第173期 - 2026年2月20日

您正在收听《生物技术闲谈》，这是一档每周直播且未经剪辑的节目，由一群生物技术领域的领导者和专家讨论行业最新动态。

You're listening to the Biotech Hangout, a live and unedited weekly discussion of all the latest news on our industry with a group of biotech leaders and experts.

我是埃里克·施密特，今天的联合主持人有萨姆·皮泽利、保罗·马蒂斯、克雷格·施尼巴和露芭·格林伍德。

I'm Eric Schmidt, my co hosts today are Sam Pizzelli, Paul Matisse, Craig Schnieba, and Luba Greenwood.

如需了解我们的主持人和特邀嘉宾的更多信息，或收听最新一期节目，请访问 thebiotechhangout.com。

For more information about our hosts and guest speakers, or to listen to the most recent episode, you can go to thebiotechhangout.com.

谢谢大家今天参与。

Well, thanks everyone for joining today.

这周虽然短，但很忙。

Is a short ish week, but a busy week.

因为上周没有举办生物技术闲谈，所以我们这次会稍微翻翻之前的素材，把上一周的一些话题拿出来讨论一下。

And I think because we didn't have biotech hangout last week, we're gonna dip back into the bag a little bit and pull out some topics from the prior week to discuss as well.

所以我们安排了一个相当充实的议程。

So we've got a pretty busy agenda lined up.

我们先从市场、交易动态、融资和生物技术谈起，或许还会讨论一下指数本身——XBI，以及它未来的发展方向，还有哪些因素有助于提升其表现。

We're gonna start with some discussion of the markets, deal flow, fundraising and biotech, and maybe a discussion of the index itself, the XBI, and kind of where heading, what might be needed to get to better performance.

关于FDA，我们有很多话题要谈，有很多更新，有好的，有坏的，也有中性的。

We've got a lot to talk about with regard to the FDA, a ton of updates some good, some bad, some indifferent.

我们会花不少时间梳理该机构的种种动态，然后最后再讨论一些公司具体的进展。

So we'll spend a fair bit of time going through all the machinations of the agency, and then we'll conclude with some company specific updates.

这周的数据不像之前几周那么多，但我们还是有一些临床数据集需要讨论。

And there wasn't as much data this week as in prior weeks, but we've got some clinical data sets to cover as well.

这就是今天的主要议程。

So that's the agenda for today.

我们先来看一下市场情况。

Let's start with a little bit of a market look.

露芭，我想你打算为我们介绍一下本周一些有趣的授权和融资交易。

And, Luba, I think you were gonna walk us through some of the more interesting licensing and fundraising deals that occurred this week.

是的，非常感谢。

Yeah, thanks so much.

本周的重点，你可能已经看到很多文章都提到了，是关于中国。

And the focus this week, and you may have seen quite a lot of articles written on this, is on China.

这周我们看到多份报告指出，今年中国对外授权交易数量大幅增加。

So we saw a number of reports this week showing a major uptick in China for out licensing deals already this year.

现在才二月中旬而已。

We're still only in mid February right now.

由于专利悬崖和研发成本削减，制药公司纷纷到中国寻找机会。

Because of patent clips and R and D cut costs, that has been the driver of pharma companies to scout in China.

去年中国对外授权交易总额创下纪录，达到约1377亿美元，诺华、默克和葛兰素史克等大型药企去年在中国达成了若干最大规模的交易。

China out licensing has hit a record last year of being about $137,700,000,000 with major pharmas such as Novartis, Merck and GSK doing some of the biggest deals in China last year.

去年的交易总数为186笔。

And the total number of deals was 186.

仅仅在今年，我们已经看到了38笔来自中国的对外授权交易。

We already, just in this year, seen 38 out licensing deals out of China.

我们已经看到交易金额增长了76%。

We have seen already deal size that has jumped by 76%.

预付款翻了一番。

Upfront fees have doubled.

所以，如果你打算去中国谈交易，那不太可能成功。

So if you're going to China thinking you're going to get a deal, that's not likely.

你可能会获得一些创新的资产，但它们会很昂贵。

You're going to get some innovative assets, but they're going to be expensive.

仅在2026年这一年，交易总额就已达到13亿美元。

Deals just this year in 2026 have reached 1,300,000,000.0.

就在本月，阿斯利康达成了一项价值约185亿美元的减重药物交易。

Just this month we've seen AstraZeneca do a deal for weight loss which was valued at about 18,500,000,000.0.

艾伯维刚刚完成了一项价值约56亿美元的肿瘤领域授权交易。

AbbVie has just done a licensing deal in oncology for about 5,600,000,000.0.

当然，这些数字并不全是前期付款。

Of course, these numbers are not all upfronts.

它们包括前期付款、里程碑款项或特许权使用费。

They include upfront fees and milestones or royalties.

所以，如果回顾过去五年的发展变化，我们看到交易规模增长了约10倍，其中中国方面的增长始于2021年。

So if you're looking over the last five years in terms of the change, we have had about 10x in terms of deal size that have included increase from China in 2021.

因此，从这些文章以及我们从制药行业领袖那里看到的评论来看，下一代创新药物很可能来自中国和美国以外的地区。

So, and in these articles and just in the commentary that we've seen from pharma leaders, the next generation of innovative drugs are likely to come out from China and just outside of The US.

这实际上非常及时。

It's actually very timely.

我刚刚撰写了一篇论文，是我合著的，题为《全球搜寻》，正是针对这一问题，帮助人们弄清楚如何在中国乃至全球范围内进行创新筛选，因为这并不容易。

I just wrote a paper that I co authored that's called Hunt Globally exactly addressing this and helping and figuring out how do you scout in China because it's not that easy and internationally as well going forward.

因此，你必须能够真正过滤掉噪音，找到最优秀的创新成果。

So you have to be able to really sift through the noise and find the best innovation.

而人工智能是实现这一目标最高效的方式之一，如今所有制药公司都在内部实施这一点。

And AI is one of the most efficient ways of doing it and something that all pharma is now implementing internally.

露巴，这最后怎么样？

Luba, how's this end?

我们会不会在某个时刻达到平衡，即中国资产的收购价格与西方世界持平，不再存在这种地域套利？

Is there a point in which we kind of hit an equilibrium and and the price paid for assets in China matches that in in in Western world, and there's no longer this geographic arbitrage?

或者你认为这种从中国引进许可的热潮还会持续多久？

Or how much longer do you think this exodus of in licensing from China is gonna continue?

这其实是个非常好的问题。

It's actually a great question.

我想引用辉瑞首席执行官阿尔伯特·贝洛夫的话，他最近在多个媒体上讨论过这个问题，还有许多其他制药业领袖也持相同观点：中国涌现的创新浪潮实际上不会停止。

And I do want to quote Albert Berlov, the CEO of Pfizer, has actually recently been on a number of outlets, having been discussing this, as well as many other pharma leaders, is the innovation and the explosion of innovation out of China is actually not going to stop.

它还会继续增长。

It's going to increase.

是的，你说得完全正确。

So yes, you're absolutely right.

我们之前看到的是来自中国的定价套利。

We saw this more of a pricing arbitrage coming out of China.

你有一些仿制药资产，不仅便宜得多，而且进展更快。

You had some Me too assets that were just much cheaper and were further along.

但这种情况已经不再存在，因为中国在研发上的投入巨大，而且无论是临床前还是临床阶段，监管门槛都比以往低得多。

But that is no longer the case just because of the amount of money for R and D and also the regulatory hurdles that are much lower in China, both preclinical and clinical that we've seen.

事实上，真正的创新将来自中国。

If anything, the actual true innovation is going be coming out of China.

目前，如果我们只看数据，大部分专利实际上都来自中国，这也是其中一个原因。

Right now, we're also and one of the reasons, if you're just looking into data, the majority of patents are now coming out of China.

这些是创新性专利。

This is innovative patents.

此外，大量领先的学术期刊和相关创新成果也来自中国。

And then also, a much larger portion of leading academic journals and innovation that's there is coming out of China as well.

因此，我们会看到越来越多的成果来自中国，而不是越来越少。

So, we're going to see more, not less, coming out.

很棒的信息。

Great stuff.

谢谢分享。

Thanks for sharing.

萨姆，我想你之前也想提一下中国的一项交易。

Sam, I think you wanted to spotlight a deal as well out of China.

是的，是的，是的。

Yeah, yeah, yeah.

我们平台也会收集许可交易，仅聚焦于治疗领域，2025年对中国来说是创纪录的一年，正如卢巴所说。

So we gather licensing deals as well in our platform and focusing only on therapeutics, 2025 was a blockbuster year for China, as I think Luba said.

如果只看超过十亿美元的生物技术交易，中国有33笔，中国以外地区有45笔。

If I only just focus on greater than a billion dollar, bio dollar deals, China there were 33 deals out of China, 45 out of ex China.

这是一个惊人的数字。

That's an enormous number.

对吧？

Right?

而且，这是中国许可交易表现最好的一年。

And and and it was the best year for China licensing deals.

不过，我得提醒一下，这非常依赖于你如何定义和统计交易，比如合作项目就不算在内。

Now, do want a little health warning here is that it's very dependent on what you measure and what you count as a deal and or or, you know, collaborations don't count here.

我们不统计医疗设备领域。

We don't do med tech.

因此，这其中有很多因素需要特别注意。

So there's a lot of elements to this that are important to bear in mind.

正如卢瓦所说，我不认为这列火车会停下，除非我们至少能实现中美在药物研发速度上的平衡。

And as Luva said, I don't see why this train is going to stop until we manage to equalize the speed of drug development in The US at the very least.

科学是一回事。

Science is one thing.

因此，中国在发现和相关研究方面所做的工作将继续吸引关注，因为资金总是流向科学前沿。

So the discovery and all the work that they're doing in China, that will continue to attract interest because that's the money goes where the science is.

但如果你看看礼来这笔交易，我本来想专门提一下，我们最终看到的是礼来与信达生物之间达成的第七笔此类交易。

But if you look at the Lilly deal, which I was gonna pick on or talk about, we end up with a situation where we've got the deal that was announced between Lilly and Innovance, the seventh deal such between the two companies.

礼来旗下的礼来创投早在十年前、十多年前就已投资信达生物。

Lilly was actually Lilly Ventures was an investor in Innovent all all way back when, ten years ago, over a decade ago.

自那以后，双方一直保持合作。

And they've been working together since then.

正如我所说，这是第七笔交易。

As I said, seventh deal.

3.5亿美元的预付款，以及约85亿美元的开发里程碑付款。

$350,000,000 upfront, about 8,500,000,000.0 development milestones.

那么这笔交易到底涉及什么？

So what is this deal about?

信达生物将主导癌症和自身免疫疾病药物在中国的研发，从发现阶段到二期临床试验。

Innovent will lead the research and development of the drugs for cancer and autoimmune disease from discovery through to phase two clinical trials in China.

对吗？

Right?

然后礼来决定是否要接手，同时在过程中支付里程碑款项。

And then Lilly decides whether they want to take it or not, and along the way pays milestones.

因此，对礼来来说，这是一笔标准的交易。

So it's a standard deal as far as Lilly is concerned.

为什么要这么做？

Why do this?

当然，我认为他们之间已经有了良好的合作关系。

Of course, I think they've clearly got a good relationship together.

但如果你仔细想想，礼来用这3.5亿美元 upfront 换来的是在中国更快的药物研发，而我们一直强调这一点，我也和约翰沟通过，我认为约翰·马拉加诺拉也说过同样的话。

But if you think about it, what Lilly gets here for the $350,000,000 upfront is faster drug development in China, which is where I think we've been saying regularly, and I spoke to John, and I think John Maraganora was here saying the same thing.

我另一个谈过的约翰是约翰·康诺利，大家都明白，在美国和欧洲，将产品获批IND并推进到临床阶段的时间太长了，相比之下，中国甚至澳大利亚都要快得多。

Another John that I talked to John Connolly, everybody understands that the time to get a product into, to get an IND approved and get a product into clinic is too long in The US and probably in Europe compared to China, and strangely enough, compared to Australia.

所以大家都在想办法缩短这个时间。

So everybody's trying to see whether we can cut that time.

而礼来在这里将利用这一点。

And Lilly here is going to be leveraging that.

他们只有在产品推进时才付款，并在一期和二期临床成功时支付里程碑款项，从而大大加快了进程。

They only pay if a product moves forward, and they pay for success in phase one and phase two, and they just get there much faster.

我认为这就是推动这一合作的关键因素，或者至少是这笔交易的核心要素。

So I think that's what's particularly driven this, or at least this is a key element of this deal.

那么Innovent能获得什么回报呢？

And what does Inoven get back?

我的意思是，他们获得了与美国最大制药公司合作的现成市场。

I mean, they get a ready market with the largest pharma company in The US.

我的意思是，你肯定会毫不犹豫地签下这笔交易。

I mean, you would you would do that deal in a heartbeat.

对吧？

Right?

当然，这对Inovent来说并没有帮助它成为未来的世界级跨国企业，而我认为这正是中国公司也感兴趣并愿意考虑的方向。

Of course, what it doesn't do for Inovent, it doesn't help it become that future multinational corporation, which is which is, I think, what Chinese China companies are also interested in and would be interested to think about.

所以这让你对那个宣布的交易有了一个大致的了解，我想那是在我们上次录制后不久宣布的。

So that that gives you an a feel for that that deal that was announced, I think, just just after the last time we recorded.

结束。

Over.

谢谢，萨姆·卢比。

Thank you, Sam Luby.

你们已经雄辩地论证了我们所讨论的这种中国商业合作路径，是行业里一场重大的变革，而且这种变革不会逆转。

You you guys have made an eloquent case that this China business partnership trajectory that we've been talking about is a major sea change in the industry that's that's not gonna change.

它将长期存在。

It's here to stay.

我想知道，你们是否对这种合作对美国生物技术生态系统可能产生的影响有什么看法或评论？

I am curious as to whether either you have comments or views on what impact it might have on The US biotech ecosystems.

这对美国生物技术公司来说是好是坏？

Is this good or or bad for US biotech companies?

先不管那些在做这些交易的农民。

Put aside the farmers that are doing these deals.

这对生物技术行业是好是坏？

Is it good or bad for biotech?

说到生物技术，似乎过去几个月里，XBI指数一直在125左右震荡。

And then speaking of biotech, it it it seems like the XBI, the index, has kind of been bouncing around this 125 range for the past couple of months here.

我想请格雷格和保罗加入讨论，聊聊当前生物技术领域的现状，以及突破我们一直卡住的125关口需要什么条件。

I I wanna bring in Greg Greg and and Paul into the discussion and and talk about biotech today and what's going on and what's gonna be required to kind of break through that 125 barrier that we seem to be stuck up against.

不过，首先请卢巴和萨姆谈谈中国对美国生物技术产业的影响。

But maybe Luba and Sam, first, you could comment on the impact of China on The US biotech franchise.

是的，我很乐意先说。

Yeah, so happy to go first.

这已经发生了，而且会持续下去。

It's here and it's here to stay.

我认为问题在于，我们该如何合作？

I think the question is, you know, how do we collaborate?

这并不是要放慢中国的发展速度。

It's not about slowing down China becoming faster.

萨姆非常清晰地提到，如果我们继续以如此缓慢的速度推进临床试验和开发执行，同时药物进入IND阶段依然如此昂贵和耗时，我们将持续落后。

Sam has mentioned very eloquently that if we continue on the same trajectory with being very slow with trials and execution on the development side, and also if it continues to be this expensive and this long to get a drug into IND, we will continue to fall behind.

所以问题在于，我们该如何合作？

So the question is, how do we collaborate?

那么，最有效的方式是什么，来发现我们可以合作的资产和信号？

And again, what's the most effective way of finding assets and signs that we can collaborate together?

开发最好在不同地点进行，不仅在中国，也在其他地方。

Development is best done across different sites, not just in China, but outside.

因此，有很多合作机会，这对患者最有利。

So, there's a lot of collaboration and the best things for patients.

最终，对患者最有利的就是让一种既安全又有效的药物获得批准并上市。

And ultimately, this is what's best for patients is getting a drug that is approved on the market that's both safe and effective.

所以，如果我们能够齐心协力，而不是彼此对抗，这将最有利于我们的创新和患者。

So, if we can all work together rather than against each other, that would make it best for us for innovation and for patients.

山姆，我很想听听你的看法。

Sam, I would love your thoughts.

是的，你说得非常好。

Yeah, I mean, you look, you said it so, so, so well.

我再补充一点。

I'll just add one little element here.

除了我们加快监管路径、让产品更快进入临床，以及让监管机构更具可预测性之外，还有一件事值得注意。

There is one thing that that could be aside from us making the regulatory path to get products to clinic faster and also having a regulator that's a bit more predictable, which we'll come to.

人工智能在这里是一个重要的因素。

AI is an element that's that's that's important here.

中美两地都在人工智能领域投入了大量资金。

There's significant amounts of money in both regions going into AI.

如果美国能够利用美国和欧洲等地多年来在患者试验和数据方面积累的海量数据的话。

If The US is capable of leveraging the enormous amount of data that and Europe, whoever, right, has generated from years of patient trials and data.

还有那些一直获得大量资金支持并仍在获得资金的公司。

And also, companies that have been and are and are being financed with meaningful money.

我刚刚和马克·泰西耶·莱文聊过，他的访谈预计几周后播出，我想应该是3月12日的播客。

I just I just had a conversation with, Mark Tessier Levine, who, hopefully will air in a in a couple of weeks two or three weeks time, I think on March 12 is the podcast aimed at.

我们谈到了一位在药物研发领域深耕多年、涉猎广泛的人。

And, you know, we talked about somebody who's been in in the in the world of drug development for years across various things.

我记得多年前我从事神经科学工作时，他就是一位科学家。

And I remember him as a scientist, when I was doing neuroscience all years ago.

他当时说，他的目标是把药物研发的时间缩短一半。

And he was thinking, he was saying, look, my ambition is to try and get, drug development time to be halved.

我认为这就是这种努力的方向。

I think it's that sort of effort.

我们这么说吧，因为这确实是一个目标，对吧？

Let's say that because that's an ambition, right?

假设这个目标成为现实，假设它在2030年实现。

Let's say that becomes a reality, let's say it's 2030%.

那么，竞争力会发生根本性转变，针对特定目标开发产品的能力也会发生变化。

Then the competitiveness completely shifts, the ability to develop products against a particular target shifts.

问题是，我们在这一领域的位置如何？

The question is, how well are we positioned on that front?

因为这涉及到与欧洲和中国的竞争。

Because it's coming versus Europe versus China.

我认为，如果投入足够的资金，并且有足够高质量的研究和科学工作借助人工智能来实现，我们可能会看到一个有趣的竞争格局。

That's the area which I think is going to be potentially an area where if enough money goes into it, and there's enough quality research and science that's done enabled by AI, I think we can see an interesting competitive environment involved.

你知道，我想补充一点。

You know, I just want to add to that.

你对人工智能的看法非常正确。

You're so right on AI.

我从事人工智能工作已经很多年了，经常有公司来找我，他们正在用人工智能进行药物发现。

And I often you know, I've been an AI for so many years and I often have lots of companies that come to me and they're working on drug discovery for AI.

他们都有崇高的目标，即利用人工智能来理解生物学。

And they all have lofty goals of using AI for understanding of biology.

但我们离真正实现由AI发现的生物学成果，并使其顺利通过三期临床试验、最终到达患者手中，还相差甚远。

And we are very far away from truly having something that is AI discovered in biology that's going to make it to all the way through phase three and make it to the patient.

所以，

So,

我希望我们能拥有更多AI工具，工具是存在的，团队也是存在的。

I wish that we had a lot more AI tools the tools are there, the teams are there.

但更重要的是如何将这些工具应用于早期药物发现，针对超新颖靶点和能够作用于已知或未知靶点、或使不可成药靶点可成药的全新分子。

But it's more of the application of those tools from very early drug discovery of super novel targets and super novel exciting molecules that can go after known or unknown targets or make targets druggable.

但更应关注那些已经降低风险的项目和资产，比如应用AI改进递送方式，或为已安全的资产寻找新的适应症。

But more going after things that are already de risked and assets that are already de risked and have, for example, applying AI to better delivery methods, to finding other indications for already safe assets.

我知道，这并不是简单地重新利用现有资产，而是真正思考如何为已有资产开拓新颖的应用场景，从而更快地实现目标。

I know, and not so much repurposing of assets, but really thinking about novel use cases for assets that are already there and getting there faster that way.

当然，正如萨姆所说，研发过程中有无数种方式可以利用患者报告结果和其他数据，以推动更快、更优的临床试验设计。

And of course, as Sam, you said, the development, there are so many ways of using patient reported outcomes and other data that we have in order to enable faster and better morphicaceous trial designs.

谢谢大家。

Thanks, guys.

让我们请保罗和格雷格来谈谈。

Let's bring in Paul and Greg here.

无论是来自中国还是其他任何因素或来源，你们在XBI领域看到了什么影响？

Whether it's impact from China or any other force or source, what are you guys seeing around the XBI?

我们需要什么才能向前推进？

What do we need to move forward?

保罗，你先说。

Paul, go ahead.

是的。

Yeah.

谢谢。

Thanks.

谢谢。

Thanks.

非常感谢。

Thanks a lot.

我会简短一点，这样Greg也能补充他的观点。

I'll I'll keep it brief so Greg can add his perspective too.

我的意思是，这其实和我们一直在讨论的并购话题息息相关。

I mean, feel like this links into the age old m and a conversation that we're having.

昨天我和我旗下一家公司的CEO喝咖啡，他第一句话就带着点调侃的语气。

And I met with the CEO of one of my companies yesterday for coffee, and the first thing he said to me was kind of tongue in cheek.

嘿，Paul，并购都去哪儿了？

Hey, Paul, where's all the M and A?

我觉得这个笑话是说，有时候卖方就像一个提前一年上发条的玩具，总说并购会增多。

And I think the joke was that, you know, sometimes the sell side can be like a year ahead outlook windup toy and saying there's gonna be more M and A.

但我认为，我们很多人都觉得并购会更多一些。

But I think a lot of us thought there'd be more M and A.

对吧？

Right?

而且，那些比我更清楚内情的人也说过，他们预计并购会多很多。

And like, you know, people with much better line of sight into that than me have said they thought there was gonna be a lot more M and A.

这和中国话题有关联吗？

And so is that linked to this China conversation?

很难说。

Hard to say.

我觉得当我们谈论并购和生物技术时，我们实际上是在讨论那些处于不同风险降低阶段或商业化阶段的资产，大部分情况下是这样。

I I feel like when we're talking about M and A and biotech, we're really talking about assets that are at, a different stage of being de risked or commercial, like for the most part.

所以我不确定这是否真的与中国的议题密切相关，但我认为人们对RevMed的发展结果感到失望，我们看到的许多并购实际上更多发生在私营领域。

So I don't really know if that's as much linked to this China conversation, but I think that's been a disappointment for people, the way RevMed played out, way some of the M and A we've been seeing has really been more on the private side.

因此，大多数公众投资者并未参与其中。

So most public investors don't participate in it.

我认为过去几个月乃至现在出现的另一个有趣动态是，这种情况变得更为极端。

I think the other sort of interesting dynamic that's been coming into play over the past few months and now is, I think, become more extreme.

这健康吗？

And is this healthy?

这不健康吗？

Is this unhealthy?

很难说。

It's hard to say.

就是这样。

It just sort of is.

但感觉现在市场对那些拥有临床催化剂的股票偏好明显更强了。

But it feels like there's just a much, much greater preference for stocks right now that have clinical catalysts.

即使你看看大型股或成熟公司，对吧？

Even when you look at large cap or established companies, right?

一些在出色上市后股价大幅下跌的公司，似乎缺乏第二根支撑腿，对吧？

Some of the names that have sold off a lot after having great launch stories are companies that don't seem to have that second leg of a stool, right?

我的意思是，我不确定这种看法是否准确，但目前对Alnylam的观感确实如此，对吧？

I mean, I don't know if that's an accurate perception, but it is kind of the perception of like an Alnylam right now, right?

它早期上市表现很好，但现在人们开始疑惑接下来会怎样，对吧？

Who had a great launch early on, and then now there's this sort of what's next vibe, right?

而当你看看Vertex这样的公司，对吧？

Whereas when you look at say a Vertex, right?

它的研发管线更有趣。

Which has a more interesting pipeline.

我认为在这样的背景下，对吧？

And I think in the backdrop of that, right?

你还会看到一种趋势，即人们因为承担临床风险而获得回报。

You've also got a dynamic where people are getting rewarded on taking on clinical risk.

所以这是件好事。

So that's a healthy thing.

我的意思是，我不确定。

So I mean, I don't know.

我的意思是，我想当我们年初启动这一年时，可能在另一次通话中，也许是和你，埃里克，或者和格雷格，我不记得还有谁在场，但我们当时在讨论情绪在1到10的尺度上处于什么位置。

I mean, I think when we kicked off this year, I think maybe on another call, maybe with you, Eric, maybe with Greg, I forget who else was on, but we were talking about where is sort of sentiment on a scale of one to 10.

我当时可能说大概是七或八。

And maybe I said like a seven or an eight.

我现在觉得大概在四到五之间，对吧？

Think I now it's sort of like a four to five, right?

我的意思是，FDA这部分是独立的一回事，我们稍后再谈。

I mean, the FDA piece is its own animal that we'll talk about.

但感觉人们还是愿意积极面对风险的。

But it feels like people are constructive and willing to take on risk.

但就整个行业的整体方向而言，感觉没有人像在JPMorgan会议前那样那么乐观了。

But as it relates to the overall direction of the sector, it just doesn't feel like anyone's nearly as bullish as they were right before JPMorgan.

是的，接着保罗的评论说一下。

Yeah, following up on Paul's comments.

对，我完全同意保罗的说法。

Yeah, I think that I would agree exactly what Paul is saying.

我认为这个行业的基本面仍然相当积极。

I think the fundamentals of the sector are still fairly positive.

话虽如此，今年XPI的起步有点慢。

That being said, the XPI has been a little slow out of the gate this year.

不过话说回来，我觉得整体市场都比较低迷。

Now that being said, look, I think the overall market is kind of slow.

我认为我们讨论的是整体市场上涨了1%到23%，而XBI正好处于这个水平。

I think we're talking about the broader markets being up 1%, 23%, and that's kind of exactly where XBI is.

我们目前并没有处于XBI相对于科技股及相关交易表现明显落后的局面。

We're not at a place where the XBI necessarily is underperforming relative to whatever's happening with tech and that kind of trade.

但话虽如此，我认为生物技术领域仍有很多专业人士关注个股，尤其是那些近期有临床催化剂的公司。

But that being said, I do think that we're still getting a lot of biotech specialists interest in individual stock names and particularly those that have near term clinical catalysts.

我的意思是，从买方和卖方互动的角度来看，生物技术市场就是这么运作的。

I mean, that's the way the biotech market works in terms of buy side, sell side interactions.

一切都取决于每个公司的独立故事。

It's all about individual stories.

从更宏观的角度来看，我同意我们确实没有太多并购活动。

Think from a broader perspective, I agree we haven't had a lot of M and A.

这多少让人感到有些失望。

And so that's been a little bit of a disappointment.

但我认为我们确实有，稍后在Hangout中我们会再聊到这一点。

I do think we have, and we'll talk about this a little bit later in the Hangout.

FDA仍然有些不一致、不可靠。

We have an FDA that still is a bit inconsistent, unreliable.

我认为，为了让普通投资者对生物科技的前景更有信心，他们只是希望看到稳定性。

And I think just for perhaps generalists to feel better about where biotech is going, you just wanna have stability.

我认为，如果我们能尽快让FDA变得稳定，特别是让大家感受到这种稳定性，这将有助于改善整体叙事。

And I think the sooner that we can get to a place, particularly with the FDA that we can get a sense that there is stability, I think that will help with the broader narrative.

保罗，你请说。

Go ahead, Paul.

露巴，你请说。

Go ahead, Luba.

哦，是的。

Oh, yeah.

我其实只是想问大家一个问题。

I actually, I just have a question for all of you.

有一件事一直让我感到惊讶，尤其是当我们像现在这样讨论时——之前在JPM之前，大家都对并购持乐观和兴奋态度，但现在情况没那么令人兴奋了，我们只是希望情况能有所改变。

I mean, one thing that's constantly surprising me, especially when we have this discussion like we're having right now, where we were, everybody was bullish and excited before JPM about M and A, now things are not as exciting and we're hoping things will change.

然后我们看到了，我知道我们稍后会讨论这一点，大型制药公司首席执行官和领导层的变化。

And then we've seen, and I know we're gonna talk about this later, changes in CEO and leadership in big pharma.

为什么制药行业不积极拥抱？他们都知道，大部分研发创新、管线中的产品以及最终上市的药物都来自外部来源。

Why isn't pharma embracing, and they all know that the majority of R and D innovation, what's in the pipeline, what ultimately makes it on the market is externally sourced.

我们多年来一直在谈论的1500亿到3000亿美元的Pappencliffe（注：此处保留专有名词原样）。

We have $150 to $300 bn Pappencliffe that we've been talking about for years.

到2030年，这将发生。

That's going to happen by 2030.

所以这只剩下四年了。

So that's in four years.

我们谈论的是数百亿美元的收入损失，这对大多数制药公司而言都是潜在的收入流失。

We're talking about hundreds of billions of dollars lost, the potential loss of revenue for many of these pharmaceutical companies, for the majority of pharmaceutical companies.

因此，我们目前看到的并购活动，我相信我们大概都能同意，并不能真正帮助它们实现这一目标。

So, and the kind of M and A that we're seeing is not really, I'm sure we probably can agree, is gonna get them all there.

那么，究竟发生了什么？

So what's happening?

我有个问题想问大家。

Just a question to all of you guys.

我可以插一句吗？

I'm Can I chime in for second?

不行。

No.

我先说，保罗。

Me me first, Paul.

今天我是主持人。

I'm a I'm a host today.

好吧。

Alright.

行吧，老兄。

Fine, dude.

你讲吧。

Go for it.

看吧。

Look.

我只是和你们的看法非常不同。

I I just have a very different view from you guys.

我更加乐观。

I I I'm much more optimistic.

我觉得我们都得冷静一下。

I I think we all gotta take a chill pill here.

我们才刚进入今年的第七或第八周。

We're seven, maybe eight weeks into the year.

因为还没发生一笔一百亿美元的并购交易，我们就都在抱怨并购活动低迷。

And because we haven't had a what $10,000,000,000 piece of M and A, we're all bemoaning the fact that M and A is

埃里克，我完全同意你的看法。

Eric, I totally agree with you, man.

我刚才还跟CEO开了个玩笑。

Actually said a joke to the CEO.

我说，你需要在情绪上放慢节奏。

I said, you need to pace yourself emotionally.

毕竟，我在波士顿。

It's still, I mean, I'm in Boston.

天气还是冷得要命。

It's still freezing.

你知道的，还没过呢，上星期一还来了个强烈的东北风暴，老兄。

Like, you know, it's not even, we're not even like past, like, you know, it's very good in North Nor'easter on Monday, man.

冬天还没过去呢。

It's still like the winter.

不，我完全同意你的看法。

No, I, I totally agree with you.

我觉得人们变得没耐心了。

I think people become impatient.

我的意思是，就连情绪上来说，保罗，我们已经涨了几个百分点了。

I mean, even in terms of the sentiment, Paul, again, we're up a couple percent.

如果不是今天，我们今年的涨幅本应达到4%。

If it weren't for today, we'd be up, I think 4% on the year.

对于年初的头一两个月来说，这已经是相当不错的表现了。

That's pretty darn good performance for the first month or two of the year.

在今天之前，我们的表现明显远超标普指数。

Was again, prior to today, seemingly well in excess of the S and P.

现在我们只是比标普指数的涨幅高出几个百分点。

Now we're just a couple percentage points above S and P performance.

我的意思是，情况真的有这么大的变化吗？

I mean, have things really changed that much?

当然，如果RevMed明天上涨，或者你最喜欢的并购标的上涨，那就太好了。

Sure, it'd be great to see RevMed go tomorrow, or you know, your favorite M and A target go.

但我不确定。

But I don't know.

我总体上仍然非常看涨，因为我们已经度过了之前在通话中讨论过的所有问题，比如药品定价，并且看到了出色的创新，以及依然有利的宏观环境。

I'm still feeling quite bullish in general about the fact that we've gotten through all the issues we've talked previously about on the Hangout, with regard to drug pricing and seeing great innovation and still a constructive macro environment.

希望这一切能继续下去，但我们拭目以待。

Hopefully that all continues, but we'll see.

萨姆，我们在换话题前，你有什么想补充的吗？

Sam, anything you want to add before we move topics?

没有，我没什么要加的。

No, I'm good.

好吧，还有其他人想谈谈XBI的未来吗？

Okay, anyone else wanna chime in on the future of the XBI?

也许我最后再补充一点。

Maybe I'll just add as a last point.

我依然对生物科技持乐观态度。

I'm still bullish on biotech.

我们刚刚发布了行业季度前瞻，确实，过程中总会有一些波折，但在我看来，自从去年下半年的反弹以来，根本性的东西并没有改变。

We just put out our sector quarter preview and, yeah, there are always gonna be some bumps along the way, but nothing materially has changed in my opinion since, you know, the rebound that we saw in the second half of last year.

并购交易需要时间，对于在座或收听的行业人士来说，你们都知道，交易总是需要一段时间的。

Deals do take time, you know, for those who are on the industry side either on this call or listening, you know, deals take a while.

他们被法律事务拖住了。

They get caught up in legal.

需要进行大量的尽职调查。

There's a lot of diligence.

我的预测将基于去年我们看到的大规模和小规模交易数量。

And my prediction will be relative to the number of large scale and smaller scale deals that we saw last year.

如果2026年结束时交易量和交易规模比以往更高，我一点也不感到惊讶。

I wouldn't be surprised if we finished 2026 with even higher volume, larger transaction volumes, deal sizes.

所以，回答你的问题，露芭，我认为我们都认为这会发生。

So to answer your question, Luba, I think we all think it's gonna happen.

而且正如你所指出的，由于农民方面专利到期带来的巨大需求，我们看到的只会是过去五到十年里一直持续的情况——每年500亿到1000亿美元的并购交易。

And and for the reasons you set up, right, there's just too much need on Farmers' part with patent expirations to see anything other than what we've seen for the last, literally five or ten years in the space, which is, you know, dollars 50 to $100,000,000,000 worth of M and A transactions each year.

我喜欢这个观点。

I love it.

好了，我们继续讨论FDA吧，它确实一直是个让人困扰且引发大量讨论的话题。

All let's move on to, let's move on to the FDA, which has certainly been a source of consternation and much, much, much discussion.

这肯定不会改变。

And that's certainly not changing.

所以，山姆，你先谈谈你看到、听到和想到的情况吧？

So Sam, why don't you kick off what you're seeing and hearing and thinking about?

是的。

Yeah.

所以，保罗和我将一起分享这些内容。

So so Paul and I are gonna kind of do this together.

我将重点谈谈Moderna过去一周的情况。

I'm gonna focus on what happened with Moderna over the past week.

我的意思是，所有这些都发生在我们上次录音之后，对吧？

I mean, all of this happened since the last recording that we did, right?

这正是让人感到头晕目眩的地方。

Which is the bit that gives you whiplash.

所以上周，前一个周末，Moderna宣布收到了关于他们的流感疫苗mRNA-1010的不予受理通知。

So last week, over the weekend, not this weekend, weekend before, Moderna announced that they got a refusal to file letter for their flu shot, which is mRNA-ten ten.

这项试验是在国际性试验中进行的，针对的是标准剂量的流感疫苗，覆盖北半球。

And this was tested against the standard dose flu shot in an international type trial, Northern Hemisphere.

然后，他们做了我们所有人都以为已经和FDA达成一致的事情。

And then they did what we all thought had been agreed with the FDA.

在收到拒绝受理通知后，他们又重复了这一做法。

And they repeated that when they got the refuse to file letter.

我们都看过这些数据。

We've all seen the data.

目前有三到四种不同类型的数据。

There's three or four different types of data out there.

他们被要求开展一项有效性研究。

They were asked to do an efficacy study.

他们开展了一项有效性研究，而不是通常的免疫原性研究——后者只需证明对病毒的免疫原性相似或更好，但他们却收到了拒绝受理通知。

They did an efficacy study rather than the usual immunogenicity study, which is just showing similar or better, if you like, immunogenicity in terms of against the virus, refused to file letter.

随后，有消息传出，这一决定是由文·普拉萨德主导，并针对FDA团队做出的。

And then the story started coming out that this was driven by Vinay Prasad against the team at the FDA.

我相信保罗会讨论这些对整个行业的影响。

And I'm sure Paul will discuss some of this in terms of ramifications for the sector as a whole.

我们仔细看了，觉得这完全说不通。

We looked at it, we thought this just doesn't make sense at all.

无论你对莫德纳是看空还是看多，这里都不相关。

Whether you're bearish or bullish on Moderna is irrelevant here.

这是一项按照FDA建议进行的试验，我们相信这家公司，我确实相信。

It's just there was a trial that was conducted according to what the FDA had suggested, we believe the company, which I do.

数据看起来不错。

And the data looked good.

它优于标准剂量的流感疫苗。

It beat the standard dose flu shot.

这种药物或疫苗是否能与他们的新冠疫苗并列，有两个重要原因。

This is an important drug or vaccine for whether or not to fit next to their COVID vaccine for two reasons.

第一，我认为我们需要一种针对流感的mRNA疫苗，因为我们不能一直沿用这种系统：必须在流感季开始前六个月就决定给患者和受试者接种什么。

One, I think we need an mRNA vaccine against flu because we can't keep running with the system that you have to decide what you're going to give patients and subjects, people six months before the season starts.

这意味着，当你有能力在七月做出决定时，这种做法已经过时了，而公司确实有这个能力。

Mean, that's archaic to a degree when you have the ability to make the decision in July, and the company does.

我不明白，为什么你不愿意让这种疫苗上市，不管人们是否接种，既然在当今世界，我们有机会更接近地匹配九月、十月即将出现的流感毒株——这本应在今年的流感季发生，但实际并没有。

And that just doesn't make any sense to me why you would not want that vaccine available, whether people take the shot or not, in a world where there is a possibility that you could actually try and match the strain of flu that's coming up in September, October much closer, which would have been hopefully would have been the case this year, this past season, which wasn't.

你为什么不想要这个呢？

Why wouldn't you want that?

当然，FDA 本可以接受这项数据，然后在审评过程中提出疑问，或许专家小组会说：‘实际上，对于65岁以上的群体，我们更希望你们再开展一项试验，然后回来提交。’

And then, of course, the FDA could have taken this and accepted it and then had a question during review and perhaps a panel saying, Well, actually, for the 65 plus, we would rather you went and did another trial and came back to us.

因此，现在情况是，他们之前发出的‘不予受理’函已经被撤回。

So it's now happened to be that it's been rescinded in terms of their refused refused to file letter has been walked back.

目前有人在猜测这件事是如何发生的。

There are speculation as to how that happened.

但我认为我们已经回归正常状态，Moderna 将继续提交申请。

But I think we're back to a normal setting and that is Moderna will go through with its filing.

我们知道他们承诺会针对高剂量疫苗开展一项65岁以上人群的有效性试验，这很好，因为并非所有人都能轻易接种到这种疫苗，它的可及性并不高。

We'll see they would have committed to doing a 65 plus efficacy trial against the high dose vaccine, which is great because not in any case, not everybody is capable or able to get that shot because it's not as openly available.

所以事情已经回归到某种正常状态。

So things have gone back to a certain normality.

这对莫德纳很重要，因为mRNA-1010的进展也会影响流感与新冠的联合疫苗，而在最佳情况下，这种疫苗正是那些希望同时预防两种疾病的人所需要的。

And it's important for Moderna because what happens with mRNA-ten ten also impacts on the flu covid combination, which in the best scenario would be the right sort of vaccine to have out there for people who do want to have protection against both.

这非常合理。

It makes a lot of sense.

因此，对于莫德纳来说，我们又回到了某种正常状态。

So for Moderna, we're back to some kind of normality.

现在我将把话题交给保罗，让他从FDA和监管角度来谈谈。

And I'm going to pass it on to Paul now with regards to the FDA and regulatory angle.

是的，当然。

Yeah, sure.

谢谢，萨姆。

Thanks, Sam.

我的意思是，问题就在于，特别是对于生物技术、疫苗领域，以及一些属于非传统范畴的罕见病治疗。

Yeah, I mean, think the question is just, you know, especially for certain areas within biotech vaccines and also anything rare disease that's a little bit outside the box.

你知道，这一直是个悬而未决的问题。

You know, it's been an ongoing question.

我们能否信任企业的监管指导？这种指导或一致性是在普拉萨德加入FDA之前达成的，还是之后才达成的？

Can we trust companies' regulatory guidance, whether or not that guidance or alignment was attained, you know, before a Prasad FDA or even after?

我说‘之后’，是因为我们不断从企业那里听到，他们在讨论关键研究设计的一致性时，他通常并不在场。

And I say after because we continue to hear from companies anecdotally that in their meetings, he's not usually an attendee when there's alignment around a pivotal study design.

这些说法来自几家与CBER互动的企业，但本周《华尔街日报》也发表了一篇文章，报道称，在九起企业声称FDA前后说法不一致、态度变得更负面的逆转案例中，消息人士告诉《华尔街日报》，维奈·普拉萨德至少参与了其中六起。

And this is anecdotally from a couple companies that are interacting with CBER, but nonetheless, there was also this Wall Street Journal article this week that reported that of the nine reversals, I guess, or reported where the company essentially said that the FDA said one thing and then now is doing something else that's more negative, sources to the Wall Street Journal said that Vinay Prasad was involved in at least six of them.

因此，我认为这引出了一个未来的关键问题：FDA的灵活性边界究竟在哪里？

And so, I mean, I think it just kind of begs the question going forward of where's the line, where's the line in FDA flexibility.

我知道还有一个更广泛的问题，可能埃里克会谈到——如果马卡里和普拉萨德离开FDA，或者被排挤出去，FDA能否回归以往的状态？

I know there's a broader question that maybe Eric is going want to touch upon about the FDA long term and what happens if Makary and Prasad are not in the FDA or they leave or they're pushed out?

FDA还能回到过去的样子吗？

Can the FDA return back to what it was?

但我想先快速聚焦在股票层面，我们正在密切关注的一个事件是Denali公司治疗亨特综合征的药物在4月5日的PDUFA截止日期。

But I think maybe just to focus on the stock side really quickly, one event that we are looking at really, really closely is this PDUFA for Denali's Hunter syndrome product on April 5.

我之所以特别提到这一点，是因为正如这个播客和其他论坛中经常讨论的那样，FDA在基因医学领域明显更加保守。

The reason why I call attention to this is, as it's been talked about a lot on this podcast and other forums, the FDA has been notably a lot more conservative in the genetic medicine space.

我曾经认为，也许这种保守态度只会局限于某些与基因治疗相关的内容，对吧？

I think for a period there was a thought, okay, well maybe this is going to be confined more to certain stuff related to gene therapy, right?

因为基因治疗在小规模临床数据获批后，上市后会出现一些安全性风险。

Because some of the safety risks with gene therapy that pop up post marketing after something's approved in a small data set.

但随后我们看到了上周五关于Disc Medicines和Bitter Pertin的情况，那是一家真正的CNPV公司，情况甚至更加离奇。

But then we saw what happened with disc medicines on Friday with bitter pertin, which was an actual CNPV company, which is just like even more bizarre.

所以我特别提到Denali的原因是，这并非要对迄今为止被FDA彻底反转决策的任何公司做出任何批评性评论。

And so the reason why I raised Denali specifically is, and this is not to make any sort of critical comment on any of the companies who've been reportedly 180 by the FDA so far.

但从罕见病灵活性的角度来看，我个人认为，Denali的这款产品堪称FDA灵活性的典范。

But if you look at this Denali product from a rare disease flexibility perspective, in my personal opinion, it is the absolute poster child of FDA flexibility.

亨特综合征是一种罕见的酶缺乏症，会引发全身性发育问题和神经问题。

Hunter syndrome is this rare enzyme deficiency that has all these systemic developmental issues and neurological issues.

目前的药物Allopraze仅能治疗全身性症状。

The current drug, Allopraze, only treats systemic.