药

Search documents
让患者有更多用药选择 抗肿瘤等领域新药研发再提速
Yang Shi Xin Wen· 2025-07-18 00:06
国家药监局药品审评中心日前最新发布2024年《中国新药注册临床试验进展年度报告》,从临床试验登记总体情况、各药物类型临床试验实施和质量控制等 方面进行汇总分析。 登记达4900项 去年我国药物临床试验 《报告》显示,2024年我国药物临床试验登记与信息公示平台登记临床试验总量高达4900项,同比增长13.9%。记者查阅最新出炉的《报告》时看到,2024 年我国药物临床试验登记总量4900项中,新药临床试验为2539项,占比51.8%。国内药企临床研发劲头十足,2024年首次公示的临床试验中,境内申办者占 比为92.8%。 国家药监局药审中心临床试验管理处处长王海学介绍: 按药物类型统计,2024年中国药物注册临床试验以化学药品占比最高,为76.9%,生物制品次之占比为21.1%; 按药物注册分类统计,以注册分类Ⅰ类的药物注册临床试验达1735项,占新药临床试验的68.3%; 按照临床试验分期统计,Ⅰ期临床试验占比最高,达46.92%,Ⅱ期Ⅲ期临床试验占比分别为22.6%和17.2%。 记者查阅最新发布的这份《报告》看到,2024年我国临床试验登记和实施效率较2023年均明显提高,新药临床试验获批和生物等效性试 ...
脑机接口再迎突破;微芯生物扭亏为盈|21健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-17 23:45
Policy Developments - The National Medical Products Administration (NMPA) has released a draft for public consultation regarding the adjustment of medical device classifications, aiming to optimize the registration and filing requirements for medical devices [1] Drug Approval - Yuyuan Pharmaceutical's YKYY029 injection has received clinical trial approval for treating hypertension, marking a significant step in the development of a novel siRNA drug [2] - Hengrui Medicine has received clinical trial approvals for four drugs, including SHR-8068 injection and Abediterib injection, with total R&D investments amounting to approximately 20.33 million yuan [3] Financial Reports - Microchip Biotech expects a net profit of 30.06 million yuan for the first half of 2025, driven by increased sales from new drug listings and optimized sales strategies [4] - China National Pharmaceutical Modern reported a 6.46% decline in net profit for the first half of the year, attributed to decreased sales and prices of certain antibiotics and other products [5] Capital Market - Tigermed announced the sale of its stake in Lixin Pharmaceutical for approximately 34.11 million USD, reflecting a strategic move in the context of the domestic pharmaceutical industry's consolidation [6] Industry Events - A breakthrough in brain-computer interface technology has been achieved in Shanghai, allowing patients with speech impairments to communicate through decoded brain activity [8] - Yuan Da Pharmaceutical's innovative nasal spray for dry eye treatment has received approval and its first prescriptions have been issued, providing a new treatment option for patients [9] Debt Resolution - Kangmei Pharmaceutical has reached a settlement agreement to resolve historical debt issues for 43.5 million yuan, facilitating the closure of related legal matters [10] Market Sentiment - Weier Pharmaceutical announced plans for its employee stock ownership platform to reduce its holdings by up to 1% of the company's shares, driven by shareholder funding needs [11]
从蛰伏到攀峰,投身创新药浪潮
券商中国· 2025-07-17 23:29
创新药研发,向来被称为人类科学探索的"珠峰之旅"。 这条从早期研发到上市的通关之路,需跨越临床前研究(3—5年)、I/II/III期临床试验(6 — 7年)及1 — 2年 审批的"三重门",耗时8 — 10年、烧钱超数十亿美元,却仍面临九死一生的残酷淘汰率。 更棘手的是,它还面临五大核心挑战:靶点与药理的不确定性随时可能颠覆前期成果,长周期与高投入让研发 进度滞后或资金链断裂成为致命隐患,严苛的监管审批在每一个细节之处都可能让前期投入付诸东流,行业地 位决定了最终的利润蛋糕分配,而上市后也可能被更优新药快速挤压市场空间。 如果说半导体研发是在原子上"雕刻未来",创新药研发就是在生物黑箱中"大海捞针"。 回顾中国创新药发展的历程,新中国成立初期可谓"一穷二白",彼时我们的医药工业基础薄弱,药品主要依赖 进口,尤其是抗生素、疫苗等,农村甚至依赖传统草药。新中国成立后,国家将医药工业纳入战略规划, 以"保障基本医疗需求"为核心,开启了仿制药工业化生产的序幕。在这一时期,我们以仿制国外成熟品种为 主,原创性药物几乎空白,技术研发能力薄弱。 改革开放后,医药行业逐步市场化,并开始与国际接轨。外资药企带着技术和新药进入中 ...
上海谊众首季净利降51%销售费率39.7% 年内股价涨70%二股东拟减持套现4.2亿
Chang Jiang Shang Bao· 2025-07-17 23:27
上海谊众(688091.SH)再遭第二大股东上海凯宝(300039)减持。 7月16日晚间,上海凯宝发布公告,公司拟择机出售所持上海谊众不超过620.11万股。目前,上海凯宝持有上海谊 众股份2470.35万股,持股比例为11.95%,为上海谊众第二大股东。 长江商报记者注意到,2022年,上海凯宝曾减持上海谊众股份104.76万股,成交金额为9727.16万元。时隔两年多 上海凯宝再次计划减持,正值上海谊众股价处于高位。 截至7月17日收盘,上海谊众报67.9元/股,年内累计上涨70%。以此计算,当前上海凯宝的持股市值约为16.77亿 元,本次拟减持部分市值约为4.21亿元。 重要股东高位减持,上海谊众正面临较大的业绩压力。作为一家创新药企,随着产品商业化,2022年上海谊众开 始盈利。但因核心产品直至2024年11月末才被纳入医保目录,在较高的营销费用投入以及产品被纳入医保后经销 商库存降价补偿等因素影响下,上海谊众业绩大幅下滑。 2025年一季度,上海谊众营业收入7103.22万元,同比增长3.39%;净利润1418.6万元,同比下降51.38%。当期公 司的销售费用、研发费用分别为2820.88万元、 ...
泰格医药出售参股公司持有的礼新医药股权;远大医药创新眼药首张处方落地|医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-17 23:19
点评:该产品上市不仅丰富了远大医药的眼科管线,更彰显了其从传统药企向创新药企转型的战略成 效。未来市场表现值得期待,但需关注医保准入和患者接受度等关键因素。 NO.3 中国医药总经理胡慧冬辞任 公司董事会收到董事、总经理胡慧冬的书面辞职报告。因工作调整原因,胡慧冬申请辞去公司董事、董 事会专门委员会委员及总经理职务,并将不再担任公司任何职务。 每经记者|陈星 每经编辑|陈俊杰 | 2025年7月18日 星期五 | NO.1 泰格医药出售参股公司持有的礼新医药股权 泰格医药公告称,公司通过泰格股权直接持有礼新医药股权比例为3.41%;通过持有基金等份额穿透后 间接持有礼新医药股权比例为4.58%。礼新医药拟将95.09%股权转让给正大制药投资(北京)集团有限 公司。公司拟同意标的公司的出售安排,配合将泰格股权直接持有的礼新医药全部股权以约3411万美元 转让给买方。本次交易完成后,公司将不再持有礼新医药的股权。 点评:作为CRO龙头企业,泰格医药通过投资+服务模式深度参与创新药企发展,此次退出既实现了投 资收益,也展现了其专业的投后管理能力。 NO.2 远大医药创新眼药首张处方落地 远大医药7月17日晚间公告, ...
港股概念追踪 | 外资集体唱多中国资产 “新机智药”赛道成今年投资胜负手(附概念股)
智通财经网· 2025-07-17 23:17
Group 1 - The interest of international investment institutions in the Chinese market has significantly rebounded, with a survey covering 83 sovereign wealth funds and 58 central banks managing approximately $27 trillion in assets [1] - Citigroup's report indicates that despite macroeconomic fluctuations, Asian stock markets are performing better than global peers, with a projected 7% return for the MSCI Asia (excluding Japan) index by mid-2026, particularly favoring the Chinese and South Korean markets [1] - Wellington Investment highlights ten key reasons for optimism regarding Chinese assets, including attractive valuations, improving fundamentals, and a resilient economic model [2] Group 2 - The National Bureau of Statistics reported a 5.3% year-on-year GDP growth in the first half of the year, leading several international investment banks to raise their GDP growth forecasts for China [2] - Nomura and Morgan Stanley have adjusted their GDP growth predictions for 2025 upwards, reflecting stronger-than-expected economic performance in the second quarter [2] - CITIC Securities notes that the A-share market has reached a new level, driven by trends such as a weak dollar cycle and continued liquidity easing [3] Group 3 - Companies like UBTECH and SUTENG are advancing in the humanoid robotics sector, with UBTECH's humanoid robot "Tian Gong Hang Zhe" receiving over 100 orders, and SUTENG establishing partnerships with over 20 humanoid robotics firms [4] - Baidu has made significant progress in the large model field by open-sourcing its Wenxin model series, marking a major development in AI technology [4] - Heptagon Pharmaceuticals has entered a strategic partnership with AstraZeneca, involving substantial financial agreements and the establishment of an innovation center in Beijing [5][6] Group 4 - The Asia-Pacific Selected ETF primarily consists of high-quality dividend assets and leading semiconductor companies in the Asia-Pacific region, with a significant portion of its holdings in stable cash flow companies [6] - The Asia-Pacific region accounted for 57.6% of global semiconductor industry revenue in 2022, highlighting its critical role in the global supply chain [6]
运用“技术流”激活“增长极”
Bei Jing Ri Bao Ke Hu Duan· 2025-07-17 21:50
金融服务科技创新、支持专精特新中小企业发展,既是国家战略部署的重要方向,也是邮储银行北京分 行深耕的核心阵地与关键战场。扎根首都科创沃土,邮储银行北京分行深刻领会中央金融工作会议精 神,投身北京国际科技创新中心建设,以发展科技金融来提升金融服务实体经济的质效,为加快发展新 质生产力注入强劲金融动能。 2025年7月9日,北京讯众通信技术股份有限公司(以下简称"讯众通信",股票代码:2597.HK)于香港 联合交易所主板成功挂牌上市。讯众通信作为中国最大的全栈式云通信服务提供商、国内最早提供云通 信服务的厂商之一,同时也是少数能够提供AI驱动通信服务的企业,其上市标志着公司发展的重要里 程碑。 邮储银行创新打造的"技术流"评价体系,精准解决了高成长性科技企业普遍面临的"准入难""测额 难""授信难"三大问题。目前,北京分行已应用该体系服务科技 型企业客户百余家,累计为成长型科技 企业提供授信近百亿元。 在此创新引领下,北京分行进一步聚焦人工智能、集成电路、信息技术、医药健康、新能源、新材料六 大行业,做好产业链纵深拓展金融服务。分行结合科技型企业全生命周期需求,通过服务模式迭代与产 品矩阵创新,为首都重点产业发 ...
上海现代制药股份有限公司2025年半年度业绩快报
Shang Hai Zheng Quan Bao· 2025-07-17 19:22
0证券代码:6004200证券简称:国药现代0公告编号:2025-057 上海现代制药股份有限公司 2025年半年度业绩快报 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 本公告所载上海现代制药股份有限公司(以下简称公司)2025年半年度主要财务数据为初步核算数据, 未经会计师事务所审计,具体数据以公司2025年半年度报告中披露的数据为准,提请投资者注意投资风 险。 2025年上半年,公司实现营业收入487,767.35万元,较去年同期下降18.16%;实现归属于上市公司股东 的净利润67,206.69万元,较去年同期下降6.46%;实现归属于上市公司股东的扣除非经常性损益的净利 润63,746.03万元,较去年同期下降6.72%。 报告期内,受市场供需影响,公司部分青霉素类原料药及中间体的销量、价格同比走低;制剂业务板 块,部分头孢类、激素类、神经类产品受药品集中采购及终端需求减少等因素影响,销售收入同比有所 下降。面对市场竞争压力,公司聚焦战略布局,积极推进科研开发,加大市场深耕力度,持续推进提质 增效、降本控费,期间费 ...
华森制药游洪涛:聚焦生命健康 研制国产好药
Shang Hai Zheng Quan Bao· 2025-07-17 18:13
Core Insights - The article highlights the journey of Huason Pharmaceutical, founded by You Hongtao, who transitioned from a stable academic career to entrepreneurship driven by a desire to produce affordable medicine for the public [2][3][4] - The company is focusing on original research and innovation, particularly in traditional Chinese medicine and innovative drugs, targeting the global pharmaceutical market [2][6][10] Company Background - You Hongtao founded Huason Pharmaceutical in the 1990s, motivated by a personal experience witnessing a child unable to afford necessary medication [3] - The company has evolved over 28 years, now emphasizing original research and innovation to ensure long-term growth [2] Challenges Faced - The company faced significant challenges during its early years, including financial difficulties and the need for technological breakthroughs [4][5] - A notable incident involved You Hongtao struggling to collect overdue payments to pay employee bonuses, highlighting the harsh realities of entrepreneurship [4] Innovation Strategy - Huason Pharmaceutical has established a dedicated innovative drug division, focusing on oncology and autoimmune diseases, with a commitment to self-sufficiency in healthcare [6][7] - The company has built 22 production lines and a smart factory, allowing for stable cash flow and reinvestment into innovation [7] Research and Development - The company has developed 7 original innovative drugs and 1 modified innovative drug, targeting various cancers and immune-related diseases [9] - Huason has established a PROTAC technology platform and is advancing multiple innovative drug projects, with some already in clinical stages [9] Market Expansion - The company is expanding into the health and wellness sector, particularly through specialized medical foods, addressing the nutritional needs of patients [10][11] - Huason is also focusing on the aging population, developing products aimed at improving sleep, nutrition, and bone health [11] Internationalization Efforts - Huason Pharmaceutical is exporting traditional Chinese medicine to Southeast Asia and chemical drugs to Europe and the US, with several products already registered in Singapore [12] - The company’s production facility has received FDA certification, positioning it well for international market entry [12]
10亿美元大单!低空经济股大涨
Shen Zhen Shang Bao· 2025-07-17 16:32
Group 1 - The core viewpoint of the news is that the low-altitude economy sector in the A-share market has experienced a collective rise, driven by a significant procurement agreement for eVTOL aircraft, marking a new record in China's eVTOL sector [1][2] - Autocraft from the UAE signed a procurement agreement worth $1 billion (approximately 71 million RMB) for 350 eVTOL aircraft developed by Shanghai's technology company, which is the largest single order for "air taxis" in China to date [1][2] - The low-altitude economy sector's overall index rose by 15.25% as of July 17, with notable individual stock performances, including Longxi Co. with a cumulative increase of 134.06% this year [2] Group 2 - The low-altitude economy industry includes segments such as low-altitude infrastructure, aircraft manufacturing, and operational support, with strong technical barriers in aircraft manufacturing [2] - The current phase of the low-altitude economy is crucial for realizing industrial logic, with some companies already showing good performance, suggesting a cautious approach for investors to select quality stocks [3]