Qilu Pharmaceutical Secures Consistency Evaluation Approval for Two Injectable Drugs; 11 Products Enter Fifth Round of National Centralized Procurement

On May 10, the NMPA website announced that Qilu Pharmaceutical’s Decitabine for Injection and Cefminox Sodium for Injection had passed the consistency evaluation. Decitabine for Injection is among the products proposed for inclusion in the fifth batch of centralized procurement. Currently, Qilu Pharmaceutical has 11 approved products participating in the fifth batch of centralized procurement, nine of which are injectables.

Cefminox, a cephamycin derivative belonging to the second-generation cephalosporins, features a broad antimicrobial spectrum, potent bactericidal activity, and a wide range of indications. Data from Menet shows that in 2020, sales of cefminox at terminal outlets of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—approached RMB 1.5 billion, with Sichuan Hexin Pharmaceutical holding a 25.46% market share. Currently, only Fuan Pharmaceutical and Qilu Pharmaceutical have obtained consistency evaluation approval for Cefminox Sodium for Injection.

Decitabine is a DNA methylation-specific inhibitor that has demonstrated favorable efficacy in the clinical treatment of high-risk myelodysplastic syndromes, refractory and highly recurrent acute myeloid leukemia, and chronic myeloid leukemia. Data from Menet shows that in 2020, sales of decitabine at public medical institutions in China exceeded RMB 600 million, with Hansoh Pharmaceutical and Chia Tai Tianqing holding market shares of 43.6% and 36.9%, respectively.

Decitabine for Injection is included in the fifth batch of drugs proposed for centralized procurement. The Decitabine for Injection products from Hansoh Pharmaceutical and Chia Tai Tianqing have previously passed the consistency evaluation, making Qilu Pharmaceutical the third company to achieve this milestone for the product. The consistency evaluation applications for Decitabine for Injection from Ask Pharm and Zhongmei Huadong Pharmaceutical are currently under review.

To date, Qilu Pharmaceutical has had 68 products (121 specifications) approved or deemed approved for consistency evaluation, among which 34 were the first in China to pass the evaluation, and 21 are injectables.

Among the 60 drug varieties included in the fifth national centralized volume-based procurement, Qilu Pharmaceutical had 11 approved varieties selected, including Oxaliplatin Injection, Isosorbide Mononitrate Sustained-Release Tablets, Docetaxel Injection, Saxagliptin Tablets, Fasudil Hydrochloride Injection, Palonosetron Hydrochloride Injection, Ceftriaxone Sodium for Injection, Ceftazidime for Injection, Gemcitabine Hydrochloride for Injection, Decitabine for Injection, and Ropivacaine Hydrochloride Injection. Of these, nine varieties are injections.

Source: Menet Database, NMPA