Meitheal Pharmaceuticals Gains Exclusive U.S. Licensing for Three Biosimilars

CHICAGO, IL, USA I October 31, 2024 I Meitheal Pharmaceuticals, Inc., a biopharmaceutical company based in Chicago, announced a new 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. These biosimilars include oncology medications pegfilgrastim and filgrastim, as well as follitropin alpha for fertility treatment.

Tom Shea, the CEO of Meitheal, expressed satisfaction with the agreement, highlighting its potential to offer significant medications at affordable prices to U.S. patients. Shea noted that this expansion aligns with Meitheal's commitment to innovation that saves costs for both patients and the healthcare system.

Follitropin alpha is a recombinant human follicle-stimulating hormone (FSH) used to stimulate egg follicle development in women and sperm production in men undergoing fertility treatment. The infertility treatment market is substantial and growing, with a branded version of FSH generating $847 million in sales in 2023. Currently, there are no biosimilars for gonadotropin follitropin alpha available in the U.S., positioning follitropin alpha to address a significant unmet need for more affordable fertility treatments.

Pegfilgrastim and filgrastim are used to stimulate bone marrow and enhance white blood cell production in patients undergoing specific cancer treatments. These medications interact with G-CSF receptors to promote the growth and activation of neutrophils, essential for fighting infections. Filgrastim is administered either subcutaneously or intravenously daily for up to 14 days during a chemotherapy cycle, while pegfilgrastim, a longer-acting alternative, is given subcutaneously once per treatment cycle. The U.S. market for these drugs is estimated to exceed $2.5 billion.

Eric Tang, President of HKF, commented on the partnership, expressing optimism that Meitheal's efforts to develop and market follitropin alpha, pegfilgrastim, and filgrastim in the U.S. will enhance access to these crucial medications. Tang emphasized HKF's ongoing investment in biosimilar innovation and its support for Meitheal's growing capabilities and portfolio.

In recent years, Meitheal's parent company and affiliates have invested over $300 million in capital and research and development, including $30 million in a monoclonal antibody drug substance facility. This new agreement adds three biosimilars to Meitheal's portfolio, bringing the total to eight treatments.

Meitheal Pharmaceuticals, founded in 2017 and headquartered in Chicago, focuses on developing and commercializing generic injectable medications. As of 2022, the company has expanded its scope to include fertility, biologic, and branded products. Meitheal currently markets over 60 FDA-approved products across various therapeutic areas such as anti-infectives, oncology, intensive care, and fertility. By the end of October 2024, Meitheal and its partners had 18 products in research and development, six additional products planned for launch in 2024, and 21 products under FDA review. Meitheal aims to provide accessible, fairly priced products through reliable manufacturing, consistent supply, and responsive customer service. The company has been recognized as one of Crain’s Fast 50 in Chicago for 2024 and among the top 100 Best Places to Work in Chicago for 2022, 2023, and 2024. Meitheal embodies the Irish principle of working together towards a common goal for the greater good.

Hong Kong King-Friend Industrial Company, founded in 2010, is a wholly owned subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF). Established in 1986, NKF is engaged in the research, development, production, and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). With three FDA-approved manufacturing sites in China and over 500 employees, including 100 research and development experts, NKF serves markets in the U.S., China, EU, and globally. The company is publicly listed on the Shanghai Stock Exchange with a market capitalization exceeding $3.0 billion.