Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara� (Ustekinumab)

GUANGZHOU, China–(BUSINESS WIRE)–#Stelara–Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, today announced that dosing has begun in 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.

“The initiation of this clinical trial represents an important milestone for our biosimilar pipeline,” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “BAT2206 is the fifth biosimilar that Bio-Thera has advanced into clinical development. It signifies Bio-Thera’s continued commitment to developing and providing safe, effective, and affordable biological 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 is approved by the NMPA in China. Bio-Thera’s lead global biosimilar is BAT1706, a biosimilar to Avastin®, has completed a global Phase III clinical trial and the BLA has been submitted and accepted by NMPA. Regulatory submissions for BAT1706 to FDA and EMA will occur in 2020Q4. Bio-Thera Solutions is also pursuing biosimilar versions of Actemra®, Cosentyx® and Simponi®.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical 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. As a leader in the next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and one of which, QLETLI® (???^®), a biosimilar to Humira^® (adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis in China. In addition, the company has multiple 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 Stelara® is a registered trademark of Johnson & Johnson Corporation

2 QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

3 Humira® is a registered trademark of AbbVie Biotechnology Ltd.

4 Avastin® is a registered trademark of Genentech, Inc.

5 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corporation

6 Cosentyx® is a registered trademark of Novartis AG

7 Simponi® is a registered trademark of Johnson & Johnson Corporation

Contacts

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

bethomas@bio-thera.com