June 30,CSPC（1093.HK）Announced the official launch of aPhase III Clinical Study（SYS6010–015）, aiming to evaluateSYS6010Combined PD-1 Monoclonal Antibody(Enlansubai Monoclonal Antibody)Compared with adjuvant PD-(L)-1 monoclonal antibody therapy, for resected stage II–IIIB driver gene-negative disease that has not achieved major pathological response（MPR）of Non-Small Cell Lung Cancer（NSCLC）Patient Safety and Efficacy.This study is designed as a randomized, open-label, multicenter trial, planned toEnrollment of the first subject was completed in July 2026.

Screenshot source: CSPC corporate announcement

SYS6010An antibody-drug conjugate (ADC) targeting EGFR, independently developed by CSPC. It consists of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. It specifically binds to EGFR receptors on the tumor surface, internalizes, and releases the cytotoxic payload to achieve precise tumor cell killing. Used in combination with enolizumab.(Recombinant Fully Human Anti-PD-1 Monoclonal Antibody)is an IgG4 variant targeting PD-1 for the treatment of various malignant tumors. CSPC has alreadyIn June 2026, clinical trial approval was received from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, permitting the conduct of the SYS6010-015 study. Subject recruitment and screening are currently progressing actively.

This timeSYS6010-015 is the sixth Phase III clinical trial initiated for this drug. Since the launch of its first Phase III trial last year in second-line NSCLC with EGFR mutations,SYS6010Cumulative Initiations7ItemPhase III study, in which6The project is being intensively advanced this year. Indications cover multiple cancer types, including non-small cell lung cancer, esophageal squamous cell carcinoma, and breast cancer. 

Source of screenshot: Mioty Pharma China Clinical Trial Database (For data, look for Mioty)

InIn the field of NSCLC,SYS6010Five Phase III trials have been deployed, comprehensively covering second-line treatment for EGFR-mutated patients, second-line treatment for EGFR wild-type non-squamous NSCLC, first-line combination therapy with PD-1 inhibitors for PD-L1-positive patients, as well as two trials in the early-stage adjuvant/neoadjuvant setting, thereby achieving full-spectrum coverage from advanced to early-stage disease.

CurrentThe EGFR ADC sector is highly competitive. LEPU BIOPHARMA’s MMAE-toxin ADC drug MRG003, based on the JMT-101 antibody (Zinmant), has been approved for nasopharyngeal carcinoma; Biokin’s EGFR/HER3 bispecific antibody ADCofLunkang Yilongtuo monoclonal antibody has also been approved for marketing in the field of nasopharyngeal carcinoma.

Screenshot source: PharmCube Global Drug R&D Database (Search Data. Find PharmCube)

The launch of the two products further validatesThe feasibility of EGFR-targeted ADCs has also accelerated CSPC’s development of SYS6010. By strategically focusing on the major indication of NSCLC, CSPC aims to build a robust chain of clinical evidence and capture a broader market share.

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