Qilu Pharmaceutical: The Top Performer in China's 2019 Generic Drug Consistency Evaluation

Original: Vernacular Chinese

According to the PharmaGo database of Medicine Magic, there were six companies that had 10 drugs pass the consistency evaluation in 2019, namely Qilu Pharmaceutical, Yangtze River Pharmaceutical, CSPC, Chia Tai Tianqing, Kelun Pharmaceutical, and Fosun Pharmaceutical.

Among them, Qilu Pharmaceutical had 17 drugs pass the consistency evaluation in 2019, becoming the biggest winner of that year. The approved drugs covered multiple therapeutic areas, including cardiology, psychiatry, and oncology. In addition, its paclitaxel (albumin-bound) injection passed the evaluation, making Qilu the third domestic manufacturer to achieve this, following Hengrui Medicine and CSPC Ouyi. Currently, this drug has been included in the second batch of the National Centralized Drug Procurement list.

In the first round of China’s National Centralized Drug Procurement, Qilu Pharmaceutical delivered an outstanding performance, with all five of its evaluated products—gefitinib, risperidone, atorvastatin, olanzapine, and tenofovir disoproxil—successfully winning bids, achieving price reductions ranging from 49% to 78%. In the recently announced list for the second round of National Centralized Drug Procurement, Qilu Pharmaceutical currently has six products eligible to participate in the bidding: adefovir dipivoxil tablets, trimetazidine hydrochloride sustained-release tablets, solifenacin succinate tablets, tadalafil tablets, tegafur/gimeracil/oteracil potassium capsules, and paclitaxel for injection (albumin-bound).

Yangtze River Pharmaceutical and CSPC each had 14 drugs pass the consistency evaluation in 2019, ranking second. Among Yangtze River Pharmaceutical’s approvals was omeprazole enteric-coated capsules, a high-difficulty variety that was the first to pass the evaluation. In the first round of national centralized procurement, two of Yangtze River Pharmaceutical’s exclusively approved varieties won bids (enalapril maleate tablets and dexmedetomidine hydrochloride injection), with prices on par with the previous “4+7” pilot program bid prices.

Among the drugs listed in the second round of centralized procurement, Yangtze River Pharmaceutical Group is currently eligible to bid for Fluconazole Tablets, Cephalexin Capsules, Meloxicam Tablets, and Cefradine Capsules. Meanwhile, CSPC is eligible to bid for Amoxicillin Capsules and Clindamycin Hydrochloride Capsules.

In 2019, Chia Tai Tianqing had a total of 13 products pass the consistency evaluation, among which several were the first domestic generics, deemed as having passed the consistency evaluation. There were two injectables, namely Azacitidine for Injection and Bendamustine Hydrochloride for Injection. The anti-tumor drug Lenalidomide (25mg specification) was approved in January this year, passed the consistency evaluation in October, and added two new specifications of 5mg and 10mg in November. Its sales revenue reached 137 million yuan in the first three quarters.