On FRUZAQLA (friquinac) being approved by the European Commission as a monotherapy for the treatment of adult metastatic colorectal cancer patients who have progressed or are intolerant to disease after treatment with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan-based chemotherapy, anti-vascular endothelial growth factor (VEGF) therapy, anti-epidermal growth factor receptor (EGFR) therapy, or trifluorothymidine tetracycline or regorafenib. Hehuang Pharmaceutical (00013) announced a partnership with Takeda (TSE:4502/NYSE:TAK) for this approval.
Based on the positive results of the global phase III clinical trial FRESCO-2, FRUZAQLA (friquinac) has been approved for the treatment of pretreated metastatic colorectal cancer patients, becoming the first innovative targeted therapy approved for this indication in the European Union in more than ten years. This is the company's first approved product in Europe and the goal was achieved in a relatively short time through cooperation with Takeda. The marketing authorization application was confirmed and accepted by the European Medicines Agency (EMA) in June 2023. The data from the FRESCO-2 study was published in The Lancet in June 2023.
According to data from the International Agency for Research on Cancer (IARC)/World Health Organization (WHO), colorectal cancer is the third most common cancer globally, with an estimated 1.9 million new cases in 2022 and over 900,000 deaths. In Europe, colorectal cancer is the second most common cancer, with an estimated 538,000 new cases and 248,000 deaths in 2022. In the United States, it is estimated that there will be 153,000 new cases of colorectal cancer and 53,000 deaths in 2024. In Japan, colorectal cancer is the most common cancer, with an estimated 146,000 new cases and 60,000 deaths in 2022. Although early colorectal cancer can be treated by surgical resection, there is still a significant unmet medical need for the treatment of metastatic colorectal cancer due to poor treatment outcomes and limited treatment options.
The company's operating income is expected to reach $890 million, $1.255 billion, and $1.575 billion in 2024, 2025, and 2026 respectively, with net income attributable to shareholders of $134 million, $237 million, and $351 million, and EPS of $0.15, $0.27, and $0.40, respectively, corresponding to PEs of 24, 13, and 9 times. The company's rating is maintained as "buy".