Huaota Biopharma Announces First-in-Human Dosing of HB0056, a Novel TSLP/IL-11 Bispecific Antibody, in New Zealand

Abstract

Huaota, a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as "Huaota"), announced: The world's first humanized bispecific antibody targeting TSLP/IL-11, HB0056, independently developed by Huaota, has completed the first subject dosing in New Zealand today.

Dr. Zhu Xiangyang, CEO of Huaota, expressed satisfaction over the completion of the first subject dosing for HB0056 and showed confidence in its clinical research. He hopes to demonstrate the efficacy and safety of HB0056 through clinical studies as soon as possible, providing better treatment options for patients with respiratory diseases such as asthma at an early date.

About HB0056

HB0056 is a bispecific antibody that uses a humanized anti-TSLP monoclonal antibody as the parent antibody, with an anti-IL-11 single-chain nanobody connected at the N-terminus. It can specifically target both TSLP and IL-11. Research indicates that TSLP plays a crucial role in the pathogenesis of various inflammatory skin diseases and respiratory conditions. IL-11 is a pleiotropic cytokine involved in the development and progression of multiple autoimmune diseases and cancers. Both TSLP and IL-11 are involved in inducing Th2 responses, airway inflammation, and the pathogenesis of asthma through different mechanisms, complementing each other in their effects on these diseases. Particularly for patients with persistent inflammation leading to airway remodeling and fibrosis, simultaneously blocking the TSLP and IL-11 pathways can offer enhanced therapeutic benefits.

Market Competition Situation

Currently, there are no drugs on the market that simultaneously target the TSLP and IL-11 signaling pathways. Tezspire (Tezepelumab), a monoclonal antibody drug targeting TSLP jointly developed by AstraZeneca and Amgen, has been approved by the FDA and the EU as an add-on maintenance therapy for treating severe asthma in pediatric patients aged ≥12 years and adults.

About Huaota

Huaota Biopharmaceuticals is a biopharmaceutical company that focuses on independent research and development with a global perspective. It specializes in the R&D of biological drugs for cancer and autoimmune diseases. Currently, there are 11 projects in clinical stages, including: an IL-36R monoclonal antibody, which has entered pivotal clinical trials as China's first domestically developed treatment for pustular psoriasis (a rare disease); a PD-L1/VEGF bispecific antibody currently in Phase II clinical trials, showing promising signals in multiple tumor types such as endometrial cancer and non-small cell lung cancer; and CD73-ADC, the first dual-action drug targeting refractory tumors.

Huaota is currently actively seeking partners both in China and internationally to jointly advance and co-develop, aiming to provide high-quality, high-level biopharmaceuticals to the global market. We are committed to meeting the widespread patient demand for accessible and affordable biologics, striving to change the world through innovation!