occurrences
Recently, the latest clinical research results of the company's two innovative drugs were selected in the 2024 American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) in the form of posters, namely the phase II/III clinical study (HLX10-015-CRC301) of the H drug Hans-like (sululimab) in combination with Hambetai and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC), and innovative anti-HER2 monoclonal HLX22 combined with Han Quyou and chemotherapy for first-line treatment of locally advanced HER2 positive or metastatic gastroesophageal junction (G) /GEJ) Phase II clinical study of cancer (HLX22-GC-201).
Comment:
Slulizumab shows positive clinical data for first-line colorectal cancer, and it is expected that the patient population will continue to expand.
Colorectal cancer is one of the most common malignancies worldwide. There were more than 1.9 million new cases and more than 900,000 deaths worldwide in 2020. mCRC accounts for approximately 44%, and current standard first-line treatments include vascular endothelial growth factor (VEGF) inhibitors (such as bevacizumab) in combination with chemotherapy.
Clinical study results showed that compared with placebo combined with bevacizumab and XELOX, PD-1 mAb plus HLX04 and XELOX significantly prolonged PFS (mPFS: 17.2 vs.
10.7 months, HR = 0.60), improved other efficacy endpoints (MoS was not achieved, HR = 0.77), and safety was controllable (incidence rate of ≥3 grade TREs: 65.5% vs. 56.1%). Previously, sululizumab had been approved for MSI-H solid tumors and included in the CSCO guidelines for colorectal cancer. Positive clinical data on first-line treatment is expected to continue to broaden the patient population.
The data on HLX22 and HLX02 combination treatment regimens is positive, showing the potential to change the current first-line gastric cancer SOC. Gastric cancer is a high-incidence cancer in China. In 2020, there were more than 1 million new cases worldwide, of which HER2 positive gastric cancer patients accounted for about 20%. Currently, the trastuzumab combined with XELOX regimen is the first-line standard treatment (SOC) for patients with advanced HER-2 positive gastric cancer. HER-2 monoclonal antibody HLX22 targets different epitopes of domain IV of HER-2 compared to HLX02 (trastuzumab analog). Clinical study results showed that the HLX22 (15 mg/kg) combination regimen showed better efficacy compared to the placebo regimen (mPFS: not achieved vs 8.2 months, HR = 0.1; MoS was not achieved, HR = 0.3); at the same time, safety was manageable (incidence of severe TREs: 5.9% vs. 5.6%). Currently, no similar HER-2 dual-target therapy for HER2-positive gastric cancer has been approved for marketing in the world. The HLX22 combination treatment plan shows the potential to change the current first-line gastric cancer SOC, and we will continue to monitor the progress of subsequent research and development.
Profit forecasting and valuation: The company focuses on drug development in oncology and other fields, and the potential is promising. It is expected to achieve revenue of 52.19/59.78/7.20 billion yuan in 2023-2025, earnings per share of 0.93/1.13/1.37 yuan/share, and maintain a “buy” rating.
Risk warning: R&D falls short of expectations, commercialization falls short of expected risks, etc.