Amphastar Pharmaceuticals Bolsters Proprietary Pipeline Through Exclusive Licensing Agreement with Nanjing Anji Biotechnology Co., Ltd.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has entered into an exclusive licensing agreement with Nanjing Anji Biotechnology for three proprietary peptides in the US and Canada. The agreement includes an initial payment of $6 million ($0.75M earnest money + $5.25M upfront), with potential milestone payments reaching $453 million over the agreement's lifetime.
The licensed products include: 1) An endogenous peptide targeting multiple poorly treated cancers, 2) A novel peptide-docetaxel conjugate designed to improve taxane therapies, and 3) An anti-VEGFR peptide eye drop for wet age-related macular degeneration treatment. The agreement includes 5% royalty payments on net sales, capped at $60 million per Licensed Product.
Amphastar Pharmaceuticals (NASDAQ:AMPH) ha siglato un accordo di licenza esclusiva con Nanjing Anji Biotechnology per tre peptidi proprietari negli Stati Uniti e in Canada. L'intesa prevede un pagamento iniziale di $6 million (caparra di $0.75M + anticipo di $5.25M), con possibili pagamenti legati a milestone che possono arrivare fino a $453 million nel corso dell'accordo.
I prodotti concessi in licenza includono: 1) un peptide endogeno che prende di mira vari tumori poco trattati, 2) un nuovo coniugato peptide-docetaxel progettato per migliorare le terapie a base di taxani, e 3) un collirio a base di peptide anti-VEGFR per il trattamento della degenerazione maculare umida legata all'et脿. L'accordo prevede royalty del 5% sulle vendite nette, con un tetto di $60 million per ciascun prodotto licenziato.
Amphastar Pharmaceuticals (NASDAQ:AMPH) ha firmado un acuerdo de licencia exclusiva con Nanjing Anji Biotechnology para tres p茅ptidos propietarios en EE.聽UU. y Canad谩. El acuerdo incluye un pago inicial de $6 million (dep贸sito de $0.75M + pago por adelantado de $5.25M), y pagos por hitos que podr铆an sumar hasta $453 million durante la vigencia del acuerdo.
Los productos licenciados son: 1) un p茅ptido end贸geno dirigido a varios c谩nceres con escasas opciones de tratamiento, 2) un nuevo conjugado p茅ptido-docetaxel dise帽ado para mejorar las terapias con taxanos, y 3) unas gotas oft谩lmicas con un p茅ptido anti-VEGFR para el tratamiento de la degeneraci贸n macular h煤meda asociada a la edad. El acuerdo establece royalties del 5% sobre las ventas netas, con un l铆mite de $60 million por producto licenciado.
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Amphastar Pharmaceuticals (NASDAQ:AMPH) a conclu un accord de licence exclusive avec Nanjing Anji Biotechnology portant sur trois peptides propri茅taires pour les 脡tats鈥慤nis et le Canada. L'accord pr茅voit un paiement initial de $6 million (acompte de $0.75M + paiement initial de $5.25M), et des paiements li茅s 脿 des jalons pouvant atteindre $453 million pendant la dur茅e du contrat.
Les produits conc茅d茅s en licence sont : 1) un peptide endog猫ne ciblant plusieurs cancers peu pris en charge, 2) un nouveau conjugu茅 peptide鈥慸oc茅taxel con莽u pour am茅liorer les th茅rapies 脿 base de taxanes, et 3) un collyre contenant un peptide anti鈥慥EGFR pour le traitement de la d茅g茅n茅rescence maculaire humide li茅e 脿 l'芒ge. L'accord pr茅voit des redevances de 5% sur les ventes nettes, plafonn茅es 脿 $60 million par produit licenci茅.
Amphastar Pharmaceuticals (NASDAQ:AMPH) hat eine exklusive Lizenzvereinbarung mit Nanjing Anji Biotechnology f眉r drei firmeneigene Peptide in den USA und Kanada abgeschlossen. Die Vereinbarung sieht eine anf盲ngliche Zahlung von $6 million (Anzahlung $0.75M + Vorauszahlung $5.25M) sowie m枚gliche Meilensteinzahlungen von insgesamt bis zu $453 million 眉ber die Laufzeit vor.
Die lizenzierten Produkte umfassen: 1) ein endogenes Peptid, das mehrere schwer behandelbare Krebsarten adressiert, 2) ein neuartiges Peptid鈥慏ocetaxel鈥慘onjugat zur Verbesserung von Taxan鈥慣herapien und 3) einen anti鈥慥EGFR Peptid鈥慉ugentropfen zur Behandlung der feuchten altersbedingten Makuladegeneration. Vereinbart sind 5% Royaltys auf den Nettoumsatz, jeweils gedeckelt bei $60 million pro lizenziertem Produkt.
- Strategic expansion into high-value oncology and ophthalmology markets
- Potential total deal value of $453 million including milestones
- Development of three potentially best-in-class peptide assets
- Agreement leverages Amphastar's existing expertise in peptide products
- Novel non-invasive eye drop treatment could replace current injection therapies
- Significant upfront cash payment of $6 million required
- Substantial development risks with early-stage pipeline products
- High milestone payment obligations totaling up to $267 million
- 10-year initial term limitation on product commercialization rights
Insights
Amphastar's licensing deal adds three promising peptide therapies to pipeline, expanding oncology and ophthalmology portfolio with significant long-term potential.
Amphastar's exclusive licensing agreement with Nanjing Anji Biotechnology represents a strategic expansion of their proprietary pipeline, adding three peptide-based candidates with potentially differentiated mechanisms. The deal structure includes
The first candidate targets multiple poorly-treated cancers through a novel mechanism involving an endogenous peptide that suppresses growth and metastasis. The second is a peptide-docetaxel conjugate designed to enhance selectivity and reduce toxicity of this established chemotherapy agent. The third represents an innovative non-invasive approach to treating wet AMD through a topical VEGFR-targeting peptide, potentially replacing current intravitreal injections.
This licensing deal aligns with Amphastar's strategic shift toward higher-margin proprietary medicines while leveraging their established expertise in peptide development and manufacturing. The company has successfully commercialized multiple peptide products, providing technical credibility for this expansion. The structure grants Amphastar exclusive rights in the US and Canada while allowing Anji to commercialize outside these territories with royalties flowing back to Amphastar.
The long-term nature of the agreement (10 years from first commercial sale, with option to extend another decade) indicates both companies' confidence in the clinical and commercial potential of these assets. While development timelines and regulatory hurdles remain unspecified, this deal significantly expands Amphastar's long-term growth opportunities in two therapeutic areas with substantial market potential.
Agreement strengthens proprietary peptide pipeline targeting high-value oncology and ophthalmology indications
RANCHO CUCAMONGA, CA / / August 12, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar"), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that it has entered into an exclusive license agreement ("Agreement") with Nanjing Anji Biotechnology Co., Ltd. ("Anji") for the development, manufacturing, use, and commercialization of three proprietary peptides, ("Licensed Products"), in the United States and Canada ("Territory").
The first product is based on the discovery by Anji of an endogenous peptide that demonstrates a novel mechanism of action that potentially suppresses the growth and metastasis of multiple poorly treated cancers.
The second product is a novel peptide-docetaxel conjugate that targets a specific receptor, designed to improve the selectivity and bioavailability of docetaxel. It is designed to reduce docetaxel-induced toxicity, which will improve the efficacy and safety of current taxane therapies.
The third product is an anti-vascular endothelial growth factor receptor (VEGFR) peptide of novel design, developed as a topical eye drop for the treatment of wet age-related macular degeneration (wAMD). It is intended to be an alternative to the routine eye injections used for current treatment.
"We are delighted to announce a strategic licensing agreement with Anji, whose cutting edge research and development expertise in peptide and polypeptide therapeutics aligns perfectly with Amphastar's mission to develop novel, proprietary, and innovative products," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer "This collaboration significantly expands our pipeline with three potentially best-in-class peptide assets, targeting high-growth markets across oncology and ophthalmology. We believe this partnership builds upon Amphastar's legacy in successfully developing and commercializing peptide products and underscores our shared commitment to bringing transformative therapies to patients."
Under the terms of the Agreement, Anji grants Amphastar an exclusive license to intellectual property controlled by Anji related to the Licensed Products in the Territory. Additionally, Anji will receive a non-exclusive license from Amphastar for certain intellectual property to develop, make, use, and commercialize Licensed Products outside the Territory.
Amphastar made an earnest money payment of
The term of the Agreement will expire, on a Licensed Product-by-Licensed Product and region-by-region basis, on the tenth anniversary of the first commercial sale of such Licensed Product in the applicable region in the Territory, with Amphastar having the right to extend the Agreement until the earlier of an additional ten years or until the expiration, lapse, or invalidation of the last remaining valid claim of the patents licensed by Anji to Amphastar that cover the Licensed Products in the Territory.
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. In recent years, the development of proprietary medicines has been a major strategic direction for the Company. Amphastar manufactures all of its drug products in the United States, and manufactures active pharmaceutical ingredients in the United States, China and France. Amphastar has multiple peptide and protein products commercialized in the US market and under development. Many of the Company's injectable finished products are used in hospital or urgent care settings while the inhalation products are sold in retail pharmacies. More information and resources are available at .
Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar庐, BAQSIMI庐, Primatene MIST庐, REXTOVY庐, Amphadase庐, and Cortrosyn庐, are the property of Amphastar.
About Nanjing Anji Biotechnology Co., Ltd.
Nanjing Anji Biotechnology Co., Ltd. is a high-tech enterprise located in Nanjing, China, focusing on the research and development of innovative peptide drugs and peptide-drug conjugates. The company possesses key technologies: (i) high-throughput endogenous micropeptide discovery technology (ii) computer-aided peptide drug design technology, along with (iii) a comprehensive preclinical drug evaluation platform.
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 the Agreement with Anji including its effects on Amphastar's pipeline, ability to bring additional products to market, ability to meet customer demand and other future events. 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, 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 ending June 30, 2025, filed with the SEC on August 7, 2025. You can locate these reports through our website at and on the SEC's website at . 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 Information:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484
SOURCE: Amphastar Pharmaceuticals, Inc.
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