Tonghua Dongbao Pharmaceutical Co., Ltd.

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 CHICAGO--(BUSINESS WIRE)-- 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 . 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. . Accessed 9.18.2023.

Phalguni Deswal @Phalguni_GD The availability of biosimilars can help reduce the cost of insulin therapies. Image Credit: Daniel Beckemeier / Shutterstock. Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Recommended Reports Reports LOA and PTSR Model - Injectable Hdv Basal Insulin For Type 1 And Type 2 Diabetes in Type 2 Diabetes GlobalData Reports LOA and PTSR Model - (Insulin Glargine + Insulin Lispro) La in Type 2 Diabetes GlobalData View all Companies Intelligence Sanofi Bristol-Myers Squibb Co Novo Nordisk AS Biocon Ltd Nanjing King-friend Biochemical Pharmaceutical Co Ltd View all Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi ’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties from the US sales. Although insulin suppliers such as Novo Nordisk , Eli Lilly, and Sanofi have reduced insulin prices in recent years , the cost of insulin remains quite high in the US. The list price for a 5-pack of Humalog 15mL is $530.40, as per Eli Lilly . The availability of biosimilars can help reduce the cost of insulin therapies, as has been seen in other therapy areas. Currently available insulin biosimilars include, Biocon and Viatris’ Semglee—a Lantus biosimilar—which  was the first insulin biosimilar approved by the FDA in 2021. Biocon also has a Novolog (insulin aspart) biosimilar, Kixelle , in its product catalogue. Kixelle has been approved in Europe. Meitheal has a number of generic drugs as part of its marketed portfolio, including several cancer drugs such as azacitidine, a generic of Bristol Myers Squibb’s Vidaza. Although Vidaza was first indicated for treatment of myelodysplastic syndromes (MDS) it is currently under investigation for treating relapsed acute myeloid leukaemia (AML) and anaplastic large cell lymphoma (ALCL).

DUBLIN, Nov. 30, 2022 /PRNewswire/ -- The "Insulin Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type and Geography" report has been added to ResearchAndMarkets.com's offering. The insulin market is projected to grow from US$ 54,611.42 million in 2021 to US$ 111,213.73 million by 2028. It is expected to grow at a CAGR of 10.8 % from 2022 to 2028. The increase in the incidence of diabetes and rapid technological developments in insulin delivery devices by major players is expected to bolster the insulin market in the years to come. Additionally, the regeneration of the diabetic pancreas with advanced transplants is likely to emerge as a significant future trend in the insulin market from 2022 to 2028. However, the risks associated with insulin delivery devices hamper the overall market growth. In diabetic people, the pancreas does not produce enough insulin, or the body does not usually respond to the insulin, increasing the blood glucose level. Insulin is a hormone that helps in lowering blood sugar levels. Insulin therapy is often an essential part of diabetes treatment. It is made by the beta cells of the pancreas and released into the blood when glucose levels rise, for example, after eating. Insulin helps glucose get into the body cells, which can be used for energy or stored for future use. Different types of insulin available vary in how quickly and for how long they can control blood sugar. Insulin does not come in pill form as the digestive system would break it down before it could work. Insulin therapy is exhausting; however, it is an effective way of lowering blood sugar levels. Products with advanced insulin technology with more benefits are a major requirement in treating diabetes. There has been a rise in advancements in diabetes treatment over the past few years. As the prevalence of diabetes is increasing worldwide, the demand for advanced products is also boosting. The insulin market is expected to grow owing to an increase in the strategic efforts made by the industry players. The market players actively support their public and private research and academic institutes for increasing research activities. A few of the recent developments related to rapid technological advancement in the insulin market are mentioned below: In May 2022, Eli Lilly and Company received US FDA approval for its Mounjar (tirzepatide) once-weekly Glucose-Dependent Insulinotropic Polypeptide (GIP) and GLP-1 Glucagon-like Peptide-1 (GLP-1) receptor agonist for the treatment of adults with type 2 diabetes. The injection is decided to be available in 6 doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg) as an auto-injector pen with a preattached hidden needle. Key Topics Covered: 1. Introduction 2. Insulin Market - Key Takeaways 3. Research Methodology 4. Insulin Market - Market Landscape 4.1 Overview 4.2 PEST Analysis 4.2.1 North America- PEST Analysis 4.2.2 Europe- PEST Analysis 4.2.3 Asia Pacific- PEST Analysis 4.2.4 Middle East & Africa- PEST Analysis 4.2.5 South & Central America- PEST Analysis 4.2.6 Expert Opinion 5. Insulin Market- Key Market Dynamics 5.1 Market Drivers 5.1.1 Increase in Incidence of Diabetes 5.1.2 Rapid Technological Developments in Insulin Delivery Devices by Major Players 5.2 Market Restraints 5.2.1 Risks Associated with Insulin Delivery Devices 5.3 Market Opportunities 5.3.1 Insufficient Competition from Biosimilars 5.4 Future Trends 5.4.1 Regeneration of Diabetic Pancreas with Advanced Transplants 5.5 Impact Analysis 6. Insulin Market- Global Analysis 6.1 Global Insulin Market Revenue Forecast and Analysis 6.1.1 Global Insulin Market, By Geography - Forecast and Analysis 6.1.2 Global Insulin Market - Market Potential Analysis, By Region 6.2 Company Analysis 6.2.1 Market Positioning of Key Players 6.2.2 Comparative Company Analysis 6.2.3 Growth Strategy Analysis 6.2.4 Performance Of Key Players 6.2.4.1 Novo Nordisk A/S 6.2.4.2 Sanofi 6.2.4.3 Eli Lily and Company 6.3 Customization Part 6.3.1 Market Share Analysis by Company 6.3.2 Market Share by Injectable GLPs 7. Insulin Market Analysis - By Type 7.1 Overview 7.2 Insulin Market Revenue Share, by Type (2021 and 2028) 7.3 Long Acting Insulin 7.3.1 Overview 7.3.2 Long Acting Insulin: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.3.2.1 Levemir 7.3.2.1.1 Overview 7.3.2.1.2 Levemir: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.3.2.2 Lantus 7.3.2.2.1 Overview 7.3.2.2.2 Lantus: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.3.2.3 Basaglar 7.3.2.3.1 Overview 7.3.2.3.2 Basaglar: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.3.2.4 Tresiba 7.3.2.4.1 Overview 7.3.2.4.2 Tresiba: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.4 Rapid Acting Insulins 7.4.1 Overview 7.4.2 Rapid Acting Insulins: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.4.2.1 Novolog 7.4.2.1.1 Overview 7.4.2.1.2 Novolog: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.4.2.2 Humalog 7.4.2.2.1 Overview 7.4.2.2.2 Humalog: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.4.2.3 Admelog 7.4.2.3.1 Overview 7.4.2.3.2 Admelog: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.4.2.4 Others 7.4.2.4.1 Overview 7.4.2.4.2 Others: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.5 Short Acting Insulins and Traditional Human Insulins 7.5.1 Overview 7.5.2 Short Acting Insulins and Traditional Human Insulins: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.5.2.1 Novolin R 7.5.2.1.1 Overview 7.5.2.1.2 Novolin R: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.5.2.2 Humulin R 7.5.2.2.1 Overview 7.5.2.2.2 Humulin R: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.5.2.3 Insuman 7.5.2.3.1 Overview 7.5.2.3.2 Insuman: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.5.2.4 Others 7.5.2.4.1 Overview 7.5.2.4.2 Others: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.6 Concentrated Insulins and Combination Insulins 7.6.1 Overview 7.6.2 Concentrated Insulins and Combination Insulins: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.6.2.1 NovoMix 7.6.2.1.1 Overview 7.6.2.1.2 NovoMix: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.6.2.2 Ryzodeg 7.6.2.2.1 Overview 7.6.2.2.2 Ryzodeg: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.6.2.3 Xultophy 7.6.2.3.1 Overview 7.6.2.3.2 Xultophy: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.6.2.4 Soliqua/Suliqua 7.6.2.4.1 Overview 7.6.2.4.2 Soliqua/Suliqua: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.7 Biosimilar Insulins 7.7.1 Overview 7.7.2 Biosimilar Insulins: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.7.2.1 Insulin Glargine 7.7.2.1.1 Overview 7.7.2.1.2 Insulin Glargine: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.7.2.2 Human Insulin 7.7.2.2.1 Overview 7.7.2.2.2 Human Insulin: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.8 Glucagon-like peptide-1 (GLP-1) 7.8.1 Overview 7.8.2 Glucagon-like peptide-1 (GLP-1): Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.9 Pens and Needles 7.9.1 Overview 7.9.2 Pens and Needles: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 7.10 Others 7.10.1 Overview 7.10.2 Others: Insulin Market - Revenue and Forecast to 2028 (US$ Million) 8. Global Insulin Market - Geographic Analysis 9. Impact of COVID-19 Pandemic on Global Insulin Market 9.1 North America: Impact Assessment of COVID-19 Pandemic 9.2 Europe: Impact Assessment of COVID-19 Pandemic 9.3 Asia Pacific: Impact Assessment of COVID-19 Pandemic 9.4 Middle East and Africa: Impact Assessment of COVID-19 Pandemic 9.5 South and Central America: Impact Assessment of COVID-19 Pandemic 10. Insulin Market-Industry Landscape 10.1 Overview 10.2 Growth Strategies in the Insulin Market (%) 10.3 Organic Developments 10.3.1 Overview 10.4 Inorganic Developments 10.4.1 Overview 11. Company Profile 11.1 Eli Lilly and Company 11.1.1 Key Facts 11.1.2 Business Description 11.1.3 Products and Services 11.1.4 Financial Overview 11.1.5 SWOT Analysis 11.1.6 Key Developments 11.2 Novo Nordisk A/S 11.2.1 Key Facts 11.2.2 Business Description 11.2.3 Products and Services 11.2.4 Financial Overview 11.2.5 SWOT Analysis 11.2.6 Key Developments 11.3 Biocon 11.3.1 Key Facts 11.3.2 Business Description 11.3.3 Products and Services 11.3.4 Financial Overview 11.3.5 SWOT Analysis 11.3.6 Key Developments 11.4 WOCKHARDT 11.4.1 Key Facts 11.4.2 Business Description 11.4.3 Products and Services 11.4.4 Financial Overview 11.4.5 SWOT Analysis 11.4.6 Key Developments 11.5 Adocia 11.5.1 Key Facts 11.5.2 Business Description 11.5.3 Products and Services 11.5.4 Financial Overview 11.5.5 SWOT Analysis 11.5.6 Key Developments 11.6 GlaxoSmithKline plc. 11.6.1 Key Facts 11.6.2 Business Description 11.6.3 Products and Services 11.6.4 Financial Overview 11.6.5 SWOT Analysis 11.6.6 Key Developments 11.7 Sanofi 11.7.1 Key Facts 11.7.2 Business Description 11.7.3 Products and Services 11.7.4 Financial Overview 11.7.5 SWOT Analysis 11.7.6 Key Developments 11.8 Pfizer Inc. 11.8.1 Key Facts 11.8.2 Business Description 11.8.3 Products and Services 11.8.4 Financial Overview 11.8.5 SWOT Analysis 11.8.6 Key Developments 11.9 Merck & Co., Inc. 11.9.1 Key Facts 11.9.2 Business Description 11.9.3 Products and Services 11.9.4 Financial Overview 11.9.5 SWOT Analysis 11.9.6 Key Developments 11.10 Tonghua Dongbao Pharmaceutical Co., Ltd. 11.10.1 Key Facts 11.10.2 Business Description 11.10.3 Products and Services 11.10.4 Financial Overview 11.10.5 SWOT Analysis 11.10.6 Key Developments 11.11 BIGFOOT BIOMEDICAL, INC. 11.11.1 Key Facts 11.11.2 Business Description 11.11.3 Products and Services 11.11.4 Financial Overview 11.11.5 SWOT Analysis 11.11.6 Key Developments 12. Appendix For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets