SYH2082可选择性激活cAMP通路，降低β-arrestin募集，从而减少受体内吞及脱敏，提升药效并延长作 用持续时间。同时，SYH2082结合长半衰期修饰平台技术和长效制剂平台技术，旨在实现给药间隔内的 持续减重。在临床前研究中，SYH2082在长效减重及维持方面较同类上市产品表现出更优的疗效，且支 持每月一次的用药方案。在毒理学研究中，SYH2082的耐受性良好，未观察到显着不良反应。 本次获批的临床适应症为肥胖或超重合并至少一种体重相关合并症人群的体重管理。此外，SYH2082亦 具备改善成人2型糖尿病(T2DM)患者的血糖控制的潜力，带来额外临床获益。本次临床试验的获批，是 集团在代谢领域创新长效产品布局的重要成果，为未来更多创新产品的开发奠定坚实基础。 格隆汇2月16日丨石药集团(01093.HK)宣布，集团开发的GLP-1/GIP受体双偏向性激动多肽长效注射液 (SYH2082注射液)已获得美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。 SYH2082有望成为临床开发阶段具领先潜力的长效GLP-1/GIP受体双重偏向性激动剂，每月给药一次。 依托集团的长效制剂技术平台，SYH20 ...

估计公司股权持有人应占溢利的下降主要由于以下因素导致营业额下降：(i)2024年一季度国内流感爆发 以致静脉输液及其他药品市场需求量旺盛，但截至2025年12月31日止的整个年度因国内没有大规模流行 病发生叠加医保控费导致药品终端销量下降;(ii)各种形式的带量采购(包括国家药品集采及地方联盟集 采)范围扩大以及国内外行业竞争加剧带来持续的价格压力;及(iii)盐酸溴己新安瓿注射液因不再通过国 家药品集采销售而营业额有所减少。 格隆汇2月16日丨石四药集团(02005.HK)公告，基于董事局目前可获得的资讯及对集团截至2025年12月 31日止年度的未经审核管理账目所作出的初步审阅後，董事局初步估计，截至2025年12月31日止年度之 公司股权持有人应占溢利与截至2024年12月31日止年度之公司股权持有人应占溢利10.61亿港元相比， 集团预计将录得介乎45%至60%的下降。 ...

Core Viewpoint - The company, 石四药集团, anticipates a decline of approximately 45% to 60% in profit attributable to equity holders for the year ending December 31, 2025, compared to HKD 1.061 billion for the year ending December 31, 2024 [1] Group 1: Profit Forecast - The estimated decline in profit is primarily due to a decrease in revenue caused by several factors, including the lack of large-scale epidemics in the domestic market and healthcare cost control measures leading to reduced drug sales [1] - The company expects that the expansion of various forms of bulk purchasing, including national and local drug procurement, along with intensified competition, will continue to exert price pressure [1] - Revenue from the product, 盐酸溴己新安瓿注射液, has decreased as it is no longer sold through national drug procurement [1] Group 2: Financial Health and Strategy - Despite the anticipated decline in profit, the company's financial position and cash flow remain robust [1] - The company has been focusing on product diversification in recent years, enhancing sales of oral formulations and active pharmaceutical ingredients to optimize its product mix [1] - The company is actively taking appropriate measures to seek improvements in performance, while closely monitoring the situation and responding in a timely manner as it progresses into 2026 [1]

Core Viewpoint - The company, Stone Four Pharmaceutical Group, anticipates a significant decline in profit attributable to equity holders, projecting a decrease of approximately 45% to 60% compared to HKD 1.061 billion for the year ending December 31, 2024 [1] Group 1: Profit Forecast - The estimated decline in profit is primarily due to a decrease in revenue driven by several factors, including the absence of large-scale epidemics and healthcare cost control measures leading to reduced drug sales [1] - The company expects that the absence of major epidemics, which previously boosted demand for intravenous infusions and other medications, will negatively impact sales for the year ending December 31, 2025 [1] - Increased price pressure from expanded volume-based procurement initiatives and intensified competition in both domestic and international markets is also contributing to the anticipated revenue decline [1] Group 2: Financial Health and Strategy - Despite the expected decline in profit, the company's financial position and cash flow remain robust [1] - The company has been focusing on product diversification in recent years, enhancing sales of oral formulations and active pharmaceutical ingredients to optimize its product mix [1] - The company is actively taking appropriate measures to seek improvements in performance, while closely monitoring the situation and responding in a timely manner as it progresses into 2026 [1]

Core Viewpoint - The approval of SYH2082 by the FDA marks a significant milestone for the company in the development of innovative long-acting products in the metabolic field, with potential benefits for obesity management and type 2 diabetes [1][2] Group 1: Product Development - The company has developed SYH2082, a long-acting GLP-1/GIP receptor dual agonist injection, which has received FDA approval for clinical trials in the U.S. [1] - SYH2082 is designed for monthly administration, enhancing patient compliance and convenience [1] - The product utilizes a long half-life modification platform and long-acting formulation technology to achieve sustained weight loss during the dosing interval [1] Group 2: Clinical Benefits - The approved clinical indication for SYH2082 is weight management in individuals with obesity or overweight with at least one weight-related comorbidity [2] - SYH2082 also shows potential for improving blood glucose control in adults with type 2 diabetes, providing additional clinical benefits [2] Group 3: Preclinical and Toxicology Findings - In preclinical studies, SYH2082 demonstrated superior efficacy in long-term weight loss and maintenance compared to similar marketed products, supporting a monthly dosing regimen [1] - Toxicology studies indicated good tolerability for SYH2082, with no significant adverse reactions observed [1]

Core Viewpoint - The approval of SYH9089 injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of postoperative analgesia, addressing a critical clinical need for long-lasting pain relief solutions [1] Group 1: Product Development - The SYH9089 injection utilizes a mechanism that inhibits sodium ion channels in nerve cells, providing reversible blockage of impulse conduction along nerve fibers [1] - This product aims to reduce the frequency of administration, fulfilling the continuous pain relief requirements in postoperative settings and decreasing reliance on opioid medications [1] - The long-acting drug delivery technology platform allows for pain relief duration of up to one week from a single administration, potentially making it the first ultra-long-acting analgesic product in China [1] Group 2: Clinical Research and Safety - Preclinical studies indicate that SYH9089 injection does not exhibit systemic toxicity or new toxic organ targets, showing significant long-lasting analgesic advantages compared to existing ropivacaine injections [1] - The approved clinical indication for this product is postoperative pain relief, highlighting its potential to meet urgent clinical demands in the ultra-long-acting postoperative analgesia market [1]

Core Viewpoint - The approval of SYH9089 injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of postoperative analgesia, addressing a critical clinical need for long-lasting pain relief solutions [1] Group 1: Product Development - The SYH9089 injection utilizes a mechanism that inhibits sodium ion channels in nerve cells, providing reversible blockage of impulse conduction along nerve fibers [1] - This product aims to reduce the frequency of administration, fulfilling the continuous pain relief requirements in postoperative settings and decreasing reliance on opioid medications [1] - The long-acting drug delivery technology platform allows for pain relief duration of up to one week with a single administration, potentially making it the first ultra-long-acting analgesic in China [1] Group 2: Clinical Research and Safety - Preclinical studies indicate that SYH9089 injection shows no systemic toxicity or new toxic organ targets, demonstrating significant long-lasting analgesic advantages compared to existing ropivacaine injections [1] - The approved clinical indication for this product is postoperative pain relief, highlighting its potential to meet urgent clinical demands in the ultra-long-acting postoperative analgesia market [1]

SYH2082可选择性激活cAMP通路，降低β-arrestin募集，从而减少受体内吞及脱敏，提升药效并延长作 用持续时间。同时，SYH2082结合长半衰期修饰平台技术和长效制剂平台技术，旨在实现给药间隔内的 持续减重。在临床前研究中，SYH2082在长效减重及维持方面较同类上市产品表现出更优的疗效，且支 持每月一次的用药方案。在毒理学研究中，SYH2082的耐受性良好，未观察到显著不良反应。 本次获批的临床适应症为肥胖或超重合并至少一种体重相关合并症人群的体重管理。此外，SYH2082亦 具备改善成人2型糖尿病(T2DM)患者的血糖控制的潜力，带来额外临床获益。本次临床试验的获批，是 本集团在代谢领域创新长效产品布局的重要成果，为未来更多创新产品的开发奠定坚实基础。 智通财经APP讯，石药集团(01093)发布公告，本集团开发的GLP-1/GIP受体双偏向性激动多肽长效注射 液(SYH2082注射液)已获得美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。 SYH2082有望成为临床开发阶段具领先潜力的长效GLP-1/GIP受体双重偏向性激动剂，每月给药一次。 依托本集团的长效制剂技术平台，SYH ...

CSPC PHARMACEUTICAL GROUP LIMITED 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，概不對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之任何損失承擔任何責任。 （股份代號：1093） （於香港註冊成立之有限公司） 承董事會命 石藥集團有限公司 自願公告 羅哌卡因長效注射液（SYH 9089注射液） 在中國獲臨床試驗批准 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 佈，本集團開發的羅哌卡因長效注射液（ SYH 9089注射液 ）（「該產品」）已獲得中華人民共和 國國家藥品監督管理局批准，可在中國開展臨床試驗。 該產品可通過抑制神經細胞鈉離子通道，阻斷鈉離子流入神經纖維細胞膜內，從而對沿神 經 纖 維 的 衝 動 傳 導 產 生 可 逆 性 的 阻 滯 ； 亦 能 降 低 給 藥 頻 率 ， 滿 足 臨 床 術 後 的 持 續 鎮 痛 需 求，減少患者對阿片類藥物的依賴，避免持續鎮痛裝置感染 ...

Core Viewpoint - The company has successfully completed the review period for the new drug clinical trial application for CBT-199, a potential best-in-class ophthalmic candidate, which is now authorized to proceed with clinical trials in the United States [1][2] Group 1: Drug Development Progress - The clinical trial application for CBT-199 has been deemed safe to advance as no clinical trial hold was issued by the FDA [1] - CBT-199 is a novel topical ophthalmic emulsion designed to treat presbyopia, a common age-related condition affecting near vision [1] - The drug utilizes a proprietary non-aqueous platform formulation that includes a parasympathomimetic miotic agent to enhance near vision through inducing pupil constriction [1] Group 2: Clinical Trials and Future Plans - The company has initiated the drug discovery process for CBT-199 in China in 2023, with preclinical animal studies assessing safety and tolerability starting in June 2023 [2] - The advancement of CBT-199's clinical trial marks a significant milestone in its clinical development, with the company now authorized to commence Phase 2 clinical trials [2] - The company will continue to monitor the review progress closely and will provide updates to shareholders and potential investors regarding business developments [2]