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远大医药 (00512) 斩获全球首款鼻喷肾上腺素产品优敏速 打破注射依赖或成中国唯一院外急救产品
Zhi Tong Cai Jing· 2025-12-23 12:52
由于严重过敏反应的进程非常迅猛,可能累及呼吸和/或循环系统。因此,第一时间进行医学干预对于患者的生存获益至关重要。但在实际临床场景 中,患者需入院后才能得到针对性治疗,这无疑会延误宝贵的救治时间。 在此情况下,如何优化严重过敏反应的急救流程,成为当前亟待解决的重要问题,而推动治疗药物——肾上腺素的院外覆盖正成为解决该问题的答案 之一。目前,肾上腺素是国内外主流的严重过敏反应临床指南或专家共识明确推荐的严重过敏反应的首选急救药物,多项研究证实,早期使用肾上腺 素可显著降低住院率、死亡率和双相反应发生率,并加快恢复速度。 长期以来,全球肾上腺素主要通过注射形式给药,包括仅在院内使用的肾上腺素注射液和可在院外自行给药的肾上腺素自动注射笔,而中国市场上目 前仅有肾上腺素注射液获批上市。这种注射给药的方式,需给药者具备一定的医疗操作专业性,一定程度上限制了肾上腺素的使用场景和用药便捷 性,这也影响了肾上腺素药物在严重过敏反应患者中的实际应用。据统计,中国仅有25%严重过敏反应在发作时应用了肾上腺素进行治疗,即使在重度 病例中,应用肾上腺素治疗的比例也仅有34%。 远大医药此次布局的优敏速 则为解决这一困境带来了新的希望 ...
远大医药(00512)斩获全球首款鼻喷肾上腺素产品优敏速® 打破注射依赖或成中国唯一院外急救产品
智通财经网· 2025-12-23 09:17
智通财经APP获悉,再传捷报!港股科技创新型医药企业远大医药(00512)近日利好消息频传,12月23日,公司再度发布公告,其与佑儿医药科技(上海) 有限公司(佑儿医药)达成产品合作协议,远大医药获得全球首款用于紧急治疗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。此次合作覆盖2mg以及1mg两种规格,分别适用于成人和30kg 以上儿童患者、15-30kg儿童患者。优敏速®已于2024年12月向国家药监局递交了上市申请并获得受理。 值得注意的是,优敏速®采用创新的鼻喷给药方式,是首个被美国FDA批准的用于I型过敏反应(包括严重过敏反应)的非注射治疗产品。本次合作由远大 医药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,这将进一步夯实远大医药在心 脑血管急救领域的龙头地位,同时彰显了远大医药持续布局全球创新产品并夯实产业核心竞争优势的战略决心。 便捷给药破解急救痛点,优敏速®有望填补院外场景使用空白 据悉,过敏反应根据免疫机制可分为四种类型,其 ...
远大医药引进全球首款用于治疗严重过敏反应的肾上腺素鼻喷雾剂
Zhi Tong Cai Jing· 2025-12-23 09:16
祐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,凭借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。 集团一直高度重视创新产品和先进技术的研发,以患者需求为核心,以科技创新为驱动,针对尚未满足 的临床需求,加大对全球创新产品和先进技术的投入,丰富和完善产品管线及产业布局,采用"全球化 运营布局,双循环经营发展"策略,形成国内国际双循环联动发展并相互促进的新格局,充分发挥集团 的产业优势和研发实力,快速将科技创新产品落地上市,为全球患者提供更先进更多样的治疗方案。 远大医药(00512)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 ...
远大医药(00512)引进全球首款用于治疗严重过敏反应的肾上腺素鼻喷雾剂
智通财经网· 2025-12-23 09:10
智通财经APP讯,远大医药(00512)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。 祐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,凭借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。 此次,集团引进的全球创新肾上腺素鼻喷雾剂优敏速®是 35 年来 FDA 首次批准的用于 I 型过敏反应的 非注射治疗产品,有望提高肾上腺素治疗产品对中国严重过敏反应患者的可及性,并填补严重过敏反应 急救药物在院外场景使用的空白。 ...
远大医药(00512) - 自愿性公告: 本集团引进全球首款用於治疗严重过敏反应的肾上腺素鼻喷雾剂
2025-12-23 09:00
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 ...
华西证券:首予远大医药“增持”评级 核药释放增长新动能
Zhi Tong Cai Jing· 2025-11-10 09:44
Core Viewpoint - Huaxi Securities has initiated coverage on Yuan Da Pharmaceutical, highlighting significant upside potential in the company's valuation due to its robust barriers in the nuclear medicine sector and the rollout of innovative drugs [1] Group 1: Financial Projections - The company is projected to achieve total revenues of HKD 12.27 billion, HKD 13.46 billion, and HKD 14.70 billion for the years 2025, 2026, and 2027 respectively [1] - Corresponding net profits for the parent company are expected to be HKD 2.01 billion, HKD 2.25 billion, and HKD 2.56 billion for the same years, with EPS estimates of HKD 0.57, HKD 0.63, and HKD 0.72 [1] Group 2: Product Development and Market Potential - The company has successfully completed Phase II clinical trials for its globally first drug STC3141, showing significant improvement in SOFA scores in the high-dose group compared to the baseline [1] - STC3141 targets the core of immune dysregulation in sepsis through an innovative mechanism, potentially filling a 40-year gap in targeted drug options and opening a market worth over HKD 10 billion [1] - The company is advised to monitor the subsequent Phase III clinical data and global registration plans for STC3141 [1] Group 3: Business Stability and Growth - The company maintains a solid foundation with over 260 medical insurance products, with core respiratory products like Cheno expected to drive nearly 27% growth in 2024 [2] - The revenue share from innovative and barrier products has rapidly increased to 51% in the first half of 2025, up from 36.1% in the same period last year, indicating significant transformation [2] - The company is positioned for a value reassessment cycle, supported by the growth of nuclear medicine, the launch of innovative drugs, and stable traditional business [2]
中金:维持远大医药跑赢行业评级 升目标价至11.7港元
Zhi Tong Cai Jing· 2025-08-25 01:25
Core Viewpoint - CICC has raised the profit forecast for Far East Pharmaceutical (00512) for 2025 and 2026 by 3.3% and 3.4% to HKD 1.91 billion and HKD 2.10 billion respectively, citing strong performance in 1H25 and good risk resilience [1][2] Group 1: Financial Performance - The company reported 1H25 revenue of HKD 6.107 billion, a year-on-year increase of 1.0%, and a 2.0% increase when excluding exchange rate effects [2] - The net profit attributable to shareholders for 1H25 was HKD 1.169 billion, exceeding expectations primarily due to higher-than-expected revenue [2] - The revenue from innovative and barrier products accounted for approximately 51% of total revenue, up from 36.1% in the same period last year [2] Group 2: Product Development - The nuclear medicine segment continued to show strong growth, with revenue of HKD 422 million in 1H25, reflecting a 105.5% year-on-year increase when excluding exchange rate effects [3] - The product 易甘泰 received FDA approval for use in primary liver cancer, marking it as the first approved treatment for both primary liver cancer and colorectal cancer liver metastases [3] - The company is advancing its innovative radiopharmaceutical drug conjugate (RDC) pipeline, with TLX-591CDx completing Phase III clinical trial enrollment [3] Group 3: R&D Focus - The company is making progress in the development of STC3141 for sepsis, having completed Phase II clinical trials in both overseas and China [4] - There is potential for STC3141 to become a first-in-class treatment, and the company is exploring various global collaboration opportunities to expedite the product's market entry [4]
远大医药(0512.HK):核药产品持续高增速 创新品种收入占比提升
Ge Long Hui· 2025-08-22 19:04
Core Insights - The company achieved a revenue of HKD 6.107 billion in the first half of 2025, representing a year-on-year growth of approximately 1.0% [1] - The net profit attributable to the parent company was HKD 1.169 billion, with a slight decline of about 5.9% compared to the same period in 2024 [1] - The company continues to invest in research and development, with total R&D expenditure amounting to approximately HKD 1.022 billion [1] Revenue and Profit Analysis - Revenue growth in RMB terms was approximately 2.0%, and if excluding the impact of the tenth batch of centralized procurement price reductions, the growth would be around 13.0% [1] - The nuclear medicine oncology diagnosis and treatment segment recorded revenue of approximately HKD 421.78 million, a significant increase of about 105.5% compared to HKD 207.24 million in the same period of 2024 [1] Product Development and Pipeline - The company has diversified its pipeline through self-developed and acquired products, with innovative and barrier products accounting for 51.0% of revenue, an increase of 14.9 percentage points year-on-year [2] - The global R&D efforts in nuclear medicine are progressing smoothly, with over 900 employees in the nuclear medicine oncology segment [2] - Five RDC drugs have been approved for clinical research globally, with four entering Phase III clinical trials, and there are 15 nuclear medicine products in the registration phase [2] Future Projections - Revenue projections for 2025-2027 are estimated at HKD 12.254 billion, HKD 13.376 billion, and HKD 14.779 billion, with year-on-year growth rates of 5.2%, 9.2%, and 10.5% respectively [3] - The net profit attributable to the parent company is projected to be HKD 2.185 billion, HKD 2.462 billion, and HKD 2.706 billion for the same period, with growth rates of -11.5%, 12.7%, and 9.9% respectively [3]
远大医药(0512.HK):创新和壁垒产品持续放量 研发管线齐推进
Ge Long Hui· 2025-08-22 19:04
Core Viewpoint - The company reported a revenue of HKD 6.11 billion for H1 2025, a year-on-year increase of 1.0%, while the net profit attributable to shareholders was HKD 1.17 billion, a decline of 25.0% [1] Group 1: Financial Performance - The company's revenue reached a new high of HKD 6.11 billion in H1 2025, reflecting a 1.0% year-on-year growth [1] - The net profit attributable to shareholders was HKD 1.17 billion, down 25.0% year-on-year; excluding the impact of Telix investment, the net profit would be HKD 1.02 billion, a decline of 5.9% [1] Group 2: Product Performance - The revenue from the nuclear medicine oncology segment was HKD 420 million in H1 2025, showing a significant growth of 106% year-on-year [1] - The ENT segment generated HKD 1.49 billion in revenue, up 23% year-on-year [1] - The respiratory and critical care segment reported revenue of HKD 1.05 billion, an increase of 10% year-on-year [1] - Innovative and barrier products accounted for 51.0% of total revenue in H1 2025, an increase of 14.9 percentage points year-on-year [1] Group 3: Innovation and Pipeline Development - The company launched the world's first fully automated "zero-radiation" nuclear medicine production facility, which has received a Class A radiation safety license and is now fully operational [2] - The Yttrium-90 microsphere injection (易甘泰) received FDA approval for a new indication to treat unresectable hepatocellular carcinoma (HCC) [2] - Five innovative RDC drugs have been approved for registration clinical trials in China, with four entering Phase III clinical trials [2] - In the respiratory and critical care field, STC3141 for treating sepsis successfully reached clinical endpoints in Phase II trials in China [2] - The company has multiple innovative pipelines advancing, providing growth momentum for future revenues [2] Group 4: Profit Forecast - The company expects revenues of HKD 12.25 billion, HKD 13.51 billion, and HKD 15.12 billion for 2025, 2026, and 2027 respectively [2] - The projected net profits attributable to shareholders for 2025, 2026, and 2027 are HKD 2.12 billion, HKD 2.45 billion, and HKD 2.80 billion respectively, with corresponding EPS of HKD 0.60, HKD 0.69, and HKD 0.79 [2]