谭勇品读医药风云
E药经理人读书谭勇品读医药风云
| Publishes | Daily | Episodes | 1468 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Language |  ZH-CN | Number of Listeners | Categories | Business NewsNewsPhilosophySociety & Culture |
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石药在高端复杂制剂出海路径上的探索，其实早在2013年前后便已开始。但那个时候，他们选择了一条看似更稳妥的路径——与国际仿制药巨头合作。
石药的初心是“借船出海”，借助国际巨头的全球化经验和执行力，一起跑得更快。
然而，现实远不如预期。由于对方的种种原因，项目一拖就是五六年，合作进度缓慢，宝贵的时间在来回沟通中被一点点消磨。石药团队焦急，却无力主导进度。
直到三年前，集团高层拍板：收回来，自己干！而注射用两性霉素B脂质体，正是这个新团队成立后瞄准的突破品种之一。
这个决策并不轻松。自主推进意味着... more
如今，石药脂质体平台的研发团队从最初的4个人，壮大到200多人。研发方向也从最初的脂质体，逐步拓展到白蛋白纳米粒、乳剂、微球、微晶、纳晶等特殊制剂技术——从无到有，从仿到创，从难到更难，石药的纳米药物技术平台在一项项挑战中“进阶”。
截至目前，石药纳米药物技术平台已有11个特殊制剂产品在全球获批，在研品种30多个，申请国家级课题近20项，申请国内外专利共120项。石药已然成为国内脂质体领域产品管线最丰富、上市产品最多、技术最成熟的企业，稳居国内第一。
更重要的是，从2004年起步的纳米药物技术平... more
两性霉素B脂质体的研发，有四道必须翻越的高墙：建立工艺参数与产品属性的关联，攻克产业化放大技术，保证多步骤生产的无菌性，完成精准的产品质量表征。
以工艺参数与产品属性的关联为例，脂质体的形成是个“牵一发而动全身”的过程，改变一个参数，多个产品属性就会跟着变，只能靠大量高成本实验，一遍遍去表征。
再看产品质量表征这一关，普通仿制药的一致性评价主要对比生物等效性即可，而脂质体则远比这复杂，除体内的生物等效性要求外，针对粒子的多项属性也需要与参比制剂保持一致。
石药零突破的背后，藏着一个从零开始的故事... more
中国脂质体制剂出海，迎来一座全新的里程碑。
4月29日，石药集团自主开发的注射用两性霉素B脂质体（HC1507G2）在欧盟获批上市，这是中国首个闯入欧洲市场的脂质体制剂，标志着中国高端制剂出海迈出了关键一步。
在当下创新药“天价授权”频频刷屏、资本竞相追捧BD交易的大环境下，石药这一突破显得并不算高调。然而，正是这条少被聚光灯照亮的赛道，映照出中国药企真正的突围底色。
近年来，脂质体这类高端制剂领域，因技术壁垒高、临床价值明确，被不少企业视为差异化出海的重要方向。头部企业纷纷搭建起立体化的核心技... more
Reviews
- 一点小建议
主播内容很好，但普通话程度不易听懂。建议使用AI阅读或找个普通话标准的人播音
Apple Podcasts3米粒不吃米
United States10 months ago
Chart Rankings
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #124 |  Singapore/Society & Culture/Philosophy |
Apple Podcasts | #243 | China/Society & Culture/Philosophy |
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Listeners, social reach, demographics and more for this podcast.
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| Interests | Professions | Age Range | |||
| Household Income | Social Media Reach | ||||
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谭勇品读医药风云 launched 2 years ago and published 1468 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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