China Merchants Securities has issued a research report maintaining its "Strong Recommendation" rating on HENLIUS (02696). The company's latest HLX43 data update further validates its potential to overcome PD-1/L1 immunotherapy non-response or resistance issues, showing potential efficacy for patients who have failed chemotherapy and targeted therapy, potentially offering new treatment options for more patients with advanced/metastatic solid tumors. The firm is optimistic about HENLIUS's HLX43 drug development potential, projecting the company's net profits for 2025-2027 at 9.0, 9.6, and 12.0 billion yuan respectively, corresponding to PE ratios of 46x, 43x, and 35x.
The updated HLX43 patient data comes from Phase Ia and Phase Ib 2.0 mg/kg and 2.5 mg/kg dose groups. A total of 56 NSCLC patients were enrolled in Phase Ia and Phase Ib 2.0 and 2.5 mg/kg dose groups, with 29 cases (51.8%) being squamous and 27 cases (48.2%) being non-squamous. Among these, non-squamous NSCLC patients had a median of 2 prior treatment lines, while squamous NSCLC patients had a median of 3 prior treatment lines.
In fourth-line and later squamous NSCLC patients (n=28), HLX43 demonstrated an ORR of 28.6% and DCR of 82.1%, showing significant clinical benefit compared to the standard treatment drug docetaxel (ORR=12.8%). Notably, third-line and later NSCLC patients who had previously received docetaxel treatment (n=10) achieved an ORR of 30.0% and DCR of 80%; patients receiving 2 mg/kg dose HLX43 treatment (n=15) achieved an ORR of 40.0% and DCR of 73.3%, indicating HLX43's significant potential in later-line treatment of lung squamous cell carcinoma.
In third-line and later non-squamous NSCLC populations (n=26), the ORR reached 46.2% with a DCR of 96.2%. Notably, EGFR wild-type non-squamous NSCLC patients (n=15) achieved a confirmed objective response rate (cORR) of 46.7% with a DCR of 93.3%. Patients receiving 2.5 mg/kg dose HLX43 treatment (n=5) achieved a cORR as high as 60.0% with a DCR of 80%, demonstrating HLX43's more significant therapeutic advantages in non-squamous NSCLC patient populations.
Regarding safety, the most common grade ≥3 treatment-related adverse events (TRAEs) were anemia (19.6%), decreased white blood cell count (19.6%), decreased neutrophil count (16.1%), and decreased lymphocyte count (12.5%), with decreased platelet count only at 3.6%. Consistent with the safety profile disclosed at 2025 ASCO, HLX43 shows lower hematological toxicity, maintaining good safety profile that supports future expansion to first-line therapy and combination treatment regimens.
The firm notes that HENLIUS is currently advancing HLX43's clinical development program at full speed, having enrolled over 300 patients globally and smoothly progressing patient enrollment in China, the United States, Japan, and other countries. The company is also actively exploring HLX43's therapeutic potential in various solid tumors, including cervical cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, colorectal cancer, gastric cancer/gastroesophageal junction cancer, continuously exploring therapeutic potential. Beyond monotherapy, clinical trials of HLX43 in combination with other products are also underway, further exploring the synergistic anti-tumor efficacy of "ADC+IO".