Summit Therapeutics Faces Regulatory Crossroads Amid China Approval Surge

Investors in Summit Therapeutics (NASDAQ: SMMT) faced a rollercoaster week as shares tumbled 36.1% following the company’s April 2025 trading halt—a pause triggered by a landmark regulatory update. The news: its partner Akeso (OTC: AKESF) secured NMPA approval for ivonescimab, a PD-L1/VEGF bispecific antibody, for PD-L1-positive non-small cell lung cancer (NSCLC). While this milestone should have been cause for celebration, the market’s reaction revealed deep-seated anxieties about Summit’s path to commercialization and its competitive positioning in a crowded immunotherapy landscape.

The Approval Paradox: Why Good News Became Bad

The NMPA approval of ivonescimab stemmed from the HARMONi-2 Phase 3 trial, which showed the drug outperformed pembrolizumab as a monotherapy in NSCLC patients. Yet Summit’s stock cratered while Akeso surged 11.7%. The disconnect hinges on ownership stakes and regulatory uncertainty. Akeso holds exclusive rights to ivonescimab in China—a market representing 40% of global lung cancer cases—while Summit retains development rights in the U.S., Europe, Canada, and Japan. Investors, however, appear skeptical about the timeline for approvals in those regions.

Competing Shadows: The Penpulimab Effect

Adding to Summit’s woes was Akeso’s concurrent FDA approval of penpulimab-kcqx, a bispecific targeting nasopharyngeal carcinoma—a first for the company’s internal pipeline. While penpulimab’s indication doesn’t overlap with ivonescimab, the dual success underscores Akeso’s growing clout. Investors may now favor Akeso’s near-term revenue potential over Summit’s reliance on pending decisions, particularly as the FDA’s scrutiny of bispecific antibodies grows. BioNTech’s (NASDAQ: BNTX) 15.4% slide earlier this month over its bispecific candidate BNT327 highlights the sector’s heightened regulatory risk.

Biotech’s Volatile Reality: Risk vs. Reward

The sell-off reflects broader biotech market dynamics. Early-stage companies like Summit face immense pressure to prove their therapies can navigate regulatory hurdles and carve out market share. The Motley Fool’s April 2025 analysis noted Summit wasn’t among its top 10 stock recommendations, citing “reliance on unproven therapies and uncertain timelines.” With ivonescimab’s U.S. PDUFA date expected in late 2025, investors are likely pricing in the risk of delays or unfavorable terms.

Conclusion: Summit’s Crossroads

Summit’s fate now hinges on three critical factors:
1. FDA Approval Timeline: A positive decision by year-end could reverse the stock’s slump, but delays could trigger further losses.
2. Competitor Dynamics: Akeso’s dominance in China and BioNTech’s pipeline setbacks illustrate how quickly market share can shift.
3. Commercial Viability: Even with approval, ivonescimab faces competition from established therapies like Roche’s Tecentriq (atezolizumab) and Merck’s Keytruda (pembrolizumab), which have extensive real-world data.

The numbers tell a stark story: Summit’s market cap has shrunk to $150 million since the NMPA announcement, versus Akeso’s $2.8 billion valuation. For Summit to rebound, it must deliver not just regulatory wins, but clear evidence of ivonescimab’s cost-effectiveness and survival benefits—a high bar in a sector where hope often outpaces reality. Until then, investors are left holding their breath—and their wallets.