BAT8006

GUANGZHOU, China, June 25, 2025 /PRNewswire/ - Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer. The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator's choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. At the Rapid Oral Abstract Session of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, early clinical data of BAT8006 demonstrated promising results in platinum-resistant ovarian cancer. Among 133 enrolled patients (regardless of FRα expression levels or prior lines of therapy) in the dose-escalation and expansion study, the therapy achieved a median progression-free survival (PFS) of 7.63 months, with an objective response rate (ORR) of 40.7% and disease control rate (DCR) of 80.5%. Importantly, no cases of interstitial lung disease or ocular toxicity were observed. These findings indicate that BAT8006 exhibits significant clinical efficacy and a favorable safety profile, highlighting its strong clinical potential for platinum-resistant ovarian cancer. Platinum-resistant ovarian cancer remains a significant clinical challenge with poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate (ADC) is approved globally, and its indication is restricted to patients with FRα expression ≥75% (only 25%-30% of the platinum-resistant population). This approved therapy demonstrates limited median progression-free survival (mPFS) and is associated with ocular toxicity. As one of the first FRα ADCs in China entering a pivotal phase 3 clinical trial, BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients (regardless of FRα expression levels). These promising data suggest BAT8006 may offer a novel therapeutic option for this difficult-to-treat population. 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 five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCETM (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in China. 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 or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT8006 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, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful 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 undertake 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. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. STARJEMZA® is a registered trademark of Hikma Pharmaceuticals. TOFIDENCE™ is a trademark of Organon LLC AVZIVI® is a registered trademark of Sandoz POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Bio-Thera Contacts Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED