Core Insights - The announcement from the Hong Kong-listed company, Yuan Da Pharmaceutical Group, reveals that its product Neffy® (优敏速®), a nasal spray for emergency treatment of type I allergic reactions, has received drug registration certification from the National Medical Products Administration of China [1] Group 1: Product Development and Market Impact - Neffy® is the first non-injection epinephrine product approved in China for severe allergic reactions, filling a gap in emergency medication for severe allergy patients outside of hospital settings [1] - The company plans to achieve localized production of Neffy® within 24 months post-approval, aiming for accelerated market penetration in China [1] - The introduction of Neffy® is expected to reshape the epinephrine drug market in China, leveraging Yuan Da Pharmaceutical's strong commercialization system in the emergency field [1] Group 2: Clinical Significance and Usage - Epinephrine plays a crucial role in emergency responses, particularly for life-threatening allergic reactions, and is recommended by clinical guidelines for severe allergic reactions [1] - The timely and convenient administration of epinephrine is critical for patients with severe allergies, as the median time to death can be as short as 5 to 30 minutes [2] - Neffy® utilizes an innovative nasal spray delivery method, making it easy to carry and use, which can significantly improve the success rate of emergency treatments for severe allergic reactions [2] Group 3: Future Product Strategy - The successful launch of the 2mg Neffy® is a key achievement under the company's "self-research + introduction" product strategy [3] - In addition to the 2mg formulation, the company is also developing a 1mg version for children weighing 15kg to 30kg, which has already been approved in the US and Japan [3] - This strategy aims to provide a comprehensive range of medication options for different age groups within the severe allergy patient population [3]

Core Viewpoint - The approval of Neffy® (优敏速®), China's first non-injection epinephrine product for emergency treatment of type I allergic reactions, marks a significant advancement in the market for severe allergic reactions, providing a more convenient option for patients [1][4]. Group 1: Product Approval and Market Impact - Neffy® has received a drug registration certificate from the National Medical Products Administration, filling a gap in emergency medication for severe allergic reactions outside of hospital settings [1]. - The product is expected to accelerate market penetration in China, reshaping the epinephrine drug market landscape due to its innovative delivery method [1][3]. - The approval reflects the company's keen market opportunity recognition and plans for localized production within 24 months post-approval [1]. Group 2: Clinical Significance and Usage Statistics - Epinephrine is crucial for emergency responses, particularly in cases of anaphylaxis, and is recommended by clinical guidelines for severe allergic reactions [1]. - In China, only 25% of severe allergic reactions receive epinephrine treatment, highlighting a significant unmet market need [2]. - The incidence of severe allergic reactions in China is reported at 8.39 per 100,000 person-years, with a global incidence rate of approximately 50-112 per 100,000 person-years [2]. Group 3: Product Advantages and Future Projections - Neffy® offers advantages such as portability, ease of use, and a 30-month shelf life, which can reduce waste and economic burden on patients [3]. - Clinical studies indicate that Neffy® achieves comparable blood concentration levels of epinephrine to traditional injection methods, with superior pharmacodynamic effects [3]. - The product is projected to generate $54 million in global revenue by 2025 and approach $500 million by 2028, positioning it as a new growth driver for the company's cardiovascular emergency segment [4].

Group 1 - The company, Yuan Da Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration of China for Neffy® (优敏速®), the world's first nasal spray epinephrine for emergency treatment of type I allergic reactions in adults and children weighing 30 kg and above [1] - The company holds exclusive commercialization rights for the product in mainland China and non-exclusive rights in Hong Kong, with plans for localized production within 24 months after approval [1] Group 2 - Neffy® is the first non-injection treatment for type I allergic reactions approved by the FDA, featuring an innovative nasal spray delivery method that is convenient and portable for emergency use [2] - The product has a shelf life of up to 30 months, which helps reduce waste from expired medications and alleviates the economic burden on patients [2] - Clinical studies show that Neffy® achieves comparable blood epinephrine levels to approved injection products and provides rapid symptom relief for allergic reaction patients [2] - The 2 mg version of Neffy® is expected to be approved for sale in the US and EU by August 2024, while the 1 mg version will be approved in the US by March 2025, and both versions are set for approval in Japan by September 2025 [2]

Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其 準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而 產生或因倚賴該等內容而引致的任何損失承擔任何責任。 ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 本集團引進的全球首款用於治療嚴重過敏反應的腎上腺素鼻噴霧劑 獲頒發藥品註冊證書 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事會 (「董事會」)自願刊發。 董事會欣然公告，近日，本集團通過與祐兒醫藥合作獲得的全球首款用於緊急治療成人和 30kg 及以上兒童患者（2mg 規格）I 型過敏反應（包括嚴重過敏反應）的腎上腺素鼻噴霧 劑 Neffy® (「優敏速® 」)獲得中華人民共和國國家藥品監督管理局（中國藥監局）頒發藥 品註冊證書，本集團擁有該產品在中國大陸合作渠道內的獨家商業化權益以及在中國香 港特別行政區的非獨家商業化權益，並計劃在產品獲批後的 24 個月之內實現本地化生產。 優敏速®是首個被美國食品藥品監督管理局(「 ...

Core Viewpoint - The company, Far East Pharmaceutical (00512), has secured exclusive commercialization rights for Neffy® (优敏速®), the world's first nasal spray epinephrine for emergency treatment of type I allergic reactions, in mainland China and non-exclusive rights in Hong Kong, marking a significant advancement in the treatment of severe allergic reactions [1][3]. Group 1: Product Development and Market Position - Neffy® is the first non-injection treatment for type I allergic reactions approved by the FDA in 35 years, utilizing an innovative nasal spray delivery method [3][6]. - The product is expected to fill a critical gap in out-of-hospital emergency scenarios, where timely administration of epinephrine is crucial for patient survival [4][6]. - The company plans to localize production within 24 months post-approval, reinforcing its leadership in the cardiovascular emergency sector [3][12]. Group 2: Clinical Need and Market Opportunity - Severe allergic reactions have a median death time of 5-30 minutes, emphasizing the need for immediate medical intervention [4]. - In China, only 25% of severe allergic reactions receive epinephrine treatment, highlighting a significant opportunity for Neffy® to improve accessibility and response times [5][7]. - The global incidence of severe allergic reactions is rising, with the Chinese market for allergy medications projected to reach $9.6 billion by 2025, indicating a growing demand for effective treatments like Neffy® [9][12]. Group 3: Competitive Advantage and Future Growth - The introduction of Neffy® enhances the company's diverse product portfolio in the cardiovascular emergency field, which includes various forms of epinephrine products [12][13]. - The company has over 30 products, with 14 included in the national emergency drug list, positioning it well to meet the needs of patients in various emergency scenarios [12][13]. - The anticipated success of Neffy® is expected to drive significant revenue growth, with projections of $540 million globally by 2025 and potential market penetration in households, schools, and travel settings [7][13].