Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the U.S.

• Agreement expands Meitheal’s growing portfolio of specialty biopharmaceuticals
• More than 37 million people have diabetes in the United States¹
• Agreement covers three biosimilars of the top selling branded insulins - aspart, lispro and glargine all expected to begin clinical trials in 2024

Meitheal Pharmaceuticals, Inc. (Meitheal), a fully integrated biopharmaceutical company based in Chicago, today, through its parent company Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical Co., Ltd. (THDB) to commercialize three insulin biosimilars — insulin aspart, insulin lispro, and insulin glargine — in the U.S. NKF has exclusive development and commercial rights for the three compounds from partner THDB and intends for Meitheal to commercialize such products in the U.S.

“As a fully integrated biopharmaceutical company, committed to supporting access to critical medicines, Meitheal is thrilled to be leveraging our strategic partnerships and internal capabilities to expand our growing portfolio to include insulin products,” said Tom Shea, CEO of Meitheal. “These products have the potential to improve patient access, increase treatment options and solve healthcare challenges for people living with diabetes.”

Under the terms of the agreement, Meitheal, through its parent company, will receive exclusive rights to commercialize biosimilar versions of insulin aspart, insulin lispro, and insulin glargine in the U.S. upon approval by the FDA, which is estimated to be on or around 2026. THDB and NKF entered into strategic cooperation and will be jointly responsible for the development and supply of the three products. Upon approval, THDB, NKF and Meitheal will receive royalties on all product sales in the United States.

“This collaboration reinforces the strength of NKF’s partnership with Meitheal and demonstrates our commitment to innovation and continued investment in our portfolio companies,” said Eric Tang, President of NKF. “With insulin being one of the most in-demand medicines today, we are pleased to support value-driving options to increase insulin supply for those living with diabetes.”

“This cooperation in the U.S. insulin market allows the parties to draw on each other's strengths and achieve complementary advantages, which is a perfect combination,” said Chunsheng Leng, Chairman and General Manager of THDB. “We look forward to bringing these three products one step closer to patients through this strategic partnership.”

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 biosimilar products. Meitheal currently markets over 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of June 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 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 among the top 100 Crain’s Best Places to Work in Chicago, 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 NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO., LTD.

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 US FDA approved manufacturing sites in China and more than 1,500 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 US $3.0 billion.

ABOUT TONGHUA DONGBAO PHARMACEUTICAL CO., LTD.

Tonghua Dongbao Pharmaceutical Co. Ltd (THDB) is a pharmaceutical company in Jilin Province, China, specializing in the R&D, manufacturing, and commercialization of insulins as well as other diabetes treatment products. Founded in 1985, Tonghua Dongbao was the first Chinese company which developed and commercialized insulins. To date, it has advanced a pipeline consisting of insulins / insulin analogs, GLP-1RA, novel drugs, for diabetes and other metabolic diseases. Currently Tonghua Dongbao has more than 3,000 employees and a turnover of approximately US $400 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of US $3.0 billion.

¹ Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed 9.18.2023.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230921263562/en/