In October, a batch of drugs were evaluated, and some varieties won the first home!

【Pharmaceutical Network Industry News】Generic drug consistency evaluation refers to the quality consistency evaluation of generic drugs that have been approved for marketing, according to the principle of consistency with the quality and efficacy of the original drug, the quality consistency evaluation is carried out in stages and batches, and according to the requirements, the generic drug needs to reach the same level
as the original research drug in terms of quality and efficacy.
Whether it can pass the consistency evaluation can be said to be the touchstone
for judging the research and development and production strength of domestic pharmaceutical companies.
In recent years, with the normalization of collection, domestic pharmaceutical companies have actively promoted the consistency evaluation of generic drugs to obtain the qualifications
to participate in collection.
Since 2022, the good news about drug evaluation has continued, of which a large number of pharmaceutical companies have reported good news
shortly after the opening of October.
For example, recently, Shisi Pharmaceutical Group announced on the Hong Kong Stock Exchange that the group's pentoxifylline injection (5ml: 100mg) was deemed to have passed the consistency evaluation and won the first place
in the country.
Pentoxifylline injection is mainly used to treat peripheral artery disease and inner ear circulation disorders
.
In addition, the group's inhaled isoprotropium bromide solution (2ml: 0.
5 mg and 2 ml: 0.
25 mg) was also considered to have passed the consistency evaluation
.
Inhaled ipratropium bromide solution is mainly used to treat bronchospasm
caused by chronic obstructive pulmonary disease, including chronic bronchitis, emphysema, and asthma.
Enhua Pharmaceutical announced at noon on October 10 that the company's flumazenil injection recently passed the consistency evaluation
of generic drug quality and efficacy.
The drug is used to reverse the central sedation effect caused by benzodiazepines, to terminate the general anesthesia induced and maintained by benzodiazepines, as a specific reversal agent for the central effect of benzodiazepines in the case of benzodiazepines, and to differentiate the diagnosis of unexplained coma
caused by benzodiazepines, other drugs or brain injury.
On October 9, Onlicon issued an announcement that recently, the company's aluminum magnesium carbonate chewable tablets (0.
5g) have passed the consistency evaluation
of generic drug quality and efficacy.
The drug is an over-the-counter drug for acid and gastric mucosal protection, and the indication is chronic gastritis; Stomach discomfort symptoms related to stomach acid, such as stomach pain, heartburn (heartburn), acid belching, fullness, etc
.
On the same day, Northeast Pharmaceutical issued an announcement that the company received the "Notice of Approval of Drug Supplement Application" issued by the State Drug Administration on the injection of pantoprazole sodium, and the drug passed the consistency evaluation
of the quality and efficacy of generic drugs.
It is reported that pantoprazole sodium for injection is suitable for the treatment
of acute upper gastrointestinal bleeding caused by duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis, acute gastric mucosal lesions, compound gastric ulcers, etc.
In addition, Haizheng Pharmaceutical also issued a good news announcement a few days ago, and the company's injection daptomycin has passed the consistency evaluation
of generic drug quality and efficacy.
The bulletin shows that daptomycin for injection is suitable for the treatment: complex skin and skin structure infections (cSSSI) in adults and pediatric patients (1 to 17 years); Staphylococcus aureus bloodstream infection (bacteremia) in adult patients (including patients with right infective endocarditis); Staphylococcus aureus bloodstream infection (bacteremia) in pediatric patients (1 to 17 years
).
The industry said that the drugs of the above companies successfully passed the consistency evaluation, which further demonstrated the company's research and development strength and product quality, and accumulated valuable experience
for the company's follow-up products to carry out generic drug consistency evaluation.
At the same time, passing the evaluation also means that its drugs have the qualification conditions to participate in the centralized procurement of national drugs, which is conducive to enhancing the competitiveness
of the product market.
Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.