13亿美元交易背后的“罗生门”:诺和诺德与KBP的跨国博弈战丨专访

2025-10-15 08:18

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一场原本被誉为“中国Biotech高光时刻”的管线收购案,在短短15个月内演变为涉及欺诈指控和8.3亿美元索赔的跨国法律战。

 

争议围绕药物Ocedurenone(KBP-5074)展开,这是一款第三代非甾体盐皮质激素受体拮抗剂,针对晚期慢性肾脏病合并未控制高血压这一临床难题——该领域存在巨大未满足的医疗需求,而该药物在临床前和II期试验阶段展现“同类最佳”的潜力。

 

正是基于这样的前景,2023年10月,丹麦制药巨头诺和诺德(Novo Nordisk)以“7亿美元首付款+1亿美元托管+5亿美元里程碑款项”的交易结构,与中国企业家黄振华创立的新加坡生物技术企业亨利医药(KBP Biosciences)达成对该款药物的收购。

 

这一总额高达13亿美元的交易,在当时被视为中国源头创新获得国际认可的重要里程碑。

 

然而,2024年5月,该药物III期临床试验由于错误的无效性分析被终止开发。更令人意外的是,科学分歧很快升级为法律对抗:诺和诺德以“欺诈性隐瞒数据”为由,对KBP及其创始人黄振华发起索赔8.3亿美元的法律诉讼,新加坡法院随后批准了全球资产冻结令。

 

KBP反击称诺和诺德“未尽商业合理努力”,并于2025年3月在美国提起仲裁。目前仲裁定于2026初开庭。

 

在全球生物医药创新格局深刻重构的今天,诺和诺德与KBP这场涉及超十亿美元、横跨多个司法管辖区的商业争端,已远远超越个案范畴,成为一个具有行业分水岭意义的标志性事件。

 

它不仅是对单一交易条款的争议,更是对中国生物科技公司作为全球创新重要力量登上国际舞台后,所面临的全新挑战与博弈规则的集中暴露。

 

当中国创新的浪潮不可逆转地涌向世界,如何在与跨国巨头的复杂交易中,既保持合作又坚守立场,既追求商业价值又管理法律风险,成为所有中国Biotech必须通过的“成人礼”。

 

基于此,同写意专访了资深跨境交易专家、Laurel Hollow Capital创始人兼管理合伙人韩峰,这位常驻纽约、拥有超过30年跨境并购经验的专家,将为我们剖析这场纷争背后的深层逻辑和核心争议,希望透过这一纷繁复杂的案例,为中国创新药出海提供参考和建议,并探寻一条在国际合作与博弈中行稳致远的路径。

 

 

韩峰

Laurel Hollow Capital创始人兼管理合伙人

 

 

 

 

 

TONACEA

01

具有历史性的案例

 

 

 

写意君:诺和诺德与KBP的争端最近引起了中国产业界的极大关注,在中国之外,国际生物科技界如何看待这个案件?

 

韩峰:在美国和国内一样,对此关注的人也非常多,主要有生物医药领域的跨国公司,以及在我们这个领域从事cross border transactions(跨境商业交易)、有中国客户的顾问公司。大家对这件事的看法也是多样化的,但总的来说这只是多个双方为了商业目的博弈有争议的商业交易之一。我们公司对此非常关注,因为这毕竟会牵涉到我们现在和未来的客户对这个事情怎么看,包括在这个事件上有什么教训, 我们团队对此也做了比较深入的专业分析。

 

写意君:在您看来,这个案例之所以重要的维度体现在什么地方?它对于当前及未来涉及中国生物科技公司的交易意味着什么?

 

韩峰:首先,这发生在越来越多药物开发创新由中国Biotech驱动的整体大背景下。形成这一趋势的原因有很多——开发成本更低(1/4的开发成本),中国人的勤奋与职业道德,以及中国庞大的人口优势使得更容易开展临床、入组病人,基于以上三重优势因素,去年已有40%的跨境交易来自于中国公司的资产,预期未来5年内超过四分之三的新药将来自中国,KBP与诺和诺德的案例正是发生在这样的大环境之下。

 

其次,交易涉及金额超过10亿美元,在几年前,这算得上是有史以来规模最大的跨境许可交易之一,而且,当前BD交易中退货的案例不在少数,但被对方指责欺诈的,这可能是唯一案例。从这个角度来讲,这也是比较具有历史性的案例。

 

我觉得,这也是中国创新药产业发展从偶然到必然的一种结果,虽然当前融资环境有所改善,中国Biotech近几年总体融资比较困难,很多企业都希望发展到一定地步后能够尽快把资产卖出去,通过技术转让/license out来得到投资的收益,在这种情况下,相信这个案例将为所有中国Biotech提供一个很好的教材,学会如何在此类交易中保护自己。

 

此外,在目前全球大的地缘政治环境下,尤其是在中国以外,存在“中国人欺诈”的潜在假设,澄清事实、消除更糟的臆测至关重要,这样KBP的科学家和顾问,以及更广泛的中国生物科技界的科学家和企业家的声誉,才不会被不公正地诋毁。

 

写意君:放在大背景下,当前中国创新药BD趋势会不会受到一些影响?比如在合规、交易细节方面的考量?

 

韩峰:倒不会影响大的趋势,大趋势还是之前提到的三大因素促使的,以后的创新应该大多数还是来自中国,只不过是在交易的过程中,相对于MNC,中国Biotech属于弱势一方,要学会如何保护自己、become more sophisticated seller。

 

 

 

 

TONACEA

02

解构双方争议焦点

 

 

 

写意君:对于当前诺和诺德与KBP的双方争议,您能详细谈谈您的看法吗?

 

韩峰:(1)诺和诺德对KBP欺诈指控的逻辑是可笑的。

 

从新加坡的法庭文件中可以得知,诺和诺德的逻辑是:KBP明知Ocedurenone的II期临床试验结果无效,却仍继续进行III期试验以寻找潜在买家并实施欺诈。但实际情况是,基于II期数据,KBP成功完成了由一些生物科技投资机构领投的超过1亿美元的融资,包括高瓴资本和本草资本(3E)

 

对于像KBP这样的小型Biotech,如果II期试验失败,首先就不可能筹集到额外资金。或者我们是否在说,要么KBP对这些精明的投资者也实施了欺诈,要么这些投资者也“参与”了欺诈,以便KBP能够启动并继续III期试验,指望像诺和诺德这样的公司进来购买该资产?这在基本逻辑上是讲不通的。

 

(2)在目前全球临床试验的制度下,隐瞒或伪造临床数据几乎是不可能的。

 

药物开发是世界上最复杂的任务之一,需要大型团队和广泛的外部合作。数据伪造,尤其是临床数据,是极其困难的。现实中,协调全球临床中心和CRO公司共同实施欺诈是不可能的。此外,启动III期试验需要获得KBP的投资者、董事会、KOLs和美国FDA的批准。组织这样的欺诈需要成千上万人的配合。事实上,在过去的法庭案例中,要证明欺诈意图几乎是不可能的。

 

(3)诺和诺德有进行尽职调查的海量资源和能力。

 

作为欧洲最大的公司之一,不仅仅局限于制药行业,诺和诺德拥有海量资源,足以在尽职调查过程中进行极其彻底、无孔不入的调查。同样从新加坡的审判文件来看,诺和诺德声称KBP未能提供II期的中期分析数据。

 

在大多数交易中,对于一个处于III期试验中的药物,特别是在已经进行过两次III期试验盲态读数之后,将II期的中期分析视为非重大信息是正常的,因为II期试验早已完成,结果也已发表在科学期刊上。事实上,KBP向诺和诺德提供了所有原始的II期数据,诺和诺德可以以任何方式分析和处理这些数据,这进一步使得诺和诺德的论点站不住脚。

 

(4)关于保加利亚临床研究中心及诺和诺德停止试验的决定。

 

诺和诺德声称,保加利亚临床中心存在异常情况,导致疗效结果优于实际情况。然而,独立的临床试验监督委员会认为,该中心存在的任何问题,均不会影响数据的完整性。该委员会由全球顶尖专家组成,享有盛誉。我个人难以信服诺和诺德将责任归咎于该临床中心——他们曾对该中心进行过审计,但当时并未发现任何可能影响数据完整性的问题。此外,CRO在其III期中期统计分析中出现错误并要求更正,但诺和诺德坚持使用错误的结果。

 

再者,诺和诺德停止III期临床试验的背景令人怀疑。诺和诺德在2024年4月短时间内停止了试验,很可能没有核实CRO那份存在错误的中期分析报告。而且,值得注意的是,在2024年2月,诺和诺德的GLP-1药物用于慢性肾病(CKD)的临床试验取得了积极结果——这不禁让人怀疑,其决策是否掺杂了商业考量。

 

最后,需要指出的是,对KBP提起欺诈诉讼的资深CEO和长期担任EVP(执行副总裁)的高管均已离职。根据我与大型跨国公司打交道的经验,大企业内部往往存在复杂的政治因素,这些因素有时会驱使企业采取有失妥当的商业行为。

 

写意君:深入到案件细节本身,是否有一些值得关注的地方?

 

韩峰:诺和诺德最先在新加坡申请资产冻结,从纯粹商业角度看是聪明的做法,但这也是其切断与生物技术合作伙伴关系的一种非常规方式——以自身悬殊的法律资源优势对小型生物技术公司施加压力。

 

从具体的交易细节来看,在新加坡法院的庭审中,诺和诺德的法律论点就是因其未能获得充分信息而未进行完整尽职调查,为了避免交易过程中的问题,要求一个full (catch all) rep,什么叫full rep?reps warranties and indemnifications,即陈述、保证、赔偿,这3个概念非常重要,而在KBP与诺和诺德的合同中,有一条非典型的陈述保证。

 

在常规交易流程中,双方会基于尽职调查清单进行问答,这个过程需要双方团队持续沟通。通常,卖方通过陈述与保证条款承诺:对所有问题的回复均真实准确。但诺和诺德在标准条款外增加了一项约束:除了已回答的问题,只要卖方认为任何其他信息与交易相关或重要,都必须主动披露。这意味着卖方不仅要保证已回答内容的真实性,还要确保全面披露所有自认为相关的信息。

 

诺和诺德的核心法律论点是:他们未能进行全面尽职调查,依赖这种full reps,warranties and indemnification clauses,并据此指控KBP未充分披露信息。

 

以我们多年交易经验来看,如此宽泛的陈述保证条款通常难被成熟交易方接受。这警示我们:与跨国公司交易时,也绝不能掉以轻心——必须对每个条款保持审慎。

 

写意君:按照您的意思,也就是说,诺和诺德的主张在既往的BD/并购案例中是没有惯例的?

 

韩峰:有,但是少数。很简单,既然你来收购我,所有数据都已公开,或者你可以查阅所有相关信息、可以随意提问,而我负责回答。但现在的要求变成了:不仅要保证我回答的内容准确无误,还必须主动判断并披露任何你认为可能相关的信息?我怎么可能完全知道、预判哪些信息会影响你的决策?

 

当然,交易文件是保密的,我们也不知道保证陈述赔偿具体内容和当时双方在谈判过程的细节。上面只是我根据新加坡法院双方的供词做的猜测。这并完全不排除另外一种可能: KBP在这一点上法律风险控制得很好,而在欺诈的情况下卖方赔偿是没有限制的,这也可能是促使诺和诺德采取“欺诈指控”作为唯一能把钱要回来的法律策略。

 

 

 

 

TONACEA

03

中国Biotech启示录

 

 

 

写意君:在中国创新药走向国际化、全球化的大背景下,您觉得这一案例给予中国Biotech哪些重要启示?您对中国Biotech与跨国公司进行交易有什么建议?

 

韩峰:在跨境交易中,中国公司需要清醒认识到,虽然与跨国药企是合作伙伴,但在谈判桌上双方更是利益博弈的对手方——这种复杂的身份定位要求中国Biotech必须提升专业能力,善于利用专业顾问,并在追求商业回报的同时,严格管理风险,审慎应对交易中的每一个细节,具体而言,可以从3个方面展开:

 

首先,在初期材料准备阶段,就要保持高度严谨,从准备最初的融资资料或项目介绍书开始,就必须确保基础信息准确无误,并加入必要的法律免责声明,所有披露的材料和信息在未来都可能成为法庭证据。

 

其次,在尽职调查过程中,要注重细节管理,每个问题的答复——无论是“Not applicable”还是“None”还是其他选项——都需要精准表述,这些细微差别往往会影响整个交易的走向。

 

最后,聘请具备丰富跨境交易经验的专业顾问,这些顾问的作用与律师不同,他们能提供市场惯例、谈判策略等全方位指导,在美国,有许多像我们这样拥有大量交易经验的顾问,相对来说,中国Biotech在交易和实操经验上仍处于早期阶段,专业顾问基于经验和专业知识提供的指导和建议,可以从各方面降低风险。

 

 

 

 

 

英译版

 

Behind the $1.3 Billion Deal: The “Rashomon” Between Novo Nordisk and KBP

 

Exclusive Interview with Feng Han, Founder and Managing Partner of Laurel Hollow Capital

 

What was once hailed as a “defining moment for China’s biotech industry” — a pipeline acquisition deal — has within just 15 months devolved into an international legal battle involving fraud allegations and an $830 million damages claim.

 

The controversy centers on Ocedurenone (KBP-5074), a third-generation non-steroidal mineralocorticoid receptor antagonist targeting uncontrolled hypertension in patients with advanced chronic kidney disease — a major unmet clinical need. The drug showed “best-in-class” potential during preclinical and Phase II trials.

 

In October 2023, Denmark’s pharmaceutical giant Novo Nordisk acquired the drug from Singapore-based KBP Biosciences, founded by Chinese entrepreneur Huang Zhenhua, under a deal structured as $700 million upfront + $100 million escrow + $500 million in milestones, totaling $1.3 billion. The transaction was celebrated as a milestone for China-origin innovation gaining global recognition.

 

However, in May 2024, Novo Nordisk terminated the drug’s Phase III trial after an erroneous futility analysis. What began as scientific disagreement quickly escalated into legal warfare: Novo Nordisk sued KBP and Huang for “fraudulent data concealment,” seeking $830 million in damages, and the Singapore High Court subsequently approved a global asset freeze.

 

KBP struck back, accusing Novo Nordisk of “failing to exercise commercially reasonable efforts,” and filed for arbitration in the U.S. in March 2025, with hearings scheduled for early 2026.

 

In today’s rapidly evolving global biotech landscape, this billion-dollar cross-border dispute has become more than a single case — it marks a watershed moment. It exposes the new challenges and rules of engagement that Chinese biotech innovators face when stepping onto the global stage.

 

As China’s innovation wave becomes irreversible, the key question for Chinese biotechs is how to balance collaboration with independence, pursue value while managing risk, and navigate the complexities of cross-border partnerships.

 

Against this backdrop, TONACEA in terviewed Mr. Feng Han, Founder and Managing Partner of Laurel Hollow Capital, a New York–based transaction expert with over 30 years of cross-border M&A experience. Mr. Han offers deep insights into the logic and implications behind this case — and lessons for Chinese biotech firms venturing abroad.

 

Q: The Novo Nordisk–KBP dispute has drawn major attention in China. How is the case viewed internationally?

 

Interest is just as strong abroad — especially among multinational pharma companies and advisory firms handling China-related cross-border deals. Opinions vary, but most see it as one of many commercial disputes arising from complex dealmaking. Our firm is studying it closely because it could affect how current and future clients view similar transactions and what lessons they take away.

 

Q: Why do you consider this case so important? What does it mean for future deals involving Chinese biotechs?

 

Several reasons:

 

1. It comes amid a global shift where China’s biotechs are increasingly driving drug innovation. Development costs are roughly one-quarter of those in the U.S.; Chinese scientists’ diligence and access to large patient populations enable faster trials. Last year, 40% of cross-border biotech deals originated from Chinese assets, and within five years, three-quarters of new drugs could come from China.

 

2. The deal’s $1 billion+ scale made it one of the largest cross-border licensing transactions in history. While terminated deals are common, being accused of fraud is almost unheard of — perhaps the first case of its kind.

 

3. The case underscores an industry evolution from chance to inevitability. Many Chinese biotechs, facing difficult funding environments, aim to monetize assets early through license-out deals. This case will serve as a wake-up call — teaching firms how to protect themselves in major transactions.

 

4. Lastly, amid today’s geopolitical climate, the stereotype of “Chinese fraud” must be addressed head-on. Clarifying facts is essential to protect the reputations of Chinese scientists, entrepreneurs, and the broader innovation community.

 

Q: Will this case impact China’s outbound BD trend?

 

No — the fundamentals remain unchanged. The three factors driving China’s innovation (cost, talent, population) still hold. But since Chinese biotech firms are often the weaker party at the table, they must learn to become more sophisticated sellers — better at protecting themselves legally and strategically.

 

Q: Could you elaborate on your opinions of the dispute between Novo Nordisk and KBP?

 

1. The Logic Behind Novo’s Accusation of Fraud Against KBP Is Laughable

 

We know from Singapore’s court file that Novo’s logic is that KBP knew the Phase II clinical results of Ocedurenone were ineffective but still proceeded with Phase III trials to find potential buyers and commit fraud.  The fact is that is that based on Phase II data, KBP was able to successfully raise over $100M financing round lead with some of the most sophisticated biotech investors including Hill House and 3E.   For a small biotech company like KBP, if Phase II had failed, it would be impossible to raise additional capital. Or are we saying either KBP has committed fraud against all these sophisticated investors, or were these investors also “in” for the fraud so KBP can initiate and continue the Phase III trial in the hope that someone like Novo would come in and buy the asset? The logic collapses. 

 

2. In Today’s World it is almost impossible to Conceal or Falsify Clinical Data

 

Drug development is one of the most complex tasks in the world, requiring large teams and extensive third-party collaboration. Data falsification, especially clinical data, is extremely difficult. In reality it would be impossible to coordinate global clinical centers and CRO companies to commit fraud. Moreover, starting a Phase III trial requires the approval of KBP’s investors, board, KOLs, and the FDA. Organizing such a fraud would require the cooperation of thousands of people. If anything, proving intention to fraud is nearly impossible in past cases in courts.

 

3. Novo had unmatched due diligence capabilities and resources.

 

As one of Europe’s largest companies – not just pharma companies, Novo has vast resources to turn over every rock over the diligence process.  Again from Singapore trial documents Novo’s claim is that KBP failed to provide an interim analysis from Phase II.

 

In majority of transactions, for a drug in the middle of Phase III, especially after a couple of blind reads of Phase III already, it is normal to consider an interim Phase II read as non-material information, as Phase II trial was completed a while ago and results were already published in scientific journals.   This is further supported by the fact that KBP provided all original Phase II data to Novo.  Novo could analyze and process this data in any way, further making Novo’s point mute.

 

4. Bulgarian clinical site and Novo’s decision to stop the trial.

 

Novo is claiming abnormalities from the Bulgarian clinical site which caused better result, but the independent clinical trial supervising committee does not think any problems with the site would cause data integrity questions. And it is a very reputable group of global KOLs. It is difficult to believe Novo’s blame on this site when they did the audit but didn’t find any findings that could affect data integrity. Then there is the CRO error in their Phase III interim statistical analysis errors and requested corrections, yet Novo insisted on using the wrong results.

 

Furthermore, the backdrop behind Novo’s stopping Phase III trial is questionable. Novo stopped the trial in a short time in April 2024, likely without verifying the CRO’s erroneous interim analysis. Also it is worth noting that in February 2024, NN’s GLP-1 CKD trial had positive results. Someone has to wonder if commercial considerations were involved. 

 

Finally, it is important to note that the veteran CEO and long-time EVP who launched fraud case against KBP were both let go.  In my experience dealing with large MNCs, there are so many internal politics that sometimes unfortunately drive commercial behavior which sometimes may not be appropriate.

 

Q: Now diving into more details of the case, what aspects are most noteworthy?

 

Novo’s initial asset-freeze motion in Singapore was a smart play from a purely commercial point of view, but it is also an unconventional way to break up a relationship with a biotech partner while applying unmatched legal resources and pressure where it has a significant advantage over a small biotech company.

 

From the transaction details learned from Singapore court, Novo argued that KBP didn’t provide full information during due diligence and relied on a “full (catch-all) representation” clause. The concept of “representations, warranties, and indemnifications” is very important.  In their contract there is likely an untypical clause. 

 

In a typical transaction process, both parties conduct a Q&A based on a due diligence checklist, which requires ongoing communication between their teams. Normally, the seller commits through representations and warranties that all responses provided are true and accurate.

 

However, Novo Nordisk added an additional obligation beyond standard terms: besides the questions already answered, the seller must proactively disclose any other information it believes is relevant or material to the transaction. This means the seller is not only responsible for the truthfulness of its responses but also for ensuring full disclosure of all information it deems relevant.

 

Novo Nordisk’s core legal argument is that, because they did not conduct a full due diligence, they relied on these “full representations, warranties, and indemnification” clauses — and on that basis accused KBP of insufficient disclosure.

 

From our years of deal experience, such broadly defined representation and warranty clauses are rarely acceptable to sophisticated counterparties. This serves as a reminder: when dealing with multinational corporations, one must never let their guard down — every clause deserves careful scrutiny.

 

Q: So, according to what you mean, Novo Nordisk’s claim is not a customary practice in past BD or M&A cases?

 

Yes, but such cases are rare. It’s quite simple: since you are the one acquiring me, all data has been made available — you can review all relevant information and ask any questions you wish, and I’m responsible for answering them. But now the requirement has become: not only must I ensure that my responses are completely accurate, but I must also proactively identify and disclose any information you might consider relevant? How could I possibly know or predict which information might affect your decision-making?

 

Of course, the transaction documents are confidential, and we don’t know the exact content of the representations, warranties, and indemnification clauses, nor the details of the negotiations at the time. The above is only our guess based on the parties’ testimonies in the Singapore court.

 

That said, another possibility cannot be ruled out: KBP may have done a very good job controlling legal risk on this point — and since seller liability is typically unlimited in cases of fraud, it’s possible that Novo Nordisk resorted to a fraud accusation as the only legal strategy to recover its money.

 

Q: Under the backdrop of Chinese innovative drugs moving toward internationalization and globalization, what key insights does this case provide for Chinese Biotech? What suggestions do you have for Chinese Biotech companies engaging in transactions with multinational corporations?

 

In cross-border transactions, Chinese companies must clearly recognize that, while they are partners with multinational pharmaceutical companies, they are also adversaries in a game of competing interests at the negotiation table. This complex identity positioning requires Chinese Biotech companies to enhance their professional capabilities, adeptly utilize professional advisors, and, while pursuing commercial returns, strictly manage risks and meticulously address every detail in the transaction. Specifically, this can be approached from three aspects:

 

First, during the initial material preparation stage, a high level of rigor must be maintained. From the preparation of the initial financing documents or project proposals, it is essential to ensure that the foundational information is accurate and error-free, and to include necessary legal disclaimers. All disclosed materials and information may potentially serve as courtroom evidence in the future.

 

Second, during the due diligence process, attention to detail management is crucial. Every response to a question—whether it’s “Not applicable,” “None,” or another option—must be precisely articulated. These subtle differences often influence the direction of the entire transaction.

 

Finally, engage professional advisors with extensive experience in cross-border transactions. These advisors, distinct from lawyers, can provide comprehensive guidance on market practices, negotiation strategies, and more. In the U.S., there are many advisors like us with substantial transaction experience. In contrast, Chinese Biotech companies are still in the early stages of transaction and operational experience. The guidance and advice provided by professional advisors, based on their experience and expertise, can reduce risks from various aspects.

 

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