Pipeline: BPI-7711


Mode of Action

  • 3rd generation irreversible EGFR-TKI for the treatment of Non Small Cell Lung Cancer (NSCLC) patients.
  • Independently developed by Beta Pharma research team. Beta Pharma, Inc. fully owns all of the IP rights, PCT patent # WO2016094821A2.
  • Overcome the drug resistance and toxicity problems of 1st/2nd generation EGFR-TKIs.
  • Well tolerated and highly effective in NSCLC patients with advanced or recurrent EGFR/T790M mutation progressed after 1st generation EGFR-TKI treatment.
  • Demonstrated a promising efficacy on brain metastases.
  • A total of 636 patients were screened and 226 were finally enrolled. Clinical study data showed excellent efficacy (also as the only one clinical trial in the third generations of EGFR-TKI which accepted positive peripheral blood sample, which is closer to the real-world screening method of most patients), good safety and tolerability, and outstanding efficacy for patients with brain metastasis. BPI-7711 is expected to be best-in-class third-generation EGFR-TKI for the treatment of patients with brain metastases.


  • Pre-clinical development complete.
  • Chinese clinical trial application (CTA) filed and approved in 2017.
  • Phase I clinical trial recruitment has been completed in November, 2019.  172 patients were enrolled.  Final data analysis and reports are in progress.
  • Pivotal phase IIb trial was launched in March 2, 2019. By December 2019, 212 patients have been enrolled and trial recruitment will complete in January 2020.
  • Pre-ind meeting with US FDA has been scheduled in February 2020.
  • Pivotal phase III trial is targeting the treatment-naive EGFR mutation NSCLC patients. Phase III trial has started and expected to be completed in 18-24 months.
  • Phase IIb Clinical Trial (2nd Line Treatment) Interim Analysis Data has been submitted in NDA. NDA approval is expected in Q2 or Q3 of 2022.
  • Phase III Clinical Trial (1st Line Treatment) patient enrolling now.

Major Publication & Key Data

Poster-2016 APLCC

Chiang Mai, THAILAND
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Poster-2019 ASCO

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Presentation-2019 NACLC

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