Core Viewpoint - The company, Stone Pharmaceutical Group, has seen its stock price increase by over 3% following the announcement of FDA approval for its self-developed siRNA drug, SYH2061 injection, to conduct clinical trials in the U.S. [1] Group 1: Company Developments - Stone Pharmaceutical Group's SYH2061 injection has received FDA approval for clinical trials in the U.S. as of November 24 [1] - The product has also been approved by the National Medical Products Administration of China to conduct clinical trials starting in October 2025 [1] - SYH2061 is a siRNA drug designed for liver-targeted delivery through GalNAc conjugation, aiming to effectively lower complement protein C5 levels [1] Group 2: Product Features - The drug utilizes subcutaneous administration to target C5, which is significant for treating IgA nephropathy and other complement-mediated diseases [1] - The product is noted for its prolonged gene silencing effect due to optimized sequences and chemical modifications, marking it as the first domestically developed siRNA drug to enter clinical trials for long-lasting C5 level reduction [1]

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed chemical class 1 new drug, SYH2061 injection, which is set to enter clinical trials in the United States. The drug has also been approved by the National Medical Products Administration of China for clinical trials starting in October 2025 [1]. Group 1 - The drug is a siRNA medication that utilizes GalNAc for targeted delivery to the liver, aiming to reduce complement protein C5 levels effectively [1]. - SYH2061 is the first domestically developed ultra-long-acting siRNA drug targeting C5 to enter clinical trials, indicating significant progress in the treatment of IgA nephropathy and other complement-mediated diseases [1]. - Preclinical studies demonstrate that SYH2061 outperforms similar siRNA products in terms of drug activity and efficacy duration, showcasing its long-lasting effects, good safety profile, and high patient compliance [1].

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed siRNA drug SYH2061 injection, allowing clinical trials in the U.S. This drug is also approved for clinical trials in China starting October 2025 [1] Group 1: Product Details - SYH2061 is a first-in-class siRNA drug that targets complement protein C5 through GalNAc conjugation for liver-targeted delivery [1] - The drug is administered subcutaneously and is designed to effectively lower C5 levels, making it suitable for treating IgA nephropathy and other complement-mediated diseases [1] Group 2: Clinical Development - This product is the first domestically developed siRNA drug to enter clinical trials in China with a long-lasting effect on reducing C5 levels [1] - Preclinical studies indicate that SYH2061 outperforms similar siRNA products in terms of drug activity and duration of effect, showcasing its potential clinical development value [1]

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 ...

Core Viewpoint - The announcement highlights that the company has received approval from the National Medical Products Administration of China for its self-developed Class 1 chemical new drug SYH2070 injection, a dual-strand 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 lasting drug effects, good safety profile, and high patient compliance [1] - The product holds significant clinical development value due to its promising characteristics [1]