# EDGAR Filing Document

**Accession Number:** 0001297184
**File Stem:** 0001297184-26-000002
**Filing Date:** 2026-1
**Character Count:** 19341
**Document Hash:** 76286a97632244c71bba4dffb227207c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001297184-26-000002.hdr.sgml**: 20260112

**ACCESSION NUMBER**: 0001297184-26-000002

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260106

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260112

**DATE AS OF CHANGE**: 20260112

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Amphastar Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001297184
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 330702205
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36509
- **FILM NUMBER:** 26527736

**BUSINESS ADDRESS:**
- **STREET 1:** 11570 SIXTH STREET
- **CITY:** RANCHO CUCAMONGA
- **STATE:** CA
- **ZIP:** 91730
- **BUSINESS PHONE:** 909-980-9484

**MAIL ADDRESS:**
- **STREET 1:** 11570 SIXTH STREET
- **CITY:** RANCHO CUCAMONGA
- **STATE:** CA
- **ZIP:** 91730

?xml version='1.0' encoding='ASCII'? Amphastar Pharmaceuticals, Inc._January 6, 2026

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**PURSUANT TO SECTION 13 OR 15(d) OF THE**

**SECURITIES EXCHANGE ACT OF 1934**

Date of Report (Date of earliest event Reported): January 6, 2026

**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<br>Incorporation) | (Commission File Number) | (I.R.S. Employer Identification<br>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**

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:

☐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))

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

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| | | |
|:---|:---|:---|
| T<br>|  |  |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| 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).

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. ☐

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**Item 1.01.** **Entry into Material Definitive Agreement and Amendment of a Material Definitive Agreement.** 

*Material Definitive Agreement.*

On January 6, 2026, Amphastar Pharmaceuticals, Inc ("Amphastar" or, the "Company"), and Nanjing Hanxin Pharmaceutical Technology Co., Ltd. ("Hanxin"), entered into a License Agreement ("License Agreement") pursuant to which Hanxin is granting an exclusive license to certain intellectual property controlled by Hanxin to develop, make, use and commercialize products incorporating or comprising of corticotropin compound ("Licensed Product") in the United States and Canada (the "Territory"). Hanxin is also granted a non-exclusive license under certain intellectual property controlled by Amphastar to develop, make, use and commercialize Licensed Product outside the Territory. Amphastar made an upfront payment of $2 million to Hanxin upon signing the License Agreement. Amphastar is also required to make payments to Hanxin consisting of up to $14 million in development milestone payments and up to $75 million in sales milestone payments, subject to the achievement of the applicable development and sales milestone events respectively, and royalty payments, not to exceed a maximum annual amount of $7.5 million each calendar year and a maximum accumulated amount of $60 million for the Licensed Product. Hanxin will pay to Amphastar a royalty payment of net sales of Licensed Product that are based on any patents licensed by Amphastar to Hanxin under the License Agreement or regulatory exclusivity covering such Licensed Product. The term of the License Agreement will expire, region-by-region basis, on the tenth anniversary of the first commercial sale of the Licensed Product in the applicable region in the Territory, with Amphastar having the right to extend the License Agreement until the earlier of ten additional years or the expiration, lapse, or invalidation of the last remaining valid claim of the patents licensed by Hanxin to Amphastar that covers the Licensed Product in the Territory.

*Distribution Amendment*

On January 6, 2026, Armstrong Pharmaceuticals, Inc. a wholly-owned subsidiary of the Amphastar and Hong Kong Genreach Limited ("Genreach") a wholly-owned subsidiary of Hanxin entered into an amendment to the Distribution Agreement (the "Distribution Amendment"), originally entered into on August 28, 2024, as previously reported by the Company on a Current Report on Form 8-K filed on August 30, 2024 (the "Distribution Agreement").

The Distribution Amendment expands the region of the Distribution Agreement with the additions of Middle East countries and Southeast Asian countries and includes additional administrative and definitional changes. The change in value of the Distribution Amendment is not determinable at this time as it is dependent on sales in the expanded region. The Company does not expect the Distribution Amendment to be material to its financial conditions or results of operations.

*Manufacturing Amendment*

On January 6, 2026, Amphastar Nanjing Pharmaceuticals, Inc., the Chinese subsidiary of Amphastar and Hanxin entered into an amendment to the Manufacturing Agreement (the "Manufacturing Amendment"), originally entered into on April 19, 2022, as previously reported by the Company on a Current Report on Form 8-K filed on April 22, 2022.

The Manufacturing Amendment expands the territory of the Manufacturing Agreement with the addition of a global territory except for the United States and Canada for Lidocaine and Cotricotropin, and a global territory for active pharmaceutical ingredient of Semaglutide, and a global territory for Finished Product of Semaglutide tablet with dose 3, 7 and 14 milligrams, clarifies intellectual property rights and adds indemnification and limitation of liability terms. The change in value of the Distribution Amendment is not determinable at this time as it is dependent on sales in the expanded territory. The Company does not consider this Manufacturing Amendment to be material to its financial condition or results of operations.

As previously disclosed in the Definitive Proxy Statement for the Company's 2025 Annual Meeting of Stockholders, as filed with 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, Henry Zhang, the son of Dr. Jack Zhang, is also the general manager, and the chairman of the board of directors of Hanxin, the parent of Genreach, and accordingly, the License Agreement, the Distribution Amendment and the Manufacturing Amendment each represent related party transactions. The Audit Committee of the Board of Directors of the Company evaluated and approved entry into each of the Distribution Amendment and the Manufacturing Amendment following review of applicable considerations.

The foregoing are brief descriptions of the License Agreement, Distribution Amendment and the Manufacturing Amendment, and do not purport to be a complete description of the rights and obligations of the parties thereunder, and

are qualified in their entirety by reference to the copy of the License Agreement, Distribution Amendment and the Manufacturing Amendment, each of which will be filed as an exhibit to the Company's Annual Report on Form 10-K to be filed with the Securities and Exchange Commission for the fiscal year ending December 31, 2025, and each of which are incorporated herein by reference.

Forward-Looking Statements

All statements in this current report that are not historical are forward-looking statements, including, among other things, statements relating to the performance of the parties under the Agreement and the expected payments thereunder. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including changes in laws and regulations and disruptions in supply chains as well as others described in Amphastar's filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the SEC on August 7, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC on November 6, 2025. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this current report speak only as of the date of the report. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this current report to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

**Item 7.01.** **Regulation FD Disclosure**

On January 12, 2026, the Company issued a press release announcing the exclusive License Agreement with Hanxin for the Licensed Product.

A copy of the press release is being furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information in Item 7.01 of this Current Report on Form 8-K is not deemed to be "filed" for the purpose of Section 18 of the Securities Act of 1933, or the Securities Act of 1934, except as expressly set forth by specific reference in such filing.

**Item 9.01. Financial Statements and Exhibits**

**(d) Exhibits**

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| | |
|:---|:---|
| Exhibit<br>No. | Description |
| 99.1 | [Press Release, dated January 12, 2026 of Amphastar Pharmaceuticals, Inc.](amph-20260106xex99d1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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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. | AMPHASTAR PHARMACEUTICALS, INC. |
| Date: January 12, 2026 |  |  |
|  | By: | **/S/WILLIAM J. PETERS** |
|  |  | William J. Peters |
|  |  | Chief Financial Officer, Executive Vice President and Treasurer |

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## Exhibit 99.1

**Exhibit 99.1**

![Graphic](amph-20260106xex99d1001.jpg)

**Amphastar Pharmaceuticals Announces Exclusive License Agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for Fully Synthetic Corticotropin Compound**

*Agreement expands Amphastar's proprietary peptide pipeline into broader inflammatory and autoimmune conditions*

RANCHO CUCAMONGA, CA / ACCESS Newswire / January, 12, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) today announced that it has entered into an exclusive license agreement (the "Agreement") with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. ("Hanxin") for the development, and commercialization of a fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analogs (also termed corticotropin), now designated AMP-110, in the United States and Canada. AMP-110 is designed to address inflammatory and autoimmune conditions with a potentially improved safety profile compared to porcine-derived ACTH products.

"AMP-110 represents a strategically important addition to our growing proprietary peptide portfolio," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "This asset aligns with our long-term vision to develop innovative proprietary products. The fully synthetic nature of AMP-110 offers a potential for a differentiated safety profile, and we believe this program positions us well in a meaningful and growing therapeutic category."

Under the terms of the Agreement, Hanxin is granting Amphastar an exclusive license to certain intellectual property related to AMP-110 in the United States and Canada. Additionally, Hanxin will receive a non-exclusive license from Amphastar for certain intellectual property to develop and commercialize the compound in all other territories.

As part of the Agreement, Amphastar made an upfront payment of $2 million to Hanxin upon signing, with additional payments to Hanxin consisting of up to $14 million in development milestone payments and up to $75 million in sales milestone payments. In addition, Amphastar will pay Hanxin royalty payments, which are not to exceed $7.5 million each calendar year and a maximum accumulated amount of $60 million. Hanxin will also pay Amphastar a royalty payment of net sales that are based on any patents licensed by Amphastar to Hanxin under the agreement.

AMP-110 is currently in early-phase human clinical development with early human studies demonstrating a promising safety profile. According to data from manufacturers in the market, in 2024, the U.S ACTH market exceeds $684 million annually, with indications including for the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis, gouty arthritis, systemic lupus erythematosus, ophthalmic inflammatory conditions, and infantile spasms.

**About Amphastar Pharmaceuticals, Inc.**

Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company's finished products are used in hospital or urgent care clinical

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settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company's website at www.amphastar.com.

The Amphastar Pharmaceuticals' logo, and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to BAQSIMI<sup>®</sup>, Primatene MIST<sup>®</sup>, REXTOVY<sup>®</sup>, Amphadase<sup>®</sup>, and Cortrosyn<sup>®</sup>, are the property of Amphastar Pharmaceuticals, Inc.

**Forward Looking Statements**

All statements in this press release referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding our expected future development and commercialization of AMP-110 under the licensing agreement, the potential benefits of AMP-110, financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, the strategic trajectory of and market for our product pipeline, the ability to commercialize additional therapies, and our manufacturing in-house expertise. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ("SEC"), including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025, and our other filings or reports that we may file with the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI<sup>®</sup>. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

**Contact:**

Bill Peters<br>Chief Financial Officer<br>(909) 476-3416

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