On June 22, 2024, Chi-Med and Takeda announced that the European Commission has officially approved the marketing of fruquintinib The European Commission has officially approved the listing of Fruzaqla (fruquintinib). Fruquintinib will be used as a single agent to treat adult metastatic colorectal cancer patients who have previously received existing standard treatments including fluorouracil, oxaliplatin, and irinotecon-based chemotherapy, anti-vascular endothelial growth factor therapy, and anti-epidermal growth factor receptor (EGFR) treatment, and trifluoruridine tepypyrimidine or regofinib. The company's core pipeline was approved as scheduled, and we maintain our profit forecast for 2024-2026. The estimated net profit to mother is -6.48/0.18/1,131 million yuan, respectively, and PS is 4.82/3.63/2.92X, respectively, maintaining a “buy” rating.
This approval is mainly based on data from FRESCO-2 International Phase III and FRESCO China Phase III FRESCO-2 research published in “The Lancet (The Lancet)” in June 2023. According to international multicenter phase III (FRESCO-2) data, the median progression-free survival of patients in the fruquintinib group (461 cases) was 3.7 months and 1.8 months in the placebo group (230 cases); the median overall survival of patients in the fruquintinib group was 7.4 months and 4.8 months in the placebo group. Fruquintinib reduced the risk of death in patients by 34% (HR = 0.66) and was generally well tolerated in patients.
Fruquintinib is expected to be approved in Japan in October 2024. Fruquintinib has entered the global rapid release period. Fruquintinib was approved in the US in November 2023. US sales were about 15 million US dollars in 2023 and 50 million US dollars in Q1 in 2024. The growth is strong, and overseas sales are expected to exceed 140 million US dollars throughout the year. Japan is expected to be approved for listing in October 2024. Domestic sales of fruquintinib are still growing (only indicated for colorectal cancer). The marketing application for 2L gastric cancer was accepted by the CDE in April 2023 and is expected to land in Q3 2024.
The company has several important catalysts in the second half of 2024, and it is expected that in addition to furoquintinib, many of the company's pipelines have important catalysts in 2024 H2. Sevotinib is expected to submit an NDA application to the FDA by the end of 2024 for the treatment of ositinib's refractory MET mutation NSCLC. Solepinib for the treatment of immune thrombocytopenia is expected to be approved for marketing within 2024, and phase IB/II clinical trials are expected to be initiated in the US. An NDA application for treatment of follicular lymphoma is expected to be submitted to the CDE in 2024.
Risk warning: Drug clinical development failure, drug safety risk, loss of core members, etc.