Home Huaota Biopharma Announces First-in-Human Dosing of HB0056, the World’s First TSLP/IL-11 Bispecific Antibody, in Asthma Patients

Huaota Biopharma Announces First-in-Human Dosing of HB0056, the World’s First TSLP/IL-11 Bispecific Antibody, in Asthma Patients

Aug 27, 2025 17:31 CST Updated 17:31
Huaota

Biological New Drug Developer

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Abstract


     

Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") independently developedThe world's first targeted TSLP/IL-11 humanized bispecific antibody HB0056 completed the dosing of the first subject for asthma indication today.

Asthma is one of the most common chronic diseases worldwide, with 358 million people affected globally.[1]The uncontrolled rate of asthma in China is as high as 55.1%.[2], with a mortality rate of 36.7 per 10,000 people[3], far exceeding the world average level.



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About HB0056



HB0056 is a bispecific antibody constructed by linking an anti-IL-11 single-chain nanobody to the N-terminus of a humanized monoclonal antibody against TSLP. It can specifically target both TSLP and IL-11. Studies have shown 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, with complementary effects on these diseases. Simultaneously blocking the TSLP and IL-11 pathways can offer better therapeutic outcomes for asthma patients, particularly those experiencing airway remodeling and fibrosis following uncontrolled inflammation.



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Market Competition Situation



      Currently, there are no drugs on the market that simultaneously target both 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 children aged 12 years and older and adult patients.



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About Huaota



      Huaota Biologics, a subsidiary of Huahai Pharmaceuticals, is a biopharmaceutical R&D company that focuses on independent research and development with a global perspective. It specializes in the R&D of biological new drugs for cancer and autoimmune diseases. Currently, it has12Projects in the clinical stage: including those that have completed pivotal clinical trials with all endpoints achieved, as the first domestically developed treatment for generalized pustular psoriasis in China.IL-36RMonoclonal Antibody; and Current ClinicalIIPositive signals have been observed in multiple tumor diseases such as endometrial cancer and non-small cell lung cancer.PD-L1/VEGFDual Antibody: The First with Dual Killing Effects Targeting Refractory TumorsCD73-ADC; The world's first bispecific antibody targeting IL-17A and IL-36RAnd other core projects.


Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, aiming to provide high-quality, high-level biopharmaceuticals to the global market. These efforts are intended to meet the needs of a broad patient base for biologic innovative drugs that are safe, effective, accessible, and affordable, with a commitment to changing the world through innovation!



References

[1]GBD 2015 Chronic Respiratory Disease Collaborators. Global,regional,and national deaths,prevalence,disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma,1990-2015:A systematic analysis for the Global Burden of Disease Study 2015[J]. Lancet Respir Med.2017;5(9):691-706.

[2]Zhong N,Lin J,Zheng J,et al. Uncontrolled asthma and its risk factors in adult Chinese asthma patients [J].Ther Adv Respir Dis.2016;10(6):507-517.

[3]Zhang Min, Zhou Xin.Disease Burden and Latest Treatment Advances in Mild Bronchial Asthma [J]. International Journal of Respiration. 2019;39(19): 1492-1496.


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