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2025系列研究框架培训 - 创新药行业框架
2025-07-25 00:52
2025 系列研究框架培训 - 创新药行业框架 20250724 摘要 Q&A 创新药板块在过去五年中的涨跌逻辑发生了哪些变化? 过去五年中,创新药板块的涨跌逻辑经历了显著变化。首先,从 2020 年至 2022 年,创新药板块的上涨主要依赖于政策托底和海外数据的映射效应。在 这段时间内,ASCO 会议期间发布的重要数据往往会引发市场对国内创新药的 创新药物从初步数据验证到最终上市销售经历五个关键阶段,包括初步 数据验证、达成 BD、海外推进三期临床、海外获批上市和销售超预期, 每个阶段都可能显著提升公司市值。药物研发不同临床阶段重点不同, 1A 期验证安全性,1B/2 期评估疗效,3 期进行大规模人群试验。 创新药投资需关注"差异化创新"和"真创新",即能显著解决未满足 需求、打开未来市场空间的新产品。疗效优越性和差异性比单纯追求 first in class 更重要。选择新兴医药公司需综合考虑产品能力、推进速 度、竞争格局及国际合作能力。 中国医药行业在全球创新中地位提升,在工程化改造和新技术如 ADC、 双抗体等领域取得进展。中国在研发效率和成本控制方面具有优势,能 够更快获得早期临床数据,吸引跨国公司 ...
拨康视云“四闯”港交所背后:四年累亏3.3亿美元,股东“内耗”、产品商业化困局待解
Hua Xia Shi Bao· 2025-06-21 09:45
华夏时报(www.chinatimes.net.cn)记者 郭怡琳 于娜 北京报道 改良阿托品背后公司第四次递交招股书,拟在香港主板上市。 近日,临床阶段眼科生物科技公司Cloudbreak Pharma Inc.(下称"拨康视云")再次于港交所递交招股书,联席保 荐人为建银国际及华泰国际。此前,该公司曾于2023年11月、2024年5月、2024年12月2日向港交所提交过上市申 请书,但最终均以"失效"告终。 招股书显示,拨康视云致力于开发各种前沿疗法,公司首家主要营运实体Cloudbreak USA于2015年9月在美国注册 成立,并于2020年11月在开曼群岛注册成立。 截至目前,公司已建立八种候选药物组成的创新管线,产品覆盖眼睛前部及后部主要疾病,其中四款处于临床阶 段、四款处于临床前阶段。两款核心产品均为自主研发,分别用于治疗 翼状胬肉及青少年近视防控。但由于尚未有药品上市实现商业化,公司一直处于亏损状态,四年累计亏损3.3亿美 元。值得注意的是,拨康视云期内经营活动的现金流量持续为负数,且负债额持续上升,使其面临流动资金风 险。截至2024年底,公司账上只剩下3490万美元。 拨康视云进入成立的第 ...
这位88岁的院士为何自称是“失败者”?
Huan Qiu Wang Zi Xun· 2025-05-09 07:10
Group 1: Core Insights - Zhang Lihe, a prominent figure in drug chemistry, has made significant contributions to the development of nucleic acid-targeted drugs and small molecules that regulate cell signaling, leading to innovative cancer treatments [1][2][4] - He emphasizes the importance of learning from failures in drug development, having voluntarily terminated a clinical trial for an anti-tumor drug due to its rapid metabolism in the human body, despite its initial promising results [5][19] - Zhang advocates for original innovation in China's pharmaceutical industry, stressing the need to move beyond imitation to create first-in-class drugs, which he considers the highest goal for scientific research [21][22] Group 2: Career and Achievements - Zhang's career spans over several decades, during which he has published over 200 influential papers and holds three significant patents, showcasing his extensive research output [23] - He played a pivotal role in establishing the National Key Laboratory of Natural Medicines and Biomimetic Drugs, and served as the dean of the School of Pharmacy at Peking University [17][19] - His research has focused on the intersection of chemistry and biology, promoting interdisciplinary collaboration to advance drug development and scientific understanding [17][19] Group 3: Personal Background and Philosophy - Born in 1937 in Jiangsu, Zhang's early life was marked by the turmoil of war, which shaped his determination to contribute to society through science [8][10] - He initially struggled academically but found his passion for drug research during his studies at Beijing Medical University, realizing the critical need for domestic drug development in China [10][13] - Zhang's philosophy emphasizes perseverance in research, stating that there are no shortcuts in scientific inquiry, and one must be prepared to endure challenges to achieve meaningful results [19][21]