Amphastar Pharmaceuticals announced a new exclusive license with its subsidiary Nanjing Hanxin Pharmaceutical Technology Co., Ltd. to develop and commercialize AMP‑110, a fully synthetic, highly purified human adrenocorticotropic hormone (ACTH) analog, in the United States and Canada. The agreement grants Amphastar U.S. and Canadian rights to the compound and includes an upfront payment of $2 million, potential development milestone payments of up to $14 million, sales milestone payments of up to $75 million, and royalty caps of $7.5 million per year and $60 million in total.
The transaction is a key milestone in Amphastar’s strategy to shift from commoditized injectables to proprietary, higher‑margin products. Management has set a target for proprietary therapeutics to comprise 50 % of the pipeline by 2026, and AMP‑110 adds a novel ACTH analog to the company’s portfolio of peptide candidates aimed at inflammatory and autoimmune indications.
The U.S. ACTH market exceeded $684 million in 2024, driven largely by treatments for infantile spasms, autoimmune disorders, and certain neurological conditions. AMP‑110’s synthetic design promises a cleaner safety profile compared with porcine‑derived ACTH products, potentially addressing unmet needs in patients who experience adverse reactions to existing therapies. The deal therefore positions Amphastar to capture a share of a sizable, growing market with a differentiated product.
Financially, the upfront $2 million is modest relative to the potential upside. The milestone structure—$14 million in development milestones and $75 million in sales milestones—could bring total payments of up to $89 million, while royalty caps limit long‑term cash outflows. These terms provide a balanced risk‑reward profile that supports Amphastar’s cash‑flow needs while allowing upside participation if AMP‑110 achieves commercial success.
Nanjing Hanxin, a fully integrated R&D and manufacturing arm of Amphastar, brings advanced peptide synthesis and purification capabilities to the partnership. AMP‑110 is currently in early‑phase human trials, with preliminary safety data reported as promising. The internal synergy between Amphastar’s commercial platform and Hanxin’s technical expertise is expected to accelerate development timelines and reduce regulatory hurdles.
Dr. Jack Zhang, Amphastar’s CEO, said the deal “strengthens our proprietary pipeline and aligns with our goal of becoming a leading developer of high‑margin peptide therapeutics. By leveraging Hanxin’s expertise, we can bring AMP‑110 to patients faster and with a product that offers a superior safety profile.”
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