Today, Hengrui Pharmaceuticals Bupivacaine Liposome Injection was successfully approved for listing in the United States. This product is the first generic drug of this species approved for marketing in the world, and its listing in the U.S. is an important milestone in the international development of the company's high-end preparations.

Bupivacaine liposome injection was first approved in the United States in 2011, and the original product is currently sold only in the United States and Europe, and has not been imported domestically. Because of its high technical barriers, no generic product has been successfully listed for more than 10 years. Hengrui Pharmaceuticals Bupivacaine Liposome Injection has been approved to be listed in China at the end of 2022, which is the exclusive global first generic of Hengrui Pharmaceuticals' Class 3 new drug, deemed to have passed the consistency evaluation, and is also the first ultra-long-acting local anesthesia drug in China, belonging to the long-lasting and slow-release preparation, which is encapsulated in the multicapsular liposome to realize the safe and slow-release through the unique DepoFoam technology.

As an innovative internationalized pharmaceutical enterprise, Hengrui Pharmaceuticals has been striving to promote high-quality pharmaceutical products to benefit patients around the world in recent years, and has achieved fruitful results in exporting high-end preparations overseas. By the end of 2023, the company's products have entered more than 40 countries, and obtained nearly 20 registration approvals in Europe, the United States and Japan, including injections, oral preparations and inhalation anesthetics. 2011, the company's anti-tumor drug irinotecan injection was approved to be listed in the U.S., and the company became the first national pharmaceutical enterprise whose injections were approved to be listed in the U.S. In 2017, the company's docetaxel injection was approved to be listed in the U.S. and designated by the U.S. FDA. In 2017, the company's docetaxel injection was approved to be listed in the U.S. and designated as a control standard preparation (RS) by the U.S. FDA.2024 Since then, the company's immunosuppressant tacrolimus extended-release capsules have been approved to be listed and sold in the U.S., and they are the first generic drugs of the species approved to be listed by the U.S. FDA.

At present, the Company is also continuing to accelerate the development of global markets and focus on emerging markets. At the same time, the company is actively practicing the "One Belt, One Road" strategy, and gradually strengthening product registration in Russia, the Middle East and Southeast Asian countries, so as to improve the accessibility of drugs to patients in different regions of the world.

Hengrui Pharmaceuticals said that the approval of bupivacaine liposome injection by the U.S. FDA will have a positive impact on the company's market expansion. The company will actively promote the preparation for the listing of the drug in the U.S. market.

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