上海本地研制药物被国际市场认可 - 2024-06-23
Hutchmed (China) Limited announced it has gained European Commission's approval for Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer who have previously been treated with other available standard therapies.
The latest approval marks another milestone for local innovative medicines to be recognized by developed markets, following its approval in the US in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA.
"This is a significant milestone for Hutchmed, as it is the first product from our research and discovery engine to be approved in Europe, achieved through our partnership with Takeda to make this possible in such a short period of time," Su Weiguo Su, chief executive officer and chief scientific officer of Hutchmed, said in a press release on Saturday.
It is looking forward to seeing the impact it would bring for patients across Europe.
China's research and development capabilities gained increasing recognition from developed nations.
Last year, the US FDA approved Shanghai Junshi Biosciences' monoclonal antibody toripalimab for a type of head and neck cancer, becoming the first China-made PD-1 inhibitor to win approval in the United States.
Colorectal cancer is the third most prevalent cancer worldwide, associated with more than 1.9 million new cases and 900,000 deaths in 2022. There is still high unmet needs with poor outcomes and limited treatment options for metastaticcolorectal cancer.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of China's mainland, Hong Kong and Macau.
It also filed for market approval to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in September 2023.
The medicine was first approved in China in 2018, and subsequently in Macau and Hong Kong in 2022 and 2024 respectively. As of mid-2023, more than 80,000 patients with colorectal cancer have been treated with fruquintinib.
Source: Shanghai Daily
