Fu Hong Han Lin (02696): Clinical trial application for injectable HLX43 (targeted PD-L1 antibody conjugate drug) combined with or without chemotherapy for the treatment of advanced/metastatic solid tumors was approved by the State Drug Administration

Zhitong Finance App News, Fu Hong Han Lin (02696) issued an announcement. Recently, a clinical trial application for injectable HLX43 (targeted PD-L1 antibody conjugate drug) (HLX43) combined with or without chemotherapy for the treatment of advanced/metastatic solid tumors was approved by the State Drug Administration. The Company plans to conduct relevant clinical trials in China (excluding Hong Kong, Macao and Taiwan regions of China; same below) when conditions are met.

HLX43 is an antibody conjugation drug (ADC) targeting PD-L1 developed by conjugating a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain ligand with an antibody targeting PD-L1 independently developed by our company. It is intended for the treatment of advanced/metastatic solid tumors.

HLX43's key subgroup data for the treatment of non-small cell lung cancer (NSCLC) was officially released in the form of an oral report at the 2026 American Society of Clinical Oncology (ASCO) annual meeting. This publication is based on the aggregated analysis of NSCLC patients in the first HLX43 human phase 1 study (HLX43-FIH101) and the global multi-center phase 2 study (HLX43-NSCLC201), and included overseas patient data for the first time. The key efficacy indicators were assessed by the Blind Independent Center (BICR), and data related to progression-free survival (PFS) was disclosed for the first time. As of February 28, 2026, a total of 205 patients with advanced NSCLC were included in the study. Of these, 99.0% had received platinum chemotherapy, 82.0% had received immunotherapy, 41.0% had received targeted therapy, 24.4% had received too much citaxel treatment, and nearly 40% had received third-line treatment or above. In addition, 27.8% of patients had bone metastases, and 13.7% of patients each had brain metastases and liver metastases. The overall disease burden in the study population was heavy. Among EGFR wild non-squamous NSCLC (nsNSCLC) patients (2.5 mg/kg, n=19), the confirmed objective response rate (CoRR) of HLX43 monotherapy reached 36.8%, the confirmed disease control rate (CDCR) reached 94.7%, and the median progression-free survival (mPFS) was 6.67 months; in patients with squamous NSCLC (sqnsCLC) who failed previous docetaxel treatment (2mg/kg, n=33), the CORR and MPFs were respectively 33.3% and 6.34 months; Among patients with sqnsCLC who failed previous docetaxel treatment and received third-line treatment (2 mg/kg, n=15), the CORR of HLX43 monotherapy was 46.7%, CDCR was 80.0%, and mPFS was 6.90 months. This data was significantly superior to the historical remission rate of this population under traditional chemotherapy (docitaxel) treatment. Furthermore, HLX43 treated patients with PD-L1 positive (TPS≥ 1%, n=29) and negative (TPS< 1% or unevaluable, n=39) had a CoRR of 37.9% and 33.3%, respectively, and the CDCR reached 89.7% and 84.6%, respectively, with no significant difference; the MPFS of the PD-L1 positive subgroup reached 6.80 months, and the MPFS of the PD-L1 negative subgroup reached 5.49 months. The results of the study showed that regardless of the patient's PD-L1 expression, HLX43 can provide stable and efficient Treatment options. In terms of safety and tolerability, it is worth noting that HLX43 as a whole also showed consistent and good safety characteristics among 205 analyzed patients with different dosage levels, different NSCLC subtypes, and different treatment backgrounds.