Kintor Pharmaceutical Limited announced that it has entered into a licensing agreement with Shanghai Fosun Pharmaceutical Development Ltd. (“Fosun Pharma Development”), on the commercialisation of proxalutamide for the treatment of COVID-19 indication in India and 28 African countries (the”Collaboration Regions”). Kintor and Fosun Pharma Development will collaborate on the emergency use authorization applications, promotion, and sales of proxalutamide for the treatment of COVID-19 indication.
According to the licensing agreement, Fosun Pharma Development will be granted exclusive rights of registration and commercialisation of proxalutamide in the Collaboration Regions. Kintor Pharmaceutical will be eligible to receive upfront payment and milestone payments up to RMB560 million (upfront and development milestone payments up to RMB110 million and commercialisation milestone payments of RMB450 million). Kintor Pharmaceutical will also be eligible to receive royalty payments that are not less than 50% of the total operating profit in the Collaboration Regions, based on a tiered structure per the amount of net sales as agreed by both companies.
Proxalutamide is a new-generation androgen receptor (AR) antagonist. Since the outbreak of the COVID-19 pandemic in early 2020, Kintor Pharmaceutical has made rapid progress on the study on proxalutamide as a potential treatment for COVID-19 indication.
In 2021, Kintor Pharmaceutical received approval from the U.S. Food and Drug Administration (FDA) and the Brazilian Health Regulatory Agency (ANVISA) to conduct phase III clinical trials with proxalutamide in patients with COVID-19. The company is now conducting two registered phase III multi-regional clinical trials (MRCT) of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT for COVID-19 inpatients in countries and regions including the United States, South America (including Brazil), the European Union, and Asia.
Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical, commented, “The global COVID-19 pandemic continues to infect patients and devastate communities. Kintor hopes to accelerate emergency use authorizations for proxalutamide in developing countries severely affected by the pandemic to improve the lives of patients infected with COVID-19. With Fosun Pharma Group’s excellent abilities in registration and commercialisation overseas, we hope to achieve win-win in the Collaboration Regions, so that more COVID-19 patients can be benefited from proxalutamide. “