Hutchmed completes trial enrolment, keeps drugs on China funding list

Hutchmed China announced a significant milestone in its clinical trials on Wednesday, as well as the inclusion of two of its drugs on the National Reimbursement Drug List (NRDL) in China.

The AIM-traded firm said it had completed patient enrollment for its phase two and three clinical trials involving the use of fruquintinib in combination with sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China.

It said the randomised, open-label study aimed to assess the efficacy and safety of the combination therapy compared to axitinib or everolimus monotherapy.

The primary endpoint would be progression-free survival (PFS), with various secondary endpoints including objective response rate, disease control rate, and overall survival.

Hutchmed said the trial had enrolled 234 patients, led by Dr Dingwei Ye of Fudan University Shanghai Cancer Center and Dr Zhisong He of Peking University First Hospital.

The company anticipates releasing topline results by the end of 2024, which, if positive, could lead to a new drug application submission to China's National Medical Products Administration (NMPA).

At the same time, Hutchmed confirmed that its drugs, 'Elunate' fruquintinib and 'Sulanda' surufatinib, would continue to be included in the National Reimbursement Drug List (NRDL) under the 2023 simple renewal mechanism.

The drugs would maintain the same terms as their current two-year agreement, starting on 1 January.

Elunate, first added to the NRDL on 1 January 2020, is used for the treatment of metastatic colorectal cancer (CRC) - a significant health concern in China with an estimated 555,000 new cases annually.

Sulanda, included in the NRDL on 1 January 2022, is indicated for treating non-pancreatic and pancreatic neuroendocrine tumours (NETs).

In China, there were around 71,300 newly diagnosed NET patients in 2020 and potentially up to 300,000 individuals living with the disease.

"The NRDL has made it possible for our innovative medicines to quickly reach more patients in need across China," said Hutchmed senior vice president and chief commercial officer Hong Chen.

"In the past few years, we have seen an array of new measures adopted by the NHSA, including the NRDL negotiation, the bidding process for non-exclusive medicines and simplified renewal rules for already listed medicines.

"Those new measures provided a solid foundation for the sustainable development of the innovative pharmaceutical industry and continuous improvement of patients' access to innovative medicines, allowing patients to truly benefit from healthcare innovations."

At 1058 GMT, shares in Hutchmed China were up 1.48% at 308p.

Reporting by Josh White for Sharecast.com.