BioCentury This Week

Ep. 334 - Pazdur’s New FDA Role, SITC & China RNAi

• BioCentury • Season 6 • Episode 334

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Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs.
BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657631

#RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation

00:01 - Sponsor Message: Voyager Therapeutics 
03:08 - FDA's Richard Pazdur
13:08 - Plausible Mechanism Pathway
19:30 - Most Favored Nation
23:12 - Takeaways from SITC
28:05 - RNAi in China
33:21 - European VCs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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[AI-generated transcript.]

Eric Pierce:

BioCentury This Week is brought to you by Voyager Therapeutics. Voyager Therapeutics is dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure– neurological diseases. Voyager addresses the challenge of delivering novel treatments to the brain through the company's innovative TRACER™ AAV capsid discovery platform, as well as Voyager's NeuroShuttle™, a non-viral delivery platform designed to transport multiple modalities of neurotherapeutics across the blood-brain barrier. The company's programs address diseases with substantial unmet needs, including Alzheimer's disease, Friedrich's ataxia, Parkinson's disease, ALS, and other diseases of the central nervous system.

Jeff Cranmer:

Richard Pazdur took the top job at FDA's CDER after initially turning it down. Why is he the right person for the job? What is he likely to try to get done and what are some of the potential flash points with FDA Commissioner, Makary and RFK Jr.? Also on the BioCentury this week podcast, we have the latest on MFN, why the most Favored nation scheme is less onerous than some thought. And FDA's new plausible mechanism pathway. Plus, as promised, we'll have our colleague, Lauren Mart's takeaways from this year's SITC Meeting. that's the Society for Immunotherapy of Cancer, for those keeping score at home. And why China's RNA therapies are in growing demand. And we'll take a quick look at two new funds from two of Europe's leading VCs. I'm Jeff Cranmer, executive editor here at BioCentury, and I'm joined by my colleagues.

Steve Usdin:

Steve Usdin, Washington Editor.

Lauren Martz:

Lauren Martz, Executive Director of Biopharma Intelligence.

Selina Koch:

And Selina Koch, executive editor.

Jeff Cranmer:

Okay, well it's London Life Sciences Week. Some just call it Jefferies for short. Like to give a shout out to everyone who is in London for the event madly dashing about and setting up meetings. Our colleagues, Simone, Stephen, and Josh are there. They'll be recording a Special Edition of the BioCentury's This Week podcast, taking it On the Road at the 3rd Biotech CEO and Investor Reception that we put on with BIA, Pioneer, and Precision Biosearch. The event is sold out. It's on Wednesday, I believe you can join the wait list on our website if you like. That is one of two upcoming Special Episodes of the BioCentury's This Week podcast this week. The other will feature a conversation with Al Sandrock, CEO of Voyager, he is also the former CMO of Biogen. All righty, Steve. So Pazdur changed his mind and took the top job at CDER. After all. Why?

Steve Usdin:

Well look, it has been a long week. So last week you're right, yeah the news was that Richard Pazdur, Director of the Oncology Center of Excellence, had turned down an opportunity to become Director of CDER. Then on Tuesday, he accepted the job based on commitments from HHS Secretary Kennedy and FDA Commissioner Makary, that he and CDER would not be subject to political interference. I usually think it's silly when people thank someone for taking a prestigious job in government. In this case, I think the appreciation expressed by patient advocates, FDA employees and biopharma executives is genuine. It really is difficult to imagine anyone who will be better as CDER director right now than Rick Pazdur. In my story about his appointment, I wrote that he represents stability at a moment when public health institutions are under strain and integrity at a time when regulatory decisions have become politicized. In over a quarter century at FDA Pazdur and the teams he's led have built regulatory frameworks that have made possible precision Medicxines, immunotherapies, and other drug classes that transformed cancer care. I think that people are looking to him and hoping that he can do something similar for CDER writ large.

Jeff Cranmer:

Steve, what do you think he's likely to try to achieve?

Steve Usdin:

Well first I, I think having, praised him so much, I have to make it very clear, he's very likely to make decisions that some people who are listening to this podcast don't like. He's never been afraid to ruffle feathers. He is very outspoken in his views, and very surefooted when he thinks something is the right thing to do. So, a few things I've observed about him that I think suggest what he'll do. First, he recruits and he retains and he supports really excellent people. You know, a quick story about that years ago, and a few less gray hairs. I hosted a TV show that was on old fashioned broadcast tv. I invited Pazdur and I asked him to suggest someone to accompany him on the show, and I said, we can invite anyone he wanted. I suggested some prominent scientists, some government leaders. He didn't miss a beat. He immediately said he wanted to bring four of his staffers on, and he said they don't get enough recognition for what they do, that's what he wanted to do. That's the kind of move that instills a great deal of loyalty among the people who he's recruited. So what's he gonna do? I think bolstering morale at CDER is gonna be his first priority. Hiring staff, including some who were pushed out or quit this year is likely to be next. I think he's gonna try to emulate the Oncology Center of Excellence by creating ways for CDER, CBER, and CDRH to collaborate much more closely around specific clinical areas like cardiovascular and neurology. Vinay Prasad, the Director of CBER, mentioned that, in a recent, um, webcast with Commissioner Makary. And I think he's gonna empower and support his staff. Pazdur's not gonna intervene to overturn regulatory decisions that he doesn't like. He's been critical of senate directors who've done that in the past, and I don't think he's gonna do that himself.

Jeff Cranmer:

We published his letter to staff, which I thought was really cool. Do you wanna speak to that a little bit?

Steve Usdin:

Yeah. Um, it, it really was in his voice. I, I really encourage people to, read it. as you said, we, we ran it in full. He didn't try to sugarcoat things. He acknowledged that there have been challenges that things have been, um, really difficult over the last year. He said he's experienced, some of the same feelings that other CDER staff have. And he said, you know, look, it's time to move on, we're gonna move, move forward, and try to bring some stability to it. He accompanied the letter with a photograph of him standing next to an open door and at the end of the letter he said something to the effect of, you know, my door's always open, I'm gonna try to make myself accessible to staff so you can come in and talk to me, if you have concerns. So it was really kind of vintage Rick Pazdur.

Jeff Cranmer:

So about the, uh, the heat shield, the promise is not to meddle. What are some of the potential flashpoint, that he might have with Makary and RFK Jr and maybe even Vinay Prasad?

Steve Usdin:

Or President Trump. Look, it's, it's impossible. This administration never ceases to amaze. So, I really couldn't predict with certainty the. But here's some things that are, that are possible, right? So Kennedy and Makary have set in motion a number of initiatives that I think could put their commitment to avoid political interference with CDER to the test. Makary has centralized power in the Office of the Commissioner, and he's tasked political appointees in his office with reviewing products that are important to the Maha agenda. He started with vaccines, and the Office of the Commissioner led initiatives that resulted in changes to vaccine regulation that were really at odds with what CBER staff thought was the correct thing to do. Right now there are reviews going on in the Office of the Commissioner that could affect CDER products, reviews of puberty blockers, SSRIs for children and adolescents, and monoclonal antibodies for RSV. Some of those have been subject to expert review panels that Makary has held. Others have been discussed in the MAHA report, and elsewhere. So, if Makary tries to dictate policies on these circumventing CDER reviewers and staff, I think that could create issues, for Rick Pazdur. Another possible Flashpoint Makary has interviewed candidates for jobs at CDER. if he tries to push out CDER staff and replace them with people he selects, that could also create a lot of tension. So those are things that were underway before Dr. Pazdur took the job. And it's gonna be really interesting to see if they continue and how, how they get resolved. There's also an issue of how CDER's going to implement some of the policies that Dr. Makary has put in place. One of them is the Commissioner's National Priority Voucher. The way that Makary has described that process kind of sidesteps a lot of the processes that CDER and CBER, have put in place over the years that are intended. To ensure kind of due diligence about reviews, but also they're intended to allow individual reviewers, scientists at FDA to speak up and express concerns that they might have and kind of like creates a safe space for them to do that. Um, the CNPV seems to make that much less likely, much more difficult. There are also issues over who's gonna actually sign the approval letters for drugs that are approved or products that are approved, that receive CNPV's, so we'll see how Dr. Pazdur navigates that. And then finally there's the Plausible Mechanism Pathway. I think we're gonna talk about that later on the show. And you know, I think that there likely, there are other kind of high profile decisions, policies that Commissioner Makary, CBER, Director Prasad are working on that are intended to advance their deregulatory agenda at FDA. And those, because they kind of disrupt the status quo, it will be important for there success for them to have the CDER Director, kind of on board with them.

Selina Koch:

So Steve, I, I, feel like one of the things is known for in oncology is bringing some coherence, some standardization to the policies and processes around accelerated approval, which has been game changing in that disease area. But when you just have one disease area like that and, and one that's has a certain amount of consistency, right, like most of the time, you know what the problem is, it's the tumor. Therefore, if you can shrink the tumor, that should be a good thing, you know, and you could build a system around that. I know there's controversy about how well that does translate into overall survival and whatnot, but it's, it makes sense at a foundational level. when you think about doing the same sort of thing across indications, all the things that CDER looks at, and then all the other stuff he has to deal with right now. Is there any chance of him being able to make some progress on bringing some consistency to accelerated approval broadly beyond cancer?

Steve Usdin:

You know, I don't have any inside. Information about that, but it wouldn't surprise me if that was a priority of his. And given the way that he is operated at OCE, my guess is it is not like he's going to try to dictate answers from the top and say, okay, well this is, this is how we're gonna do it. He tends to have a much more collaborative approach to things, and my guess would be that at some point down the line, he would bring together people from CBER, from CDER. Again, maybe even from CDRH when it's appropriate and try to create those kind of, that kind of consistency. He's got an awful lot of other things to worry about right now. I think first you know, it's really necessary to kind of right the ship because there really has been, and still is, there's an ongoing crisis in morale, and in consistency and in the ability to meet the basic. Things that, um, CDER has to do, you know, to kind of like keeping the lights on, keeping the ship moving forward, whatever analogy you want to use. So I think that's gonna have to be the first priority. But I would imagine things like accelerated approval will come down the road. I think that you, you're also likely to see a push for, um, more transparency and accountability in the form of advisory committees. You maybe remember that under Commissioner Califf, there was a big controversy at FDA over how to reform the advisory committee process. And there was a dispute between some people at FDA who wanted to eliminate or scale back the use of voting by advisory committees. And Dr. Pazdur was very much on the side of wanting to retain voting. He thinks that it leads to more clarity about what the decisions are. I know that there's some in industry who take a very different, view from that, but I, I think that one of the marks that we'll see of whether he's able to, able to kind of bring CDER back to a trajectory that's more like what it was on before January, will be his ability to ramp up advisory committee meetings and other kinds of forums where there's public accountability and transparency around things like endpoints for specific diseases. And that would flow into the Accelerated Approval to be.

Jeff Cranmer:

Alright, Steve, will you tease the Plausible Mechanism story which you wrote last week, this new pathway at FDA, and I've gotta say it inspired you to become a political cartoonist and I'm impressed. What can I say? Uh, I didn't know you were an artist, Steve.

Steve Usdin:

Well, I get, I do get a little assistance from ChatGPT on that, but, um, and that, that was like a little silly thing. It's on LinkedIn. But basically, the story that I wrote about the Plausible Mechanism Pathway, it's kind of two parts. It's a little complicated. I think that a lot of people in the rare disease community especially really applaud this and they really look forward to FDA defining a new pathway that's going to be science-based and rigorous. And that's gonna allow for the approval and facilitate the development of drugs for rare and especially for ultra rare diseases. And to that extent, I think people are really happy with, with the plausible mechanism pathway. On the other hand, the paper that was written in the New England Journal of Medicxine announcing it is very vague. It's short on a lot of details. There's no process in there. And that's led some people to be very concerned about whether this is really going to happen and if it happens, if it's gonna happen in a predictable fair way that gives companies the the kind of assurances that they need to invest in the development of these products and gives patients the sense that, they're going to be able to kind of participate in this process really to lead it as I think that they should be. Now you mentioned my cartoon, my cartoon really was pointing out that I think that FDA, Commissioner Makary haven't done themselves any favor by calling this pathway the plausible mechanism pathway, the idea of plausible, it's just a really unfortunate word. I mean, can you imagine a patient going into a physician and being told, here's a, a drug for you. I think you should take it. FDA says it's plausible. It also gives payers an easy way to avoid covering products, or leverage for trying to reduce the payment for products by saying, well, the, these products are not as safe and effective, the standards for approving them weren't um as high as they are for other products, FDA just says they're plausible. So again, I think if this is done properly, the science behind it, the certainty around it, should be very high because what they're talking about doing is intervening in basic, the basic fundamental biological pathways that create disease. And then being able to see changes, to be able to see halts and progression, maybe in some cases even reversals, so that

Selina Koch:

Yeah. This comes down to causal biology, really. Right? Like if you know what the cause of biology is. If you understand the disease and then you intervene in a very sort of direct way, maybe they should call it the root cause pathway. What do you think, Steve?

Steve Usdin:

That would be a good name! Or the, or the causal biology or the what, whatever, you know, something, something that expresses the idea that this, this is something that's actually based on applying science in a way that didn't exist when the standards, the standard methods that FDA uses the empirical methods, you know, a placebo controlled trial or two placebo controlled trials, running them and just seeing what happens, and then making a decision based on that. This is based on science that didn't exist when those standards were created. I think the other thing that's gonna be really important is creating the right guardrails around it for things that, where it is possible, and preferable to run randomized controlled trials, the companies still are required to do that. The other thing of course is important is to have really rigorous collection of outcomes data and then, adjusting approvals based on that data that comes out.

Selina Koch:

Steve, is this just for programs that have indications smaller than like a thousand patients, is there a cutoff like that?

Steve Usdin:

No, they specifically say in the New England Journal of Medicxine piece that, um, well, it's, it's really the examples that they give, you know, Baby KJ, the N-of-one therapy, and they talk about bespoke therapies, but they also say, you know, that this pathway in the future could be applied to more common diseases. That's again, something that's gonna have to really be explained in guidance. They've said, that there's going to be joint CDER CBER guidance on how this is implemented. And I think a lot of people are gonna be really, really very interested in seeing how that guidance is developed and hopefully the FDA will also find ways to allow the patient advocates and scientists from companies and scientists from academia to have their voices heard in the way that FDA develops that guidance.

Selina Koch:

Yeah, I'm keenly interested in that because I think we all recently saw what happened to uniQure, right? So Huntington's disease, that's monogenic. We understand the causal biology, the therapy intervenes in the causal biology company was said it could use it and it's very rare. It's not quite n-of-one ultra rare, but it's rare. But was told it could use, a natural history comparator, and then it was told it couldn't. So I feel like everybody's just sort of like a little bit on the edge of their seats being like, but, there's these mixed messages coming out and what's it actually gonna be, you know?

Steve Usdin:

I agree. And the, the real question is, are they gonna walk the talk? You know, are they actually going to do this. The thinking behind the plausible mechanism pathway, leaving aside the terrible name is something that I think that a lot of people really would applaud. And it is actually consistent with what's happening internationally. I've had extensive discussions recently, with people in the U.K. about a similar concept that they're developing, and I'm gonna write about that soon. The kind of thinking around the world is converging along similar lines, the important thing will be the nitty gritty details of how it's actually put into practice.

Jeff Cranmer:

All right, Steve, quickly, MFN you, uh, you wrote that it turns out that it may be a little less onerous than, uh, once thought, quick thoughts there?

Steve Usdin:

Yeah. So when President Trump, and uh other members of his administration first talked about MFN months ago, they said the United States was gonna get the lowest price for drugs paid anywhere in the industrialized world. There were legions of consultants that went out and started doing, you know, running their spreadsheets showing what us prices would be like if they were pegged against, for example, Luxembourg, or South Korea, or Greece or something like that. And those would be really enormous drops in US prices. But it turns out, that it seems to be what the administration is talking about now is the second lowest price among the G7 leaving out the US and Denmark and Switzerland. That is a much more generous target or benchmark than just saying it's gonna be the lowest among all industrialized countries. There isn't that big a gap between the first, the most expensive in the G7 plus Denmark and Switzerland compared to the number two, that isn't really the issue. It's really the issue is limiting it to those countries and leaving out other industrialized countries that have much more stringent price controls.

Jeff Cranmer:

All right, and Steve story on MFN on the plausible mechanism up online. And, you also have, uh, his latest in a series of stories uh about the bouncing ball that has been Dr. Pazdur over the past 10 days or so. We're gonna take a quick break and we'll return to talk SITC.

Alanna Farro:

BioCentury This Week is brought to you by The 5th East-West Biopharma Summit in South Korea. An arc of innovation is emerging across Asia, and Western biopharma leaders are taking note-from cross-border deals to newcos. In March, 2026, The 5th BioCentury-BayHelix East-West BioPharma Summit visits South Korea for the first time. Meet the biopharma leaders putting Korea innovation on the global map. Learn why Korea has become a clinical trial in manufacturing hub. Discover if Korea is the next hotspot for NewCo formation. Plus, meet biopharma innovators from India to Singapore, to China and Japan. Register now at BioCenturyEastWest.com.

Jeff Cranmer:

Okay. And East-West, I have started recruiting Presenting Companies to appear at the conference. If you're interested, drop me a line on LinkedIn. And we aren't just looking for Korean companies. We'll have a good group of Korean companies for sure, but we'd love to get some Western companies, some companies from Japan, China, Australia. So if you'd like to learn more, reach on out. Lauren, let's draw you into the conversation here. You took a close look at Bispecifics in your analysis of abstracts out of this year's Society for Immunotherapy of Cancer annual meeting. why'd you choose that to focus on?

Lauren Martz:

Thanks Jeff. yeah, so I picked. Three translational trends from the analysis of the SITC abstracts. And all three of those are ways to help bispecifics be more effective against solid tumors. So this was just something that came up over and over again throughout the abstracts at this conference, and that's why I chose to focus there. So the first one is stromal targets for bispecifics. Companies and academic groups have been attempting to sort of bring down the tumor stroma with different therapeutic strategies, uh, for a long time. And backing up, so the tumor stroma is the fibrotic tissue that surrounds the tumor and protects it against immune cells and in some cases against therapeutics. So this idea that you could use a bispecific T cell engager to target the tumor stroma was relatively new to me. The idea that we saw in, in several abstracts was that these tumor stroma targets could be used as new ways to sort of help selectively target a solid tumor, which has been one of the big challenges in this space. There aren't a lot of targets that can direct the T cells there and not to healthy organs. So it's, it's sort of another way to attempt that. And then potentially, bringing the T cells to these actual fibroblasts or other types of cells in the tumor stroma to try to eliminate them and bring down that barrier. And then another interesting note there is that bispecifics are one way to do that. There are also some abstracts describing CAR T cells that may do a similar thing, hit the tumor trauma instead of tumor antigens and tumor cells themselves.

Selina Koch:

Are these meant to be combination strategies, then like if you can use a T cell engager, get the T cell to attack the fibroblasts and take down some of that barrier, would those same T cells then be able to attack the cancer or do you need that second component?

Lauren Martz:

so that leads into the next trend that I saw. yes. I think the idea of some of these is a combination. And in some cases we're seeing companies deliver two bispecifics. Some of them will, you know, one targeting the tumor stroma, one targeting the tumor itself. So you could bring T cells directed against both of them at the same time. The other feature of I think at least two of the abstracts was that one of those targeted CD3 on the T cells. Another targets an alternative costimulatory receptor on a T cell, so the idea there is that you're providing a T cell with both of the signals that it needs for complete activation, while also, you know, targeting the tumor, the tumor stroma, and targeting the tumor. So that second trend was alternatives or additions to CD3. Most of the bispecific T cell engagers that we've seen go through the clinic target CD3 on T cells, and they help provide that main T cell activation signal. We've started to see some of these costimulatory T cells targeting CD2 or CD28 also make their way into the clinic. And at SITC this year, we're seeing trispecifics or combinations of bispecifics. So you know, a trispecific targets CD3, CD2, for example, end a tumor antigen. So you're providing both of the signals that a T cell needs or you're, you know, using two bispecifics to provide both of those signals. And that becomes especially important with solid tumors because the second costimulatory signal comes from other immune cells in the tumor microenvironment. So if it's a cold tumor with an immunosuppressive microenvironment, the T cells may not be getting that signal and may not be that effective without this therapeutic way to provide it.

Jeff Cranmer:

Good stuff, Lauren. What, about the third?

Lauren Martz:

Yeah. So the third thing I noticed was an additional class of targets. These are the glycan and lectin targets. So glycans are the sugars that are expressed on the surface of cancer cells. They're modified and their composition is altered in certain ways versus expression on normal cells. And then lectins are receptors that can be expressed on immune cells. And when this interaction happens to connect as a sort of checkpoint function and dampen the immune cell activity against the cancers. The idea of creating bispecifics that act as lectin decoys, that sort of blocked this interaction was something that was presented at SITC and then some other modalities were also proposed as ways to disrupt this interaction.

Jeff Cranmer:

All right. Uh, thanks for that, Lauren. Let's turn to China's RNAi therapeutics space. Recent IPOs and deals out of China, biotechs are signaling. That this is likely the next major modality out of China. China's expertise in antibody engineering, of course, as well established. But, uh, these these early signs are suggesting that the region may soon become highly competitive in RNAi. Lindsay Martin, a new member of our editorial team, took a look and Selina edited the piece. Uh, Selina.

Selina Koch:

Yeah. Thanks Jeff. Well the question we had when we dived into this analysis was, are RNA silencing technologies becoming a growing modality over there, because we had heard anecdotes, but we hadn't really dug into the the data in a more systematic way, so that is what Lindsay did. And I think what she found supports that idea. You know, we've all heard this phrase, China speed, right? And usually it's used to describe how quickly companies over there can, can get a, a candidate into the clinic. But her analysis really impressed on me how China speed really exists on these other fronts as well, like the rapid expansion and diversification of technology expertise in particular. Yeah, I mean she just set out to round up RNA silencing programs. So these are oligo nucleotides an, you know, antisense oligos and siRNAs in particular. Be cause they both try to do the same thing, which is that they go after a target by reducing the amount of that target, by attacking the it at the RNA level, so less of it gets produced. So they have similar functions and she found, you know, looking for companies who have disclosed pipelines of multiple programs of these types, at least a dozen of them. And two years ago there was really no Dealmaking in these RNA silencing technologies. Dealmaking activity right now is still small. There haven't been a ton of disclosed agreements, but in the last two years there have been four that have been sort of big enough and splashy enough, you know, to be announced in press releases and whatnot. And, and, and those four are all worth, in total biobucks, they're worth north of a billion dollars, their upfronts range from tens of millions to a couple hundred million.

Jeff Cranmer:

and who were the, who were the Western companies who were first to kind of seize on this?

Selina Koch:

Yeah, so those deals, Novartis is responsible for two of them. Boehringer Ingelheim for one, and then the, the fourth was not a, a major pharma, but was a company called Kalexo Bio. All four happened to be for siRNAs and in either cardiometabolic spaces or in, um, MASH. And so, that's kind of the beginning of what we expect to be a bigger trend. She actually found 97 siRNA programs over there. Of which only 11 are partnered right now. So hot tip to anyone out there looking for siRNA programs, um, a lot of unpartnered programs coming up in China And

Jeff Cranmer:

Yeah. And Lindsay, no doubt with, Selina's help put together a great, table. And just looking at it quickly, the, the names that jump out at me, uh, Argo, a 4-year-old company, still private, has over 40 programs, seven are in the clinic, four are partnered. Ribo, company out of Suzhou, they've been around for, uh, almost 20 years. They've got a lead in Phase II, just like Argo, and they have 18 programs, three of which are partnered. And then the other player that, you know, tops 10 uh, programs is Anlong Bio, another private company there, and they have a a dozen programs, 11 preclinical, and three of which are partnered. So this is, uh, a really great table just to, uh, help you with your, deal hunting, uh, maybe this week in London, or, uh, coming up in, uh, what I assure you will be a very sunny San Francisco in January. You can find this story on BioCenturypodcast.com.

Selina Koch:

Oh Jeff. And if I could make one more point about this, so Lindsay then analyzed, all these programs by their therapeutic areas, and this is just offer is like an example, I think that highlights how far China is diversifying beyond cancer. It's doing that in its antibodies as well, but here we have in the RNA programs, a really bolus of them in cardiovascular, and metabolic and endocrine, and neurology and a handful of others.

Jeff Cranmer:

Yeah, well that sort of tracks with what we've been seeing, uh, in, in China deals and, and the like, right. A move toward growing expertise in other areas. Neurology, especially INI, obesity. Yeah, it's not your, uh, mother's, uh, China anymore. We're moving beyond oncology. All right, uh, Selina, thanks for that. Let's hit up a little finance two of Europe's most well-known VCs, Medicxi, and Sofinnova partners raise new funds as announced in the past few days. Sofinnova just overnight. Uh, our colleague, Paul Bonanos, who's the news editor here at BioCentury. And follows the venture beat quite closely. He caught up with leaders at each firm, Medicxi, is largely staying the course with its new fifth fund. Paul, found in his conversation with Giovanni Mariggi. He found that the firm plans to invest its capital in attractive assets rather than technology development projects that carry greater risk. Medicxi's fund five, 500 million Euros. It's the sixth since the firm broke away from Index about nine years ago. Targeting investments in 20 to 25 companies, many of them will be newly created. And Paul also spoke with Sofinnova Partners, Antoine Papiernik, who sees the firm's latest and largest fund, a vote of confidence in European life sciences. That fund 650 million Euro, it's about 40% larger than its predecessor. As with prior funds, the firm expects to invest about 70% of it in Europe, in the balance in US startups. And that, raise gives the firm flexibility to build, more companies with the fund, perhaps as many as 18. So check out Paul's stories on BioCentury.com, BioCentury podcast.com. Also on BioCentury, Cidara, wow. Capping a Cinderella year with a $9 billion takeout by Merck. Plus Lauren took a look at the new label for a Sarepta gene therapy. And as always, if you like what you're hearing, like subscribe, drop us a comment. We'd love to hear from you. And, uh, if you see Simone, Josh, or Stephen, uh, wandering around the streets of London, give him a shout. Kendall Square Orchestra provides the music for BioCentury's This Week. The group connects science and technology professionals and other members of the greater Boston community to collaborate innovate and inspire through music, while supporting causes related to healthcare and education.

Eric Pierce:

BioCentury would like to thank Voyager Therapeutics for supporting the BioCentury This Week podcast. To learn more about Voyager's programs advancing transformative medicines for neurological diseases, visit voyagertherapeutics.com.

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