Core Viewpoint - The recent collaboration between YuanDa Pharmaceutical and YouEr Pharmaceutical Technology marks a significant advancement in the treatment of severe allergic reactions, with the introduction of the first non-injection epinephrine nasal spray, Neffy®, in China [1][4]. Group 1: Product Collaboration and Market Entry - YuanDa Pharmaceutical has secured exclusive commercialization rights for Neffy® in mainland China and non-exclusive rights in Hong Kong, covering both 2mg and 1mg formulations [1]. - The product has been submitted for regulatory approval in China, with the application accepted by the National Medical Products Administration [1][4]. Group 2: Medical Significance and Urgency - I-type allergic reactions, particularly severe ones, can escalate rapidly, necessitating immediate medical intervention to prevent fatalities [2]. - Epinephrine is the recommended first-line treatment for severe allergic reactions, and early administration has been shown to significantly reduce hospitalization and mortality rates [2]. Group 3: Innovation in Delivery Method - Neffy® represents a breakthrough as the first FDA-approved non-injection treatment for I-type allergic reactions, utilizing a nasal spray delivery method that enhances ease of use and accessibility [3][4]. - The product's design allows for quick administration by patients or bystanders, addressing the limitations of traditional injection methods [3]. Group 4: Market Potential and Financial Projections - Neffy® has already achieved significant sales in the U.S., with revenue reaching $12.8 million in Q2 2025, reflecting a growth of approximately 180% [4]. - Global revenue projections for Neffy® are expected to reach $54 million in 2025, with potential to approach $500 million by 2028 [4].

Core Viewpoint - The announcement highlights a strategic partnership between YuanDa Pharmaceutical and YouEr Pharmaceutical for the commercialization of Neffy, the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions in mainland China and Hong Kong [1] Group 1: Partnership Details - YuanDa Pharmaceutical has secured exclusive commercialization rights for Neffy in mainland China and non-exclusive rights in Hong Kong [1] - The partnership includes two formulations of Neffy: 2mg for adults and children over 30kg, and 1mg for children weighing between 15-30kg [1] Group 2: Regulatory Progress - Neffy has submitted its application for market approval to the National Medical Products Administration (NMPA) in December 2024, and the application has been accepted [1]

本文源自：金融界AI电报 远大医药(00512.HK)发布公告，近日，集团与祐儿医药科技(上海)有限公司(祐儿医药)达成产品合作协 议。集团将获得全球首款用于紧急治疗成人和 30kg 及以上儿童患者(2mg 规格)以及 15-30kg 儿童患者 (1mg 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® )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。本次合作由集团位于北京市昌 平区的子公司远大医药(北京)有限公司主导推进，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, 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].

Group 1 - The company, YuanDa Pharmaceutical, has entered into a product cooperation agreement with YouEr Pharmaceutical Technology (Shanghai) Co., Ltd. to commercialize the world's first epinephrine nasal spray, Neffy, for emergency treatment of type I allergic reactions in adults and children [1] - The agreement grants the company exclusive commercialization rights in mainland China and non-exclusive rights in Hong Kong, with plans for local production within 24 months after product approval [1] - YouEr Pharmaceutical focuses on pediatric medicine, aiming to introduce and develop safe and effective pediatric drugs for children in China, leveraging both global imports and local R&D [1] Group 2 - Neffy is the first non-injection treatment product approved by the FDA for type I allergic reactions in 35 years, expected to improve accessibility for severe allergic reaction patients in China and fill a gap in out-of-hospital emergency medication [2] - The company plans to leverage its extensive resources and established channel systems in emergency care to accelerate academic promotion and market education for Neffy, aiming for rapid market penetration in various out-of-hospital settings [2] Group 3 - The cardiovascular emergency rescue sector is a key focus area for the company, addressing both emergency rescue and chronic disease management [3] - The company has over 30 products in this sector, with 14 included in the national emergency medication catalog and 16 in the shortage medication catalog, providing a comprehensive product mix for various emergency scenarios [3] - The company has more than 20 products in development for cardiovascular emergency and chronic disease treatment, combining innovative R&D with complex generic technology breakthroughs [3] Group 4 - The company emphasizes the importance of innovative products and advanced technology development, focusing on unmet clinical needs and increasing investment in global innovations [4] - The strategy involves a "global operation layout and dual circulation development," promoting a new model of domestic and international interlinked development [4] - The company aims to rapidly bring innovative products to market, providing advanced and diverse treatment options for patients worldwide [4]

Core Viewpoint - The company has entered into a product cooperation agreement with Youer Pharmaceutical Technology (Shanghai) Co., Ltd. to commercialize the world's first epinephrine nasal spray, Neffy® (优敏速®), for emergency treatment of type I allergic reactions in adults and children in China [1][2] Group 1: Product Cooperation and Market Potential - The agreement grants the company exclusive commercialization rights in mainland China and non-exclusive rights in Hong Kong for Neffy®, which is expected to enhance accessibility for severe allergic reaction patients [1][2] - Neffy® is the first non-injection treatment product approved by the FDA for type I allergic reactions in 35 years, filling a gap in emergency medication for out-of-hospital scenarios [2] Group 2: Company’s Strategic Focus - The company is focusing on the cardiovascular emergency sector, which includes both emergency rescue and chronic disease management, with over 30 products in its portfolio [3] - The company has a strong presence in the emergency medication market, with 14 products listed in the national emergency medication catalog and 16 in the shortage medication catalog [3] Group 3: Innovation and Development Strategy - The company emphasizes innovation and advanced technology development, aiming to meet unmet clinical needs and enhance its product pipeline through global innovation [4] - The strategy includes a dual-circulation development model that promotes both domestic and international growth, leveraging the company's industrial advantages and research capabilities [4]

根据披露，佑儿医药是一家专注于儿科领域的本土创新医药公司，致力于为中国儿童专门引进及开发安 全有效、便利易用的儿科药物，凭藉在儿科领域内的深厚经验，依靠全球引进和本土研发双轮驱动，助 力中国儿科治疗方案的提升，为中国的儿科医生、患儿及家庭提供更多的创新治疗选择。 格隆汇12月23日丨远大医药(00512.HK)发布公告，近日，集团与佑儿医药科技(上海)有限公司("佑儿医 药")达成产品合作协议。集团将获得全球首款用于紧急治疗成人和30kg及以上儿童患者(2mg规格)以及 15-30kg儿童患者(1mg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®")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的非独家商业化权益。本次合作由集团位于北京 市昌平区的子公司远大医药(北京)有限公司主导推进，并计划在产品获批后的24个月的内实现本地化生 产。 ...

Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 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。 自願性公告 本集團引進全球首款用於治療嚴重過敏反應的腎上腺素鼻噴霧劑 -2- 此次，本集團引進的全球創新腎上腺素鼻噴霧劑優敏速®是 35 年來 FDA 首次批准的用 於 I 型過敏反應的非注射治療產品，有望提高腎上腺素治療產品對中國嚴重過敏反應患 者的可及性，並填補嚴重過敏反應急救藥物在院外場景使用的空白。待該產品上市後， 本集團將充分依託在急救領域積累的豐富科室資源與成熟的渠道體系，加速推進其學術 推廣和市場教育，助力產品快速放量。憑藉其獨特的便攜性與操作友好性，優敏速®有望 迅速滲透至家庭、學校、旅行等多種院外場景，成為本集團心腦血管急救板塊新的增長 引擎。 心腦血管急救板塊是本集團製藥科技領域重點佈局的方向之一，兼顧了急搶救與慢性疾 病管理兩大方 ...

Core Viewpoint - The recent advancements in the nuclear medicine pipeline of the company signify a major breakthrough, particularly with the FDA approval of the innovative radioactive drug conjugate (RDC) GPN01530 and the positive results from the Phase III clinical trial of TLX591-CDx for prostate cancer diagnosis, indicating imminent commercialization prospects [1][2]. Group 1: Product Development and Clinical Results - TLX591-CDx is a globally innovative diagnostic radioactive drug targeting prostate-specific membrane antigen (PSMA), showing a high positive predictive value (PPV) of 94.8% for overall tumor detection and 100.0% for recurrence in the prostate bed and non-bone metastatic tumors [2][3]. - The successful Phase III clinical trial results for TLX591-CDx provide robust evidence for its high accuracy and clinical utility in diagnosing prostate cancer, supporting its upcoming new drug application in China [3][4]. Group 2: Market Potential and Strategic Positioning - TLX591-CDx has demonstrated strong sales performance globally, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a growth rate exceeding 25% [3]. - The success of TLX591-CDx in China marks a significant step in the company's strategy to build an integrated diagnostic and therapeutic product portfolio for prostate cancer, which is expected to enhance treatment standards and improve patient quality of life [4].

Core Viewpoint - The company has achieved positive topline results in the Phase III clinical trial of its innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, meeting the primary clinical endpoint [1] Group 1: Product Development - TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for both initial diagnosis and recurrent prostate cancer [1] - The company has secured exclusive rights for multiple innovative RDC products, including TLX591-CDx, in Greater China through a strategic cooperation agreement with Telix [1] - TLX591-CDx has been approved for sale in several countries, including the US, Australia, Canada, Brazil, and the UK, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a year-on-year growth of over 25% [1] Group 2: Research and Development - The company has initiated an international multicenter Phase III clinical study for another innovative RDC product, TLX591, in China [2] - The company has established a comprehensive layout in the nuclear medicine sector, covering research, production, distribution, and sales, with R&D bases in Boston and Chengdu [2] - The product pipeline includes 16 innovative products in the research registration stage, utilizing five types of radioactive isotopes and covering seven cancer types, including liver cancer and brain cancer [2] Group 3: Industry Positioning - The company has six innovative RDC products approved for registration clinical research, with four currently in Phase III clinical trials, indicating a harvest period for innovative nuclear medicine products [2] - The nuclear medicine R&D and production base in Chengdu received a Class A Radiation Safety License in May 2025 and commenced operations in June 2023, meeting the demand for various therapeutic and diagnostic nuclear medicines [2]