Recently, E-nitiate Biopharmaceuticals received the"Drug Clinical Trial Approval Notice"issued by CDE (Notice No. : 2022LP00652,2022LP00653,2022LP00654,2022LP00655), QY101 ointment approved for clinical trial in the treatment of atopic dermatitis.
QY101 is a class of innovative drugs independently developed by E-nitiateBio, which has been approved for the indication of atopic dermatitis. QY101 is a non hormonal and non steroidal anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor. Atopic dermatitis has been shown to be associated with over-activation of PDE4, which can be effectively treated with PDE4 inhibitors. QY101 ointment showed good PK characteristics, excellent efficacy and high safety in animal experiments, which can meet the treatment needs of different age groups.
QY101 project is the second IND approval project after QY201 project since the establishment of the company. During this period, all departments of the company cooperated closely, linked efficiently and completed the application for approval ahead of schedule, which is another significant milestone for the company.
Ding Shizhe, general manager of E-nitiate Biopharmaceuticals , said that PDE4 is a high potential target for the treatment of inflammatory skin diseases. At present, it is difficult to achieve a good balance between the efficacy and safety of products, so a new generation of products is urgently needed. QY101 has obvious advantages over competitive products in terms of multiple molecular characteristic indexes. The preclinical studies showed that it has good local absorption characteristics and rapid degradation ability in the system. The company will quickly promote the clinical trial of QY101 project, open a wider treatment window, improve the response rate and avoid or reduce toxic and side effects. At present, China's biomedical industry is still in the primary stage, and the independent R & D force needs to be strengthened. The mission of the company is to improve the quality of human life and develop breakthrough new drugs. We will pay more attention to the medical needs of patients and continue to invest in the development of new and good drugs to benefit more patients.
Dr.Liu Pengfei, R&D Director of E-nitiate Biopharmaceuticals , said that the pathogenesis of atopic dermatitis is complex and difficult to treat, especially for infants and children. The preclinical study of QY101 showed good target selectivity, PK / PD correlation and safety. It is expected that QY101 ointment can provide more opportunities to alleviate symptoms for patients with atopic dermatitis, especially with infants and children.
Atopic dermatitis (AD, also known as atopic eczema) is the most common chronic inflammatory skin disease, characterized by recurrent chronic eczema-like rashes with marked dryness and itching. Worldwide, up to 10% of adults and 20% of children suffer from atopic dermatitis. With the changes of lifestyle and environment, the prevalence of atopic dermatitis in China has been increasing in the recent 10 years, and affects people of all all ages. According to the Guidelines for the Diagnosis and Treatment of Atopic dermatitis in China (2020 edition), the prevalence rate of atopic dermatitis in children aged 1-7 years in 12 cities in China is 12.94%, and that in infants aged 1-12 months is 30.48%.
Founded in 2020 as a Joint Venture Company between VivaVision Biotech and Betta Pharmaceuticals fund, E-nitiate Biopharmaceuticals (Hangzhou) Co.,Ltd. is committed to the development of innovative drugs for autoimmune diseases, through independent research and development, and strategic collaborations, to address unmet medical needs and to improve the quality of human life.
E-nitiateBio is a key introduction project of Hangzhou Linping National Development Zone and won the first prize of "national finals of 2020 Hangzhou overseas high-tech talent innovation and Entrepreneurship Competition (life and Health Group)". The company obtained tens of millions of yuan in angel investment from Betta Fund, and reached a strategic collaboration with Betta Pharmaceuticals to jointly promote the clinical development of the company's pipeline. Since its establishment, QY201 and QY101, are a class of innovative drugs independently developed by E-nitiate with global patents, and have been approved for clinical trials. Meanwhile, many products in the pipeline, such as QY211 and QY301, are about to be submitted for IND applications.
Adhering to the value concept of "open innovation, truth-seeking and pragmatic, win-win cooperation", E-nitiate has gathered more than ten outstanding people to join, with 70% being of master and/or doctoral educational backgrounds. The company has formed first-class R&D and industrialization potential capabilities, and strives to become a leader in the development of innovative drugs for autoimmune diseases.
