Core Viewpoint - The company, Shiyao Group, has received approval from the National Medical Products Administration of China to conduct clinical trials for its self-developed chemical Class 1 new drug SYH2061 injection, a double-stranded small interfering RNA (siRNA) drug [1] Group 1: Product Details - SYH2061 is designed for liver-targeted delivery through the conjugation of N-acetylgalactosamine (GalNAc) and aims to effectively reduce the levels of complement protein C5 [1] - The drug is the first domestically developed ultra-long-acting siRNA drug to enter clinical trials for lowering C5 levels, suitable for treating IgA nephropathy and other complement-mediated diseases [1] Group 2: Clinical Development Value - Preclinical studies indicate that SYH2061 demonstrates superior drug activity and sustained efficacy compared to similar siRNA products, showcasing differentiated advantages such as prolonged drug action, good safety profile, and high patient compliance [1]

Core Viewpoint - The announcement highlights that the company has received approval from the National Medical Products Administration of China for its self-developed chemical Class 1 new drug SYH2061 injection, a double-stranded small interfering RNA (siRNA) drug, to conduct clinical trials in China [1] Group 1: Product Details - SYH2061 is designed for liver-targeted delivery of siRNA through the conjugation of N-acetylgalactosamine (GalNAc) and aims to effectively reduce levels of complement protein C5 [1] - The drug is administered subcutaneously and is the first domestically developed ultra-long-acting siRNA drug to lower C5 levels, suitable for treating IgA nephropathy and other complement-mediated diseases [1] Group 2: Clinical Development and Advantages - Preclinical studies indicate that SYH2061 demonstrates superior drug activity and sustained efficacy compared to similar siRNA products, showcasing long-lasting effects, good safety profiles, and high patient compliance [1] - The product has significant clinical development value due to its differentiated advantages in drug action and safety [1]

SYH2061注射液（雙鏈小干擾RNA藥物） 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，本集團自主研發的化學1類新藥SYH2061注射液（ 雙鏈小干擾RNA（「si RNA」）藥物 ）（「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。 該產品是一款通過偶聯乙醯半乳糖胺(Gal NAc)實現肝臟靶向遞送的si RNA 藥物，以皮下給 藥的方式靶向補體蛋白C5（「C5」），能有效降低C5水平。通過優化序列和化學修飾的策略， 該產品可實現更持久的基因沉默效果，是國內自主研發並進入臨床試驗階段的首款超長效 降低C5水平的si RNA藥物，適用於治療Ig A腎病及其他補體介導相關性疾病。 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份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMI ...

Core Insights - The company Shiyao Group (01093) has received FDA approval for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, allowing clinical trials in the United States [1] - The product has also been approved by the National Medical Products Administration of China to conduct clinical trials in China starting September 2025 [1] Product Details - SYH2070 is designed for liver-targeted delivery of siRNA through the conjugation of N-acetylgalactosamine (GalNAc), administered subcutaneously to target angiopoietin-like protein 3 (ANGPTL3), effectively lowering ANGPTL3 levels [1] - The drug aims to provide a long-lasting gene silencing effect, potentially serving as an ultra-long-acting siRNA drug for treating hypertriglyceridemia or mixed hyperlipidemia, with the ability to reduce the risk of elevated residual cholesterol levels [1] Clinical Research Findings - Preclinical studies indicate that SYH2070 demonstrates superior drug activity and efficacy duration compared to similar siRNA products, showcasing prolonged drug effects, good safety profiles, and high patient compliance, highlighting its significant clinical development value [1]

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed chemical new drug SYH2070 injection, a dual-strand siRNA drug, allowing it to conduct clinical trials in the United States. The drug is also set to receive approval from China's National Medical Products Administration for clinical trials by September 2025 [1]. Group 1: Product Details - SYH2070 is designed for liver-targeted delivery using GalNAc conjugation, administered subcutaneously to target ANGPTL3, effectively lowering its levels [1]. - The drug employs optimized sequences and chemical modifications to achieve prolonged gene silencing effects, positioning it as a long-acting siRNA drug for treating hypertriglyceridemia or mixed dyslipidemia, with potential to reduce the risk of elevated residual cholesterol levels [1]. Group 2: Clinical Research Insights - Preclinical studies indicate that SYH2070 outperforms similar siRNA products in terms of drug activity and efficacy duration, showcasing advantages such as sustained drug effects, good safety profile, and high patient compliance, highlighting its significant clinical development value [1].

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份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 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 自 主 研 發 的 化 學 1 類 新 藥 SYH2070 注 射 液（ 雙 鏈 小 干 擾 RNA（「 si RNA 」）藥 物 ） （「該產 品」）已獲 得美 國食 品藥 品監 督管 理局 (FDA) 批 准， 可在 美國 開展 臨床 試驗 。該 產品 亦於2025年9月獲得中華人民共和國國家藥品監督管理局批准在中國開展臨床試驗。 該產品是一款通過偶聯乙醯半乳糖胺(Gal NAc)實現肝臟靶向遞送的si RNA 藥物，以皮下給 藥的方式靶向血管生成素樣蛋白3（「ANGPTL3」），能有效降低ANGPTL3水平。通過優化序 列和化學修飾的策略，該產品實現更持久的基因沉默效果，有望成為超長效降低ANGPTL3 的si RNA藥物，適用 ...

该产品是一款通过偶联乙醯半乳糖胺(GalNAc)实现肝脏靶向递送的siRNA药物，以皮下给药的方式靶向 血管生成素样蛋白3(ANGPTL3)，能有效降低ANGPTL3水平。通过优化序列和化学修饰的策略，该产 品实现更持久的基因沉默效果，有望成为超长效降低ANGPTL3的siRNA药物，适用于治疗高甘油三酯 血症或混合型高脂血症，具备有效降低残余胆固醇水平升高风险的潜力。 临床前研究显示，该产品在药物活性和药效持续性方面均优于同类型siRNA产品，展现出药物作用效果 持久、安全性良好、患者依从性高等差异化优势，具有较高的临床开发价值。 石药集团(01093)发布公告，集团自主研发的化学1类新药SYH2070注射液(双链小干扰RNA(siRNA)药物) (该产品)已获得中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 ...

Core Viewpoint - The approval of SYH2070 injection, a novel siRNA drug developed by the company, marks a significant advancement in targeted therapies for hypertriglyceridemia and mixed dyslipidemia, with potential benefits in reducing residual cholesterol levels [1] Group 1: Product Development - The drug SYH2070 is a chemically modified siRNA that targets ANGPTL3 through subcutaneous administration, utilizing GalNAc for liver-targeted delivery [1] - Preclinical studies indicate that SYH2070 demonstrates superior drug activity and prolonged efficacy compared to similar siRNA products, highlighting its differentiated advantages in terms of sustained drug action and safety [1] Group 2: Clinical Implications - The drug is expected to provide a long-lasting effect in lowering ANGPTL3 levels, which is crucial for treating conditions like hypertriglyceridemia and mixed dyslipidemia [1] - The potential for high patient compliance is noted, which could enhance the drug's market acceptance and therapeutic impact [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, to conduct clinical trials in China [1] Group 1: Product Details - SYH2070 is designed for liver-targeted delivery of siRNA through the conjugation of N-acetylgalactosamine (GalNAc) and aims to target angiopoietin-like protein 3 (ANGPTL3) to effectively lower ANGPTL3 levels [1] - The product utilizes optimized sequences and chemical modifications to achieve a more prolonged gene silencing effect, positioning it as a long-acting siRNA drug suitable for treating hypertriglyceridemia or mixed hyperlipidemia [1] - It has the potential to effectively reduce the risk of elevated residual cholesterol levels [1] Group 2: Clinical Development Value - Preclinical studies indicate that SYH2070 demonstrates superior drug activity and efficacy duration compared to similar siRNA products, showcasing differentiated advantages such as sustained drug effects, good safety profile, and high patient compliance [1] - The product holds significant clinical development value due to its promising characteristics [1]

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的內容概不負責，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份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 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，本集團自主研發的化學1類新藥SYH2070注射液（ 雙鏈小干擾RNA（「si RNA」）藥物 ）（「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。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 SYH2070注射液（雙鏈小干擾RNA藥物）在中國獲臨床試驗批准 香港，2025年9月30日 於 本 公 告 日 期 ， 董 事 會 包 括 執 行 董 事 蔡 東 晨 先 生 、 張 翠 龍 先 生 、 王 振 國 先 生 、 潘 衛 東 先 生、王懷玉先生、李春雷博士、姚兵博士、蔡鑫先生及陳衛平先生；及獨立非執 ...