China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation to BL-B01D1 for patients with recurrent small cell lung cancer who have failed platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibody therapy, Sichuan Baili Tianheng Pharmaceutical announced today.
BL-B01D1, a pioneering EGFR × HER3 bispecific antibody-drug conjugate (ADC), represents a significant advancement in targeted cancer therapy. It holds the distinction of being the first and only bispecific ADC of its kind to reach clinical development globally.
Expanding Treatment Portfolio
The latest designation marks the fifth breakthrough therapy status for BL-B01D1, demonstrating its broad potential across multiple cancer indications. Previous breakthrough designations were received for:
- Recurrent or metastatic nasopharyngeal carcinoma (April 2024)
- Advanced non-squamous non-small cell lung cancer with EGFR mutations post-EGFR-TKI failure
- EGFR wild-type non-small cell lung cancer after failed anti-PD-1/PD-L1 therapy (September 2024)
- Recurrent or metastatic esophageal squamous cell carcinoma (October 2024)
Comprehensive Clinical Development Program
The drug is currently undergoing extensive clinical evaluation in both China and the United States, with more than 20 ongoing clinical trials. The development program includes:
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Seven Phase III trials evaluating BL-B01D1 monotherapy for later-line treatment across multiple cancers, including:
- Two non-small cell lung cancer indications
- One small cell lung cancer indication
- Two breast cancer indications
- One esophageal squamous cell carcinoma indication
- One nasopharyngeal carcinoma indication
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Nine combination studies with PD-(L)1 therapies for first-line treatment in various cancers, including small cell lung cancer, non-small cell lung cancer, nasopharyngeal cancer, and other solid tumors
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Two Phase II trials investigating combinations with TKIs in lung cancer
Regulatory Implications
Under the NMPA's breakthrough therapy program, BL-B01D1 will receive prioritized resource allocation and enhanced regulatory guidance to expedite its development. The designation is specifically designed to accelerate the development of promising therapies that address significant unmet medical needs.
The company noted that while this designation represents an important milestone, drug development remains subject to various uncertainties including technical challenges, regulatory requirements, and market dynamics. Baili Tianheng has committed to advancing these development programs in accordance with regulatory requirements and will provide timely updates on the project's progress.
