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众生药业(002317.SZ):一类创新药RAY1225注射液新增适应症药物临床试验获批准
智通财经网· 2025-12-04 09:17
RAY1225 能选择性结合并激活GLP-1受体和GIP受体,以葡萄糖依赖的方式促进胰岛素分泌和抑制胰高 血糖素从而控制血糖,同时抑制胃排空,抑制食欲,降低体重,降低外周胰岛素抵抗,改善肝脏脂肪变 性和气球样变等。RAY1225 的临床前研究结果表明,在MASH动物模型中RAY1225可改善的NAS评分 (评估肝脏炎症、坏死、纤维化等)、降低体重、改善脏体系数、糖脂代谢和肝脏脂肪水平,并呈现剂量 相关性,临床上有望用于MASH的治疗。 RAY1225注射液是众生睿创研发的、具有全球自主知识产权的创新结构多肽药物,具有GLP-1受体和 GIP受体双重激动活性,得益于优异的药代动力学特性,具备每两周注射一次的长效药物潜力。目前, RAY1225注射液用于治疗中国肥胖 /超重患者的安全性和有效性的III期临床试验(REBUILDING-2研究) 已顺利启动并完成全部参与者入组工作;RAY1225注射液单药治疗2型糖尿病患者的安全性和有效性、安 慰剂对照的III期临床试验(SHINING-2)和RAY1225注射液与口服降糖药物联合治疗2型糖尿病患者的安 全性和有效性、司美格鲁肽注射液对照的III期临床试验(SHIN ...
20cm速递|科创创新药ETF国泰(589720)领涨超1.7%,连续3日迎资金净流入,国内创新药研发呈现“多快好省”优势
Mei Ri Jing Ji Xin Wen· 2025-12-04 02:57
财通证券表示,中国药企的BD交易在全球交易总额占比约30%,创新药研发呈现"多快好省"的特 点,成为海外药企产品引进的重要来源。国内药企从创新药项目需求方转变为提供方,BD收入已成为 拓展收入的重要来源。 (责任编辑:董萍萍 ) 【免责声明】本文仅代表作者本人观点,与和讯网无关。和讯网站对文中陈述、观点判断保持中立,不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考,并请自行承担全部责任。邮箱: news_center@staff.hexun.com 注:如提及个股仅供参考,不代表投资建议。指数/基金短期涨跌幅及历史表现仅供分析参考,不 预示未来表现。市场观点随市场环境变化而变动,不构成任何投资建议或承诺。文中提及指数仅供参 考,不构成任何投资建议,也不构成对基金业绩的预测和保证。如需购买相关基金产品,请选择与风险 等级相匹配的产品。相关标的在市场波动、基本面变化等因素下,向下弹性或释放。基金有风险,投资 需谨慎。 每日经济新闻 科创创新药ETF国泰(589720)聚焦科创板创新药企业,跟踪汇聚30家代表性优质公司的上证科创 板创新药指数,以高成长biotech为主,产品20%涨 ...
广生堂:公司目前暂未安排该试验中期揭盲分析计划
Mei Ri Jing Ji Xin Wen· 2025-12-03 21:49
广生堂(300436.SZ)12月3日在投资者互动平台表示,尊敬的投资者,您好!GST-HG141的III期临床试 验是一项48周治疗的随机双盲研究,是公司创新药研发管线的重点项目,正按计划全力推进。为确保数 据的完整性,公司目前暂未安排该试验中期揭盲分析计划。公司将持续高效推进试验进程并及时披露创 新药重大进展,感谢您的关注和支持! (记者 曾健辉) 每经AI快讯,有投资者在投资者互动平台提问:请问广生堂141三期临床会不会出中期数据?如果会的 话大概在什么时候出? ...
深化创新药研发布局 打造业绩增长新引擎
Core Viewpoint - 泰恩康 is committed to deepening its focus on the pharmaceutical industry and implementing an innovation-driven development strategy during the "14th Five-Year Plan" period, aiming to contribute more to the construction of a healthy China [1] R&D Progress - 泰恩康's subsidiary, Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd., received a notice from the National Medical Products Administration for the acceptance of a Phase II clinical trial application for CKBA cream in treating non-segmental vitiligo in children aged 2-12 [1][2] - The company successfully completed a Phase II clinical trial for CKBA in adult vitiligo and plans to submit a Phase III clinical trial application soon [2] - CKBA is a novel immune modulator derived from traditional Chinese medicine, showing targeted action and safety for treating pediatric vitiligo [2] Clinical Research and Potential - CKBA has shown significant potential in treating other immune-related diseases, including Alzheimer's disease, with research published in the journal Nature Aging [3] - 泰恩康 has initiated preclinical research for CKBA in Alzheimer's treatment, with plans to submit an IND application by the second half of 2026 [3] Innovation Development Strategy - 泰恩康 has transformed its business model from a sales-production-research model to a research-production-sales model, with R&D investment increasing from 6.9% to 21.96% of revenue from 2022 to 2024 [4] - The company emphasizes a "pyramid" R&D strategy, focusing on generic drug development at the base, modified chemical drugs and biological drugs in the middle, and innovative drug research at the top [4] Product Structure Enhancement - 泰恩康 has established three main product segments: sexual health, gastrointestinal, and ophthalmology, with core products gaining high recognition in their respective fields [4][5] - The company has several core drugs in the pipeline, including domestic first generics, expected to be approved or submitted by the end of this year to next year, which will further enhance its product structure [5]
股价飙涨的热景生物急于寻找第二增长曲线
Guo Ji Jin Rong Bao· 2025-12-03 13:28
Core Viewpoint - The company, 热景生物, is significantly increasing its investment in 舜景医药 and 尧景基因, aiming to strengthen its position in the innovative drug sector while facing challenges in its core IVD business [1][4][10]. Investment Plans - 热景生物 plans to invest 371 million yuan in 舜景医药, increasing its stake from 43.18% to 50.23% and gaining control through board restructuring [1][4]. - The company will also invest 24 million yuan in 尧景基因 to enhance its gene technology capabilities [4][14]. - 舜景医药 is set to implement a 40 million yuan equity incentive plan [4]. Stock Performance - Following the announcement of these investment plans, 热景生物's stock price rose by 2.52% to 183.3 yuan per share, with an increase of over 900% since September 2024 [4][13]. - The company's market capitalization reached approximately 16.993 billion yuan [13]. Business Strategy - 热景生物 is pursuing a dual-driven strategy of "diagnostics + innovative drugs," focusing on antibody and nucleic acid drugs [6][7]. - The company aims to counteract the downward pressure in the IVD industry by diversifying into the innovative drug sector [11]. Financial Performance - In the first three quarters of 2025, 热景生物 reported a revenue of 310 million yuan, a year-on-year decrease of 19.8%, and a net loss of 109 million yuan, which is a 168.12% increase in losses compared to the previous year [10]. - The company's revenue has significantly declined from 5.14 billion yuan in 2020 to 5.41 million yuan in 2023, with a projected further decline to 5.11 billion yuan in 2024 [10][11]. Challenges in the IVD Industry - The IVD industry is experiencing a downturn due to policy impacts, leading to a 13.94% revenue decline and a 32.20% drop in net profit across the sector [11]. - Over 70% of IVD companies are expected to report losses in 2025, with a cumulative loss exceeding 5.6 billion yuan [11]. R&D and Future Prospects - 舜景医药 is in the early stages of development, with no profitable products yet, but has promising drug candidates like SGC001 for acute myocardial infarction [7][8]. - The company has reduced its R&D investment from 191 million yuan in 2022 to 113 million yuan in 2024, raising concerns about its ability to support innovative drug development [12].
“西方药企私下忧心,他们在创新药研发领域也要被中国赶超了”
Guan Cha Zhe Wang· 2025-12-02 14:18
【文/观察者网 王一】在上海郊区,工程师们正检查一排巨大的不锈钢发酵罐,里面源自仓鼠卵巢细胞 的生物药即将进入量产阶段,每个罐体的容量足以生产5万升这种药物。得益于当地政府快速的审批流 程和"保姆式"支持,生产这些药物的工厂自今年2月动工至今已提前一个月进入投产准备阶段。 麦肯锡报告显示,中国药企在新药研发各环节的时间与成本均具有明显的优势——从锁定靶点到推进候 选药物进入早期临床试验,中国的速度可以比全球平均水平快两到三倍。药物进入临床后,中国庞大的 患者群体让试验入组速度比全球快两到五倍。 "过去三四年,中国的发展速度非常迅猛,已成为全球最重要的创新源泉之一。"上海碧博生物医药科技 有限公司创始人兼首席执行官焦鹏说,中国的基础研究已相当成熟,但还需要通过大量实验来确定合适 的制剂配方。 他补充说:"这更像是一个谜题,需要的是工程思维而非科学思维。这类工作需要一支高效的团队,能 够迅速行动,找出可行的解决方案。" 碧博生物的新工厂距离特斯拉上海超级工厂不远,坐落于一个专为生物科技初创企业打造的产业园区, 里面的企业可以获得补贴、优惠的租金以及来自地方政府的全程支持。工厂建设方案获批仅用了9天, 而在欧洲,同 ...
机构称医药行业进入“创新驱动”的营收时代,关注恒生创新药ETF(159316)、医药ETF(512010)等配置价值
Sou Hu Cai Jing· 2025-12-02 11:22
Group 1 - The pharmaceutical sector experienced a decline today, with the China Securities Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index down by 1.3%, the Hang Seng Hong Kong Stock Connect Innovative Drug Index down by 1.4%, the CSI 300 Pharmaceutical and Health Index down by 1.5%, the CSI Innovative Drug Industry Index down by 1.6%, and the CSI Biotechnology Theme Index down by 1.8% [1] - Huachuang Securities stated that the fundamental reason for the pharmaceutical industry's ability to reach new highs despite ongoing challenges is the continuous demand for pharmaceuticals and the increasing number of unmet needs, along with pharmaceutical companies continuously increasing R&D investments to meet these demands [1] - China has become a significant participant in global innovative drug R&D, with overseas licensing heat continuing to rise year after year, marking the pharmaceutical industry’s entry into a revenue era driven by innovation [1] Group 2 - The index focuses on leading innovative drug companies in the A-share market, consisting of no more than 50 stocks involved in innovative drug R&D, gathering the main players in A-share innovative drugs [5] - The index has seen a decline of 1.6%, with a rolling price-to-earnings ratio of 50.2 times and a valuation increase of 72.8% since its launch [6] - The biotechnology ETF tracks the CSI Biotechnology Theme Index, which focuses on leading biotechnology companies in the A-share market, consisting of no more than 50 stocks involved in gene diagnostics, biopharmaceuticals, blood products, and other human biotechnology [7] - The biotechnology index has declined by 1.8%, with a rolling price-to-earnings ratio of 54.7 times and a valuation increase of 63.4% since its launch [8] - The pharmaceutical ETF exclusively tracks the CSI 300 Pharmaceutical and Health Index, focusing on leading companies in the pharmaceutical and health industry within the CSI 300 Index, covering various segments of the future health industry [9] - The pharmaceutical index has declined by 1.5%, with a rolling price-to-earnings ratio of 30.4 times and a valuation increase of 43.1% since its launch [10]
复星医药:创新药的“未来三重奏”
Core Insights - Fosun Pharma has successfully treated over 84 million severe malaria patients in Africa with its artemisinin-based products, showcasing its commitment to addressing unmet clinical needs [1] - The company has established a clear strategic focus for the 14th Five-Year Plan, emphasizing innovation, deep internationalization, and embracing AI as key pillars for high-quality development [1][7] - Fosun Pharma has achieved significant milestones in innovation, including the launch of 12 self-developed and licensed innovative drugs during the 14th Five-Year Plan [1][4] Innovation and Product Development - Fosun Pharma has developed several firsts in the industry, including China's first self-developed biosimilar drug Hanlikang and the first CAR-T cell therapy product Yikaida [2][3] - The company has built a comprehensive innovation system with four core technology platforms: small molecules, antibodies, ADCs, and cell therapy, enabling full-cycle innovation from R&D to commercialization [3] Financial Performance - In the first three quarters of 2025, Fosun Pharma's innovative drug revenue exceeded 6.7 billion yuan, reflecting an 18.09% year-on-year growth [4] - The company aims to continue optimizing its innovation pipeline value over the next five years, focusing on unmet clinical needs [4] Global Expansion Strategy - Fosun Pharma has actively expanded its global market presence, with its anti-tumor innovative drug approved in approximately 40 countries and regions during the 14th Five-Year Plan [5][6] - The company has established a marketing team of over 1,000 people and a network covering more than 110 countries, emphasizing localized strategies for different markets [6] Embracing AI in Development - Fosun Pharma is committed to integrating AI into its operations, viewing it as a tool for enhancing R&D efficiency and organizational evolution [7][8] - The company has launched its internally developed PharmAID decision-making platform, which is already being utilized in various stages of drug development [7][8]
三生制药(01530.HK)拟配售1.05亿股总筹31.15亿港元 加速创新药管线开发与深化商业化布局
Ge Long Hui· 2025-12-02 00:33
Group 1 - The core point of the article is that Sangfor Technologies (01530.HK) has entered into a placement agreement with Morgan Stanley to issue approximately 105 million shares at a price of HKD 29.62 per share, representing about 4.32% of the total issued shares as of the announcement date [1] - The estimated total proceeds from the placement are approximately HKD 3.115 billion, with a net amount of about HKD 3.087 billion [2] Group 2 - The company plans to use approximately 80% of the net proceeds for research and development expenses, which includes advancing clinical studies for innovative drugs in China and the U.S., supporting the expansion of indications for commercialized drugs, and building global infrastructure [2] - The remaining 20% of the net proceeds will be allocated for working capital and other general corporate purposes to support the company's ongoing operations and strategic plans [2]
三生制药(01530.HK)拟配售1.05亿股总筹31.15亿港元 加速创新药管线开发与深化商...
Xin Lang Cai Jing· 2025-12-02 00:33
配售事项的估计所得款项总额及所得款项净额将分别约为31.15亿港元及30.87亿港元。公司拟按以下方 式使用配售事项所得款项净额:(i)约80%用于研发相关开支,包括:(a)推进处于研发阶段的在研创新药 在中国及美国的临床研究,以加快管线进度,包括但不限于705(PD1/HER2)、706(PD1/PDL1)、 008(B7H3/IL15)、59(MUC17/CD3/CD28)、626(BDCA2)及627(TL1A),(b)支持已商业化药物的适应症扩 展或在中国境外的临床试验,以进一步提升产品价值及扩大市场覆盖范围,包括但不限于特比澳 (TPO)、益比奥(EPO),(c)建设全球基础设施及配套设施;及(ii)约20%用作营运资金及其他一般公司用 途,以支持集团的持续营运及战略计划。 来源:格隆汇APP 格隆汇12月2日丨三生制药(01530.HK)发布公告,2025年12月2日(交易时间前),公司与独家配售代理(即 摩根士丹利)订立配售协议,据此,公司已有条件同意透过独家配售代理按每股配售股份29.62港元的价 格向不少于六名承配人配售合共约1.05亿股配售股份。配售股份占本公告日期已发行股份总数约 4.3 ...