According to Zhitong Finance APP, a research report maintains HENLIUS (02696) "Buy" rating, expecting the company's total revenue for 2025-2027 to be RMB 5.873/5.970/7.125 billion respectively, with year-on-year growth of 2.60%/1.64%/19.36%; net profit attributable to shareholders of listed companies to be RMB 827/797/1.122 billion respectively, maintaining previous forecasts unchanged. Considering that HLX43's updated data further expands the product's advantageous indications, the company's long-term earnings forecast has been raised, with the target price increased from HK$78.01 per share to HK$120.87 per share.

Main observations are as follows:

HLX43 continues high efficacy and low toxicity performance, with outstanding data in EGFR wild-type NSCLC

The NSCLC patient data updated at this WCLC conference comes from phase Ia + phase Ib 2.0 mg/kg dose group and 2.5 mg/kg dose group, with a total of 56 NSCLC patients enrolled (as of June 28, 2025), of which 29 cases (51.8%) were squamous carcinoma patients and 27 cases (48.2%) were non-squamous carcinoma patients; 54 cases (96.4%) of patients had received platinum-based drug treatment, 50 patients (89.3%) had received immunotherapy, and 26 cases (46.4%) had received targeted therapy.

For evaluable patients (n=54), the overall ORR reached 37.0% and DCR reached 87.0%. Among 26 non-squamous carcinoma patients who had received third-line or more treatments, ORR reached 46.2%; among 28 squamous carcinoma patients who had received fourth-line or more treatments, ORR reached 28.6%. It showed significant advantages in previously multi-line resistant NSCLC patients.

In subgroup analysis, among EGFR wild-type non-squamous NSCLC patients (n=15), cORR reached 46.7%; ORR in PD-L1 negative (TPS<1%, n=21) population reached 38.1% and 85.7%, suggesting that HLX43's anti-tumor activity may not depend on PD-L1 expression levels.

In terms of safety, the most common ≥grade 3 TRAEs of HLX43 were anemia (19.6%), leukopenia (19.6%), neutropenia (16.1%), and lymphopenia (12.5%). Notably, the incidence of ≥grade 3 thrombocytopenia was low (3.6%), with low hematologic toxicity and overall controllable safety profile.

Worth noting, a total of 12 cases (21.4%) of patients experienced immune-related adverse events (irAE), including 8 cases (14.3%) of immune-related pneumonitis, mostly grade 1-3, which could be controlled through routine management. Higher efficacy levels were observed in patients who developed immune-related pneumonitis (cORR 50%, tumor shrinkage rate 100%).

HLX43 is believed to have excellent efficacy, good safety, and is not limited by PD-L1 expression, potentially becoming a globally scarce broad-spectrum next-generation ADC drug.

HLX07 shows impressive efficacy, may provide new approach for 1L sqNSCLC treatment

The WCLC conference updated data from a phase II dose exploration study of HLX07 (EGFR monoclonal antibody) combined with serplulimab (PD-1 monoclonal antibody) for first-line treatment of EGFR high-expression (nearly 90% proportion) sqNSCLC patients: Patients with EGFR high expression (H-score ≥150) and no prior systemic treatment were randomized 1:1 into two groups, receiving intravenous HLX07 800 mg or 1000 mg respectively, combined with serplulimab and chemotherapy.

At median follow-up of 18.6 months, the high-dose group achieved mPFS of 17.4 months, while the low-dose group's mPFS had not been reached at follow-up, and neither group's mOS and mDOR were reached. Most TEAEs during treatment, such as rash, were within controllable range with good safety.

Considering that the standard therapy for 1L sqNSCLC has mPFS around 7 months, and competing products under research also have mPFS around 10 months, this 17-month mPFS of HLX07 + serplulimab may provide new approaches for 1L sqNSCLC treatment.

Risk warnings: Product sales below expectations, centralized procurement risks, policy risks, innovative drug clinical trial risks, operational risks, subjective calculation risks.