Meitheal Pharmaceuticals Announces Launch of Generic Paclitaxel Formulation in the United States Through Exclusive Commercial Licensing Agreement

• Meitheal, through parent company Hong Kong King-Friend, launches generic paclitaxel
• Protein-bound paclitaxel formulation is used to treat various types of cancer, including metastatic breast cancer and metastatic adenocarcinoma of the pancreas
• More than 168,000 people live with metastatic breast cancer in the U.S., with only one-third of patients surviving 5 years after diagnosis¹
• Bringing paclitaxel to market underscores Meitheal’s commitment to meeting patients’ needs through a sustainable, affordable supply of critical medicines

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 launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”), paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane^®2, in the U.S.

The 100mg/vial single-dose presentation of protein-bound paclitaxel for injectable suspension is indicated for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and locally advanced or metastatic non-small cell lung cancer.

“Many patients living with difficult-to-treat cancers are faced with the unfortunate reality that the complex, life-saving treatments they need are too expensive or unavailable. At Meitheal, we’re committed to closing this gap – we believe that today’s launch is critical to ensuring that cancer patients get the medicines they need,” said Tom Shea, Chief Executive Officer of Meitheal. “We’re excited to bring this to market in the U.S. and provide patients and providers with a reliable supply of an effective cancer care treatment.”

The launch of paclitaxel increases Meitheal’s portfolio of on-market generic injectables to 68 products, and builds on Meitheal’s successful 12 product launches in 2024. In addition to paclitaxel, Meitheal is planning to launch 20 new products this year across its core therapeutic areas as it continues to identify gaps in the marketplace and evaluate opportunities to address the needs of both patients and providers.

ABOUT PACLITAXEL

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a type of chemotherapy, interfering with microtubules and causing cancerous cells to die. Paclitaxel is largely used for the treatment of metastatic breast cancer, and additional types of cancer.

IMPORTANT SAFETY INFORMATION

INDICATIONS

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

SELECT IMPORTANT SAFETY INFORMATION

WARNING: SEVERE MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3.

Monitor for neutropenia, which may be severe and result in infection or sepsis.

Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound).

CONTRAINDICATIONS

Neutrophil counts of < 1,500 cells/mm3; and severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound).

WARNINGS AND PRECAUTIONS

Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. Sepsis occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1,500 cells/mm3, then resume treatment at reduced dose levels. Pneumonitis occurred with the use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; permanently discontinue treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine. Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug. Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) contains albumin derived from human blood, which has a theoretical risk of viral transmission. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.

DRUG INTERACTIONS

Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

This is not the complete list of all the safety information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound). Please click to see the full Prescribing Information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound).

ABOUT MEITHEAL PHARMACEUTICALS, INC.

Founded in 2017 and based in Chicago, Meitheal 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. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of April 2025, Meitheal, directly or through its partners, has 30 products in the research and development phase, 16 additional products planned for launch in 2025, and 23 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 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for—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 Susan G. Komen Foundation. February 21, 2025. Metastatic Breast Cancer. https://www.komen.org/breast-cancer/facts-statistics/what-is-breast-cancer/metastatic-breast-cancer/

² Abraxane^® is a registered trademark of Celgene.

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