Guangzhou, China --(BUSINESSWIRE)-- 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.mjtiyu.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT2606 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.

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