Qilu Pharmaceutical's Granisetron Hydrochloride Injection Becomes First-to-File Generic Approved in China

On April 26, the NMPA website updated information on drug approval documents, with Qilu Pharmaceutical’s Granisetron Hydrochloride Injection becoming the first to pass the consistency evaluation. Data from Menet shows that granisetron is among the top six antiemetic and antinausea drugs, with terminal sales exceeding RMB 400 million in 2019 across China’s public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers.

Figure 1: Product Information of Qilu Pharmaceutical That Has Passed the Consistency Evaluation

Source: NMPA Official Website

Granisetron is a highly selective 5-HT3 receptor antagonist, indicated for the prevention and treatment of nausea and vomiting induced by tumor radiotherapy and chemotherapy. In 2019, its sales at the terminal of public medical institutions in China exceeded RMB 400 million, with injections accounting for as high as 97%, tablets for approximately 2%, and both capsules and patches each accounting for less than 1%.

Table 1: Antiemetic and Antinausea Drugs Previously Granted Approval or Deemed Approved

Source: Menet MED2.0 China Drug Review Database

Note: * denotes the first company to pass the evaluation.

Data from Menet shows that five antiemetic and antinausea products had previously passed the consistency evaluation or were deemed to have passed it. Qilu Pharmaceutical secured the first approval for aprepitant capsules, ondansetron hydrochloride tablets, ondansetron hydrochloride injection, and palonosetron hydrochloride injection. The recently approved granisetron hydrochloride injection marks Qilu’s sixth product in the antiemetic and antinausea category to pass the evaluation (and its fifth to achieve first-in-class approval).

Table 2: Brand Rankings of Qilu Pharmaceutical’s Antiemetic and Antinausea Drugs in H1 2020

Source: Competitive Landscape of China’s Public Medical Institution Terminals, Menet Network

According to the MENET MID Drug Index Comprehensive Database, Qilu Pharmaceutical has seven products in the antiemetic and antinausea category, four of which ranked among the top 20 brands in China’s public healthcare institutions for antiemetics and antinauseants in the first half of 2020, with a combined market share exceeding 20%. Currently, only Tropisetron Hydrochloride Injection has not yet passed the consistency evaluation. Once this product successfully passes the evaluation, all of Qilu Pharmaceutical’s approved antiemetic and antinausea drugs will have passed the consistency evaluation.

Source: Menet Database, NMPA Official Website

Review data statistics are current as of April 26. Please point out any errors or omissions.