Biotech Companies BIO-THERA and SteinCares Sign Licensing and Commercialization Agreement for Two Investigational Biosimilar Drugs, Valued at $6 Million

BIO-THERA and SteinCares, two prominent biotech companies, have recently entered into a significant licensing and commercialization agreement worth $6 million. This agreement involves the exclusive rights to develop and market two investigational biosimilar drugs, BAT2506 (Golimumab Injection) and BAT2606 (Mepolizumab Injection), in Brazil and other Latin American markets. The partnership aims to leverage the expertise of both companies to bring these innovative therapies to patients in need.

BIO-THERA announced on March 18th that it has signed an agreement with SteinCares granting them the licensed rights and commercialization privileges for BAT2506 and BAT2606 in Brazil and other Latin American regions. Under the terms of the agreement, BIO-THERA will be responsible for the research, development, production, and commercial supply of both biosimilar drugs. Additionally, BIO-THERA will submit the necessary applications for regulatory approval to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As part of the agreement, BIO-THERA stands to receive a total payment of up to $6 million, including an upfront payment of $1.2 million and milestone payments of up to $4.8 million. Furthermore, BIO-THERA will also be entitled to a percentage of net sales as a revenue-sharing arrangement. SteinCares, on the other hand, will gain exclusive distribution and sales rights for these biosimilar drugs in Brazil and other Latin American markets.

BAT2506, a biosimilar of Golimumab developed by BIO-THERA, selectively targets soluble and transmembrane human TNF-α, thereby inhibiting its activity by blocking the binding of TNF-α to its receptor TNFR. Golimumab is an antibody that has shown efficacy in treating various inflammatory conditions. BAT2606, another biosimilar developed by BIO-THERA, is a Mepolizumab-based therapy that specifically binds to human IL-5, blocking its interaction with the alpha chain of the receptor complex expressed on eosinophils. This mechanism helps reduce eosinophil levels and alleviate inflammation associated with conditions such as asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).

BIO-THERA's strategic approach in pursuing a global development strategy for biosimilar drugs has proven successful. In recent years, the company gained approval for its biosimilar drugs, including Trastuzumab and Bevacizumab, in the European and American markets. This achievement marked a significant milestone for domestically-produced antibody biosimilars entering the global market. Notably, BIO-THERA, along with other domestic companies such as Qilu Pharmaceutical and Fosun Pharma, has demonstrated remarkable success in the commercialization of antibody biosimilar drugs in the Chinese market.

The licensing and commercialization agreement between BIO-THERA and SteinCares for two investigational biosimilar drugs, BAT2506 and BAT2606, represents a significant step towards expanding access to innovative therapies in Brazil and other Latin American markets. This collaboration leverages the strengths and expertise of both companies, with BIO-THERA leading the research, development, and production of the biosimilars, while SteinCares assumes exclusive distribution and sales rights. The partnership not only holds promising potential for patients in need but also highlights the growing prominence of Chinese biotech companies in the global biosimilars market.