Author: Tomato
On November 19, 2020, the State Food and Drug Administration released 40 drug approval documents to be collected, including drugs that passed the consistency evaluation: 10 drugs passed the consistency evaluation, and 8 drugs were deemed to have passed the consistency evaluation.
Figure 1: Partial November 19 drug approval information
Source: The official website of the State Food and Drug Administration
Note: The red box is a drug that has passed the consistency evaluation
The blue box is deemed to be evaluated by consistency
Among the drug varieties that passed the consistency evaluation (or deemed to be passed), 10 of them were the first to be evaluated, including Cefoxidin sodium for injection of Yangtze River Pharmaceutical Group, edaravone injection of Simcere Pharmaceutical, and furosemide tablets of Tianjin Lisheng Pharmaceutical, among which Jiangsu Chenpai Pharmaceutical and Ribavirin tablets of Guangdong South China Pharmaceutical obtained approval information at the same time and passed the consistency evaluation.
Table 1: Basic information on overrated drugs
Data source: Kenshu Technology China Drug Review Database Kenshu Technology Consistency Evaluation Database
<h1 class= "pgc-h-arrow-right" > Simcere Pharmaceuticals: edaravone injection</h1>
Edaravone is a brain protector (free radical scavenger). Clinical studies suggest that N-acetylspartic acid (NAA) is a marker of specific surviving nerve cells, with a sharp decrease in the initial levels of cerebral infarction. The administration of edaravone in patients with acute cerebral infarction can inhibit the reduction of local cerebral blood flow around the infarction, so that the NAA content in the brain on the 28th day after the onset of the disease is significantly higher than that of the glycerol control group. It improves neurological symptoms, ability to perform activities of daily living, and dysfunction due to acute cerebral infarction.
Figure 2. Edaravon" basic information
Source: Kenshu Technology Global Drug Discovery Database
< h1 class = "pgc-h-arrow-right" > ribavirin tablets</h1>
Ribavirin is a synthetic nucleoside antiviral drug, which was listed abroad in the 1970s, and ribavirin developed in China was listed in the 1980s. At present, ribavirin is mainly used clinically for the treatment of viral pneumonia caused by respiratory syncytial virus and viral diseases such as bronchitis and cutaneous herpes virus infection.
Ribavirin tablets are currently one of the few broad-spectrum antiviral drugs available clinically, the first overrated, can replace non-evaluated tablet products, quickly seize the non-basic drug ribavirin injection market; because the injection has no original research reference, can not be evaluated, and adverse reactions are large, will be gradually eliminated.
Jiangsu Chenpai Pharmaceutical and Guangdong Huanan Pharmaceutical's ribavirin tablets obtained approval information and passed the consistency evaluation. According to jianshu technology's China drug review database, Jiangsu Chenpai Pharmaceutical declared the consistency evaluation task in July 2019, and Guangdong South China Pharmaceutical also declared in November of the same year. So far, only Jiangsu Chenpai Pharmaceutical and Guangdong South China Pharmaceutical's ribavirin tablets have passed the consistency evaluation, and Zhejiang Zhebei Pharmaceutical is still under approval.
Figure 2. Review information for ribavirin tablets
Source: Kenshu Technology China Drug Review Database
<h1 class="pgc-h-arrow-right" > previous periods</h1>
11.12 Drug Approval Information! 17 drugs are deemed to have passed the consistency evaluation
2020.11.04Pharmaceutical approval information! 11 drugs passed the consistency evaluation
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