Amphastar Pharmaceuticals, Inc. 8-K

What Happened
Amphastar Pharmaceuticals filed an 8‑K reporting that on January 6, 2026 it entered a License Agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. under which Hanxin granted Amphastar an exclusive license to develop, make, use and commercialize corticotropin-containing products in the United States and Canada. Amphastar paid $2.0 million upfront and agreed to additional development and sales milestone payments and capped royalty arrangements. The company also announced related amendments to an existing Distribution Agreement and Manufacturing Agreement between Amphastar subsidiaries and Hanxin affiliates to expand territories and clarify terms.

Key Details

• License signed: January 6, 2026; press release furnished January 12, 2026.
• Payments: $2.0M upfront; up to $14M in development milestones; up to $75M in sales milestones; royalties payable by Amphastar are capped at $7.5M per year and $60M in total for the Licensed Product.
• License term: expires region-by-region 10 years after first commercial sale in each region, with Amphastar option to extend up to 10 additional years (subject to patent life/claims).
• Related-party: Hanxin is majority‑owned by family members of Amphastar’s CEO and Chair; the Distribution and Manufacturing amendments were reviewed and approved by Amphastar’s Audit Committee. Distribution territory expanded to include Middle East and Southeast Asia; Manufacturing Amendment expands global rights (outside US/Canada for certain products) and adds IP, indemnity and liability terms.

Why It Matters
This deal gives Amphastar exclusive U.S./Canadian rights to a corticotropin compound, a product area that could generate future commercial revenue if developed and approved. The agreement requires a modest upfront payment but includes sizable potential milestone and royalty obligations tied to development progress and sales; royalties are capped, which limits Amphastar’s long‑term royalty exposure. The transactions are related‑party in nature, which the company disclosed and had reviewed by its Audit Committee — a governance detail investors should note when assessing potential conflicts and strategic benefits.