
谭勇品读医药风云
| Publishes | Daily | Episodes | 1442 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Language | Number of Listeners | Categories | Society & CultureNewsPhilosophyBusiness News |

一款罕见病明星药物引发的监管拉锯,正在将安进推向风暴眼。近日,FDA药物评价与研究中心(CDER)提议撤销安进重磅药物阿伐可泮的上市批准,这已经是FDA与安进围绕阿伐可泮展开的第三轮“正面对峙”。回顾双方长达五个月的博弈过程,可谓一波三折、充满戏剧性:2026年初,FDA已经要求安进自愿撤市,遭到安进强硬拒绝。而后2026年3月,FDA进一步发布安全通报,将该药物的死亡数据曝光,确认该药物造成76例药物性肝损伤病例,其中8例死亡,但安进仍坚守其立场。事件的关键在于,阿伐可泮究竟出现了什么问题,安... more
这一路走来,可清晰窥见上海莱士创新转型的核心特征。
一是从“仿制”到“首创”,验证“AI+单抗”核心技术平台能力。徐俊透露,在SR604的研发过程中,AI分子模拟技术起到了关键作用。研发团队利用AI技术,将抗体与抗原APC的相互作用解析精度推进到“埃米级别”,在海量的可能性中模拟、筛选并优化出了具有最高亲和力的抗体序列。AI的介入,使得“点石成金”成为可能,将一个其他团队未能成功的靶点推进到临床后期。
一是在传统血液制品“挖出新金矿”。在徐俊看来,创新并非只有“从0到1”的颠覆,上海莱士还在通过... more
如果说现有再平衡疗法是在“刹车系统”上做文章,那把安全做到极致也难免失灵。上海莱士自主研发的创新药SR604的颠覆性在于,它跳出了这套系统,在更精妙的维度上完成了“再平衡”。
首先,SR604的作用机制是全球首创,从根源上破解“血栓与止血”的矛盾。通常来讲,APC作为人体抗凝系统中的重要一环,当血管发生损伤时,蛋白C才会被激活为APC,避免凝血反应过度放大。
但血友病患者本就凝血因子匮乏、凝血功能低下,若抗凝系统持续强力运作,会进一步压制本就薄弱的止血能力。SR604正是通过特异性结合并精准调控... more
全球血友病治疗赛道,正站在一个关键的十字路口。
在全球约80万血友病患者的需求面前,传统凝血因子替代治疗沉疴难愈,新兴的非因子疗法百花齐放,却始终绕不开致命的“血栓”阴影和FDA的“黑框警告”。
市场喧嚣与期待交织。在近日举办的2026年世界血友病联盟(WFH)全球大会上,上海莱士副董事长、总经理徐俊博士分享了自主研发的创新药SR604临床试验进展,其I/Ⅱ期关键数据远超预期效果。作为全球首个靶向活化蛋白C(APC)的血友病单抗产品,这款中国原研新药带来了“零血栓、每两月一针、广谱覆盖”的差异... more
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
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #51 | |
Apple Podcasts | #133 |
Listeners, social reach, demographics and more for this podcast.
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谭勇品读医药风云 launched 2 years ago and published 1442 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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