Bio-Thera Solutions and Hikma Pharmaceuticals announce exclusive commercialization and license agreement for BAT2206 in the US, a proposed biosimilar referencing Stelara® (ustekinumab)

Guangzhou and London, 27 August 2021 – Bio-Thera Solutions, Ltd. (688177.SH) and Hikma Pharmaceuticals PLC (LSE: HIK) today announced that they have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar referencing Stelara® (ustekinumab), in the United States (US). BAT2206 is currently in a global Phase III clinical trial.

Press Release Corporate 27 August 2021

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206.  Hikma will have exclusive rights to commercialize the product in the US. The agreement also provides Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million.

“Partnering with Hikma to commercialize BAT2206, our ustekinumab biosimilar, further validates the high quality of the work performed at Bio-Thera,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “We are proud to expand our network of partners to include another great company like Hikma.”

“This partnership provides us with a unique opportunity to enter the biosimilar market in the US, building on our position as a leading generic manufacturer in the US,” said Siggi Olafsson, Chief Executive Officer of Hikma. “Tapping into the growth of the biosimilar market in the US has been an area of focus for Hikma. Our established commercial presence in the US market and Bio-Thera’s strong technical capabilities for the development and manufacturing of biological products are highly complementary and we are excited by the potential this partnership offers.”

About BAT2206 (ustekinumab)

BAT2206 is a proposed biosimilar to Jansen’s Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases.  Stelara® is currently approved for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults.

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