The Approval and Global Expansion of Fruquintinib, a Breakthrough Cancer Treatment from China
26 Jun 2024
Drug ApprovalPhase 3BiosimilarClinical Result
On November 9, 2023, a historically significant day, fruquintinib was officially approved by the U.S. Food and Drug Administration (FDA), making it successfully available in the U.S. market and bringing new hope of treatment for a large number of patients with metastatic colorectal cancer. As the first anti-cancer new drug developed by Hutchison China MediTech (Chi-Med), fruquintinib has achieved its breakthrough in the international pharmaceutical market, following three of its predecessor drugs.
The approval of fruquintinib was attributable to its unique pharmacological mechanism and remarkable clinical effects. Based on the in-depth exploration of the FRESCO-2 study, fruquintinib has significantly prolonged the median overall survival time of patients with metastatic colorectal cancer and effectively reduced the risk of death. More notably, despite its outstanding efficacy, the incidence rate of adverse reactions of fruquintinib is not significantly different from similar drugs, which has undoubtedly greatly increased its safety in clinical application.
Only seven months later, fruquintinib received another good news - it successfully entered the European market and became the first colorectal cancer treatment drug approved by the European Union. This milestone breakthrough not only demonstrates the strength of China's original innovative drugs, but also brings new treatment options to colorectal cancer patients worldwide. Meanwhile, the efficacy of fruquintinib in gastric cancer, non-small cell lung cancer, and other fields is also highly regarded, and it has entered the phase III clinical trial stage, which is expected to bring benefits to more patients in the future.
When developing fruquintinib, Chi-Med set the starting point in China, but the goal was far beyond the European and American markets. To further expand its market share, Chi-Med has submitted a marketing application for fruquintinib in Japan and obtained the strong support of its powerful partner, Takeda Pharmaceutical. Through the joint efforts of both parties, the market launch of fruquintinib in Japan is also steadily progressing.
The rapid recognition of fruquintinib in the U.S. market is not only reflected in its FDA approval, but also in its inclusion in authoritative treatment guidelines. This honor has undoubtedly laid a solid foundation for the promotion and sales of fruquintinib in the U.S. market. According to market research, the sales peak of fruquintinib in multiple fields is expected to reach tens of billions, making it a shining star in the global pharmaceutical market.
Globally, multiple VEGF/VEGFR-targeted drugs have been launched, providing more treatment options for cancer patients. However, fruquintinib stands out in the fiercely competitive pharmaceutical market with its unique pharmacological mechanism and remarkable clinical effects. With the successful entry into the European market and the imminent approval in Japan, the sales of fruquintinib are expected to further increase, bringing benefits to more patients while also bringing substantial economic returns to Chi-Med.
Reviewing the development history of fruquintinib, we cannot help but feel proud of the rise of China's pharmaceutical industry. From research and development to market launch, from the domestic market to the international market, every step of fruquintinib has been the result of the wisdom and sweat of countless researchers. We believe that in the future, with the emergence of more original innovative drugs from China, we will be able to bring more hope and blessings to patients around the world.
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