GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera
Solutions, Ltd., a clinical-stage pharmaceutical company, today
announced that the China National Medical Products Administration (NMPA)
has approved its Investigational New Drug (IND) application to initiate
a Phase I clinical study to compare the pharmacokinetics and safety of
BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced
and EU-sourced reference product in normal healthy volunteers. The
clinical study will be a randomized, double-blind, parallel group,
single-dose study that is expected to enroll approximately 270 healthy
volunteers.
“This IND approval represents an important milestone for our biosimilar
pipeline,” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “BAT2206
will be the fifth biosimilar that Bio-Thera will advance into clinical
development. It signifies Bio-Thera’s continued commitment to developing
and commercializing biosimilar products for patients in China and
around the world.”
Bio-Thera Solutions is developing several additional biosimilar
products, including QLETLI®, a biosimilar to Humira®, which was recently
approved by the NMPA in China and BAT1706, a biosimilar to Avastin®,
which is currently being evaluated in a global Phase III clinical trial.
Bio-Thera Solutions is also pursuing biosimilar versions of Actemra®,
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. The company has one approved product in China and
has advanced four candidates into late stage clinical trials. 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.fulannite.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Stelara® is a registered trademark of Johnson & Johnson Corporation
2 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
3 Avastin® is a registered trademark of Genentech, Inc.
4 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corporation
5 Cosentyx® is a registered trademark of Novartis AG
6 Simponi® is a registered trademark of Johnson & Johnson Corporation