20250910-国元国际控股-宜明昂科-B-01541.HK-PD-L1xVEGF双抗临床疗效及安全性数据优秀_3页_374kb

【Clinical Data Summary】

• Phase I Trial Results (Sq-NSCLC cohort)
  • Objective Response Rate (ORR): 35.3% (6/17 evaluable pts)
  • Disease Control Rate (DCR): 76.5% (13/17 evaluable pts)
  • Median Response Duration (DoR): 7.59 months (95% CI: 4.07–NA)
  • Median Progression-Free Survival (PFS): 9.4 months (95% CI: 1.87–NA)
• Safety Profile
  • Common ≥ Grade 3 TRAEs (23 pts enrolled): Thrombocytopenia (8.7%), Lymphopenia (8.7%), Infusion-Related Reactions (8.7%)
• Mechanism Advantage
  • Unique VEGF blockade targeting multiple VEGF receptors; designed to enhance ADCC through IgG1 Fc engagement
  • Differentiated from other VEGF/PD-(L)1 bispecifics (ORR: >35.3% vs. <33%, PFS >9.4 months)
• Development Progress
  • NDA filing for III-Phase registration trial (IO failure sq-NSCLC cohort) expected soon
  • Ongoing combinations with chemotherapy, IMM27M, IMM01, ADC; U.S. IND approved for refractory solid tumors

【Pipeline Highlights】

• Immune-Oncology (IO)
  • IMM2510: Dual-targeting PD-L1/VEGF; Filed NDA for sq-NSCLC registration
• Immuno-Oncology (IO)
  • IMM01 (CD47 fusion protein): Advanced Phase III for CMML and cHL with favorable preclinical design
  • IMM0306 (CD47xCD20 bispecific): Phase Ib shows strong efficacy in SLE (DCR: ≥85.2%)
• Other
  • IMM72 (PAH indication): Phase II trial initiated (NH approved June 2025)

【Investment Perspective】

• IMM2510 demonstrates robust ORR/PFS and favorable safety in sq-NSCLC
• Diverse clinical development programs (IO, CD47 inhibitors, PAH); Valuation considered undervalued at 57 HKD billion market cap.