HUTCHMED Receives Breakthrough Therapy Designation from China’s NMPA

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HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

HUTCHMED, a commercial-stage biopharmaceutical company, announced on Sept. 13, 2021, that China’s National Medical Products Administration granted breakthrough therapy designation (BTD) for amdizalisib (HMPL-689) for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin's lymphoma (NHL). According to a company press release, this condition affects roughly 17% of patients with NHL.

Amdizalisib is an inhibitor for PI3Kδ (phosphoinositide 3-kinase delta), a lipid kinase that controls the activation of several important signaling proteins. When an antigen binds to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. According to the press release, the abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, HUTCHMED considers PI3Kδ a promising target for drugs that aim to treat certain hematologic cancers.

HUTCHMED has an ongoing Phase II clinical study in China concerning the use of amdizalisib featuring 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma. A phase I/Ib study in the United States and Europe is also ongoing.


“The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor,” said Christian Hogg, CEO of HUTCHMED, in the press release. “There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes.”