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Based on patient needs, Health Yuan's sodium omeprazole for injection has passed the consistency evaluation.
Published Time：
2021-06-18
Recently, Lizhu Pharmaceutical Factory (hereinafter referred to as "Lizhu Pharmaceutical Factory"), a subsidiary of the Group, received the "Approval Notice for Drug Supplement Application" issued by the National Medical Products Administration. The injectable omeprazole sodium produced by Lizhu Pharmaceutical Factory has passed the consistency evaluation of quality and efficacy of generic drugs.
Injectable omeprazole sodium is the first proton pump inhibitor to be marketed It has been used clinically for over 20 years and is a Class B variety in the "National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalog" (Medical Insurance [2020] No. 53). It is mainly used for digestive ulcer bleeding, anastomotic ulcer bleeding; acute gastric mucosal damage that occurs in stressful situations, acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs; prevention of upper gastrointestinal bleeding caused by stress and post-gastric surgery in critically ill patients (such as cerebral hemorrhage, severe trauma, etc.), and can also be used as an alternative therapy when oral therapy is not suitable for duodenal ulcers, gastric ulcers, reflux esophagitis and Zollinger-Ellison syndrome. Its listing and passing the evaluation are good news for the majority of patients and also strengthens the company's future performance.
The change process of omeprazole sodium in the Chinese market is regarded as a microcosm of the germination and development of large-variety original research drugs in China. In 1987, omeprazole sodium was first listed in Luxembourg, and in 1989 it was listed in the US market. It was not until 2003 that AstraZeneca's injectable omeprazole sodium was approved for listing in China. Since the promulgation of the "Twelfth Five-Year Plan" for National Drug Safety on January 20, 2012, in order to improve the safety and effectiveness of drugs and ensure the safe and effective use of drugs by the people, it is explicitly required that generic drugs that have not passed the consistency evaluation of drug quality will not be re-registered and their drug approval certificates will be revoked. At present, the main dosage forms of omeprazole sodium that have been listed in China include injections, tablets and capsules, among which injections account for the largest sales share. Up to now, a total of 103 enterprises in China hold production licenses for injectable omeprazole sodium (40mg), among which, only 10 enterprises, including Lizhu Pharmaceutical Factory, have passed the consistency evaluation.
In recent years, the Group has actively increased its efforts in new product research and development and innovation, driven by innovation, and adhering to "For health, for tomorrow", "Making good medicine and new medicine with care" development philosophy, and has made every effort to meet the strict standards of consistency evaluation.
The continuous advancement of the consistency evaluation process for generic drugs in China will accelerate the alignment with international mature markets, and the quality level of domestic substitution will be improved as a whole. With the successful passing of the evaluation of injectable omeprazole sodium, the 5 drug projects that have passed the consistency evaluation under HealthGen have become increasingly competitive.
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