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(Sharecast News) - Hutchmed China announced on Thursday that the new drug application (NDA) for sovleplenib, an oral inhibitor targeting spleen tyrosine kinase (Syk), had been accepted for review and granted priority review by China's National Medical Products Administration (NMPA).
The AIM-traded firm said the move was a significant development in the treatment of primary immune thrombocytopenia (ITP) in adult patients.
It said the submission was based on data from the ESLIM-01 trial, a phase three study conducted in China involving 188 adult patients with primary ITP who had previously undergone at least one standard therapy.
In August, Hutchmed reported that the trial successfully achieved its primary endpoint by demonstrating a clinically meaningful and statistically significant increase in the durable response rate for patients treated with sovleplenib compared to those who received a placebo.
Secondary endpoints, including response rate and safety, were also met, with detailed trial results to be made available in the future.
The initial proof of concept study leading to ESLIM-01 was published in the Lancet Haematology.
Hutchmed added that the NMPA had granted breakthrough therapy designation (BTD) to sovleplenib for the specific indication studied in ESLIM-01 in January 2022.
"We are pleased to have initiated the rolling submission of an NDA for sovleplenib in China as we look to bring this novel treatment to ITP patients," said Hutchmed's executive director, chief executive officer and chief scientific officer Dr Weiguo Su.
"Our submission includes data from the successful phase three ESLIM-01 trial in China which demonstrated a durable response rate of sovleplenib for patients.
"There is a significant need for new therapies in adult primary ITP which can significantly impair the quality of life for patients."
At 1338 GMT, shares in Hutchmed China were up 4.58% at 262.49p.
Reporting by Josh White for Sharecast.com.
