Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection

• FDA approves Garzulys™ (insulin aspart-fsan), a rapid-acting insulin analog to improve glycemic control in adults and pediatric patients with diabetes mellitus
• Meitheal serves as the U.S. Regulatory Agent for Garzulys and holds exclusive U.S. commercialization rights under its license agreement with Emerge, the BLA holder
• Approval marks an important milestone in Meitheal’s continued expansion into complex biologics and essential medicines

CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog^® (insulin aspart). Emerge Bioscience Pte. Ltd. (“Emerge”) is the holder of the approved Biologics License Application (BLA) for Garzulys. Meitheal serves as the product’s U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under its license agreement with Emerge.

Garzulys is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Garzulys formulations are approved for both subcutaneous and intravenous administration.

Please see the Important Safety Information below.

Garzulys was developed through a collaboration between Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao”) and companies affiliated with Meitheal. Tonghua Dongbao was responsible for drug substance development, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) was responsible for drug product development, Xentria, Inc. (“Xentria”) led the clinical development program, and Meitheal, serving as the U.S. Regulatory Agent, led the U.S. regulatory work supporting FDA approval. Emerge is the BLA holder and is responsible for key supply-chain activities associated with the product.

The collaboration initiated in 2023 between Tonghua Dongbao and NKF encompasses Garzulys and two additional insulin biosimilar candidates currently in development. Through its exclusive license agreement with Emerge, Meitheal holds exclusive U.S. commercialization rights for Garzulys and the two additional product candidates.

“The FDA approval of Garzulys represents an important milestone in Meitheal’s continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products,” said Tom Shea, Chief Executive Officer of Meitheal. “We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options. Our leadership of the U.S. regulatory process for Garzulys demonstrates the strength of our platform and the disciplined execution we bring to complex products and global partnerships.”

This approval further expands Meitheal’s presence in diabetes care and advances the company’s strategy to build a broader portfolio of biologics and branded products. Since its founding in 2017, Meitheal has developed a diversified U.S. platform supporting more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility.

INDICATIONS AND USAGE
Garzulys™ (insulin aspart-fsan) injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

IMPORTANT SAFETY INFORMATION FOR GARZULYS™
Garzulys (insulin aspart-fsan) is biosimilar* to NovoLog (insulin aspart).

Contraindications

• Garzulys™ is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Garzulys or one of its excipients.

Warnings and Precautions

• Never Share a Garzulys Prefilled Pen between Patients, even if the needle is changed. Patients using Garzulys vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
• Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
• Hypoglycemia: Hypoglycemia is the most common adverse effect of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.
• Risk Factors for Hypoglycemia: The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Garzulys may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitantly administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia.
• Hypoglycemia Due to Medication Errors: To avoid medication errors and accidental mix-ups between Garzulys and other insulin products, instruct patients to always check the insulin label before injection.
• Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Garzulys.
• Hypokalemia: All insulins, including Garzulys, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
• Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Garzulys. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
• Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Garzulys continuous subcutaneous infusion route (insulin pump): Do not mix Garzulys with any other insulin or diluent.

Adverse Reactions

• Adverse reactions observed with Garzulys include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. 

Drug Interactions

• Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
• Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
• Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
• Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Garzulys has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Please see Prescribing Information for Garzulys

Additional Patient Information Leaflets are available at http://www.meithealpharma.com or call 1-844-824-8426.

ABOUT MEITHEAL PHARMACEUTICALS, INC.
Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of generic injectable, biologic, fertility and branded products. Meitheal currently markets more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility.

Meitheal combines an established U.S. commercial platform with regulatory expertise and strategic development and manufacturing partnerships to support complex pharmaceutical products. Building on its foundation in generic injectables, the company is making deliberate, long-term investments to expand its biologics and branded portfolio and broaden access to high-quality, fairly priced medicines.

Meitheal is guided by the traditional Irish principle for which it is named—working together toward a common goal, for the greater good.

Learn more at www.meithealpharma.com.

ABOUT TONGHUA DONGBAO PHARMACEUTICAL CO., LTD.
Founded in 1985 and based in Jilin Province, China, Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao”) is a biopharmaceutical company specializing in the research, development, manufacturing and commercialization of therapies for diabetes and other endocrine and metabolic diseases. In 1998, Tonghua Dongbao developed China’s first domestically produced recombinant human insulin. The company’s portfolio and pipeline include human insulin, insulin analogs, GLP-1 receptor agonists and other therapies for diabetes and related metabolic conditions. Tonghua Dongbao is publicly listed on the Shanghai Stock Exchange under stock code 600867.

ABOUT EMERGE BIOSCIENCE PTE. LTD.
Established in 2024 and based in Singapore, Emerge Bioscience Pte. Ltd. (“Emerge”) is a subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) that supports NKF’s international pharmaceutical trading and supply-chain activities. Emerge coordinates with manufacturers, regulatory authorities, logistics providers and commercial partners to support the reliable, compliant and timely delivery of pharmaceutical products and NKF’s broader international growth strategy.

ABOUT NANJING KING-FRIEND BIOCHECMICAL PHARMACEUTICAL CO., LTD.
Founded in 1986 and headquartered in Nanjing, China, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) is an integrated biopharmaceutical company engaged in the research, development and manufacturing of active pharmaceutical ingredients and finished dosage forms. Building on its established expertise in heparin APIs and sterile injectable products, NKF has expanded its capabilities across generic, biologic and branded products in therapeutic areas including oncology, critical care, fertility and diabetes. NKF supports products and partners in the United States, China, Europe and other global markets and is publicly listed on the Shanghai Stock Exchange under stock code 603707.

ABOUT XENTRIA, INC.
Established in 2020, Xentria Inc. (“Xentria”) works across life science communities creating innovative and authentic collaborations and partnerships that advance challenging drug development. Xentria, derived from “centrality”, is dedicated to delivering customized approaches to ambitious drug innovation through meaningful patient engagement and effective partnerships. Headquartered in Chicago, Xentria is taking the lead to support surging life sciences initiatives for global audiences, while nurturing diversity, individualism, and sustainability.

To learn more about Xentria visit www.xentria.com MAT-US-BIO-00002-1 07/2026