Access Pharmaceuticals Inc., focused on developing treatments in the areas of oncology and diabetes, today announced that its MuGard partner in China, RHEI Pharmaceuticals, has received the acceptance letter from the State Food and Drug Administration (SFDA) of China, confirming that all the documents needed for marketing approval for MuGard have been submitted and accepted.
MuGard is an oral wound rinse and coating designed to manage oral mucositis, a debilitating side effect of some anticancer treatments. As part of its licensing agreement with Access, RHEI is responsible for securing regulatory approvals for MuGard.
Together with its marketing partner Jian An Pharmaceuticals, RHEI has completed all the required steps to receive marketing approval in China and its other South East Asian territories. The company said it anticipates receiving marketing approval in the second half of this year.
“The acceptance of MuGard submission is a critical step in receiving marketing approval for MuGard in China and South East Asian territories,” Phillip Wise, vice president of Business Development and Strategy for Access stated in the press release. “We knew that the SFDA would perform a significant amount of due diligence before it would accept our MuGard submission. Receiving the acceptance letter helps us, as a company, gauge more accurately the timeline to marketing approval. We are pleased with RHEI and Jian An’s ability to streamline the process thus far and their continued progress and commitment to advancing the marketing approval.”
Access and RHEI noted that they recently signed a $30 million supply agreement for MuGard that ensures the manufacturing capacity of at least $30 million of product in the licensed territories.
RHEI also recently signed a sub-license agreement with Jian An, to leverage Jian An’s sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan.
For more information visit www.accesspharma.com