Potential FIC! Long-acting TSLP/IL33 bispecific antibody seeking overseas partners | DrugTimes BD Project

Thymic stromal lymphopoietin (TSLP) has been a hot target in the autoimmune field in recent years.

The most representative drug, tezepelumab, was approved by the FDA in December 2021 as an add-on maintenance therapy for patients aged 12 years and older with severe asthma.. Results from the Phase III NAVIGATOR study showed that, compared to placebo combined with standard therapy, Tezepelumab combined with standard therapy reduced the annual exacerbation rate in severe asthma patients by 56%. The drug has also been approved in Japan and Europe. According to AstraZeneca’s 2024 financial report, Tezepelumab generated $684 million in revenue in 2024, a year-on-year increase of 98%.

At the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting held in March 2025, the Phase III DIRECTION study results of Tezepelumab in Asian patients with severe asthma were prominently announced. The results showed that, compared to placebo, Tezepelumab significantly reduced the asthma exacerbation rate by up to 74% over 52 weeks, demonstrating impressive efficacy.

IL-33 is another hot target in the autoimmune field that has garnered attention in recent years, with major pharmaceutical companies such as AstraZeneca, Sanofi, Pfizer, Eli Lilly, and GSK having corresponding pipelines.

In May 2025, Sanofi/Regeneron announced positive results from their Phase III AERIFY-1 study of the investigational IL-33 monoclonal antibody Itepekimab in former smokers with COPD. The results showed that, compared to placebo, Itepekimab significantly reduced the rate of moderate-to-severe COPD exacerbations by 27% over 52 weeks.

Currently, the DrugTimes BD team is seeking overseas rights partners for a potential first-in-class (FIC) TSLP/IL33 bispecific antibody. Project details are as follows:

• Project Code: DT-20250506-044
• Project Name: A Long-Acting Bispecific Antibody (TSLP x IL33) with Outstanding Efficacy and High Safety
• Indications: Asthma, Chronic Obstructive Pulmonary Disease (COPD), Atopic Dermatitis(AD)
• Drug Type: Bispecific Antibody
• Targets: TSLP x IL-33
• Development Stage: IND Enabling
• Project Highlights:

1. 1. Demonstrated efficacy comparable to TSLP + lL-33 combination therapy and significantly out performed either monotherapy.
   2. Fc-symmetric architecture ensures Manufacturing efficiency and Unimpeded bivalent binding.
   3. The smaller molecular weight than conventional antibodies can potentially contribute to its better exposure in target disease tissues.
   4. Half-life extension technology supports less frequent dosing, with projected Q12W (or longer) regimens in clinical settings.
   5. IND will be submitted in August.

• Collaboration: Licensing ex-china rights

Contact us:

For any questions, please contact DrugTimes BD Team at BD@drugtimes.cn, please include Project ID in the subject. Many thanks!