Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (SKB BIO) will release results from three oncology programs at the American Society of Clinical Oncology (ASCO) Annual Meeting, 29 May–2 June 2026, Chicago.

Sac-TMT + Pembrolizumab (OptiTROP-Lung05, Phase III) • 413 untreated PD-L1 ≥ 1 % advanced NSCLC patients were randomised 1:1 to sac-TMT (4 mg/kg Q2W) plus pembrolizumab (400 mg Q6W) or pembrolizumab alone. • Median follow-up: 10.50 months (cut-off 29 Sep 2025). • Progression-free survival: not reached vs 5.70 months; HR 0.35 (95 % CI 0.26–0.47; p<0.0001). • Objective response rate: 70.2 % vs 42.0 %. • Overall survival trend: HR 0.55 (95 % CI 0.36–0.85; data immature). • Subgroup consistency: PD-L1 TPS 1–49 % HR 0.28; TPS ≥ 50 % HR 0.47; non-squamous HR 0.28; squamous HR 0.44. • Grade ≥ 3 TEAEs: 55.3 % vs 31.4 %; permanent discontinuation of sac-TMT 3.8 %, pembrolizumab 5.3 %. A supplemental NDA for the combination is under priority review by China’s NMPA.

Lunbotinib Fumarate (A400/EP0031, Phase II) • 71 pre-treated and 92 treatment-naïve RET-fusion positive NSCLC patients; median follow-up 22.60 and 20.70 months, respectively (cut-off 29 Oct 2025). • Confirmed ORR (IRC): 87.1 % (95 % CI 77.0–93.9) pre-treated; 81.3 % (95 % CI 71.8–88.7) naïve. • Median PFS: 27.50 months pre-treated (immature); not reached in naïve group. • 24-month PFS: 52.1 % and 59.9 %. • Median OS not reached; 24-month OS 65.7 % and 74.1 %. • Intracranial ORR among patients with brain metastases: 82.6 % (pre-treated) and 75.0 % (naïve), including six complete responses in each cohort. • Grade ≥ 3 TRAEs: 40.5 %; permanent discontinuation 1.2 %; no fatal TRAEs. The NDA for lunbotinib in RET-fusion positive NSCLC has been accepted by the NMPA.

SKB500 (B7-H3 ADC, First-in-Human) Early safety and efficacy findings from an open-label Phase I study in advanced solid tumours will be delivered as a rapid oral presentation on 2 June 2026.

Product and Partnership Context • Sac-TMT, licensed to Merck & Co. (MSD) outside Greater China, already carries four approved indications in China—including triple-negative breast cancer and EGFR-mutant NSCLC—and two of these are covered by the National Reimbursement Drug List. • Sac-TMT is the first TROP2 ADC approved for lung cancer worldwide and holds six Breakthrough Therapy Designations from the NMPA. • MSD is running 17 global Phase III trials with sac-TMT; SKB BIO is conducting nine China-based registrational studies. • Lunbotinib is concurrently in a multinational Phase II study (NCT05443126) overseen by Ellipses Pharma outside Greater China.

Risk Reminder Future regulatory approvals are not guaranteed; investors should exercise caution when dealing in SKB BIO securities.