Incident: Recently, the company released its 2024 semi-annual report. The first half of the year achieved operating income of 0.204 billion yuan (no revenue for the same period in 2023), net profit attributable to shareholders of listed companies was -0.345 billion yuan, and net profit attributable to shareholders of listed companies after deduction was -0.381 billion yuan.
Sulvortinib continues to advance: In April 2024, Schwarzhe received the “CSCO Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2024 Edition)” level I recommendation, which is the only Level I recommendation for EGFR Exon20InS NSCLC. In April 2024, it was “recognized as a breakthrough therapy” by the US FDA for first-line treatment of EGfrexon20ins NSCLC. It is currently the only drug in the world that has been fully certified as a breakthrough therapy by the FDA to treat EGfrexon20ins NSCLC. Furthermore, “Goku 1B”, the first globally registered clinical trial, has reached the main research goal, accounting for more than 40% of non-Asian patients, and the preliminary analysis results were presented orally at the 2024 American Society of Clinical Oncology (ASCO) Conference. The global multi-center phase III clinical study “Goku 28” (WU-KONG28) for first-line treatment of EGFR Exon20InS NSCLC is also being successfully carried out.
Golisitinib was successfully approved for marketing: On June 18, 2024, the new Class I drug developed by the company, was approved by the NMPA. The single drug is suitable for adult patients with recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least first-line systematic treatment in the past. In April 2024, Gao Ruizhe was recommended by the “CSCO Lymphoma Diagnosis and Treatment Guidelines (2024 Edition)” level II as an innovative drug included in the priority review process of the State Drug Administration.
Investment advice: The company is an innovative biomedical enterprise focusing on the research, development and commercialization of innovative therapies in the field of malignant tumors and immune diseases. We expect the company to achieve revenue of 0.492/1.094/1.567 billion in 2024-2026, maintaining an “gain” rating.
Risk warning: risk of changes in industry policies, risk of new drug development, risk of uncertain marketing of products under development, risk of poor progress in internationalization, risk of market competition, etc.