Hutchmed Ltd on Thursday said that its novel treatment for haematological malignancies and immune diseases had been progressed to the next stage of approval by the country’s national bureau for drug supervision.
Hutchmed, a Hong Kong-based immunotherapy developer, said that its sovleplenib drug targets a key protein in hematological and autoimmune disorders. These include primary immune thrombocytopenia, a condition for which Hutchmed claims there are currently ‘no effective treatment options’.
Following the August announcement of positive, statistically significant results from a phase-3 trial of sovleplenib, the company’s new drug application has now been accepted for review and granted priority by the China National Medical Products Administration. The drug is currently under clinical investigation and awaits evaluation of its safety and efficacy by regulatory authorities.
Chief Executive Officer and Chief Scientific Officer Dr Weiguo Su said: ‘Our submission includes data from the successful (phase 3) trial in China which demonstrated a durable response rate of sovleplenib for patients. There is a significant need for new therapies in adult primary primary immune thrombocytopenia which can significantly impair the quality of life for patients.’
Shares in Hutchmed were up 3% at 258.50 pence each in London on Thursday morning.
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