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On September 26, Osaikang submitted an application for the imitation of Roxatidine Hydrochloride Acetate Hydrochloride for Injection and was accepted.
Figure 1: The latest products declared by Osaikang
Source: CDE official website
The commonly used H2 receptor antagonists in clinic are divided into four generations: the first generation cimetidine, the second generation ranitidine, the third generation famotidine, rosatidine is the fourth generation, and its bioavailability It is the highest among this class of drugs and is a selective histamine H2 receptor antagonist.
Figure 2: Sales of Roxatidine Hydrochloride Acetate for Injection (Unit: Ten Thousand Yuan)
Source: Mi Nei.
According to data from Menet.
At present, the approved domestic pharmaceutical companies involve Harbin Pharmaceutical Group and Beijing Sihuan Pharmaceutical.
Table 1: Status of products declared by Osaikang since 2021
Source: Meinenet MED2.
Since 2021, Osaikang has also declared that a Class 1 new drug has been approved for clinical use, and dexlansoprazole for injection of a Class 2.
Source: CDE official website, Minet database
The review data statistics are as of September 27, if there are any errors or omissions, please correct me