CSPC PHARMA (01093.HK): Phase III Trial of Becotatug (JMT101) plus Osimertinib Meets Primary Endpoint, Significantly Extending PFS

NewTimeSpace News: On 24 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) announced that the Phase III clinical trial of Becotatug (JMT101), developed by the Group, combined with osimertinib as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR exon 20 insertion mutations (EGFR ex20ins) met its primary endpoint at the prespecified interim analysis, achieving positive topline results. Compared with platinum-based chemotherapy combined with pemetrexed, the combination significantly prolonged progression-free survival (PFS) and showed a trend of overall survival (OS) benefit.

The trial is a randomised, open-label, parallel-controlled Phase III study, with the primary endpoint of PFS assessed by the Independent Review Committee (IRC) under RECIST 1.1. Under the prespecified statistical analysis plan, following review and resolution by the Independent Data Monitoring Committee (IDMC), the PFS benefit of the Becotatug-plus-osimertinib arm reached the prespecified statistical superiority boundary for the interim analysis, with significant clinical relevance and a favourable safety profile.

Becotatug is a high-affinity humanised EGFR-targeting monoclonal antibody; combined with the EGFR tyrosine kinase inhibitor osimertinib, it forms a chemotherapy-free dual-targeted regimen acting on EGFR signalling both extracellularly and intracellularly. The Group plans to present the trial results at upcoming academic conferences, and key Phase III studies of the product in first-line treatment of EGFR classical-mutated non-squamous NSCLC and in advanced metastatic colorectal cancer after failure of at least two prior lines of standard therapy are ongoing.

Lung cancer is the malignancy with the highest incidence and mortality in China; NSCLC accounts for about 85% of lung cancer, EGFR mutations account for approximately 40-50% of NSCLC in the Chinese population, and EGFR ex20ins is the most common EGFR mutation type after classical mutations. Such tumours show high heterogeneity, a high incidence of brain metastases and poor prognosis, leaving unmet clinical needs for prolonged disease control, improved long-term survival and better treatment tolerability.

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