CSPC PHARMA (01093.HK): Phase I/II Data of SYS6010 Combined with Enlangsuba Monoclonal Antibody in Previously Untreated Driver-Gene-Negative Advanced NSCLC Presented as Oral Presentation at 2026 WCLC

NewTimeSpace News: On 14 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093.HK) announced on a voluntary basis that it presented, as an oral presentation at the 2026 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC), the Phase I/II clinical study data of SYS6010 combined with Enlangsuba monoclonal antibody (恩朗苏拜单抗) for the treatment of previously untreated driver-gene-negative advanced non-small cell lung cancer (NSCLC). The study is a multicentre Phase I/II trial (ChiCTR2400089402) led by Professor Zhou Caicun of Shanghai East Hospital, and the results presented relate to the randomised controlled portion evaluating SYS6010 combined with Enlangsuba monoclonal antibody injection, a programmed death receptor-1 (PD-1) inhibitor, for previously untreated driver-gene-negative advanced NSCLC under regimen 1 (SYS6010 4.2 mg/kg plus Enlangsuba monoclonal antibody 360 mg once every three weeks) and regimen 2 (SYS6010 3.6 mg/kg plus Enlangsuba monoclonal antibody 240 mg once every two weeks).

As of 13 July 2026, a total of 123 participants had been enrolled and treated under the two regimens, comprising 62 participants in regimen 1 and 61 in regimen 2, with a median follow-up of 10.8 months. Both regimens showed generally manageable safety profiles, with grade 3 or above treatment-related adverse events occurring in 51.6% (regimen 1) and 52.5% (regimen 2) of participants, and treatment-related adverse events leading to discontinuation in 9.7% and 8.2% respectively. Both regimens showed preliminary efficacy in the study population, with more pronounced benefit in non-squamous and PD-L1 high-expression populations and efficacy observed in both squamous and non-squamous patients with high PD-L1 expression; confirmed objective response rates (ORR) were 58.9% and 49.2% in the overall population, 64.1% and 56.1% in non-squamous patients, 77.8% and 82.4% in PD-L1 high-expression (TPS 50% or above) patients, and 81.8% and 91.7% in PD-L1 high-expression non-squamous patients.

The combination of SYS6010 and Enlangsuba monoclonal antibody injection has entered Phase III clinical trials, and the Group intends to develop it for first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC (NCT07633873). SYS6010 is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) independently developed by the Group, comprising a humanised anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. SYS6010 specifically binds to EGFR on the surface of tumour cells and, after internalisation, releases the cytotoxic payload intracellularly to exert its anti-tumour effect.

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