The Rising Influence of Chinese Biotech in Global Oncology and the Strategic Implications for ivonescimab

The global oncology landscape is undergoing a seismic shift, driven by the rapid ascent of Chinese biotech firms. At the forefront of this transformation is Akeso Biopharma and its collaboration with Summit Therapeutics on ivonescimab, a PD-1/VEGF bispecific antibody. This molecule has emerged as a high-risk, high-reward asset, reflecting both the promise and volatility of cross-border biotech innovation. For investors, understanding the interplay between clinical progress, regulatory dynamics, and M&A trends is critical to assessing ivonescimab’s potential to redefine cancer treatment—and its strategic value in a competitive market.

Clinical Progress: A Mixed but Promising Picture

Ivonescimab’s development has been marked by significant milestones and lingering uncertainties. The HARMONi-A trial demonstrated a statistically significant improvement in overall survival (OS) for non-small cell lung cancer (NSCLC) in China, securing regulatory approvals and establishing a foundation for global expansion [1]. However, the international HARMONi trial initially missed OS significance, with a hazard ratio (HR) of 0.79 and a p-value of 0.057 [2]. A subsequent analysis of Western patients, however, revealed a more favorable trend (HR=0.78, p=0.0332), suggesting regional differences in response patterns [3].

This duality underscores ivonescimab’s potential: its mechanism of action—simultaneously targeting PD-1 and VEGF—offers a novel approach to overcoming resistance in cold tumors and immune-oncology (IO) refractory settings [1]. The drug’s ability to reduce disease progression by 49% in HARMONi-2 compared to Keytruda further positions it as a disruptive force in first-line NSCLC treatment [4]. Yet, the inconsistent OS data across trials highlights the risks inherent in extrapolating results from diverse patient populations.

Strategic Value in a Shifting M&A Landscape

Chinese biotechs are no longer peripheral players in global oncology. In 2025, they accounted for 30% of in-licensed molecules by U.S. pharma giants, a stark contrast to the near-zero participation in 2019 [5]. Deals such as Merck’s partnership with Hengrui Pharma and Novartis’s collaboration with Shanghai Argo exemplify the growing appetite for Chinese innovation [2]. Ivonescimab, with its robust clinical pipeline and differentiated mechanism, sits at the intersection of this trend.

Akeso and Summit’s strategy—leveraging ivonescimab alongside next-generation bispecific-ADC therapies like AK146D1—positions them as pioneers in the “IO 2.0” era [1]. This pipeline strength has attracted global attention, with Summit describing the drug as a “potential Keytruda killer” [2]. However, geopolitical tensions, including the U.S. Biosecure Act and concerns over data integrity, introduce friction into cross-border partnerships [5]. For ivonescimab to realize its full potential, Akeso and Summit must navigate these risks while maintaining the momentum of their 13 ongoing Phase III trials.

High-Reward Potential, High-Stakes Challenges

The rewards for ivonescimab are substantial. If the drug secures broader regulatory approvals—particularly in the U.S. and Europe—it could capture a significant share of the $60 billion IO market. Its performance in cold tumors and IO-resistant indications further expands its addressable market [1]. Additionally, the molecule’s inclusion in 13 global trials, spanning eight lung cancer and five other oncology indications, reflects its versatility and scalability [3].

Yet, the path to commercialization is fraught with challenges. Regulatory scrutiny, particularly from the FDA, remains a wildcard. Recent restructuring of the agency’s oncology divisions and proposed pharmaceutical tariffs could delay approvals or inflate costs [6]. Moreover, the mixed OS results in the HARMONi trial necessitate longer follow-up data to confirm durability of benefit—a process that could take years.

Conclusion: A Calculated Bet on Innovation

Ivonescimab embodies the dual-edged nature of Chinese biotech’s global ambitions. Its clinical data, while promising, require careful interpretation. Its strategic value, however, is undeniable in a market where pharma giants are desperate to replenish pipelines amid patent expirations. For investors, the key lies in balancing optimism with caution: betting on the molecule’s potential to disrupt IO while hedging against regulatory and geopolitical headwinds.

As Akeso and Summit await China’s regulatory decision on ivonescimab’s NDA in Q2 2024 [3], the world watches. The outcome could not only determine the fate of this bispecific antibody but also signal whether Chinese innovation can truly reshape global oncology standards.

Source:
[1] Akeso's 2025 Interim Results: Commercial Sales Reach New All-Time Highs [https://www.prnewswire.com/news-releases/akesos-2025-interim-results-commercial-sales-reach-new-all-time-highs-302539063.html]
[2] Summit's Global PD-1xVEGF Data Show New Promising OS [https://www.fiercepharma.com/pharma/summit-global-pd-1xvegf-data-challenge-regional-consistency-claims-new-promising-survival]
[3] HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332 [https://finance.yahoo.com/news/ivonescimab-plus-chemotherapy-demonstrates-consistent-100800464.html]
[4] The Biotech Growth Trust — Encouraging recent performance [https://www.edisongroup.com/research/encouraging-recent-performance/BM-2105/]
[5] China is Making Large Inroads into Biotech: Is Investment Money Following? [https://pharmaceuticalintelligence.com/2025/07/28/china-is-making-large-inroads-into-biotech-is-investment-money-following/]
[6] US Deals 2025 Midyear Outlook- Pharmaceutical and Life ... [https://www.linkedin.com/pulse/us-deals-2025-midyear-outlook-pharmaceutical-life-landman-karny-mnzdc]