HUTCHMED (00013) announces Takeda's approval to market FRUZAQLA (fruquintinib) in Japan.

HUTCHMED (00013) announced that its partner Takeda (TSE: 4502/NYSE: TAK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and sell FRUZAQLA (fruquintinib) for the treatment of refractory metastatic colorectal cancer patients. FRUZAQLA becomes the first innovative targeted therapy approved for the treatment of metastatic colorectal cancer in Japan in over a decade, regardless of the patients' biomarker status. According to statistics from the National Cancer Center of Japan, colorectal cancer is the most common type of cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths expected in 2023. FRUZAQLA is approved for the treatment of advanced or recurrent colorectal cancer that cannot be completely cured or removed, and has progressed after chemotherapy. Dr. Weiguo Su, CEO and CSO of HUTCHMED, stated, "Takeda's approval of FRUZAQLA in Japan demonstrates the strength of our global data package and the potential of this new drug to provide much-needed treatment options for patients with metastatic colorectal cancer. Takeda has been a leader in the treatment of metastatic colorectal cancer in Japan for over a decade, and we are confident in Takeda's ability to bring FRUZAQLA to Japanese patients." Dr. Takayuki Yoshino, Deputy Director of the National Cancer Center Hospital East in Kashiwa, Japan, and Director of the Department of Drug and Diagnostic Development Promotion and Chief of the Gastrointestinal Oncology Division, stated, "The approval of FRUZAQLA in Japan is a major milestone for patients with metastatic colorectal cancer who have long been anticipating new effective treatment options. The global FRESCO-2 study has demonstrated the positive impact of this therapy in the clinical setting. In Japan, the emergence and widespread adoption of screening and effective therapies have continuously improved the treatment outcomes for colorectal cancer patients, and we look forward to the introduction of FRUZAQLA bringing new hope to patients with such diseases."