Kelun-Biotech says Phase III trial shows trastuzumab botidotin extends PFS vs T-DM1 in HER2+ metastatic breast cancer

• Sichuan Kelun-Biotech published Phase III results in Journal of Clinical Oncology for trastuzumab botidotin versus Roche’s T-DM1 in advanced HER2-positive breast cancer.
• Findings were previously presented as a late-breaking oral presentation at the 2025 ESMO Congress.
• The study showed stronger disease control with more durable tumor responses than T-DM1, supporting a differentiated efficacy profile.
• Safety appeared favorable versus T-DM1, with fewer serious events and discontinuations; eye-related side effects were the most common issue.
• China’s regulator has cleared the drug for second-line or later HER2-positive breast cancer, positioning it as a domestic alternative in a key segment.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN10950) on September 14, 2026, and is solely responsible for the information contained therein.