Qilu Pharma Submits Application for Bupivacaine Liposome Injection Amid 456% Sales Surge in China

　　【Pharmaceutical Network Product InformationAccording to the disclosure on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the marketing application of Bupivacaine Liposome Injection submitted by Qilu Pharmaceutical (Hainan) Co., Ltd. under Chemical Drug Registration Classification 3 has been accepted. Data shows that the product's sales revenue in the first half of 2025 increased by 456% year-on-year, indicating a promising market outlook.
 

Bupivacaine liposome for injection at surgical sites to control postoperative pain was originally developed by Pacira and received FDA approval in the U.S. in November 2011. Currently, the original product has not yet been marketed in China.
 

Data shows that, as of now, only two pharmaceutical companies in China, Jiangsu Hengrui Medicine and Hunan Kelun Pharmaceutical, have received approval and passed the consistency evaluation for bupivacaine liposome injectable. In November 2022, Hengrui Medicine's bupivacaine liposome injectable, filed under Category 3, was approved by the NMPA. After being added to the national reimbursement drug list in 2023, the product’s market grew rapidly, with sales exceeding 170 million yuan in 2024. In the first half of 2025, sales increased by 456% year-on-year, surpassing 200 million yuan. In October 2024, Hunan Kelun Pharmaceutical, a subsidiary of Kelun Pharmaceutical, successfully obtained approval for its "bupivacaine liposome injectable" and passed the consistency evaluation, becoming the second such product to be marketed in China.
 

Industry insiders indicate that with the acceleration of China's aging process, the number of surgical patients is increasing year by year. There is a growing urgent demand for long-term, continuous, and safe postoperative analgesic drugs. Bupivacaine Liposome Injectable has shown broad development prospects in the Chinese market.
 

Data show that bupivacaine liposome injection, relying on DepoFoam technology, encapsulates bupivacaine within multivesicular liposomes to form a long-acting sustained-release formulation. After entering the body, these liposomal vesicles gradually rupture and slowly release bupivacaine. Although the amount of bupivacaine released with each vesicle rupture is limited, the overall structure of the vesicles remains stable. The difference in rupture timing of the vesicles extends the release duration of bupivacaine. Bupivacaine liposome injection can provide analgesic effects for up to 72 hours, far exceeding the typical 6 to 8 hours of current local anesthetics.
 

It is predicted that by 2030, the global market size of liposomal bupivacaine injection is expected to reach 907 million US dollars, with a steady annual growth rate (CAGR) of 8.60% in the coming years.
 

It is reported that currently in China, including Qilu Pharmaceutical, six pharmaceutical companies have submitted the market application for the generic version of Bupivacaine Liposome Injectable Suspension (Category 3), all of which are under review and approval. If Qilu Pharmaceutical is successfully approved, the competitive market landscape will embrace new changes.
 

In recent years, Qilu Pharmaceutical has demonstrated strong R&D and submission capabilities, cumulatively submitting marketing applications for 18 generic drug varieties. On September 4, the CDE website also showed that Qilu Pharmaceutical's marketing application for Capmatinib Hydrochloride Tablets, registered as a Category 4 chemical drug, has been accepted. As a milestone drug in the precise treatment of MET-driven lung cancer, this product is currently only available as an original research drug in China. If Qilu Pharmaceutical receives approval, it may become the first generic version in China.
 

At the same time, the company has successfully obtained approval for 23 varieties and passed the consistency evaluation smoothly. Among them, five products—namely, Ixazomib Citrate Capsules, Ibrutinib Tablets, Etoposide Injection, Amisulpride Injection, and Olanzapine for Injection—are the first-to-market varieties to pass the evaluation.
 

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