BDB-201 is under clinical development by Seven and Eight Biopharmaceuticals and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect BDB-201’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 27 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their BDB-201 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

BDB-201 overview

Orien X-010 (BDB-201) is under development for the treatment of acral melanoma and solid tumors. The drug candidate is administered through intratumor route. The drug candidate consists of a replicating recombinant attenuated herpes simplex virus type I (Type I Herpes Simplex Virus, HSV-1) oncolytic vectors isolated from Chinese Han population. The genotype of HSV-1 was deleted from the genome of OrienX-010 and the DNA fragment encoding human GM-CSF was inserted so that the product only replicates specifically in tumor cells.

Orien X-010 was also under development for the treatment of malignant solid tumors including liver cancer, pancreatic cancer and lung cancer.

Quick View BDB-201 LOA Data

Report Segments
  • Innovator
Drug Name
  • BDB-201
Administration Pathway
  • Intratumor
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.