Qilu Pharmaceutical Accelerates R&D: Bupivacaine Liposome Injection Nears Approval as the Third Domestic Entrant, Expanding Its Liposomal Pipeline

(Source: Mosen Medical Big Data)

Recently, according to the official website of China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE),Qilu Pharmaceutical(Hainan) The marketing application for liposomal bupivacaine injection, filed under Chemical Drug Registration Category 3, has been accepted. Currently, only two pharmaceutical companies in China hold the production approval for this product.

Bupivacaine Liposome (brand name Exparel) is manufactured byPaciraOriginally developed by the company, it was approved for marketing by the U.S. FDA in November 2011 and is used for injection at surgical sites to control postoperative pain. In November 2022,$Hengrui Pharma(600276)Bupivacaine Liposome Injectable, filed as Category 3, Receives NMPA Approval. Hengrui Pharma's Bupivacaine Liposome Injectable was successfully approved for marketing in the United States on July 1, 2024, becoming the world’s first generic version of this drug to be marketed. Following its inclusion in China’s National Reimbursement Drug List (NRDL) in 2023, the product experienced rapid market growth, with sales exceeding 170 million yuan in 2024 and surpassing 200 million yuan in the first half of 2025 alone, representing a year-on-year increase of 456%. The market outlook is highly promising.

Sales Database

The original product of bupivacaine liposome has not been launched in China, and so far, there is only bupivacaine liposome injection domestically.Jiangsu Hengrui Pharma、Hunan Kelun Pharmaceutical Co.,Ltd.Two pharmaceutical companies have been approved and passed the consistency evaluation. According toMoxie Pharma DatabaseIt shows that currently, six pharmaceutical companies have submitted the market application for the generic version of Liposomal Bupivacaine Injection (Category 3), all of which are under review and approval.Qilu PharmaceuticalIf successfully approved, it is expected to rise as a latecomer, becoming the third domestically produced variant in China, bringing new changes to the market competition landscape.

The national negotiation agreement for bupivacaine liposome injection will expire at the end of 2025 and needs to be renewed this year. Hengrui Pharma received approval for a new indication on the last day before the national negotiation deadline, giving it an advantage in the renewal. Although renewals this year typically involve price reductions and Kelun has emerged as a new competitor, increasing bidding pressure, the addition of a new indication may help it secure a more favorable price. Moreover,Qilu PharmaceuticalAlready holding liposomal doxorubicin, liposomal amphotericin B under review, and liposomal irinotecan conducting BE trials, the liposome pipeline is steadily advancing.

Since the beginning of this year,Qilu Pharmaceutical(Including subsidiaries) have demonstrated strong R&D and submission capabilities, cumulatively submitting marketing applications for 18 generic products, all of which are currently in the review and approval stage. Meanwhile, the company has successfully obtained approval for 23 products, which have also passed the consistency evaluation smoothly. Among them, five products—Citrate Ixazomib Capsules, Ibrutinib Tablets, Etoposide Injection, Amisulpride Injection, and Olanzapine for Injection—are the first to pass the evaluation, highlighting Qilu Pharmaceutical's leading position in the industry.

Reference Source:

[1] CDE Official Website

[2] Mosec Pharma (formerly Yiyao Rongyun) Database