Bora Pharmaceuticals Partners With TaiRx to Manufacture Breakthrough Anti-Cancer Drug
Bora Pharmaceutical Laboratories Inc., a division of Bora Pharmaceuticals, has partnered with TaiRx, Inc., a premier Taiwan new drug development company, to manufacture a novel anti-cancer 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 US FDA. Based on results of the Phase 1 clinical studies, CVM-1118 obtained the approval to conduct two Phase 2 clinical trials by both the US 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,” added Dr. Du-Shieng Chien, President and CEO.
The manufactured batches will be used to further support Phase 2 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 $100-million 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. Find more information on its current services here.
Bora Pharmaceuticals is a premier international CGMP CDMO specializing in complex oral solid dosage, non-sterile liquids, nasal sprays, and semi-solids pharmaceutical Rx and OTC products for late-phase clinical through commercial manufacturing and packaging. Bora owns and operates three state-of-the-art CGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. Our TAA-compliant sites deliver to more than 100 markets around the world, including the US, Canada, EU, Southeast Asia, Middle East, and South and Central Americas. Bora handles high potency compounds, solvents, flammables, and IR/SR/ER release profile products. For more information, visit www.boracorpcdmo.com.
TaiRx, Inc. was founded in 2011, a Taiwan R&D based pharmaceutical company with global talents focusing on a new generation of oncology molecule for Asian and global markets. TaiRx has a rich product pipeline and many of products are moving rapidly into various clinical stages to ensure the safety and efficacy of the drug products. TaiRx has profound global drug development knowledge and experience to expedite the drug development process.
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