China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development.
Clinical Trial Approval
The NMPA’s nod allows Huahai Pharma to initiate clinical studies of HB0056 in asthma patients. The drug’s dual-target mechanism aims to address key pathways involved in the disease’s pathogenesis, offering a novel therapeutic approach.
Drug Profile
HB0056 is a bispecific antibody (BsAb) designed to simultaneously block thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) signaling pathways. Both pathways play critical roles in inducing Th2 immune responses and airway inflammation, which drive asthma progression. By inhibiting these pathways, HB0056 aims to reduce airway hyperresponsiveness and improve lung function.
Mechanism of Action
The drug’s dual inhibition of TSLP and IL-11 differentiates it from existing therapies, which typically target a single pathway. Preclinical data suggest HB0056 can modulate immune responses and suppress inflammation more effectively than monospecific antibodies, potentially offering a breakthrough for patients with moderate-to-severe asthma.-Fineline Info & Tech
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