Meitheal Pharmaceuticals Secures Exclusive Commercial Licensing Agreement for Three Biosimilars in the U.S.

• Agreement expands Meitheal’s portfolio to eight biosimilars across diabetes, oncology, fertility, and autoimmune indications
• Portfolio growth underscores Meitheal’s commitment to sustainable patient access and delivering impactful products that address gaps in accessible treatment options
• Agreement includes the follicle-stimulating hormone (FSH) follitropin alpha used in fertility treatment
• With no FSH biosimilar currently available in the U.S., availability would meaningfully address the unmet need for affordable fertility solutions

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”) to market and distribute three biosimilars in the U.S. The agreement covers biosimilars for oncology medications pegfilgrastim and filgrastim as well as follitropin alpha in the fertility space.

“We are pleased to expand our biosimilars portfolio with this licensing agreement, which will allow us to deliver three more significant medications to patients in the U.S. at fair and sustainable prices,” said Tom Shea, Chief Executive Officer of Meitheal. “This expansion furthers our commitment to delivering cost-saving innovation to patients and the broader healthcare system.”

Follitropin alpha is a form of recombinant human follicle-stimulating hormone (FSH) and is used to stimulate follicle development in women and spermatogenesis in men during fertility treatment. The infertility treatment market is large and growing – a branded formulation of FSH generated $847 million in sales in 2023¹ and there are currently no biosimilars for the gonadotropin follitropin alpha available in the U.S. As a result, follitropin alpha has the potential to fulfill the significant unmet need for more affordable treatment options for women trying to conceive.

Pegfilgrastim and filgrastim are bone marrow stimulants that support white blood cell production for patients receiving certain cancer treatments. The medications work by binding to G-CSF receptors to stimulate the proliferation, differentiation, and activation of neutrophils to fight infection. Filgrastim is dosed subcutaneously or intravenously daily for up to 14 days during a chemotherapy treatment cycle. Pegfilgrastim, a longer-acting form of treatment, is dosed subcutaneously once per treatment cycle. The U.S. market for pegfilgrastim and filgrastim is estimated at over $2.5 billion.²

“We are pleased that Meitheal will be developing and commercializing follitropin alpha, pegfilgrastim, and filgrastim in the U.S. and that our partnership will increase access to these critical medications,” said Eric Tang, President of HKF. “We are continuing to invest in biosimilar innovation and we look forward to supporting Meitheal’s growing capabilities and portfolio in this important space.”

Meitheal’s parent company and related entities have invested over $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody drug substance facility. This agreement adds three biosimilars, bringing Meitheal’s total biosimilar portfolio to eight treatments.

ABOUT MEITHEAL PHARMACEUTICALS

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 on Crain’s Fast 50 in Chicago 2024 and also among the top 100 Crain’s Best Places to Work in Chicago in 2022, 2023 and 2024, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF)

Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of NKF, founded in 2010.

ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF)

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion.

¹ Merck KGaA Annual Report 2023. https://www.emdgroup.com/en/annualreport/2023/_assets/downloads/entire-emd-ar23.pdf (Last Accessed October 28, 2024).

² IQVIA, September 2024.

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