Fruquintinib's Swift Commercialization Sets a New Benchmark for Chinese Innovative Drugs Going Global

On November 9th, the U.S. Food and Drug Administration (FDA) granted approval for the use of fruquintinib, developed by Hengrui Medicine and licensed by Takeda, in the treatment of refractory metastatic colorectal cancer. In less than 48 hours after approval, on November 10th, the first prescription for fruquintinib was already issued.

This rapid commercialization speed carries significant implications. It not only reflects the efforts made by Takeda, the licensing partner, in the early stages of commercialization but also highlights the substantial unmet needs among patients with metastatic colorectal cancer. Several factors may have contributed to fruquintinib's rapid uptake in the United States, laying a solid foundation for its success.

Colorectal cancer (CRC), also known as colon cancer or rectal cancer, is a common malignant tumor in the gastrointestinal tract, encompassing both colon and rectal cancer.

In 2020, colorectal cancer ranked third globally in terms of incidence and second in terms of mortality among all cancers, making it one of the most prevalent types of cancer. The majority of metastatic CRC (mCRC) patients cannot be cured, with approximately 20% of CRC patients experiencing metastasis at the time of diagnosis and over 50% experiencing metastasis during the course of their illness.

In the United States, it is estimated that there will be an additional 153,000 new cases of colorectal cancer in 2023, accounting for 7.8% of all new cancer cases and ranking as the second leading cause of cancer-related deaths. Approximately 70% of colorectal cancer patients experience metastasis at or after diagnosis, and metastasis remains the primary cause of colorectal cancer-related deaths.

Metastatic colorectal cancer lacks effective treatment options, and patients often have a poor prognosis. Colorectal cancer is classified into four stages, with a five-year survival rate of 94% for stage I, 82% for stage II, 67% for stage III, and a mere 11% for metastatic or stage IV colorectal cancer.

Fruquintinib, as a novel VEGFR inhibitor, has shown significant improvements in overall survival and progression-free survival for mCRC patients in global clinical trials compared to first-generation products. It overcomes the toxicity issues associated with earlier drugs and offers significant survival benefits without adversely affecting patients' quality of life.

Fruquintinib's overseas sales trajectory can be compared to that of regorafenib, a recommended third-line therapy for colorectal cancer in major guidelines. Regorafenib has been used in approximately 50% of patients in the third-line setting, with peak sales reaching $556 million in 2021.

The expansion of fruquintinib's indications abroad is ongoing. In addition to its approval for metastatic colorectal cancer in the United States, Hengrui Medicine is conducting Phase I/Ib clinical trials for triple-negative breast cancer and Phase Ib/II clinical trials for microsatellite-stable (MSS) colorectal cancer (which accounts for 95% of colorectal cancer cases) that are insensitive to immunotherapy. Fruquintinib holds great potential for addressing the significant unmet needs in these diseases, further advancing its commercialization in the future.

In China, fruquintinib is being studied in combination with toripalimab and sintilimab, among other PD-1 inhibitors, for gastric cancer, renal cell carcinoma, endometrial cancer, and small cell lung cancer. The new drug application (NDA) for fruquintinib in combination with paclitaxel for second-line gastric cancer treatment was accepted by the Center for Drug Evaluation (CDE) in April 2023.

Although Takeda, the licensee of fruquintinib's overseas rights, is a Japanese pharmaceutical company, its strength has been recognized by global industry investors, placing it among multinational corporations (MNCs). In the fiscal year 2022, Takeda's revenue from the U.S. market approached 50%, making it the company's largest regional base.

Takeda is globally renowned for its gastrointestinal business. According to Takeda's fiscal year 2022 financial report (April 2022 - March 2023), the company's revenue primarily comes from five segments: gastrointestinal, rare diseases, plasma-derived therapies, neuroscience, and oncology. Among these, the gastrointestinal product business contributes the most to Takeda's revenue, with an annual revenue of ¥529.8 billion (approximately $52.05 billion), representing a 25% year-on-year growth.

The highest-selling drug in Takeda's gastrointestinal business is vedolizumab (Entyvio), a humanized monoclonal antibody targeting α4β7 integrinthat is used for the treatment of inflammatory bowel disease (IBD). The success of vedolizumab has demonstrated Takeda's expertise and strong presence in the gastrointestinal field.

Takeda's strategic partnership with Hengrui Medicine in licensing fruquintinib has further strengthened its position in the oncology market. Takeda has leveraged its global infrastructure, expertise in commercialization, and established relationships with healthcare providers to expedite the launch of fruquintinib in the United States.

The swift commercialization of fruquintinib sets a new benchmark for Chinese innovative drugs going global. It demonstrates the potential of Chinese pharmaceutical companies to develop and commercialize cutting-edge therapies that meet unmet medical needs worldwide. Fruquintinib's success also underscores the importance of international collaborations and partnerships in bringing innovative treatments to patients.

In conclusion, fruquintinib's rapid commercialization in the United States after FDA approval highlights the urgent need for effective treatments for metastatic colorectal cancer. The drug's significant clinical benefits and improved safety profile position it as a promising therapy for patients with refractory mCRC. Takeda's strategic partnership with Hengrui Medicine and its strong presence in the gastrointestinal and oncology markets have played a crucial role in fruquintinib's successful launch. This achievement sets a new benchmark for Chinese innovative drugs going global and showcases the potential of Chinese pharmaceutical companies in the global healthcare landscape.