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

Rhea-AI Summary

Amphastar (NASDAQ:AMPH) entered an exclusive U.S. and Canada license with Nanjing Hanxin for AMP-110, a fully synthetic human ACTH analog targeting inflammatory and autoimmune conditions.

Key deal terms include a $2 million upfront payment, up to $14 million in development milestones, up to $75 million in sales milestones, and royalty payments to Hanxin not to exceed $7.5 million per year with a $60 million cumulative cap. Hanxin retains non-exclusive rights outside the U.S. and Canada. AMP-110 is in early-phase human studies with an early promising safety profile. The U.S. ACTH market exceeded $684 million in 2024.

Positive

• Exclusive U.S./Canada license for AMP-110
• Upfront payment: $2 million
• Potential commercial milestones: up to $75 million
• Early-phase human data show a promising safety profile
• Targets a U.S. ACTH market > $684 million (2024)

Negative

• Development milestones up to $14 million represent added cash obligations
• Royalty obligations capped at $7.5 million per year and $60 million total
• AMP-110 remains in early-phase trials, creating clinical and regulatory risk

News Market Reaction

+5.98%

3 alerts

+5.98% News Effect

+$76M Valuation Impact

$1.35B Market Cap

0.1x Rel. Volume

On the day this news was published, AMPH gained 5.98%, reflecting a notable positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $76M to the company's valuation, bringing the market cap to $1.35B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Upfront payment: $2 million Development milestones: Up to $14 million Sales milestones: Up to $75 million +3 more

6 metrics

Upfront payment $2 million Paid to Hanxin upon signing AMP-110 exclusive license

Development milestones Up to $14 million Potential payments to Hanxin tied to AMP-110 development

Sales milestones Up to $75 million Potential payments to Hanxin based on AMP-110 sales

Annual royalty cap $7.5 million Maximum royalty payments to Hanxin per calendar year

Total royalty cap $60 million Maximum cumulative royalty payments to Hanxin under agreement

U.S. ACTH market $684 million+ annually 2024 U.S. ACTH market size from manufacturer data

Market Reality Check

Price: $26.07 Vol: Volume 244,646 vs 20‑day ...

low vol

$26.07 Last Close

Volume Volume 244,646 vs 20‑day average 354,685 (relative volume 0.69) ahead of this announcement. low

Technical Price 27.74 is trading above the 200‑day MA of 25.59, indicating a pre‑news uptrend bias.

Peers on Argus

Peers showed mixed moves: HROW -8.27%, TLRY -8.66%, EVO -0.54%, while AVDL +0.09...

Peers showed mixed moves: HROW -8.27%, TLRY -8.66%, EVO -0.54%, while AVDL +0.09% and BGM +5.29%. No clear sector‑wide direction relative to AMPH’s flat pre‑news price.

Historical Context

5 past events · Latest: Jan 07 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 07	Conference presentation	Neutral	-1.1%	J.P. Morgan 2026 Healthcare Conference presentation announcement and webcast details.
Dec 15	FDA approval	Positive	+4.1%	FDA approval of teriparatide injection ANDA judged equivalent to FORTEO.
Nov 24	Conference presentation	Neutral	+2.7%	Participation in Piper Sandler healthcare conference via analyst‑moderated fireside chat.
Nov 12	Conference presentation	Neutral	+2.5%	Jefferies Global Healthcare Conference fireside chat with senior executives.
Nov 06	Earnings release	Neutral	-4.3%	Q3 2025 results with strong BAQSIMI sales and notable litigation provision and R&D payment.

Pattern Detected

Recent stock reactions to company news have generally been modest, with positive regulatory milestones like FDA approval drawing the strongest upside move.

Recent Company History

Over the last few months, Amphastar reported several corporate and regulatory milestones. An 8-K and 10-Q on November 6, 2025 detailed Q3 2025 results and financials, while an earnings release the same day saw shares down modestly despite solid revenues. FDA approval of teriparatide injection on December 15, 2025 coincided with a 4.12% gain, the strongest move in this window. Multiple conference presentation announcements in November 2025 and January 2026 produced smaller, mixed price reactions, suggesting investors react more strongly to concrete product milestones than to investor‑relations events.

Market Pulse Summary

The stock moved +6.0% in the session following this news. A strong positive reaction aligns with Amp...

Analysis

The stock moved +6.0% in the session following this news. A strong positive reaction aligns with Amphastar’s strategy of expanding its proprietary peptide portfolio. The AMP-110 license adds exposure to a U.S. ACTH market exceeding $684 million, following prior milestones like the teriparatide approval. However, past news often produced only moderate moves, and insider activity in late 2025 reflected net selling. If enthusiasm became extreme, limited volume (relative volume 0.69) could make sharp reversals more likely once buying cooled.

Key Terms

adrenocorticotropic hormone, acth, corticotropin, autoimmune, +4 more

8 terms

adrenocorticotropic hormone medical

"a fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analogs"

Adrenocorticotropic hormone (ACTH) is a signaling protein made by the pituitary gland that tells the adrenal glands to release cortisol and other stress-related hormones; think of it as a thermostat that triggers the body’s emergency response. For investors, ACTH matters because it is a target for diagnostic tests, drug development, and therapeutic treatments for adrenal and stress-related disorders, influencing regulatory approvals, clinical trial outcomes, and market demand for related medicines and assays.

acth medical

"human adrenocorticotropic hormone (ACTH) analogs (also termed corticotropin)"

ACTH is a hormone produced by the pituitary gland that tells the adrenal glands to release cortisol, the body’s main stress-response hormone; think of it as a thermostat setting that controls how much cortisol is pushed into the bloodstream. Investors care because drugs, diagnostics, or devices that alter ACTH signaling or measure its levels can drive clinical trial results, regulatory approvals, and revenue shifts for companies in endocrinology and diagnostics.

corticotropin medical

"ACTH analogs (also termed corticotropin), now designated AMP-110"

Corticotropin is a naturally occurring hormone (also used as a drug) that acts like a messenger telling the adrenal glands to release cortisol, the body’s main stress and inflammation-control chemical. Investors care because corticotropin-related products are prescribed for certain inflammatory and neurological conditions, and their clinical effectiveness, regulatory approvals, manufacturing capacity, pricing, and reimbursement can directly affect pharmaceutical and biotech company revenues and risk profiles.

autoimmune medical

"designed to address inflammatory and autoimmune conditions with a potentially improved safety"

An autoimmune condition is when the body’s natural defense system mistakenly attacks healthy tissues, like a security guard that can’t tell residents from intruders. For investors, autoimmune diseases matter because they create long-term treatment needs, ongoing healthcare costs, and large markets for drugs, diagnostics, and devices; progress or setbacks in therapies, clinical trials, or approvals can strongly affect the value of companies working in this area.

multiple sclerosis medical

"indications including for the treatment of acute exacerbations of multiple sclerosis, rheumatoid"

A chronic neurological disease in which the immune system damages the protective coating (like insulation on electrical wires) around nerves, disrupting signals between the brain and body and causing symptoms such as numbness, weakness, vision problems, fatigue and mobility issues. It matters to investors because the unpredictability and long-term nature of the condition drive ongoing demand for treatments, influence the value of companies developing therapies, affect healthcare costs and shape regulatory and reimbursement decisions.

rheumatoid arthritis medical

"acute exacerbations of multiple sclerosis, rheumatoid arthritis, gouty arthritis, systemic lupus"

A long-term autoimmune disease that causes the immune system to mistakenly attack the lining of joints, leading to pain, swelling, stiffness and progressive joint damage; it can also affect other organs. For investors, it matters because the condition drives sustained demand for treatments, influences clinical trial and regulatory outcomes, and affects healthcare spending and workplace disability—so drug approvals, new therapies or cost shifts can materially change the market value of companies involved.

systemic lupus erythematosus medical

"rheumatoid arthritis, gouty arthritis, systemic lupus erythematosus, ophthalmic inflammatory"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's immune system mistakenly attacks healthy tissue, causing inflammation that can affect skin, joints, kidneys, heart, lungs and other organs. It matters to investors because disease severity, prevalence, and gaps in effective treatments drive demand for new drugs and diagnostics—think of it as a large, persistent market need where a successful therapy can change patient outcomes and create significant commercial value.

infantile spasms medical

"ophthalmic inflammatory conditions, and infantile spasms."

Infantile spasms are a rare seizure disorder in babies, usually appearing in the first year of life, characterized by sudden brief contractions or stiffening often occurring in clusters and frequently linked to delayed development. Investors care because effective treatments are few, making successful therapies high-value: drugs can qualify for faster approval and special incentives, clinical results can quickly change a company’s outlook, and any breakthrough can command premium pricing in a focused but urgent market.

AI-generated analysis. Not financial advice.

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 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^®, Primatene MIST^®, REXTOVY^®, Amphadase^®, and Cortrosyn^®, 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^®. 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
Chief Financial Officer
(909) 476-3416

SOURCE: Amphastar Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Amphastar announce about AMP-110 on January 12, 2026?

Amphastar announced an exclusive U.S. and Canada license from Nanjing Hanxin to develop and commercialize AMP-110, a fully synthetic ACTH analog.

What are the upfront and milestone payments in the Amphastar AMP-110 deal (AMPH)?

Amphastar paid $2 million upfront, with up to $14 million in development milestones and up to $75 million in sales milestones.

How large is the U.S. ACTH market referenced in the Amphastar AMP-110 announcement?

The U.S. ACTH market exceeded $684 million in 2024 according to manufacturer data cited.

What royalty obligations did Amphastar agree to for AMP-110?

Royalties to Hanxin are capped at $7.5 million per year with a maximum accumulated amount of $60 million.

Does Amphastar have global rights to AMP-110 after the license (AMPH)?

No; Amphastar holds exclusive rights in the U.S. and Canada while Hanxin retains non-exclusive rights in other territories.

What is the development status of AMP-110 and its safety profile?

AMP-110 is in early-phase human clinical development, with early studies reporting a promising safety profile.