Zhejiang Huahai Pharmaceutical (600521.SH): The HB0056 injection project has received drug clinical trial approval for a new indication.

Zhejiang Huahai Pharmaceutical (600521.SH) announced that recently, its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") and Huabo Biopharmaceutical Technology (Shanghai) Co., Ltd. (hereinafter referred to as "Huabo Biopharmaceutical," a wholly-owned subsidiary of Huaota) received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for the HB0056 injection project's new indication. The company's self-developed HB0056 is a bispecific antibody targeting TSLP and IL-11. Among them, TSLP is mainly involved in airway inflammatory responses, while IL-11 is closely related to fibroblast activation and tissue remodeling. By simultaneously blocking two signaling pathways, HB0056 is expected to inhibit airway inflammation while intervening in tissue remodeling, providing a differentiated treatment strategy for COPD. Compared with existing single-target biologics, HB0056 has the mechanistic innovation advantage of dual-pathway intervention and potential clinical application value. Currently, two targeted biologics for specific COPD patient populations have been approved for marketing in China, including the IL-4R monoclonal antibody dupilumab from Sanofi/Regeneron approved in 2024 and the IL-5 monoclonal antibody mepolizumab from GSK approved in 2025, marking the gradual development of COPD treatment toward precision targeted therapy.