Kintor, Visum Enter COVID-19 Manufacturing Partnership
By Tim Wright, Editor, Contract Pharma | 04.19.21
To expand proxalutamide manufacturing for treatment of COVID-19 patients.
At present, Kintor Pharmaceutical is completing the Brazilian clinical trials of proxalutamide for treatment of male and female COVID-19 patients with mild or moderate symptoms and COVID-19 patients with severe symptoms. Preliminary data indicates that after proxalutamide treatment, the risk of hospitalization for male patients with mild or moderate COVID-19 symptoms is reduced by 100%, while that of female patients is reduced by 90%. The risk of death for patients with severe symptoms is reduced by 92%, and the hospital stay is shortened by 9 days.
Kintor Pharmaceutical recently announced that its Investigational New Drug (IND) application for Phase III clinical of proxalutamide for the treatment of COVID-19 patients has been approved by the U.S FDA.
"We are pleased to partner with Visum. With the clinical progress Kintor is making with proxalutamide for COVID-19 indications, Kintor needs to rapidly expand its existing GMP production capacity to cope with the demand necessary to fight the epidemic,” said Youzhi Tong, co-founder, chairman, and CEO of Kintor Pharmaceutical. “Visum has demonstrated technical strength in research and development, and the production of pharmaceutical products with stringent quality standards and extensive experience with U.S. FDA certifications. We believe that our partnership with Visum will offer proxalutamide as a significant contribution to the global COVID-19 prevention and control efforts."
Zhu Honggang, chairman of Visum, said, "It is a great honor to be able to provide high-quality and high-efficiency manufacturing services for Kintor as they approach regulatory approvals for proxalutamide. Since our founding in 2010, Visum has consistently adhered to the highest international quality standards and passed on-site inspections by the U.S. FDA with ‘zero defect.’ Visum looks forward to making full use of our existing high-end preparation processing production lines, and the high-standard and high-specification quality control systems to accelerate the availability of proxalutamide in the fight against Covid 19."