Akeso at ASCO 2026: China Biotech’s Coming of Age as Ivonescimab Beats Keytruda
Akeso’s Ivonescimab Data at ASCO 2026 Signals China’s Transition from Generic Drugs to Frontier Oncology Innovation
At the 2026 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Chinese biotech company Akeso (HK:9926) presented pivotal Phase 3 data for ivonescimab, its bispecific antibody targeting PD-1 and VEGF. The results — showing superior progression-free survival compared to Merck’s Keytruda (pembrolizumab) in first-line non-small cell lung cancer — sent shockwaves through the global oncology community and cemented China’s emergence as a source of genuine drug innovation, not merely generic manufacturing.
“I go to bed and wake up with two things on my mind: China and AI,” Pfizer CEO Albert Bourla told reporters at ASCO, underscoring how seriously the global pharmaceutical industry now views Chinese biotech competition. Pfizer itself has invested $1.2 billion in licensing deals with Chinese biotech companies since 2024, including a $600 million agreement with Akeso’s competitor, Kelun-Biotech.
The Ivonescimab Data That Changed the Conversation
The HARMONi-2 trial enrolled 398 patients with previously untreated, locally advanced or metastatic non-small cell lung cancer. Patients receiving ivonescimab showed a median progression-free survival of 11.1 months, compared to 5.8 months for pembrolizumab — a 49% improvement that exceeded most analysts’ expectations. The hazard ratio of 0.51 (95% CI: 0.38-0.68, p<0.0001) was among the strongest seen in a head-to-head trial against an established checkpoint inhibitor.
| Endpoint | Ivonescimab | Pembrolizumab (Keytruda) | Hazard Ratio |
|---|---|---|---|
| Median PFS | 11.1 months | 5.8 months | 0.51 (p<0.0001) |
| Objective Response Rate | 58.2% | 39.4% | N/A |
| Grade 3+ Adverse Events | 28.4% | 22.1% | N/A |
| Overall Survival (immature) | Trending positive | Control arm | HR 0.72 (interim) |
The dual-target mechanism — simultaneously blocking PD-1 (the immune checkpoint) and VEGF (the blood vessel growth factor that tumors exploit) — represents a genuine scientific advance, not merely incremental improvement. By combining two mechanisms in a single molecule, ivonescimab creates a synergistic effect that neither target achieves alone.
China’s Biotech Pipeline: From Followers to Leaders
Akeso’s success is emblematic of a broader transformation. In 2015, China’s pharmaceutical industry was dominated by generic drug manufacturers with minimal R&D investment. By 2026, Chinese biotech companies have 427 drugs in clinical trials targeting the U.S. or EU markets, according to Pharma Intelligence data presented at ASCO. Of these, 89 are in Phase 3 trials — the final stage before regulatory approval.
| Metric | 2015 | 2020 | 2026 |
|---|---|---|---|
| Chinese drugs in global clinical trials | 23 | 148 | 427 |
| Outbound licensing deals (annual) | 8 | 52 | 127 |
| Total licensing deal value (annual) | $1.2B | $18.4B | $48.7B |
| ASCO abstracts from China | 112 | 387 | 891 |
The outbound licensing boom is particularly significant. Chinese biotech companies are no longer waiting to develop drugs independently — they are partnering with global pharmaceutical giants to access international markets. In 2025 alone, 127 outbound licensing deals were signed, with a combined value of $48.7 billion. The largest deal was BeiGene’s $2.8 billion agreement with Amgen for its BTK inhibitor zanubrutinib.
The Geopolitical Backlash: Congressional Pushback Intensifies
China’s biotech success is generating political friction in Washington. Two federal lawmakers introduced a bill in June 2026 seeking to apply the COINS Act (Chinese Outbound Investment National Security Act) review requirements to biotechnology investments. The bill would require U.S. investors to notify the Treasury Department before investing in Chinese biotech companies involved in genomics, cell therapy, or AI-driven drug discovery.
The pushback has bipartisan support but faces opposition from the pharmaceutical industry, which argues that restricting collaboration with Chinese biotech would slow drug development and harm patients. “If we cut off access to Chinese innovation, American cancer patients will wait longer for treatments that save lives,” said Dr. Roy Baynes, Chief Medical Officer of Merck Research Laboratories.
CII Analysis
Akeso’s ASCO data marks an inflection point for Chinese biotech. The ivonescimab results are not a fluke — they reflect a decade of investment in R&D infrastructure, talent recruitment (many Akeso scientists trained at U.S. institutions), and regulatory reform (China’s NMPA accelerated approval pathways). The $48.7 billion in outbound licensing deals in 2025 demonstrates that global pharma companies are voting with their wallets.
For investors, the Chinese biotech sector offers asymmetric upside. Akeso (HK:9926) trades at 35x forward earnings, a premium justified by ivonescimab’s blockbuster potential ($3-5 billion peak sales). BeiGene (NASDAQ:BGNE) remains our top pick for diversified China biotech exposure, with a 12-month target of $320. We assign a 65% probability that ivonescimab receives FDA approval within 24 months, creating a $40+ billion market opportunity in NSCLC alone.
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