Bio-Thera Announces NMPA Approval of BAT2306, the First Secukinumab Biosimilar Approved in China

GUANGZHOU, China, Oct. 26, 2026 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, today announced that the National Medical Products Administration (NMPA) has approved its marketing authorization for BAT2306, a secukinumab biosimilar.  This approval marks the first secukinumab biosimilar approved in China and also the first secukinumab biosimilar approved by any major Regulatory Agency in the world.  BAT2306 will be marketed under the name 优卓美^® (YOUZHUOMEI) and is approved by NMPA for the following indications: psoriasis, ankylosing spondylitis, and psoriatic arthritis.

There are many patients with autoimmune diseases, such as psoriasis and ankylosing spondylitis, in China, and the demand for affordable biological agents is particularly prominent. The approval of 优卓美^® (YOUZHUOMEI) will bring a new and affordable treatment option to patients and help improve the clinical accessibility of biological agents.

"The approval of BAT2306 by NMPA is a major milestone for the company", said Shengfeng Li, CEO of Bio-Thera Solutions.  "Bio-Thera is committed to bringing biosimilars of important biologics to patients around the world.  The NMPA approval is the first step in fulfilling that promise with BAT2306."

Bio-Thera has signed commercialization agreements with multiple partners for BAT2306, covering countries and regions such as the Middle East and North Africa. (MENA), Latin America (LATAM) and Southeast Asia, extending the reach of BAT2306 to autoimmune patients around the world.

About Bio-Thera Solutions:

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including six approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in the EU, TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in the EU, a/k/a POBEVCY® in China, and GOTENFIA® (golimumab) in the EU and IMMGOLIS™ (golimumab-sldi) in the US. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).

Bio-Thera Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT2306, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.

Bio-Thera Contact:
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: [email protected]

SOURCE Bio-Thera Solutions, Ltd