Core Viewpoint - The company has received regulatory approval for Neffy, the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions, which is expected to enhance accessibility for patients in China [1][4]. Group 1: Product Approval and Features - Neffy has been granted a drug registration certificate by the National Medical Products Administration of China, allowing the company exclusive commercialization rights in mainland China and non-exclusive rights in Hong Kong [1]. - Neffy is the first non-injection treatment product for type I allergic reactions approved by the FDA, featuring a convenient nasal spray delivery method [2]. - The product has a shelf life of 30 months, reducing waste from expired medications and alleviating economic burdens on patients [2]. Group 2: Clinical Significance and Market Potential - Type I allergic reactions can escalate rapidly, with severe cases potentially leading to death, highlighting the critical need for immediate medical intervention [3]. - Current guidelines recommend epinephrine as the first-line treatment for severe allergic reactions, but only 25% of patients in China use it during an episode [4]. - Neffy aims to fill the gap in emergency treatment options outside of clinical settings, potentially increasing the usage of epinephrine among patients [4]. Group 3: Company Strategy and Market Position - The company is focused on the cardiovascular emergency sector, with over 30 products, including 14 listed in the national emergency drug catalog [5]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and expand its product pipeline [6]. - The strategy includes a dual-circulation development model to enhance both domestic and international market presence [6].
远大医药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