Bio-Thera Solutions

Bio-Thera Solutions, Ltd. is a commercial-stage biopharmaceutical company based in Guangzhou, China, focused on developing biosimilars and innovative therapies. The company specializes in researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, and eye diseases, as well as other severe unmet medical needs. Bio-Thera Solutions has advanced multiple candidates into late-stage development, including three approved products in China: QLETLI, POBEVCY, and BAT1806. In the US, the company has one approved product, TOFIDENCE (BAT1806).

Bio-Thera Solutions has a robust pipeline of biosimilar candidates, including proposed biosimilars for Simponi, Stelara, Cosentyx, and Nucala. The company's BAT1806, a biosimilar to Actemra (tocilizumab), was approved by China's National Medical Products Administration (NMPA) in January 2023 for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. In December 2023, the US Food and Drug Administration (FDA) approved Avzivi (bevacizumab-tnjn), Bio-Thera's biosimilar referencing Avastin, marking the company's second FDA-approved product.

Bio-Thera Solutions utilizes its expertise in next-generation antibody discovery and engineering to develop its product pipeline. The company has more than 20 promising candidates in clinical trials, with a focus on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). In November 2023, Bio-Thera announced positive results from a Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara (ustekinumab), demonstrating similar efficacy and safety profile in patients with moderate to severe plaque psoriasis.

Key customers and partnerships

Bio-Thera Solutions has established several strategic partnerships to expand its global reach. In September 2021, the company entered into a license and commercialization agreement with Sandoz for Avzivi (BAT1706). Under this agreement, Bio-Thera is responsible for development and manufacturing, while Sandoz handles commercialization in the US and other countries worldwide.

In March 2024, Bio-Thera Solutions partnered with SteinCares to market two biosimilars in Latin America. This collaboration grants SteinCares exclusive rights to distribute and market Bio-Thera's pharmaceuticals in Brazil and other Latin American countries. Additionally, Bio-Thera has a commercialization and license agreement with Hikma for BAT2206, signed in August 2021, under which Hikma will commercialize the product in the US.