Amphastar Pharmaceuticals Inc. has entered into an exclusive license agreement with Nanjing Hanxin Pharmaceutical Technology Co. Ltd. for the development, and commercialization of fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analogs, now designated AMP-110, in the United States and Canada.

AMP-110 is designed to address inflammatory and autoimmune conditions with a potentially improved safety profile compared to porcine-derived ACTH products. It is currently in early-phase human clinical development with early human studies demonstrating a promising safety profile.

“AMP-110 represents a strategically important addition to our growing proprietary peptide portfolio,” said Dr. Jack Zhang, Amphastar’s President and CEO. “This asset aligns with our long-term vision to develop innovative proprietary products. The fully synthetic nature of AMP-110 offers a potential for a differentiated safety profile, and we believe this program positions us well in a meaningful and growing therapeutic category.”

Under the terms of the Agreement, Hanxin is granting Amphastar an exclusive license to certain intellectual property related to AMP-110 in the United States and Canada. Additionally, Hanxin will receive a non-exclusive license from Amphastar for certain intellectual property to develop and commercialize the compound in all other territories.

As part of the Agreement, Amphastar made an upfront payment of $2 million to Hanxin upon signing, with additional payments to Hanxin consisting of up to $14 million in development milestone payments and up to $75 million in sales milestone payments. In addition, Amphastar will pay Hanxin royalty payments, which are not to exceed $7.5 million each calendar year and a maximum accumulated amount of $60 million. Hanxin will also pay Amphastar a royalty payment of net sales that are based on any patents licensed by Amphastar to Hanxin under the agreement.