Regulatory Hutchmed eyes Drug for autoimmune disease approved in China...

Hutchmed eyes Drug for autoimmune disease approved in China following phase 3 success


Hutchmed, a pharmaceutical company, is in the final stages of preparing a submission for the approval of sovleplenib, its novel drug, in its home market of China. This decision follows a successful phase 3 trial of the drug, which is a Syk inhibitor. The trial focused on individuals in China who were suffering from primary immune thrombocytopenia, a condition marked by a low count of blood platelets and an associated heightened risk of bleeding. These patients had already undergone at least one previous standard therapy.

The trial, which included 188 adult participants, utilized a placebo as a control measure. The primary goal of the trial was met as sovleplenib demonstrated both a statistically significant and clinically meaningful increase in the rate of durable responses when compared to the placebo. This positive outcome was not limited to the primary endpoint; secondary endpoints such as response rate and safety were also successfully achieved by the drug.

Although Hutchmed refrained from sharing specific details of the trial results, the company committed to unveiling the findings at an upcoming scientific conference. Sovleplenib’s mechanism of action is rooted in inhibiting spleen tyrosine kinase (Syk), a pivotal component of the Fc receptor and B-cell receptor signaling pathway. The drug’s therapeutic potential extends beyond primary immune thrombocytopenia, as it is also being explored in a phase 2/3 trial for warm antibody autoimmune hemolytic anemia and a phase 1 study in non-Hodgkin lymphoma.

Bolstered by the trial’s positive outcomes, Hutchmed intends to lodge a new drug application with Chinese regulatory authorities by the close of 2023. With an estimated 110,000 individuals in China afflicted by primary immune thrombocytopenia and no effective treatment options currently available, the company perceives a substantial market opportunity within its own country. Moreover, beyond China, there are roughly 145,000 patients grappling with the chronic variant of this autoimmune disorder within major global pharmaceutical markets.

While some treatments are already in existence, Hutchmed underscores their limited curative potential and the propensity for patients to develop resistance, rendering them vulnerable to relapse. As such, a significant segment of patients remains inadequately responsive to existing therapies, creating a pressing need for new and improved treatments.

The landscape of thrombocytopenia research also features other players, like Takeda, a Japanese pharmaceutical company. In a phase 3 trial, Takeda unveiled interim results demonstrating that patients who received its ADAMTS13 replacement therapy, TAK-755, as a preventative measure did not experience acute thrombotic thrombocytopenic purpura attacks. This stood in contrast to current standard treatments that rely on plasma-based therapies.

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