Amphastar (NASDAQ: AMPH) inks $2.8M related-party AMP-107 cell bank pact

Rhea-AI Filing Summary

Amphastar Pharmaceuticals entered into a three-year contract research agreement with Nanjing Hanxin Pharmaceutical Technology effective September 15, 2025. Under this deal, Hanxin will develop Recombinant Peptide Research Cell Banks (RCBs) for Amphastar’s product candidate AMP-107 and license them under a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license.

All title to the RCBs and related development and manufacturing know-how, including engineering, scientific data, designs, and procedures, will belong to Amphastar. The total cost of the agreement will not exceed approximately $2.8 million, paid in Chinese yuan, including an initial payment of about $0.3 million on the effective date, with any extra work billed on a cost-plus basis subject to prior approval.

The filing notes this is a related-party transaction because Amphastar CEO Dr. Jack Zhang, COO and Chairman Dr. Mary Luo, and certain family members beneficially own a majority of Hanxin’s equity. The independent and disinterested members of the Audit Committee evaluated and approved Amphastar’s entry into the agreement.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

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CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

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Date of Report (Date of earliest event Reported): September 15, 2025

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Amphastar Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

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Delaware	001-36509	33-0702205
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification Number)

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11570 6th Street	​
Rancho Cucamonga, California	91730
(Address of Principal Executive Offices)	(Zip Code)

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Registrant's telephone number, including area code: (909) 980-9484

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Securities registered pursuant to Section 12(b) of the Act:

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Title of each class	​	Trading Symbol(s)	​	Name of each exchange on which registered
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Common Stock, par value $0.0001 per share	​	AMPH	​	The Nasdaq Stock Market LLC
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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).

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Emerging growth company ☐

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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. ☐

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Item 1.01. Entry into a Material Definitive Agreement.

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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.

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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.

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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.

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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.

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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.

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	AMPHASTAR PHARMACEUTICALS, INC.
Date: September 18, 2025
​	By:	/S/WILLIAM J. PETERS
	​	William J. Peters
	​	Chief Financial Officer, Executive Vice President and Treasurer
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FAQ

What agreement did Amphastar Pharmaceuticals (AMPH) enter into with Nanjing Hanxin?

Amphastar Pharmaceuticals entered into a three-year contract research agreement with Nanjing Hanxin Pharmaceutical Technology under which Hanxin will develop Recombinant Peptide Research Cell Banks (RCBs) and license them to Amphastar under a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license.

How will the RCBs developed by Hanxin be used by Amphastar (AMPH)?

The RCBs developed by Hanxin will be used by Amphastar to create Master Cell Banks for one of its product candidates, AMP-107, supporting further development and manufacturing activities for that program.

What is the total cost and payment structure of Amphastar’s agreement with Hanxin?

The total cost of the agreement to Amphastar will not exceed approximately $2.8 million, with all payments made in Chinese yuan and adjusted based on actual exchange rates. Amphastar will pay Hanxin about $0.3 million on the effective date, and any additional work outside the agreed Scope of Work will be billed on a cost plus basis, subject to Amphastar’s prior approval.

Who owns the RCBs and related technology under Amphastar’s agreement?

Under the agreement, Amphastar will own all title to the RCBs that Hanxin develops, prepares, and produces, as well as any confidential and proprietary information and technology related to the development and manufacturing of the RCBs, including engineering data, research results, designs, and procedures.

Why is the Amphastar–Hanxin contract considered a related-party transaction?

The contract is considered a related-party transaction because Amphastar’s CEO, President, and Director Dr. Jack Zhang, its Chairman and COO Dr. Mary Luo, and certain members of their family beneficially own a majority of Hanxin’s equity interest, as previously disclosed in Amphastar’s 2025 definitive proxy statement.

How was the related-party aspect of the Amphastar–Hanxin agreement approved?

The agreement was evaluated and approved by the independent and disinterested members of Amphastar’s Audit Committee after they reviewed applicable considerations, reflecting the company’s internal governance process for related-party arrangements.

What is the duration of Amphastar’s contract research agreement with Hanxin?

The term of the agreement between Amphastar and Hanxin is three years from the effective date of September 15, 2025, as specified in the contract research agreement.