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].

Core Insights - The approval of Neffy, a non-injection epinephrine nasal spray by YuanDa Pharmaceutical, marks a significant advancement in emergency treatment for severe allergic reactions in China, filling a gap in out-of-hospital emergency medication options [1][5] Group 1: Product Approval and Market Impact - Neffy is the first non-injection epinephrine product approved for emergency treatment of type I allergic reactions in China, providing a more convenient option for patients [1] - The product is expected to accelerate market penetration in China, reshaping the epinephrine drug market landscape due to its innovative delivery method [1][4] - The approval reflects YuanDa's keen market opportunity recognition and plans for local production within 24 months post-approval [1] Group 2: Clinical Significance and Usage Barriers - Epinephrine is critical for treating life-threatening allergic reactions, with timely administration being crucial for patient survival [2] - Current barriers in China include the injection method of administration, limiting its use to hospital settings, with only 25% of severe allergic reactions treated with epinephrine [2][3] - The nasal spray format of Neffy addresses these barriers, allowing for quicker access and administration in emergency situations [4] Group 3: Market Potential and Financial Projections - The global incidence of severe allergic reactions is rising, with an estimated market size for epinephrine in China projected to reach approximately 3.209 billion yuan by 2025 [3] - Neffy is anticipated to capture significant market share due to its portability and ease of use, potentially generating global revenues of 54 million USD by 2025 and nearing 500 million USD by 2028 [5] Group 4: Strategic Positioning and Future Plans - YuanDa Pharmaceutical's strategy includes a comprehensive product lineup for emergency scenarios, with plans for additional formulations targeting different patient demographics [6] - The company aims to leverage its established resources and distribution channels to enhance academic promotion and market education for Neffy [5][6] - The successful launch of Neffy is expected to strengthen YuanDa's competitive position in the cardiovascular emergency sector and contribute to sustained revenue growth [6][7]

本文源自：金融界AI电报 远大医药(00512.HK)发布公告，近日，本集团通过与祐儿医药合作获得的全球首款用于紧急治疗成人和 30kg 及以上儿童患者(2mg规格)I型过敏反应(包括严重过敏反应)的肾上腺素鼻喷雾剂Neffy® (优敏速®) 获得中国国家药品监督管理局(中国药监局)颁发药品注册证书，本集团拥有该产品在中国大陆合作渠道 内的独家商业化权益以及在中国香港特别行政区的非独家商业化权益，并计划在产品获批后的24个月之 内实现本地化生产。 ...

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].

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].

Core Viewpoint - The approval of Neffy, the first non-injection epinephrine nasal spray in China, marks a significant advancement in emergency treatment for severe allergic reactions, providing a more convenient option for patients outside of hospital settings [1][3]. Group 1: Product Approval and Market Impact - Neffy has received a drug registration certificate from the National Medical Products Administration, making it the first non-injection epinephrine product approved for emergency treatment of type I allergic reactions in China [1]. - The product is expected to fill a gap in the emergency treatment market for severe allergic reactions, offering a more accessible option for patients [1][3]. - The company plans to achieve localized production within 24 months post-approval, aiming to accelerate market penetration and reshape the epinephrine drug market in China [3]. Group 2: Clinical Significance and Usage Statistics - Epinephrine is crucial for treating life-threatening allergic reactions, with timely administration being critical for patient survival; however, only 25% of severe allergic reactions in China currently receive epinephrine treatment [4][5]. - The global incidence of severe allergic reactions is approximately 50-112 per 100,000 people annually, with a rising trend; in China, the incidence is reported at 8.39 per 100,000 people per year [5]. Group 3: Product Advantages and Market Potential - Neffy offers significant advantages such as portability and ease of use, allowing patients or bystanders to administer the drug quickly during emergencies [6][7]. - The product has a shelf life of 30 months, reducing waste and economic burden on patients due to expired medications [6]. - Clinical studies indicate that Neffy achieves comparable blood concentration levels of epinephrine to traditional injection methods, with superior pharmacodynamic effects [6][7]. Group 4: Strategic Positioning and Future Growth - The successful launch of Neffy is part of the company's strategy to enhance its product portfolio in the cardiovascular emergency sector, which is a key focus area for the company [8][9]. - The company is also developing a 1mg version of Neffy for pediatric patients, further expanding its market reach and addressing the needs of different age groups [8]. - With over 20 products in development for cardiovascular emergencies and chronic disease management, the company is well-positioned to maintain a competitive edge in the market [9].

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(「 ...

Major Events - Kuaishou-W (01024) strongly condemns illegal activities related to black and gray industries, has reported to law enforcement and relevant authorities [1] - Sihon Pharmaceutical (02096) receives clinical trial approval for SIM0610 (EGFR/cMET bispecific antibody-drug conjugate) from the National Medical Products Administration [1] - Sinopec Engineering (02386) plans to acquire 100% equity of East China Pipeline Design Institute [1] - Yanda Pharmaceutical (00512) introduces the world's first epinephrine nasal spray for treating severe allergic reactions [1] - Valiant Pharmaceuticals-B (09887) reports the first subject has been dosed in Phase I trial of LBL-047 [1] - Xinyi Energy (03868) intends to acquire 100% equity of Jinzhai Xinyi Wind Power for 62 million yuan [1] - Zhongneng Holdings (00228) plans to receive a premium of approximately 9.03% for a full acquisition offer, with resumption of trading on December 24 [1] Operating Performance - Xipuni (02583) issues a profit warning, expecting annual net profit to increase year-on-year [1] - AEON CREDIT (00900) reports a profit of 353 million HKD for the first three quarters, an increase of 28.11% year-on-year [1] - New Fire Technology Holdings (01611) anticipates an annual net loss not exceeding 10 million HKD [1]

Core Viewpoint - The company, Far East Pharmaceutical (00512), has secured exclusive commercialization rights for Neffy, the world's first nasal spray epinephrine for emergency treatment of type I allergic reactions in mainland China, 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 approved by the FDA for type I allergic reactions, utilizing an innovative nasal spray delivery method [3][6]. - The product is expected to fill a gap in out-of-hospital scenarios for severe allergic reactions, where timely medical intervention is critical [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 - The incidence of severe allergic reactions is rising globally, with a reported rate of approximately 50-112 per 100,000 people annually, and a lifetime prevalence of 0.3%-5.1% [9]. - In China, the incidence rate is 8.39 per 100,000 people annually, with a notable increase in severe allergic reactions among individuals under 18 [9]. - The Chinese market for allergy medications is projected to reach $9.6 billion by 2025, with the epinephrine market expected to hit $1.1 billion [9]. Group 3: Competitive Advantage and Future Growth - The introduction of Neffy enhances the company's diverse product offerings in the cardiovascular emergency field, which includes various forms of epinephrine products [12][13]. - The company has a robust pipeline with over 30 products, including 14 listed in the national emergency drug catalog, positioning it favorably in the market [12][13]. - The anticipated success of Neffy in China is expected to significantly increase accessibility for patients experiencing severe allergic reactions, thereby driving growth in the company's emergency response segment [7][13].