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Bio-Thera Solutions, Ltd., a clinical-stage pharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers. The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 270 healthy volunteers.
“This IND approval represents an important milestone for our biosimilar pipeline,” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “BAT2206 will be the fifth biosimilar that Bio-Thera will advance into clinical development. It signifies Bio-Thera’s continued commitment to developing and commercializing biosimilar products for patients in China and around the world.”
Bio-Thera Solutions is developing several additional biosimilar products, including QLETLI®, a biosimilar to Humira®, which was recently approved by the NMPA in China and BAT1706, a biosimilar to Avastin®, which is currently being evaluated in a global Phase III clinical trial. Bio-Thera Solutions is also pursuing biosimilar versions of Actemra®, Cosentyx® and Simponi®.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. The company has one approved product in China and has advanced four candidates into late stage clinical trials. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Stelara® is a registered trademark of Johnson & Johnson Corporation
2 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
3 Avastin® is a registered trademark of Genentech, Inc.
4 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corporation
5 Cosentyx® is a registered trademark of Novartis AG
6 Simponi® is a registered trademark of Johnson & Johnson Corporation
Bio-Thera Solutions, Ltd.:
Bert E. Thomas IV +1.410.627.1734
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