Hutchmed's 'Elunate' approved under new Hong Kong rules

The AIM-traded firm said Elunate is an oral inhibitor targeting vascular endothelial growth factor (VEGF) receptors -1, -2, and -3, crucial for hindering tumour angiogenesis.

It described the achievement as a significant milestone, as Elunate would become the first medicine to be approved under the newly established ‘1+’ mechanism for the registration of new drugs, introduced by the Hong Kong Government in October last year.

The mechanism, operational since 1 November, enabled drugs beneficial in treating life-threatening or severely debilitating diseases to seek registration in Hong Kong with the support of local clinical data and recognition from relevant experts, even if approved by just one reference drug regulatory authority, instead of the typical two.

Hutchmed said it based its application on Elunate’s approval from the China National Medical Products Administration (NMPA), supplemented by local clinical data.

Notably, fruquintinib also received approval from the US Food and Drug Administration (FDA) in November.

The approved indication for Elunate applies to metastatic CRC patients who had previously undergone fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who had received or were not suitable for anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type).

Elunate would be distributed and promoted in Hong Kong under the Hutchmed brand.

Its development and commercialisation in mainland China was achieved in collaboration with Eli Lilly.

Takeda holds the exclusive global licence for fruquintinib, excluding mainland China, Hong Kong and Macau, and markets the drug in the United States under the brand name Fruzaqla.

“We have made it a priority to do everything we can to bring the benefits of our innovative medicines to Hong Kong, our company's birthplace, and are excited to have our first medicine now approved here,” said executive vice-president and chief operating officer Dr Karen Atkin.

“We appreciate the streamlined drug registration process, showing the efficiency and commitment of the Hong Kong government to accelerate patient access to novel therapies.

“As we advance our pipeline of drug candidates in other cancer types and immunological diseases, we look forward to bringing additional therapies to benefit patients in Hong Kong.”

At 1516 GMT, shares in Hutchmed China were down 2.53% at 200.3p.

Reporting by Josh White for Sharecast.com.