Setting Sail for the Sea – FDA Filing the IND Approval for QY201 of EnitiateBio
August 18,2023E-nitiate Biopharmaceuticals


On July 26, 2023, Beijing time, E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. (hereinafter referred to as "EnitiateBio" or "Qiyuan") received the IND approval for QY201 from the FDA. This is the first clinical approval obtained by EnitiateBio from the FDA and the first U.S. IND application that was fulfilled by EnitiateBio on its own, marking the official launch of the overseas expansion plan of EnitiateBio QY201.

QY201 is a next generation JAK1/TYK2 inhibitor independently developed by EnitiateBio with global intellectual property rights. By inhibiting JAK activity and blocking the JAK-STAT pathway, it reduces the expression of pro-inflammatory cytokines, thereby playing a role in the treatment of autoimmune diseases such as atopic dermatitis and psoriasis.  QY201 has high selectivity and high activity against JAK1 and TYK2 and has increased selectivity for JAK1 over JAK2 compared to similar products, indicating that QY201 has the potential to avoid JAK2-mediated hematotoxicity.

At present, a Phase Ia clinical trial in healthy subjects and a Phase Ib clinical trial in subjects with moderate-to-severe atopic dermatitis are completed. The preliminary results show that QY201 tablets have good overall safety and tolerability, and can rapidly relieve pruritus and improve skin lesions, winning wide recognition from subjects and investigators. At present, a Phase II clinical trial in subjects with moderate-to-severe atopic dermatitis is being conducted at multiple centers domestically.

The R&D of QY201 demonstrates the ability of EnitiateBio to independently develop innovative Class 1 new drugs with BIC potential. The IND approval from FDA  demonstrates EnitiateBio’s forward-looking overseas strategic layout and the efficient execution of the team. It also marks the determination of EnitiateBio to step onto the global stage of innovative drug research and development.

Dr. Shi Jun, CMO of EnitiateBio, said that,

"QY201 has outstanding molecular advantages: 1) Its JAK1 inhibitory activity is comparable to Upadacitinib; 2) Its JAK2/JAK1 selectivity is significantly better than that of Upadacitinib; 3) It also has a less than 1 nM-level TYK2 inhibitory activity that other JAK1 inhibitors do not have. With years of overseas development experience, Qiyuan management has designed a data-driven, agile and cost-effective overseas strategy for QY201. The clinical science team adheres to the basic strategy of differential development, did a great amount of comparison to competitor compound s, and selected the top three major unmet medical needs in the world under the guidance of external KOLs/TAEs, and the indications that have been validated by existing clinical data for overseas development. What is particularly valuable is that Qiyuan's registration affairs, medical science and clinical operations work together as one, and it has independently completed the IND submission in the United States in a relatively short period of time, proving EnitiateBio's first step toward the world."

Mr. Kevin Ding, CEO of EnitiateBio, said that,

"With the increasingly intensified competition in China's biotech industry, to develop a global pipeline has become a general trend. Having an ability for international clinical development has become one of the basic thresholds in this industry. Only with this capability can companies compete and survive natural selection in the global landscape. Although EnitiateBio still has a lot to prove and develop, it is undoubtedly an important milestone that QY201, as one of its core products, has obtained the IND approval of from the United States FDA. This milestone is sufficient to demonstrate the efficient execution of the EnitiateBio biological team., and I personally feel very proud of the team."


About  EnitiateBio

Founded in 2020, EnitiateBio (Hangzhou) Co., Ltd. is an innovative pharmaceutical company that focuses on innovative drugs for autoimmune diseases, develops breakthrough drugs through independent research and development and strategic cooperation, and is committed to addressing the unmet needs of patients and improving the quality of human life.

The company is headquartered in Hangzhou, Zhejiang, and has set up a clinical center and a R&D center in Shanghai. EnitiateBio is a key introduction project of the Linping National Economic and Technological Zone in Hangzhou. It won the first prize in the "2020 Hangzhou Overseas High-Level Talent Innovation and Entrepreneurship Competition (Life and Health Group)" and received about 0.1 billion ren-min yuan of angel investment from healthcare focused industrial capital Betapharm. EnitiateBio also established a strategic partnership with Betapharm to jointly promote the clinical development of its drug candidates. In 2022, the company completed Series A financing of nearly 100 million CNY.

Upholding the values of "embracing competition, relentless pursuit, and candid dedication", EnitiateBio has assembled a team of scientists with successful new drug whole-phase development experience from early new drug research and development to clinical translation, and clinical management. The company owns global patents for several innovative Class 1 drug candidates including QY201, QY101 and QY211, with multiple indications rapidly advancing into different clinical stages, and several IND filings are on the horizon. The company pays attention to the unmet clinical needs, independently develops differentiated molecules, and has a prospective portfolio in autoimmune diseases. Through tireless efforts, EnitiateBio strives to become a leader in the development of innovative drugs for autoimmune diseases.