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2025年新兴生物技术面临的5个问题

5 questions facing emerging biotech in 2025

BioPharma Dive 等信源发布 2025-01-14 20:57

可切换为仅中文


As 2025 begins, emerging biotechnology firms can be sorted into two groups: haves and have-nots.

随着2025年的开始,新兴生物技术公司可以分为两类:富人和穷人。

Venture funding rose last year, but a good portion of that money was concentrated into

去年风险投资有所增加,但其中很大一部分资金集中在

nine-figure “megarounds”

九位数“百万发”

that became more common.

这变得更加普遍。

Initial public offerings

were primarily open only to companies that fit a certain profile. And among already public U.S. biotechs, many saw their stock prices slide as pharmaceutical companies looked elsewhere for deals.

主要只对符合特定特征的公司开放。在已经上市的美国生物技术公司中,随着制药公司寻求其他交易,许多公司的股价下跌。

The result has been what Piper Sandler analysts described in a report earlier this month as a “stock-pickers’ market,” with the few outperformers outnumbered by many more that are struggling. That description could apply to the private sector, too, where companies focused on immunology and cardiometabolic research had an easier time winning investment..

结果就是派珀·桑德勒(Piper Sandler)分析师在本月早些时候的一份报告中描述的“选股市场”,少数表现优异的股票数量超过了更多挣扎的股票。这种描述也适用于私营部门,专注于免疫学和心脏代谢研究的公司更容易赢得投资。。

With the year looking particularly uncertain, drug startups have several hurdles to overcome in the months ahead. Here are five questions they face in 2025:

今年看起来特别不确定,制药初创公司在未来几个月还有几个障碍需要克服。以下是他们在2025年面临的五个问题:

How will China licensing deals affect U.S. biotech?

中国的许可协议将如何影响美国生物技术公司?

Pharma companies and U.S.-based biotechs have for years turned to China for help making drugs or running clinical trials. Increasingly, they’re looking to China to acquire new drug prospects they can plug directly into their pipelines — a trend that could have ripple effects across the U.S. biotech ecosystem..

多年来,制药公司和美国生物技术公司一直向中国寻求药物生产或临床试验的帮助。他们越来越希望中国获得可以直接插入其管道的新药前景,这一趋势可能会对美国生物技术生态系统产生连锁反应。。

Both the number and average value of licensing deals involving drugs discovered in China reached record levels in 2024, according to data published in December by Jefferies, an investment bank. Jefferies expects a further acceleration this year. Those figures extended a reversal from 2022, when a few high-profile regulatory setbacks involving China-discovered medicines led to a dip in deals.

投资银行杰弗里斯(Jefferies)12月份公布的数据显示,2024年,中国发现的涉及毒品的许可交易数量和平均价值均达到创纪录水平。Jefferies预计今年会进一步加速。这些数字延续了2022年的逆转,当时涉及中国发现药物的一些备受瞩目的监管挫折导致交易下降。

Notably, according to Jefferies, 2024’s transactions involved less proven medicines than previously and drew from a broader group of therapeutic areas — possibly signaling a change in deal strategy by U.S. companies..

值得注意的是,据杰弗里斯(Jefferies)称,2024年的交易涉及的药品比以前少,并且来自更广泛的治疗领域,这可能标志着美国公司交易策略的改变。。

A report last week from Stifel’s Tim Opler, meanwhile, showed that pharma companies are now sourcing about one-third of their in-licensed molecules from China, up from between 10% to 12% during 2020 to 2022. Merck & Co., for example,

与此同时,Stifel的蒂姆·奥普勒(TimOpler)上周的一份报告显示,制药公司目前约有三分之一的in许可分子来自中国,从2020年至2022年的10%上升至12%。例如,默克公司,

bought

已购买

a

trio

三重奏

of

属于

China-originated medicines

中国原产药物

last year that were in either preclinical or early testing.

去年正在进行临床前或早期测试。

Novartis

诺华公司

and

GSK

GSK 公司

sprung for similar deals too.

类似的交易也如雨后春笋般涌现。

Analysts at Jefferies believe the pattern is the result of China emerging as a hotspot for “me too better” versions of drugs, enabling dealmakers to cheaply pluck assets they can quickly advance through testing. In many cases, these medicines are aimed at drug targets that have recently become coveted due to emerging clinical data from other companies..

杰弗里斯(Jefferies)的分析师认为,这种模式是中国成为“我太好了”药物热点的结果,这使得交易撮合者能够以低廉的价格收购他们可以通过测试快速推进的资产。在许多情况下,这些药物针对的是最近由于其他公司新出现的临床数据而令人垂涎的药物靶标。。

The flurry of China dealmaking may come at the expense of U.S. biotechs, whose drugs are typically more expensive to acquire because of “scarcity value” or because their makers are already publicly traded, Jefferies analysts wrote.

杰弗里斯(Jefferies)分析师写道,中国交易的热潮可能以美国生物技术公司(biotechs)为代价,由于“稀缺价值”或其制造商已经上市,美国生物技术公司的药品收购成本通常更高。

While venture capitalists are forming startups around China-based drugs, too, they may end up getting bypassed by pharmas that can do the work themselves, Stifel’s Opler wrote. —

Stifel的Opler写道,虽然风险资本家也在围绕中国药品成立初创公司,但他们最终可能会被能够自己完成这项工作的制药公司所绕过-

Ben Fidler

本 菲德勒

Will biotech keep contracting?

生物技术会继续收缩吗?

A year ago, biotech investors and executives were hopeful the industry had weathered the worst of a prolonged market pullback. They had reasons for their optimism, too, as 2023 ended on a multi-month stock rally fueled by a spurt in dealmaking and expectations of interest rate cuts.

一年前,生物技术投资者和高管们希望该行业能够度过市场长期回调的最糟糕时期。他们也有理由保持乐观,因为2023年结束时,由于交易激增和降息预期的推动,股市出现了长达数月的反弹。

Instead, the sector continued to contract. More than 100 biotech companies restructured, laid off staff, or reshuffled their pipelines in 2024, according to a report from the investment firm Mizuho Securities. The industry’s flagship stock indices again underperformed the broader market. Public biotech acquisitions slowed.

相反,该行业继续萎缩。根据瑞穗证券(Mizuho Securities)的一份报告,2024年,100多家生物技术公司进行了重组、裁员或重组。该行业的旗舰股指再次表现不佳。公共生物技术收购放缓。

A series of negative study readouts and rising regulatory uncertainty associated with the incoming administration brought further gloom..

与即将上任的政府相关的一系列负面研究读数和不断上升的监管不确定性带来了进一步的悲观情绪。。

Along the way, the number of publicly traded biotechs declined for a third consecutive year, either through acquisitions, reverse mergers, stock delistings or outright closures. Mizuho analysts predicted such consolidation will continue in 2025, dragging the number of existing biotech companies down closer to pre-pandemic levels.

与此同时,上市生物技术公司的数量连续第三年下降,无论是通过收购、反向合并、股票退市还是彻底关闭。瑞穗分析师预测,这种整合将在2025年继续,将现有生物技术公司的数量拉近大流行前的水平。

About 16% had market values lower than their cash reserves, reflecting how the group is trading at what Piper Sandler analysts called in their report “historically low valuations.”.

大约16%的人的市值低于其现金储备,反映出该集团的交易价格为Piper Sandler分析师在其报告中所称的“历史最低估值”。

There’s been more of the same already at 2025’s start, with several struggling companies laying off staff or considering “strategic alternatives,” a process that usually results in a sale or merger.

2025年伊始,情况已经变得越来越相似,几家陷入困境的公司纷纷裁员或考虑“战略替代方案”,这一过程通常会导致出售或合并。

While more venture dollars were invested in biotech startups last year, that money went to fewer companies in the form of larger rounds supported by broader investor syndicates, according to a report from HSBC Innovation Banking.

汇丰创新银行(HSBC Innovation Banking)的一份报告显示,虽然去年有更多风险资金投资于生物技术初创公司,但这些资金以更广泛的投资者财团支持的更大规模投资的形式流向了较少的公司。

That trend could help young companies achieve goals that boost their value. But it may also saddle them with bloated valuations that make for a “tougher path” to the public markets, HSBC analysts warned. —

这种趋势可以帮助年轻公司实现提升价值的目标。但汇丰银行(HSBC)分析师警告称,这也可能给它们带来估值过高的困扰,这将为它们进入公共市场开辟一条“更艰难的道路”-

Ben Fidler

本 菲德勒

Will the IPO backlog clear?

IPO积压是否会清理?

After three years of waiting for the IPO window to open, drug startups are largely still in a holding pattern.

在等待IPO窗口开放三年后,制药初创公司基本上仍处于控股模式。

Since hitting a record high in 2021, the number of biotech IPOs per year has settled around 20. Last year’s 23 stock issuances were primarily priced by biotechs with drugs in mid-to-late stage testing, according to

自2021年创历史新高以来,生物技术公司每年的首次公开募股数量已稳定在20家左右。据英国《每日邮报》报道,去年23只股票的发行主要是由生物技术公司在中后期测试中定价的

BioPharma Dive data

BioPharma 潜水 数据

.

.

Meanwhile, the startups that formed during the pandemic-era funding boom have matured. Industry watchers have maintained this backlog of companies is just waiting for the right opportunity.

与此同时,在大流行时代的资金热潮中形成的初创公司已经成熟。行业观察人士认为,这些积压的公司只是在等待正确的机会。

'It's a very long line, and that line is made up of companies all the way back from 2021,” said Jon Norris, a managing director at HSBC Innovation Banking.

汇丰创新银行(HSBC Innovation Banking)董事总经理乔恩·诺里斯(JonNorris)表示:“这是一条很长的线,这条线是由2021年以来的所有公司组成的。”。

There were signs of momentum last fall. Between September and October, eight drugmakers went public in quick succession, raising a collective $1.5 billion. Many raised more than they had intended, an indication of investor demand.

去年秋天出现了势头的迹象。9月至10月,八家制药商相继上市,共筹集了15亿美元。许多人筹集的资金超过了预期,这表明投资者的需求。

But post-IPO stock performance has remained listless, with most of the companies that went public last year trading at or below their offer price.

但IPO后的股票表现仍然萎靡不振,大多数去年上市的公司的股价都在或低于发行价。

Preclinical companies

临床前公司

have had a hard time, while some of the top performers were already in Phase 3 testing when they debuted — perhaps reflecting a lower appetite for drug development risk among public investors.

经历了一段艰难的时期,而一些表现最好的公司在上市时已经处于第三阶段测试阶段,这可能反映了公众投资者对药物开发风险的偏好较低。

Startups that penciled in an IPO may therefore need to wait. Doing so will be easier for some, however, as the number of “mega-rounds,” or financings of more than $100 million, grew by 70% to 106 last year, according to HSBC. More than half included the “crossover” investors that can bridge companies to a public stock offering, suggesting a “strong IPO window in 2025-2026,” HSBC wrote..

因此,打算首次公开募股的初创公司可能需要等待。然而,根据汇丰银行(HSBC)的数据,对一些人来说,这样做会更容易,因为去年“超级回合”的数量(即超过1亿美元的融资)增长了70%,达到106次。汇丰银行写道,超过一半的投资者是“交叉”投资者,他们可以将公司连接到公开募股的桥梁上,这表明“2025-2026年将有一个强大的IPO窗口”。。

“At a minimum, people can say, 'I don't know if the IPO market is going to be busier or not in 2025, but if I have the option not to care by staying down as a private company, then that feels like a pretty good option,’” said Jack Bannister, an analyst at investment firm Leerink Partners. —

投资公司Leerink Partners的分析师杰克·班尼斯特(JackBannister)表示:“至少,人们可以说,‘我不知道2025年IPO市场是否会更加繁忙,但如果我可以选择不关心私人公司,那么这感觉是一个不错的选择’。”-

Gwendolyn Wu

吴文多林(Gwendolyn Wu)

What might rekindle the cell and gene therapy field?

什么可能重新点燃细胞和基因治疗领域?

Gene therapy’s problems have graduated. The field, which recorded the first U.S. approval of a gene therapy for an inherited disease just eight years ago, has now produced over a

基因治疗的问题已经逐渐突出。该领域记录了八年前美国首次批准针对遗传性疾病的基因疗法,现在已经产生了超过

dozen marketed products

十几种上市产品

, including treatments for sickle cell disease, hemophilia, muscular dystrophy, blindness and a rare brain disorder. Scores of clinical trials testing others are underway.

,包括治疗镰状细胞病、血友病、肌肉萎缩症、失明和罕见的脑部疾病。许多临床试验正在测试其他人。

The pipeline is perhaps even broader in cell therapy, which has grown beyond its blood cancer applications and is now seen as a promising approach for immune diseases as well.

在细胞治疗方面,这条管道可能更为广泛,它已经超出了血癌的应用范围,现在也被视为治疗免疫疾病的有前途的方法。

Despite those accomplishments, there’s a considerable amount of gloom. Many publicly traded biotechs working in the field have had to cut costs, lay off staff or restructure their research over the past year. Some of those decisions were brought on by company-specific challenges; others by changing outlooks for the markets they hoped to enter.

尽管取得了这些成就,但仍有相当多的悲观情绪。过去一年,许多在该领域工作的上市生物技术公司不得不削减成本、裁员或重组研究。其中一些决定是由公司特定的挑战引起的;其他人则通过改变他们希望进入的市场的前景。

Large pharmaceutical companies like Pfizer and Roche have .

辉瑞(Pfizer)和罗氏(Roche)等大型制药公司都有。

pulled the plug

拔下插头

or

written off

已报废的

past investments.

过去的投资。

All of that has trickled down to the private markets, where funding for new cell and gene therapy developers has ebbed,

所有这些都流入了私人市场,对新细胞和基因治疗开发人员的资金已经减少,

according to BioPharma Dive data

根据生物制药潜水数据

.

.

One of the chief problems the field now faces is proving that these therapies, in more cases than not, are going to be commercially viable products when they reach market.

该领域目前面临的主要问题之一是,证明这些疗法在更多情况下,在进入市场后将成为商业上可行的产品。

“Gene therapy has come of age, but commercial launches have been largely underwhelming,” wrote analysts at Piper Sandler in the sixth edition of a sector report they published in October.

Piper Sandler的分析师在10月发布的一份行业报告的第六版中写道:“基因治疗已经成熟,但商业启动基本上没有什么吸引力。”。

Bluebird bio is a case study. The company has three approved gene therapies: Zynteglo for beta thalassemia, Skysona for cerebral adrenoleukodystrophy and Lyfgenia for sickle cell. Yet the firm has come close to running out of money and,

蓝鸟生物是一个案例研究。该公司有三种批准的基因疗法:用于β地中海贫血的Zynteglo,用于脑肾上腺白质营养不良的Skysona和用于镰状细胞的Lyfgenia。然而,该公司已接近资金枯竭,

even now

即使是现在

, doesn’t project breaking even until the second half of this year.

,直到今年下半年才实现收支平衡。

The field needs more examples of commercial success. And for new technologies like gene editing, proof that the complex and cutting-edge medicines are

该领域需要更多商业成功的例子。对于基因编辑等新技术,证明复杂和尖端的药物

clearly more compelling to patients

显然对患者更有吸引力

than drugs made with established platforms. —

而不是用既定平台制造的药物-

Ned Pagliarulo

内德 帕格里尔

Will the upswing in private M&A continue?

私人并购的增长还会继续吗?

Public biotech acquisitions may have slowed last year, but the number of private M&A deals swelled. According to HSBC, seven were worth $1 billion or more in value, with notable deals including GSK’s purchase of

去年,公共生物技术收购可能有所放缓,但私人并购交易的数量激增。据汇丰银行(HSBC)称,其中7宗交易价值10亿美元或以上,其中包括葛兰素史克(GSK)收购

Aiolos Bio

Aiolos 生物

and Merck’s deal for

和默克的交易

EyeBio

眼睛

.

.

Such deals can provide the exits that private companies’ venture backers may be seeking when IPOs are a more uncertain prospect.

当首次公开募股前景更加不确定时,此类交易可以为私营公司的风险投资支持者寻求退出。

'When the rubber hits the road … for these later-stage companies and they can't hit the public market, what is that going to look like?” HSBC’s Norris said. For companies with little to show potential acquirers, it could be a year of consolidation, while others might seek out reverse mergers. According to Norris, the latter is an option when companies can’t increase their valuations any higher, but need more capital to continue R&D..

“当这些后期公司无法进入公开市场时,当橡胶进入道路……那会是什么样子?”汇丰银行的诺里斯表示。对于几乎没有潜在收购者的公司来说,这可能是一年的合并,而其他公司可能会寻求反向合并。根据诺里斯的说法,当公司无法提高估值,但需要更多资金才能继续研发时,后者是一种选择。。

Pharma companies may also be in need of M&A to bolster their pipelines as they face the

制药公司在面临

loss of exclusivity for some of their best-selling drugs

失去一些畅销药物的排他性

, said Scott Beardsley, a managing partner at Novo Holdings.

,Novo Holdings管理合伙人斯科特·比尔兹利(ScottBeardsley)表示。

'[Investors] are going to have to start making money again, and I think the easiest thing to fix that is M&A,' Beardsley said. “A couple of wins” with big private M&A deals could also provide a boost to public deals.

比尔兹利说,“(投资者)将不得不再次开始赚钱,我认为最容易解决的是并购。”。大型私人并购交易的“两场胜利”也可能推动公共交易。

On Monday, there were two: GSK bought IDRx for $1 billion upfront, and Lilly

周一,有两种情况:葛兰素史克(GSK)预付10亿美元收购了IDRx,礼来(Lilly)

acquired Scorpion Therapeutics’ principal drug

for up to $2.5 billion. —

高达25亿美元-

Gwendolyn Wu

吴文多林(Gwendolyn Wu)