Amphastar Pharmaceuticals announced on August 12, 2025, that it has secured exclusive licensing rights to three novel peptide therapeutics from Nanjing Anji Biotechnology through a comprehensive agreement potentially worth up to $453 million. The deal significantly expands Amphastar's proprietary pipeline with assets targeting high-value oncology and ophthalmology markets in the United States and Canada.
Three Distinct Therapeutic Approaches
The licensing agreement encompasses three innovative peptide products, each addressing different therapeutic challenges. The first product centers on Anji's discovery of an endogenous peptide that demonstrates a novel mechanism of action potentially suppressing the growth and metastasis of multiple poorly treated cancers.
The second asset represents a novel peptide-docetaxel conjugate designed to target a specific receptor, with the goal of improving docetaxel's selectivity and bioavailability. This conjugate is specifically engineered to reduce docetaxel-induced toxicity, which could enhance both the efficacy and safety profile of current taxane therapies.
The third product is an anti-vascular endothelial growth factor receptor (VEGFR) peptide of novel design, developed as a topical eye drop for treating wet age-related macular degeneration (wAMD). This formulation is intended to serve as an alternative to the routine eye injections currently used for wAMD treatment.
Strategic Partnership Structure
Under the agreement terms, Anji grants Amphastar exclusive licensing rights to intellectual property related to the three products within the specified territory. Reciprocally, Anji receives a non-exclusive license from Amphastar for certain intellectual property to develop, manufacture, use, and commercialize the licensed products outside the US and Canadian markets.
"We are delighted to announce a strategic licensing agreement with Anji, whose cutting edge research and development expertise in peptide and polypeptide therapeutics aligns perfectly with Amphastar's mission to develop novel, proprietary, and innovative products," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "This collaboration significantly expands our pipeline with three potentially best-in-class peptide assets, targeting high-growth markets across oncology and ophthalmology."
Financial Terms and Milestones
The financial structure includes immediate payments totaling $6 million, comprising a $0.75 million earnest money payment and a $5.25 million upfront payment to Anji upon signing. The agreement establishes additional potential development milestone payments of up to $42 million and sales milestone payments reaching up to $225 million, contingent upon achieving specific milestones based on annual net sales.
Amphastar will pay Anji 5% royalty payments on net sales, with a maximum accumulated amount of $60 million for each licensed product. Additionally, Anji will pay Amphastar low single-digit royalty payments on net sales of licensed products based on any patents licensed by Amphastar to Anji under the agreement.
Agreement Duration and Extension Rights
The licensing agreement will expire on a product-by-product and region-by-region basis ten years after the first commercial sale of each licensed product in the applicable region within the territory. Amphastar retains the right to extend the agreement for an additional ten years or until the expiration, lapse, or invalidation of the last remaining valid patent claim covering the licensed products in the territory, whichever occurs first.
Company Positioning and Expertise
Amphastar positions itself as a biopharmaceutical company focused on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. The company has identified proprietary medicine development as a major strategic direction in recent years and maintains manufacturing operations in the United States for all drug products, with active pharmaceutical ingredient production facilities in the United States, China, and France.
Nanjing Anji Biotechnology operates as a high-tech enterprise based in Nanjing, China, specializing in innovative peptide drugs and peptide-drug conjugates research and development. The company's technological capabilities include high-throughput endogenous micropeptide discovery technology, computer-aided peptide drug design technology, and a comprehensive preclinical drug evaluation platform.
