QY201 Tablets for Moderate to Severe Atopic Dermatitis in Phase Ib/II Clinical Trial Completes First Patient Enrollment (FPI)
April 28,2023E-nitiate Biopharmaceuticals


(hereinafter referred to as "QYB") announced that the first patient enrollment (FPI) has been successfully completed in the Chinese Phase Ib/II clinical trial of QY201 tablets, an innovative drug for the treatment of moderate-to-severe atopic dermatitis, and the Phase Ia study of QY201 tablets in healthy subjects was completed at the end of September. Data lock.

This study, "Phase Ib/II clinical study on the safety, efficacy and pharmacokinetic characteristics of QY201 tablets in patients with moderate-to-severe atopic dermatitis", will be conducted at multiple centers across China, with the Hangzhou First People's Hospital as the group leader. The aim is to evaluate the safety and efficacy of QY201 tablets in patients with moderate-to-severe atopic dermatitis.


Professor Wu Liming of Hangzhou First People's Hospital said that atopic dermatitis is a refractory, chronic relapsing, systemic skin disease, and the global incidence of AD has been gradually increasing in the past 30 years, which has become one of the world's public health problems and seriously affects patients' quality of life. QY201 tablets are JAK1/TYK2 dual-target highly selective and highly inhibitory active oral drugs, which are expected to provide new treatment options for the majority of AD patients with a new therapeutic option.


Dr. Shi Jun, Chief Medical Officer of E-nitiate Biopharmaceuticals Biologics, said that QY201 tablets have been safe and well tolerated in healthy subjects, which gives us confidence to carry out subsequent patient studies, and that the phase Ib/II moderate-to-severe atopic dermatitis study initiation and enrollment preparation have overcome many difficulties.


Mr. Ding Shizhe, General Manager of E-nitiate Biopharmaceuticals Biologics, said that the first patient enrollment is a key milestone for the clinical project and that Director Wu Liming of Hang Shiyi is the leader of QY201 Tablets, leading all participating research centers to make continuous progress toward science. E-nitiate Biopharmaceuticals particularly values Director Wu's team's commitment to medical disease, research momentum and strong execution capabilities. We look forward to a longer and deeper collaboration with the Hang Shiyi team, taking the medical treatment as their mission and working together to provide the best medical benefits to our patients.



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 itching of the skin. 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 QY201 Small Molecule Drug

QY201 tablet is a new class 1 drug with independent intellectual property rights developed by E-nitiate Biopharmaceuticals Biologicals (Hangzhou) Co., Ltd. QY201 tablet acts on the dual target of JAK1/TYK2, with high selectivity and inhibitory activity, pharmacologically superior to similar drugs under development or marketed at present disclosed, and hopefully can play a better role in the treatment of autoimmune diseases such as atopic dermatitis and psoriasis.


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