Hutchison China MediTech (Chi-Med) has secured approval from the National Medical Products Administration of China (NMPA) for the use of fruquintinib capsules to treat metastatic colorectal cancer (CRC).

The indication covers patients who have failed at least two previous systemic antineoplastic therapies with or without prior anti-vascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor (EGFR) treatments.

Chi-Med’s fruquintinib is an oral, selective and potent small molecule inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2 and 3. In China, these capsules will be available under the Elunate brand name.

The company intends to jointly work with its partner Eli Lilly for the market launch of the drug in the country.

Chi-Med chairman Simon To said: “Today’s approval is a major achievement for Chi-Med. Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomised clinical trial in China.”

“We look forward to making this world-class new therapy available as quickly as possible to patients with CRC in China.”

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By GlobalData

The Chinese regulatory approval comes after a review of results from the pivotal Phase III FRESCO clinical trial conducted in 416 colorectal cancer patients in China.

“Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomised clinical trial.”

Data revealed statistically significant and clinically meaningful improvement in overall survival of patients administered with Chi-Med’s fruquintinib, when compared to placebo.

In fruquintinib arm, median overall survival was 9.3 months, while the measure was 6.6 for placebo.

It was further observed that the drug’s good kinase selectivity can limit off-target toxicity and offer improved tolerability.

These properties are expected to enable assessment of fruquintinib in combination with other treatments such as chemotherapies, targeted therapies and immunotherapies.

The regimens will maximise the proportion of patients who may potentially benefit from the therapy.