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石药集团:SYH2061注射液(双链小干扰RNA药物)在中国获临床试验批准
Zhi Tong Cai Jing· 2025-10-24 09:38
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,本集团自主研发的化学1类新药SYH2061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。 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 补体蛋白C5(C5),能有效降低C5水平。通过优化序列和化学修饰的策略,该产品可实现更持久的基因 沉默效果,是国内自主研发并进入临床试验阶段的首款超长效降低C5水平的siRNA药物,适用于治疗 IgA肾病及其他补体介导相关性疾病。 ...
石药集团(01093) - 自愿公告 - SYH2061注射液(双链小干扰RNA药物)在中国获临床试...
2025-10-24 09:31
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 ...
互联网涨幅居前,银行、消费紧随其后,医疗陷入调整
Ge Long Hui· 2025-10-24 04:10
恒生指数探底回升,截至收盘上涨0.72%。其中互联网涨幅居前,银行、工商、科技、地产等紧随其 后;大消费也有不错表现。 内容只是个人观点,仅供参考,不作为投资依据!欢迎关注交流,互相学习、共同探讨! 银行开盘后执行拉升,随后全天维持在中轴上方盘整,截至收盘上涨0.88%。其中邮储银行大涨 4.59%,民生银行上涨2.39%,农业银行、工商银行、招商银行等多股涨幅均在1%上方。 大消费探底回升后收涨0.35%,其中臣子生物大涨6.68%,李宁上涨6.55%,金沙江中国上涨4.4%,美团 上涨4.06%,美高梅上涨3.42%,阿里巴巴、华润啤酒、理想汽车等多股涨幅均在1%上方。 医疗低开低走,临近尾盘小幅反转,截至收盘下跌1.31%。其中石药集团下跌2.96%,中国生物制药下 跌2.78%,翰森制药、三生制药、康方药业、阿里健康等多股跌幅均在1%上方。 互联网探底回升,截至收盘上涨1.07%,其中美团大涨4.06%,阿里巴巴上涨1.67%,腾讯控股上涨 1.52%,京东集团上涨1.5%,百度集团上涨1.22%;商汤、哔哩哔哩、金蝶国际等股逆势收跌。 ...
盘中重挫3.5%!港股通创新药ETF(520880)延续高溢价,或有巨量资金逢跌吸筹
Mei Ri Jing Ji Xin Wen· 2025-10-23 03:29
Core Viewpoint - The Hong Kong stock market's innovative drug sector is experiencing a decline, with the Hong Kong Stock Connect Innovative Drug ETF (520880) dropping over 3.5% as of the report, indicating a potential buying opportunity for investors despite the downturn [1] Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) has seen a trading volume exceeding 200 million yuan, continuing to exhibit high premiums in the market [1] - The innovative drug sector faced a significant drop recently, with the ETF attracting over 75 million yuan in a single day, totaling over 120 million yuan in the last four days [1] Group 2: Recent Developments - The ESMO 2025 conference recently showcased positive data for several core projects of Chinese innovative drugs [1] - On October 22, Innovent Biologics announced a global strategic partnership with Takeda Pharmaceutical worth 11.4 billion USD, setting a record for the value of business development (BD) transactions in China's innovative drug sector, involving three product rights and pipeline development [1] Group 3: Future Outlook - Huafu Securities suggests that the recent adjustments in the Hong Kong innovative drug sector may present a significant opportunity for investment in late October [1] - The long-term outlook remains positive for companies with commercialization capabilities and rich pipelines, particularly in BioPharma, potential BD targets, and cutting-edge technology [1] - The innovative drug industry is expected to benefit from interest rate cuts, with performance anticipated to improve, and the end-of-year BD period may act as a catalyst for growth [1] Group 4: Index Composition - The Hong Kong Stock Connect Innovative Drug ETF (520880) and its linked fund (025220) passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which includes top ten weighted stocks such as BeiGene, China Biologic Products, Innovent Biologics, and others [1]
国金证券:国产新药成ESMO全场焦点 持续关注泛癌种潜力的新一代疗法等机会
智通财经网· 2025-10-23 01:37
Core Insights - The report from Guojin Securities highlights the significant advancements in China's innovative drug research presented at the ESMO conference, indicating a potential boost for the international expansion of these drugs [1] Group 1: Innovative Drug Research - The number of significant research publications from Chinese pharmaceutical companies at ESMO has reached a historical high, making it a focal point of the conference [1] - A total of 35 Chinese studies were included in the regular oral abstracts for the 2025 ESMO conference, with 14 formal oral presentations, a significant increase from 5 in 2024 [1] - The inclusion of 23 Chinese studies in the Late-Breaking Abstracts (LBA) category also set a new record, showcasing the research strength and academic influence of Chinese companies on the international stage [1] Group 2: ADC Developments - Domestic ADCs are demonstrating the potential to redefine existing clinical treatment standards, with notable products like Kelun's SKB264 showing promising Phase III clinical data for NSCLC and HR+/HER2- breast cancer [2] - The mOS data for SKB264 in the second-line EGFRm NSCLC treatment is particularly impressive, with a hazard ratio of 0.60, indicating a significant survival benefit [2] - Bai Li Tian Heng's ADC, iza-bren, has achieved breakthroughs in treating nasopharyngeal carcinoma, marking a critical milestone from concept validation to efficacy verification [2] Group 3: Bispecific and Multi-specific Antibodies - Bispecific and multi-specific antibodies are poised to upgrade existing immunotherapy and targeted therapy, with significant data from Kangfang Biotech's PD-1/VEGF bispecific antibody showing superior results compared to traditional treatments for advanced squamous NSCLC [3] - The mPFS for the combination of the bispecific antibody and chemotherapy was reported at 11.14 months versus 6.90 months for the comparator, with a hazard ratio of 0.60, indicating a strong potential to reshape first-line treatment standards [3] - The HER2 bispecific antibody KN026 from Shiyao Group/Kangning Jierei has shown promising results in III phase trials for gastric cancer, indicating its potential as a global leader in this category [3]
一批热门基金三季报出炉 “冠军基”规模暴增近9倍
Zheng Quan Shi Bao· 2025-10-22 18:04
Core Insights - The article highlights the significant performance of certain funds in the third quarter, particularly the "Yongying Technology Smart Selection" fund, which achieved a remarkable 194% increase, making it the top-performing fund of the year [1][2] - The report indicates a substantial growth in fund size, with "Yongying Technology Smart Selection" increasing from 1.166 billion to 11.521 billion yuan, nearly a ninefold increase in a single quarter [2] - The article also discusses the ongoing optimism in the innovative pharmaceutical sector, with funds like "Great Wall Pharmaceutical Industry Selection" showing over 100% growth [1][4] Fund Performance - "Yongying Technology Smart Selection" fund's top holdings include leading optical module stocks such as "Yizhongtian" (Xinyi Sheng, 300502), Zhongji Xuchuang (300308), and Tianfu Communication (300394), which significantly contributed to its net value [2] - The fund's share count surged from 700 million to 3.466 billion, resulting in a profit of 4.715 billion yuan for investors in the third quarter [2] - The "Great Wall Pharmaceutical Industry Selection" fund also saw its size grow from 1.132 billion to 1.790 billion yuan, with a share increase from 678 million to 932 million [5] Sector Insights - The global cloud computing industry remains a focal point, with AI model valuations increasing and a notable 100% quarter-on-quarter growth in token numbers [3] - The innovative pharmaceutical sector continues to attract attention, with funds maintaining high stock positions despite recent market adjustments [6][8] - The article suggests that the technology and pharmaceutical sectors may still have upward potential, although careful stock selection is advised [8] Future Outlook - The article indicates that the technology sector, particularly AI and cloud computing, is expected to see increased investment, with potential for new opportunities in the industry chain [9] - The innovative pharmaceutical sector is projected to strengthen its global competitiveness, supported by upcoming industry conferences and positive data trends [8] - The article emphasizes the importance of not solely relying on past performance to predict future outcomes in the cloud computing sector, highlighting the need for caution [9]
“妖股”ST景峰拿到重整路条,石药5亿救场能否改写退市命运?
Tai Mei Ti A P P· 2025-10-22 13:49
Core Viewpoint - ST Jingfeng's capital fate has reached a critical turning point as the Hunan Changde Intermediate People's Court has officially accepted creditors' restructuring applications, marking a significant step in the company's efforts to survive amidst financial difficulties [2][8]. Group 1: Company Background and Financial Performance - ST Jingfeng, originally a subsidiary of Yibai Pharmaceutical, once thrived with peak sales exceeding 1 billion yuan, particularly driven by its core product, the Ginkgo Biloba Glucose Injection [3]. - The company experienced a dramatic decline in revenue starting in 2019, with a nearly 50% drop in operating income and over 70% decline in injection product revenue, leading to continuous losses over five years [5]. - Cumulatively, from 2019 to 2023, ST Jingfeng reported losses of nearly 2.4 billion yuan, with a skyrocketing asset-liability ratio of 114.49% by the end of 2023, indicating a severe liquidity crisis [6]. Group 2: Stock Market Performance - Despite its poor financial performance, ST Jingfeng's stock exhibited extreme volatility, achieving 46 trading limits in 54 days from July 2 to September 13, 2024, with a cumulative increase of over 500% during this period [7][8]. Group 3: Restructuring Process - The court's acceptance of the restructuring application signifies the transition from a year-long pre-restructuring phase to a substantive restructuring process, making ST Jingfeng the seventh A-share company to receive a restructuring approval in 2024 [8]. - The restructuring plan involves Shiyao Group investing 526 million yuan for controlling stakes, with an additional 122 million yuan from a local state-owned platform, totaling 648 million yuan [9]. Group 4: Strategic Implications for Shiyao Group - Shiyao Group's involvement as the lead investor in the restructuring is pivotal, as it aims to enhance its oncology product pipeline, which has faced declining sales in recent years [10][11]. - The acquisition of ST Jingfeng's assets, particularly in the field of anti-tumor plant drugs, is expected to fill gaps in Shiyao Group's product matrix and strengthen its market position [11][12].
港股创新药ETF(159567)跌0.46%,成交额9.07亿元
Xin Lang Cai Jing· 2025-10-20 10:03
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.46% on October 20, with a trading volume of 907 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 17, 2024, the fund's shares totaled 8.134 billion, with a total size of 6.968 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund has seen a remarkable increase of 1957.27% in shares and 1744.35% in size since December 31, 2023 [1] - The fund's cumulative trading amount over the last 20 trading days reached 27.487 billion yuan, with an average daily trading amount of 1.374 billion yuan [1] - Year-to-date, the cumulative trading amount is 224.063 billion yuan, averaging 1.173 billion yuan per day over 191 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 71.34% during the management period [2] - The fund's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2]
石药集团:JSKN003于中国再次获授予突破性治疗认定,用于治疗HER2阳性晚期结直肠癌患者
Xin Lang Cai Jing· 2025-10-20 00:56
Core Viewpoint - The announcement highlights the collaboration between Shanghai Jinmant Biotech Co., Ltd. and Jiangsu Kanion Pharmaceutical Co., Ltd. for the development of JSKN003, a targeted HER2 bispecific antibody-drug conjugate, which has received breakthrough therapy designation from the National Medical Products Administration for treating HER2-positive advanced colorectal cancer patients who have failed previous treatments [1] Group 1 - The drug JSKN003 is specifically indicated for use as a monotherapy in patients with HER2-positive advanced colorectal cancer who have previously failed treatments with oxaliplatin, fluorouracil, and irinotecan [1] - The breakthrough therapy designation signifies the potential of JSKN003 to offer significant benefits over existing therapies for the targeted patient population [1]
石药集团(01093):JSKN 003于中国再次获授予突破性治疗认定用于治疗HER2阳性晚期结直肠癌患者
智通财经网· 2025-10-20 00:47
Core Insights - The company, Shiyao Group, announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for the treatment of HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1][4] Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2] - In China, colorectal cancer has a high incidence rate, second only to lung cancer, with over 500,000 new cases annually, and the number is rising [2] - Current approved treatments for HER2-positive advanced colorectal cancer patients who have failed previous therapies include regorafenib, fruquintinib, and trifluridine/tipiracil, but these have limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2] Clinical Research Findings - Preliminary clinical research results for JSKN003 show significant efficacy and good safety in the target patient population, with an objective response rate (ORR) of 61.9% and a disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3] - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3] - Safety data indicated that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), and no TRAEs led to treatment discontinuation or death [3] Regulatory Developments - JSKN003 has received its second breakthrough therapy designation, previously granted for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4] - The ongoing clinical studies for JSKN003 in China include multiple Phase II and III trials for various solid tumors, including breast cancer, ovarian cancer, and gastric cancer, which will expedite the product's development and review process [4]