HUTCHMED: FRUZAQLA® (fruquintinib) was launched by Takeda in Japan

According to the Zhitong Finance APP, Hutchmed China (00013) announced that following the pricing approval of FRUZAQLA® (furmonertinib) 1mg/5mg capsules in Japan and its commercial launch by its partner Takeda (TSE: 4502/ NYSE: TAK) for the treatment of patients with previously treated metastatic colorectal cancer, Hutchmed China will receive a milestone payment. Earlier, FRUZAQLA® had obtained production and sales approval from the Japanese Ministry of Health, Labour and Welfare (MHLW). FRUZAQLA® is the first oral innovative targeted therapy approved for the treatment of metastatic colorectal cancer in Japan in over a decade, regardless of the patient's biomarker status. FRUZAQLA® is approved for the treatment of advanced or recurrent colorectal cancer that cannot be completely cured or surgically removed and has progressed after chemotherapy. According to statistics from the National Cancer Center in Japan, colorectal cancer is the most common type of cancer in Japan, with an estimated 161,000 new cases in 2023, resulting in 54,000 deaths. Regarding the commercial launch of FRUZAQLA® in Japan by Takeda, Dr. Su Weiguo, CEO and Chief Scientific Officer of Hutchmed China, stated: "The launch of FRUZAQLA® in Japan marks our continued progress in global collaboration with Takeda. Leveraging Takeda's leadership in the treatment of metastatic colorectal cancer in Japan over the past decade, they are well-positioned to bring this differentiated treatment option to patients." Following the approval in Japan based on the results of the FRESCO-2 Phase III study conducted primarily in the United States, Europe, Japan, and Australia in September 2024, FRUZAQLA® will officially be commercially available. The results of the FRESCO-2 study were published in The Lancet in June 2023. Takeda holds the global exclusive license to further develop, commercialize, and manufacture furmonertinib outside of mainland China, Hong Kong, and Macau, and will market it under the brand name FRUZAQLA®. Furmonertinib was approved in the United States in November 2023, in the European Union in June 2024, in Switzerland in August 2024, in Canada, Japan, and the UK in September 2024, and in Argentina, Australia, and Singapore in October 2024. Regulatory applications in several other countries and regions are also underway. It is reported that furmonertinib is a selective oral inhibitor targeting all three types of VEGFR (VEGFR-1, -2, and -3). VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis. Furmonertinib is designed to have higher kinase selectivity, aiming to reduce off-target kinase activity, thereby achieving sustained coverage of the target with drug exposure and greater flexibility when potentially used as combination therapy. The registration applications submitted to global regulatory authorities are based on data from two large, randomized controlled Phase III clinical trials, namely the international multicenter clinical trial FRESCO-2 study and the FRESCO study conducted in China, which demonstrated consistent benefits among a total of 734 patients treated with furmonertinib. The safety profiles of the studies were also consistent. The results of the FRESCO-2 study were published in The Lancet in June 2023, while the results of the FRESCO study were published in the Journal of the American Medical Association (JAMA) In mainland China, Hong Kong, and Macau, furmonertinib is marketed under the brand name Aito® (ELUNATE®) through a collaboration between Hutchmed China and Eli Lilly. It was included in the National Medical Insurance Drug List of China in January 2020. Since the launch of furmonertinib in China, over 100,000 colorectal cancer patients have received treatment with furmonertinib