UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
On September 15, 2025 (the “Effective Date”) Amphastar Pharmaceuticals, Inc. (the “Company”), entered into a contract research agreement (the “Agreement”) with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. (“Hanxin”). Pursuant to the Agreement, Hanxin will develop Recombinant Peptide Research Cell Banks (“RCBs”) for the Company and license the RCBs to the Company subject to a fully paid, exclusive, perpetual, transferable, sub-licensable license worldwide (the “Transaction”). The RCBs will be used by the Company to make Master Cell Banks for one of its product candidates, AMP-107. Hanxin is obligated to keep the Company informed of progress of development and research as set forth in the Scope of Work, which is incorporated as Appendix A to the Agreement (the “Scope of Work”). Per the terms of the Agreement, all title to the RCBs developed, prepared and produced by Hanxin in conducting research and development will belong to the Company. The Company will also own any confidential and proprietary information, technology regarding development and manufacturing of the RCBs, which include, but are not limited to, engineering, scientific and practical information and formula, research data, design, and procedures to develop and manufacture the RCBs, in use or developed by Hanxin. Each of the Company and Hanxin have made customary representations, warranties and covenants in the Agreement. The term of the Agreement is three years from the Effective Date.
Payments under the agreement will be made in Chinese yuan. The total cost of the Agreement to the Company will not exceed approximately $2.8 million, with payments adjusted based on actually currency exchange rates. The Company will pay Hanxin approximately $0.3 million on the Effective Date. Any additional work or changes to the Scope of Work requested by the Company will be charged by Hanxin to the Company on a cost plus basis, plus any applicable taxes. Any additional cost must be provided to the Company for approval prior to the work being performed.
As previously disclosed in the Definitive Proxy Statement for the Company’s 2025 Annual Meeting of Stockholders, as filed with the Securities and Exchange Commission (the “SEC”) on Schedule 14A on April 14, 2025, Dr. Jack Zhang, the Company’s Chief Executive Officer, President, and Director; and Dr. Mary Luo, the Company’s Chairman, Chief Operating Officer, and Director; and certain members of their family beneficially own a majority of the equity interest in Hanxin. Accordingly, the independent and disinterested members of the Audit Committee of the Board of Directors of the Company evaluated and approved entry into the Agreement following their review of applicable considerations.
The foregoing is a brief description of the material terms of the Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the copy of the Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q to be filed with the SEC for the fiscal quarter ending September 30, 2025, and is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMPHASTAR PHARMACEUTICALS, INC. | ||
Date: September 18, 2025 |
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By: | /S/WILLIAM J. PETERS |
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| William J. Peters | ||
| Chief Financial Officer, Executive Vice President and Treasurer | ||
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Document and Entity Information |
Sep. 15, 2025 |
|---|---|
| Document and Entity Information [Abstract] | |
| Document Type | 8-K |
| Document Period End Date | Sep. 15, 2025 |
| Entity Registrant Name | Amphastar Pharmaceuticals, Inc. |
| Entity Incorporation, State or Country Code | DE |
| Entity File Number | 001-36509 |
| Entity Tax Identification Number | 33-0702205 |
| Entity Address, Address Line One | 11570 6th Street |
| Entity Address, City or Town | Rancho Cucamonga |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 91730 |
| City Area Code | 909 |
| Local Phone Number | 980-9484 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $0.0001 per share |
| Trading Symbol | AMPH |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
| Entity Central Index Key | 0001297184 |
| Amendment Flag | false |