GUANGZHOU, China I October 14, 2022 I Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala® (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers. The clinical study is a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 207 healthy volunteers.
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody that is administered subcutaneously with a syringe or autoinjector. Mepolizumab is currently indicated for the following conditions: 1) as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype, 2) as an add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal, 3) the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, 4) the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome for ≥6 months without an identifiable non-hematologic secondary cause.
After the conclusion of the Phase 1 study Bio-Thera plans to run a global Phase 3 study and request approval for all available indications at the time of filing the BLA/MAA with NMPA, FDA, EMA and other regulatory bodies around the world.
Bio-Thera Solutions is developing several additional biosimilar products for the global market including biosimilar versions of Avastin®, Actemra®, Cosentyx®, Simponi® and Stelara®. QLETLI®, a biosimilar to Humira®, and Pobevcy®, a biosimilar to Avastin®, are approved by the NMPA and being commercialized in China.
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. A leader in next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and has two approved products, QLETLI® and POBEVCY® in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).
1 Nucala® is a registered trademark of GSK plc
2 Avastin® is a registered trademark of Genentech, Inc
3 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corporation
4 Cosentyx® is a registered trademark of Novartis AG
5 Simponi® is a registered trademark of Johnson & Johnson Corporation
6 Stelara® is a registered trademark of Johnson & Johnson Corporation
7 QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd
8 Humira® is a registered trademark of AbbVie Biotechnology Ltd
9 Pobevcy® is a registered trademark of Bio-Thera Solutions, Ltd
SOURCE: Bio-Thera Solutions
