This is the English version of the article published on September 19th. For the Chinese version, please refer to the link: https://www.pharmadj.com/ssr/article/1968651021909618689

Reported by: Judy Li
Edited by: Justin Fischer

The cross-border acquisition dispute between Danish pharmaceutical giant Novo Nordisk A/S and China’s KBP Biosciences has rattled the global life sciences community. The Singapore International Commercial Court has refused to lift a worldwide asset freeze on KBP Biosciences and its founder, Dr. Huang Zhenhua, in a fraud dispute with Novo Nordisk. The decision, handed down in August 2025, leaves hundreds of millions of dollars in limbo and has sharpened questions about disclosure obligations in billion-dollar drug deals.

Court filings and industry records show that the dispute reflects broader tensions between scientific uncertainty in clinical development and the risks embedded in billion-dollar licensing deals.At its core lies not just a commercial disagreement, but a fundamental clash over how to interpret and disclose clinical trial data.

How the Deal Collapsed

KBP-5074, an experimental therapy for resistant hypertension in chronic kidney disease patients, showed promising results in a 2020 Phase II trial. Buoyed by these findings, KBP raised $75 million in mid-2021 and launched a global Phase III trial later that year.

In October 2023, KBP signed an asset purchase agreement with Novo Nordisk. The deal closed just a month later, with Novo Nordisk paying a $700 million upfront fee, depositing $100 million in escrow and agreeing to milestone payments tied to future development.

By 2024, however, an interim analysis of the Phase III trial (Clarion-CKD) led Novo Nordisk to halt the study early, citing insufficient efficacy, and to take a substantial write-down on the asset.

The situation escalated in February 2025 when Novo Nordisk accused KBP of fraud and petitioned Singapore’s International Commercial Court to freeze the global assets of both KBP and its founder, Huang Zhenhua, while also seeking repayment of the upfront fee. The court clarified that the asset freeze was temporary—an interlocutory measure—and did not constitute a ruling on the underlying fraud allegation. In August 2025, the court denied KBP and Huang’s request to lift the freeze.

The Interim Analysis Debate

Novo Nordisk argues that KBP withheld material information. According to court filings, in June 2020, KBP ran an exploratory interim analysis of the first 90 patients who had completed 12 weeks in its Phase II trial of KBP-5074. The snapshot analysis showed no clear efficacy signal. But when negotiations took place in 2023, KBP shared only the full Phase II dataset rather than highlighting that early readout. Novo Nordisk claims this omission amounted to concealing material negative information.

KBP counters that the real issue is not whether the analysis existed, but whether such data should be considered material evidence—and whether it carried the same disclosure obligations as final results. Interim analyses are primarily intended to monitor safety or make adjustments to trial design, rather than to draw definitive conclusions. Because they involve smaller sample sizes and limited follow-up periods, regulators such as the FDA do not treat them to carry the same weight as full Clinical Study Reports (CSRs).

Indeed, in drug development history, interim data can be misleading. In Boehringer Ingelheim’s LUME-Lung 2 trial, an interim analysis suggested futility and led to an early stop, yet the final data later showed the drug met its primary endpoint, prolonging progression-free survival.

KBP maintains that its 2020 readout of KBP-5074 was not a pre-specified analysis, but an “administrative” check with little statistical weight. The complete Phase II trial later confirmed a significant blood-pressure benefit and was published in a peer-reviewed journal.

The company also stresses that Novo Nordisk received the final CRS report, patient-level datasets, and a full electronic data room—the same materials regulators use to assess progression to Phase III. Novo Nordisk, KBP argues, had every opportunity to re-analyze the data and perform sensitivity checks.

Focus on One Bulgarian Clinical Site

Novo Nordisk has argued that Ocedurenone’s Phase 2 efficacy was “driven almost entirely” by one Bulgarian site, citing similar concerns from Otsuka.

KBP disputes that view. It says efficacy signals appeared in other regions as well, and that focusing on Bulgaria alone ignores the global dataset. The Bulgaria site, a dedicated early-phase unit in Sofia led by Comac Medical, a major full-service CRO and SMO (Site Management Organization) with experience in hypertension and kidney trials, had successfully completed the AMBER trial in the same indication and has worked with Sanofi and Bayer. KBP stresses that it is a professional and qualified clinical trial operator.

Court filings show Novo Nordisk audited the site after acquisition and complained to the FDA and EMA in late 2024, but no regulator has imposed sanctions. In December 2024, Dr. Bertram Pitt and Dr. Janet Wittes—two internationally reputable experts in hypertension and CKD—told Novo Nordisk they had found no convincing evidence of falsification.

According to people familiar with KBP, its Phase II trial, conducted from 2018 to 2020, experienced operational challenges during COVID, and KBP also switched CRO in 2019 to improve data quality. The Bulgaria site was added by the new CRO, Worldwide Clinical Trials (WCT). Recruitment began in March 2020 and was completed by June. The interim analysis Novo Nordisk points to occurred before Bulgaria enrolled patients.

KBP argues that stricter sites often generate clearer efficacy signals, while noisier cohorts dilute results. Such heterogeneity is common in resistant hypertension trials, where endpoints are sensitive to posture, time of day, and measurement methods.

Indeed, high variability has tripped up other companies. In September 2025, Alnylam reported that its siRNA candidate Zilebesiran failed to meet the primary endpoint in Phase II, largely due to baseline imbalances. Yet the company continued development, citing encouraging subgroup results and moving directly into Phase III.

A Statistical Misstep and Commercial Context

The Phase III futility episode deepened the rift. Parexel’s initial topline analysis indicated futility; Novo Nordisk stopped the trial. Parexel later corrected calculation errors, after which the corrected read met one futility threshold (SBP criterion) but not the p-value threshold—meaning the program retained some development potential. KBP argues that this nuance was not sufficiently reflected in Novo Nordisk’s public case.

According to KBP, internal documents show Novo Nordisk’s decision was not purely based on clinical data but also commercially driven. In early 2024, Novo Nordisk’s own GLP-1 program in CKD was yielding positive results, raising questions about whether strategic prioritization, not solely science, played a role.

What it Means for Deal-Making

With arbitration pending in New York and hundreds of millions at stake, the dispute is already influencing industry practice:

Cross-border licensing is rarely “one-and-done.” Small and mid-sized pharma companies must keep an eye on their programs after out-licensing, since clinical uncertainty or a partner’s strategic shift can halt projects—or spark legal disputes.

Contracts matter. Beyond upfront payments, agreements should clearly define who bears the risk if development fails or disputes arise, protecting smaller firms from wasted investments or unexpected liability.

Data transparency is key. Seller companies should organize complete trial datasets—interim analyses, site-specific results, and statistical methods—and explain the science proactively during due diligence, reducing conflicts from information gaps or differing interpretations.

The Novo Nordisk-KBP dispute lays bare a difficult truth: When billion-dollar deals collide with inherently noisy clinical science, the boundary between uncertainty and alleged misconduct can be dangerously thin.

Reference:
1. Bakris G, Pergola PE, Delgado B, et al. Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study. Hypertension. 2021;78(1):74-81. doi:10.1161/HYPERTENSIONAHA.121.17073
2. Pitt, B., Jaisser, F., & Bakris, G. (2021). An evaluation of KBP-5074 in advanced chronic kidney disease with uncontrolled hypertension. Expert Opinion on Investigational Drugs, 30(10), 1017–1023. https://doi.org/10.1080/13543784.2021.1985462
3. IN THE SINGAPORE INTERNATIONAL COMMERCIAL COURT OF THE REPUBLIC OF SINGAPORE [2025] SGHC(I) 22. https://www.elitigation.sg/gdviewer/sicc/2025_SGHCI_22
4. KBP Biosciences Welcomes Court’s Decision to Maintain Injunction Pending Arbitration with Novo Nordisk. https://biopharmaapac.com/regulatory/89/6729/kbp-biosciences-welcomes-courts-decision-to-maintain-injunction-pending-arbitration-with-Novo Nordisk-nordisk.html
5. When licensing deals go bad - Novo Nordisk sues KBP Bio for $830m: Novo Nordisk Seeks $830M in Fraud Case Against Singaporean Biotech Over Kidney Drug. https://www.biospace.com/deals/Novo Nordisk-seeks-830m-in-fraud-case-against-singaporean-biotech-over-kidney-drug
6. Court rejects application to set aside worldwide freezing order. https://sbr.com.sg/healthcare/news/court-rejects-application-set-aside-worldwide-freezing-order
7. SICC upholds USD730m worldwide freezing order obtained by Novo Nordisk. https://www.setialaw.com/sicc-upholds-billion-dollar-worldwide-freezing-order-obtained-by-Novo Nordisk-nordisk/
8. Alnylam to Advance Zilebesiran into Global Phase 3 Cardiovascular Outcomes Trial. https://www.businesswire.com/news/home/20250830851819/en/Alnylam-to-Advance-Zilebesiran-into-Global-Phase-3-Cardiovascular-Outcomes-Trial