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Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

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Bio-Thera Solutions, a clinical-stage pharmaceutical company, today
announced that dosing has begun in a Phase I clinical study to compare
the pharmacokinetics and safety of BAT1806, a proposed biosimilar of
Actemra® (tocilizumab), to US-sourced Actemra® and
EU-sourced RoActemra® in normal healthy volunteers. The
clinical study is a randomized, double-blind, three-arm, parallel group,
single-dose study that is expected to enroll approximately 130 healthy
volunteers.

"Initiating our Phase I clinical trial for BAT1806, our proposed
biosimilar for Actemra®, is an important step for Bio-Thera
as we work to develop and commercialize safe and effective biosimilars
in China, the EU, the US and the rest of the world," said Shengfeng Li,
CEO, Bio-Thera Solutions. "Biosimilars will provide increased access to
important therapeutics to patients around the world."

Bio-Thera Solutions is developing several additional proposed
biosimilars, including a biosimilar version of Avastin®,
which is currently being evaluated in a global Phase III clinical trial.
Bio-Thera Solutions is also pursuing biosimilar versions of Humira®,
Stelara®, Cosentyx® and Simponi®.

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 five candidates into late stage
clinical trials and has applied for marketing authorization for one
candidate. In addition, the company has multiple promising candidates in
early clinical trials and IND-enabling studies, focusing on innovative
targets in immuno-oncology and autoimmune diseases. For more
information, please visit www.bio-thera.com/en/
or follow us on Twitter (@bio_thera_sol)
and wechat (Bio-Thera).

1 Actemra® is a registered trademark of Genentech, Inc
2
RoActemra® is a registered trademark of Genentech, Inc
3
Avastin® is a registered trademark of Genentech, Inc
4
Humira® is a registered trademark of Abbvie, Inc
5
Stelara® is a registered trademark of Janssen Biotech, Inc
6
Cosentyx® is a registered trademark of Novartis
Pharmaceuticals Corporation
7 Simponi® is a registered
trademark of Janssen Biotech, Inc

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