QY211 gel has completed first dose enrollment in Phase Ia healthy subjects
April 28,2023E-nitiate Biopharmaceuticals


("QYB") is conducting a Phase I clinical study to evaluate the safety and preliminary efficacy of QY211 gel for the treatment of mild to moderate atopic dermatitis in healthy Chinese subjects and patients with mild to moderate atopic dermatitis.

The study, officially launched on March 8, 2023, is led by Huashan Hospital of Fudan University with Professors Jing Zhang and Jinhua Xu as principal investigators, and the project is being conducted simultaneously at multiple centers across China.

QY211 gel mechanism of action is a JAK1/TYK2 inhibitor, which can be used to treat atopic dermatitis by binding to the JAK kinase structural domain and blocking the JAK-STAT signaling pathway, which in turn inhibits a variety of inflammatory cytokines.


Dr. Jun Shi, CMO of E-nitiate Biopharmaceuticals Biologics

We are pleased to see that QY211 gel has successfully completed the first dose group study, which marks the full clinical development stage of E-nitiate Biopharmaceuticals Biologics' current three pipelines. We will uphold our patient-centered, clinical value-oriented, focused product differentiation development and quality-first strategy to efficiently advance their development process. Available data show that QY201 (oral tablet) has significant efficacy and good safety in patients with moderate to severe atopic dermatitis. QY211 as its topical gel will bring more treatment options for patients.


Shi-Zhe Ding, CEO of E-nitiate Biopharmaceuticals Bio

I am impressed by the spirit of excellence shown by Huashan Hospital in the clinical trial. As the team leader of the project, Prof. Jing Zhang and Prof. Jinhua Xu's team put great efforts into the preliminary preparation and gave us a lot of guidance. We are especially grateful for their strong support and strict control, as well as for the services and cooperation provided to us by various collaborators in the project.


Thanks to QYB's efficient project management and execution, the first dose enrollment of Part1 healthy individuals in the QY211 gel project was completed on March 20, 2023 at Huashan Hospital of Fudan University, the group leader unit, and as of now, the treatment follow-up of the first dose group has been completed with good safety of the subjects.



About atopic dermatitis

Atopic dermatitis (AD, also known as atopic eczema) is the most common chronic inflammatory skin disease that is characterized by recurrent episodes of chronic eczema-like rash with significant dryness and pruritus. Worldwide, up to 10% of adults and 20% of children suffer from atopic dermatitis. With changes in lifestyle and environment, the prevalence of atopic dermatitis in China has been increasing in the last decade or so, affecting people of all ages. According to the China Atopic Dermatitis Treatment Guidelines (2020 Edition), the prevalence of atopic dermatitis in children aged 1-7 years in 12 cities in China reached 12.94%, and the prevalence of atopic dermatitis in infants aged 1-12 months reached 30.48%.


About QY211 Small Molecule Drug

QY211 gel is a new class 1 drug with independent intellectual property rights developed by E-nitiate Biopharmaceuticals Bio (Hangzhou) Co. diseases such as atopic dermatitis and psoriasis.