Qilu Pharmaceutical's Cefepime Hydrochloride for Injection Becomes First in China to Pass Generic Consistency Evaluation

On April 20, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s Cefepime Hydrochloride for Injection had passed the consistency evaluation, marking it as the first domestic product to achieve this status. Data from Menet shows that Qilu Pharmaceutical currently has 65 products that have passed or are deemed to have passed the consistency evaluation, including 18 injections (7 of which were the first to pass). Additionally, there are 26 injection products under review for supplemental applications for consistency evaluation or new classification production approvals.

Source: Official Website of the National Medical Products Administration

Cefepime Hydrochloride inhibits bacterial cell wall synthesis and is a broad-spectrum bactericidal agent effective against both Gram-positive and Gram-negative bacteria. It is clinically indicated for the treatment of moderate to severe infections in adults and children aged 2 months to 16 years caused by susceptible organisms, and may also be used for the treatment of bacterial meningoencephalitis in pediatric patients.

Currently, the only dosage form of cefepime hydrochloride marketed in China is the injection. Data from Menet shows that the terminal sales of this product in 2019 exceeded RMB 500 million in China’s public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers.

Application Status for the Consistency Evaluation of Cefepime Hydrochloride for Injection

Source: Menet MED2.0 China Drug Review Database

Currently, nine companies have submitted supplementary applications for the consistency evaluation of Cefepime Hydrochloride for Injection. Among them, Qilu Pharmaceutical’s product has successfully passed the evaluation, marking it as the first in China. Data from Menet shows that Qilu Pharmaceutical currently has 65 varieties that have passed or are deemed to have passed the consistency evaluation, including 18 injectable products.

Qilu Pharmaceutical's Injectables That Have Passed Consistency Evaluation

Source: Menet MED2.0 China Drug Review Database

Among the 18 evaluated injectables, seven products—Cefepime Hydrochloride for Injection, Palonosetron Hydrochloride Injection, Ondansetron Hydrochloride Injection, Irinotecan Hydrochloride Injection, Fasudil Hydrochloride Injection, Oxaliplatin Injection, and Bivalirudin for Injection—were the first to pass the evaluation.

Qilu Pharmaceutical’s extensive portfolio of generics that have passed the consistency evaluation has enabled it to excel in China’s National Centralized Drug Procurement (NCDP). In the fifth round of NCDP, which has already entered the volume declaration phase, injectables account for more than half of the products. Qilu Pharmaceutical has eight injectable products included, namely: Oxaliplatin Injection, Docetaxel Injection, Fasudil Hydrochloride Injection, Palonosetron Hydrochloride Injection, Ceftriaxone Sodium for Injection, Ceftazidime for Injection, Gemcitabine Hydrochloride for Injection, and Ropivacaine Hydrochloride Injection.

Qilu Pharmaceutical: Injectable Products Under Review for Consistency Evaluation (Including New Classification Marketing Applications)

Note: No company has yet passed the evaluation for items marked with *.

Source: Menet MED2.0 China Drug Review Database

Data from Menet shows that among the supplementary applications for consistency evaluation or new classification production submissions for injectables filed by Qilu Pharmaceutical, 26 are still under review, with 16 of them having no approved products from any company yet.

Source: Menet Database, National Medical Products Administration Official Website

Note: Data statistics are current as of April 21. Any omissions or errors are welcome to be corrected!