2025-06-05-Bernstein-中国制药与生物技术_2025年美国临床肿瘤学会（ASCO）会议第三部分-来自IBI363_ZL-1310和SHR-1826的积极更新；重点回顾_12页_511kb

China Pharma and Biotech: ASCO 2025 Positive Updates

Key Highlights

1. ZL-1310 (DLL3 ADC)

   • In extensive stage small cell lung cancer (ES-SCLC), ZL-1310 demonstrated a 79% objective response rate (ORR) in second-line (2L) patients at a 1.6mg/kg dosage.
   • The safety profile was favorable, with only 23% Grade ≥3 treatment-related adverse events (TRAEs), outperforming global competitors.
   • Early data suggest potential for broad-market impact, but survival data are pending.

2. IBI363 (PD-1/IL-2 Bispecific)

   • In non-small cell lung cancer (NSCLC) patients who have failed PD-(L)1 treatment, IBI363 showed a 37% confirmed ORR and 9.3 months median progression-free survival (mPFS) in squamous cell carcinoma patients.
   • Superior efficacy compared to Dato-DXd, making it a strong candidate for first-line (1L) expansion.

3. SHR-1826 (C-met ADC)

   • Demonstrated a 29% confirmed ORR in patients with c-met alterations who had not responded to standard-of-care (SoC) therapy.
   • The drug targets a significant market (10-60% of NSCLC cases globally), but further data are needed.

Investment Implications

• Outperform Ratings: Maintained for Akeso, Hansoh, Innovent, and Hengrui.
  • Market-Perform for BeiGene, CSPC, Sino Biopharm, and Zai Lab.
• BIC Potential: ZL-1310 is highlighted as a breakthrough immunotherapy candidate requiring survival data for full validation.

Market Context

• TAM Focus: Dominant markets include NSCLC (~$30Bn) and Breast Cancer (~$35Bn). Chinese drugs show competitive efficacy across these areas, with notable differentiation in TNBC and c-met alterations.
• Solid Tumors: Encouraging data in gastrointestinal cancers and other tumors highlight individual drug strengths.

Legal and Disclosure Notes

• Comprehensive legal disclosures regarding conflicts of interest, ratings, and compliance apply globally.