economic burden on patients [2]. - Clinical studies show that Neffy achieves comparable blood levels of epinephrine to approved injection products and provides rapid symptom relief [2]. Group 2: Market Context - Severe allergic reactions, particularly type I, are critical and can escalate quickly, with a global incidence rate of approximately 50,112 per 100,000 people per year, and a lifetime prevalence of 0.3%-5.1% [3]. - Current guidelines recommend epinephrine as the first-line treatment for severe allergic reactions, yet only 25% of patients in China use it during an episode [4]. Group 3: Strategic Implications - Neffy is expected to fill a gap in the emergency treatment landscape for severe allergic reactions outside of clinical settings, enhancing the company's market position [4]. - The company plans to leverage its established resources and distribution channels to promote Neffy and accelerate market penetration [4]. - The cardiovascular emergency segment is a key focus for the company, with over 20 products in development aimed at both emergency and chronic disease management [5]. Group 4: Innovation and Development - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and expand its product pipeline [6]. - A strategy of global operational layout and dual-circulation development is being adopted to enhance the company's competitive edge and facilitate the launch of innovative products [6].
远大医药(00512)引进的全球首款用于治疗严重过敏反应的肾上腺素鼻喷雾剂获颁发药品注册证书