HUTCHMED Announces Takeda Receives Japanese Approval for FRUZAQLA® (Fruquintinib) for Previously Treated Metastatic Colorectal Cancer

HUTCHMED (00013) announced that its partner Takeda (TSE: 4502 / NYSE: TAK) has obtained approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for the production and sale of FRUZAQLA.^®(Fruquintinib) for the treatment of previously treated metastatic colorectal cancer patients. FRUZAQLA^®Becoming the first innovative targeted therapy approved in Japan for the treatment of metastatic colorectal cancer in over a decade, regardless of the patient’s 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 in 2023.

FRUZAQLA^®Approved for the treatment of advanced or recurrent colorectal cancer that is incurable, unresectable, and has progressed after chemotherapy.

HUTCHMED CEO and Chief Scientific Officer Dr. Su Weiwen said, "Now that Takeda has obtained approval for FRUZAQLA in Japan, this 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. Over the past decade, Takeda has been a leader in the treatment of metastatic colorectal cancer in Japan, and we are confident that Takeda will successfully bring FRUZAQLA^®"To patients in Japan."

Dr. Takayuki Yoshino, Deputy Director of the National Cancer Center Hospital East in Kashiwa, Japan, Director of the Drug and Diagnostic Development Promotion Department, and Chief of the Gastrointestinal Oncology Department, said: "FRUZAQLA^®The approval in Japan is significant news for patients with metastatic colorectal cancer, who have long awaited new and effective treatment options. The FRESCO-2 global study demonstrates the positive impact this therapy brings to patients in clinical practice. In Japan, the advent and widespread adoption of screening and effective therapies have continuously improved treatment outcomes for colorectal cancer patients. We look forward to FRUZAQLA.^®"The emergence will bring new hope to patients with such diseases."