Sichuan Biokin Launches Phase III Trial of T‑Bren for HER2‑Mutant NSCLC

Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today the enrollment of the first patient in its Phase III clinical trial of T‑Bren for Injection (HER2 ADC) versus pembrolizumab plus platinum‑based chemotherapy for first‑line treatment of advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) with HER2 mutations.

Key Trial Highlights

• First‑in‑class HER2‑targeting antibody‑drug conjugate (ADC) – T‑Bren (BL‑M07D1) has shown significant antitumor efficacy in early‑phase studies.
• Phase III design – Randomized, open‑label, multi‑center study comparing T‑Bren to the current standard of care (pembrolizumab + platinum).
• Patient enrollment milestone – First patient screened and dosed on the study site, marking the official start of the Phase III program.
• Strategic positioning – The trial targets the growing market of HER2‑mutant NSCLC, a subset with limited therapeutic options and poor prognosis.

About T‑Bren (BL‑M07D1)

• Innovative HER2‑ADC platform – Combines a humanized HER2‑specific antibody with a potent cytotoxic payload, delivering targeted cell‑killing while sparing normal tissue.
• Preclinical/early‑phase data – Demonstrated robust tumor regression in HER2‑positive models and favorable safety profile.
• Competitive advantage – First ADC to specifically target HER2 mutations in NSCLC, potentially offering superior efficacy over existing checkpoint‑based therapies.

Strategic Impact for Sichuan Biokin

• Accelerated development pipeline – Successful Phase III initiation positions T‑Bren for regulatory submission in China, the U.S., and other key markets.
• Market differentiation – By addressing an underserved patient population, the company can capture significant market share in the rapidly expanding HER2‑oncology segment.
• Future roadmap – Positive results could pave the way for T‑Bren’s expansion into other HER2‑driven malignancies (e.g., breast, gastric) and combination strategies.

Forward‑Looking Statements

This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech