1. Fruquintinib has been approved by the European Union, becoming the first original innovative drug from Shanghai to enter the international market in Europe and America; 2. Colorectal cancer is the second leading cause of cancer-related deaths worldwide and the second most common type of cancer in China, with a large unmet medical need.
On June 22, the daily bulletin of the star (reporter Zheng Bingxun) announced that Hutchmed (China) (0013.HK, HCM.O, HCM.L) announced that its independently developed anti-tumor new drug fruquintinib has been approved by the European Commission for treating refractory metastatic colorectal cancer.
Fruquintinib not only became the first innovative targeted therapy approved by the European Union for treating metastatic colorectal cancer in more than 10 years, but also the first original innovative drug from Shanghai to enter the two major international markets in Europe and the United States.
In November 2023, fruquintinib was approved for listing in the United States and the first prescription was issued within 48 hours. Earlier in 2018, fruquintinib was approved in China and was included in the medical insurance list in 2019.
Since its launch, fruquintinib's sales revenue has been on the rise. According to PDB hospital sample data, fruquintinib's market share for colorectal cancer in the sample of major tertiary hospitals in 30 cities has increased from 2% at the end of 2018 to 47% in Q2 2023, and it is in a leading position in the Chinese colorectal cancer market.
In 2023, the market sales of fruquintinib in China were USD 108 million, a year-on-year increase of 15%, while the sales in the United States one month after listing were USD 15.1 million. Based on the financial reports of Hutchmed (China) and Takeda Pharmaceutical, fruquintinib has already achieved sales revenue of approximately USD 65 million in the first five months of its launch in the United States.
Regarding the approval of fruquintinib in Europe, the CEO and CTO of Hutchmed (China), Su Weiguoguo, said, "This is an important milestone for Hutchmed (China). Currently, this innovative anti-tumor drug is improving the prospects for the treatment of this disease in the United States and China, and we are also looking forward to extending its impact to Europe patients."
According to the data, fruquintinib is Hutchmed (China)'s first product to be approved for listing. It is a selective oral inhibitor targeting all three VEGFR (VEGFR1, 2 and 3), and VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis.
Hutchmed (China) said that fruquintinib was designed to have higher kinase selectivity, aiming to reduce off-target kinase activity, thereby achieving higher drug exposure, sustained target coverage, and higher flexibility when potentially used as a combination therapy.
According to the data from the Global Cancer Observatory, colorectal cancer (CRC) is the third most common cancer in the world, accounting for about 10% of all cancer cases, the second leading cause of cancer-related deaths worldwide, and also the second most common cancer in China. According to data from the International Cancer Research Institute (IARC)/World Health Organization (WHO), it is estimated that there will be more than 1.9 million new cases of colorectal cancer in 2022, causing more than 900,000 deaths.
Although early-stage colorectal cancer can be treated by surgery, refractory metastatic colorectal cancer currently has poor treatment results and limited treatment options. This means that there is still a large unmet medical need.