Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals has partnered with TaiRx, Inc., a premier Taiwan new drug development company, to manufacture a novel anticancer drug, CVM-1118.
CVM-1118 is a new small molecule chemical entity being developed by TaiRx as a potential anti-cancer agent in numerous human cancer cell lines with strong anti-cancer activity, high safety margin, and multiple mechanisms of actions in targeting cancer-specific factors.
In particular, CVM-1118 possesses the novel mechanism of inhibiting a unique structure known as vasculogenic mimicry (VM), which is associated with metastasis and drug-induced resistance in malignant tumors. The safety of orally administering CVM-1118 on a human is evaluated from the phase 1 study U.S. FDA. Based on results of the Phase I clinical studies, CVM-1118 obtained the approval to conduct two Phase II clinical trials by both the U.S. FDA and Taiwan FDA.
Commenting on the partnership Bobby Sheng, CEO of Bora Pharmaceuticals said: “We are extremely excited about this new partnership with TaiRx. As a trusted global pharmaceutical partner, we look forward providing many of our technical and quality resources to TaiRx and supporting them on this important project.”
“As we enter the second stage of clinical trials, we hope our success continues and we hope to gain approval from the NDA for CVM-1118 in the near future.”, said Dr. Du-Shieng Chien, President and CEO.
The manufactured batches will be used to further support Phase II clinical trials and then submitted to the NDA for approval. Bora Pharmaceuticals’ sites already have an excellent track record with many regulatory agencies around the world including the USFDA, MHRA, TFDA, ANVISA, Health Canada, and many others.
Bora Pharmaceuticals recently announced it acquired a $100m Biologics site in Taiwan as part of its 5-year growth plan. The investment enables Bora Pharmaceuticals to significantly expand its capabilities in the Biologics space, which will allow its customers to gain access to high-quality manufacturing facilities for their new and innovative pharmaceutical products.