1 November 2022 - - Dosing has begun in a Phase III clinical study for BAT2306, a proposed biosimilar of Cosentyx (secukinumab), China-based commercial-stage pharmaceutical company Bio-Thera Solutions, Ltd. (688177.SH) said.

The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2306 to Cosentyx in patients with moderate to severe plaque psoriasis.

Secukinumab is a human IgG1κ monoclonal antibody that binds to the protein interleukin -17A. In the US, secukinumab is prescribed for the following indications: people 6 years of age and older with moderate to severe plaque psoriasis, people 4 years of age and older with active enthesitis-related arthritis, people 2 years of age and older with active psoriatic arthritis adults with active ankylosing spondylitis, adults with active non-radiographic axial spondyloarthritis and objective signs of inflammation.

After the conclusion of the Phase 3 study Bio-Thera plans to 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 Actemra, Simponi, Stelara, and Nucala. QLETLI, a biosimilar to Humira, and Pobevcy, a biosimilar to Avastin, are approved by the NMPA and being commercialized in China.

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 eight 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.