Shanghai Henlius Biotech, Inc. Class H · HKEX:2696
Shanghai Henlius Biotech, Inc. Class H — Technical Presentation (May 2026)
10 slides from Shanghai Henlius Biotech, Inc. Class H's technical presentation, May 31, 2026
Slide 1: Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced NSCLC
Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer Investigators: Jie Wang, Jianjun Zhang, Ning Li, Rui Wan, Xin Wang, Shan Zeng, Lin Wu, Hua Zhong, Jingxun Wu, Runxiang Yang, Shaozhang Zhou, Guowu Wu, Bin Yang, Donglin Wang, Chuan Jin, Haifeng Liu, Xi
Slide 2: Background
2 Background • The majority of NSCLC patients still face resistance, Molecular components of HLX43 including both de novo and acquired resistance.1, 2 PD-L1 antibody • High-affinity, internalizable PD-L1 • By specifically delivering cytotoxic payloads to tumor antibody cells, antibody-drug conjugate
Slide 3: Study design
3 Study design Phase 1a Phase 1b Pooled analysis to evaluate the HLX43-FIH101 China only China only efficacy in NSCLC patients Key inclusion criteria 4.0 mg/kg • For phase 1a, histologically or 3.0 mg/kg Q3W 3.0 mg/kg n = 20 4.0 mg/kg HLX43, Q3W cytologically confirmed advanced 2.5 mg/kg n=5 Screeni
Slide 4: Baseline characteristics
4 Baseline characteristics Data cutoff: Feb 28, 2026 Median follow-up: 7.5 months Of the total patients, 5 were from the United States, 2 from Australia, and the remainder from China. NSCLC (n = 205) NSCLC (n = 205) 1, 2, 2.5, 3, 4 mg/kg 1, 2, 2.5, 3, 4 mg/kg Median age (range), years 60 (36–75) PD-
Slide 5: BICR assessed confirmed tumor response
5 BICR assessed confirmed tumor response 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg Nsq-NSCLC Nsq-NSCLC Nsq-NSCLC Nsq-NSCLC Nsq-NSCLC Nsq-NSCLC Sq-NSCLC Sq-NSCLC Sq-NSCLC Tumor responsea EGFR wild type EGFR mutant EGFR wild type EGFR mutant EGFR wild type EGFR mutant (n = 33) (n = 29) (n = 8) (n = 23) (n = 13) (
Slide 6: BICR assessed efficacy at the potential RP3D and in subgroups
6 BICR assessed efficacy at the potential RP3D and in subgroups Confirmed Confirmed Median PFS (95% CI), month ORR % (95% CI) DCR % (95% CI) NSCLC subtype Squamous 2.0 mg/kg (n = 33) 33.3 (18.0, 51.8) 81.8 (64.5, 93.0) 6.34 (4.07, 7.13) Docetaxel failed (≥ 3L) (n = 15) 46.7 (21.3, 73.4) 80.0 (51.9,
Slide 7: Safety and tolerability
7 Safety and tolerability Event, n (%) 1.0 mg/kg 2.0 mg/kg 2.5 mg/kg 3.0 mg/kg 4.0 mg/kg NSCLC 100 Most common TRAE in NSCLC patients (≥ 10%) (n = 3) (n = 89) (n = 85) (n = 23) (n = 5) (n = 205) 90 Any TRAE 3 (100.0) 85 (95.5) 83 (97.6) 23 (100.0) 5 (100.0) 199 (97.1) Grade 1-2 Grade 3-5 80 Grade ≥3
Slide 8: Conclusions
8 Conclusions • Efficacy at RP3D dose ✓ IO- and chemo-treated Squamous NSCLC ✓ IO- and chemo-treated, EGFR WT Non-squamous NSCLC ✓ cORR: 33.3%; mPFS: 6.34 months ✓ cORR: 36.8%; mPFS: 6.67 months ✓ Docetaxel failed (≥ 3L) cORR: 46.7%; mPFS: 6.90 months • Biomarker independent: efficacy observed irres
Slide 9: Lay Summary
9 Lay Summary What did this research tell us? • HLX43 (an antibody-drug conjugate) provided promising clinical and survival benefits in patients with heavily pretreated advanced NSCLC, regardless of subtypes, brain metastasis, and PD-L1 expression • HLX43 was well tolerated Who does this research im
Slide 10: Acknowledgements
10 Acknowledgements The authors would like to express their gratitude to all the patients who participated in this trial, their families, the study personnel at each study hospital, as well as the clinical study team from Shanghai Henlius Biotech, Inc., for their support with trial conduct. PRESENTE
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