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【Pharmaceutical Network Industry News】With the rise of domestic pharmaceutical innovation and the advancement of review and review, it can be clearly found that the launch
of domestic new drugs is accelerating.
Recently, a number of pharmaceutical companies have announced that related products have obtained drug registration certificates
.
Among them, many companies also said that the acquisition of drug registration certificates will further enrich the company's product line and enhance market competitiveness
.
Lukang Pharmaceutical On November 8, Lukang Pharmaceutical issued an announcement that essomeprazole sodium for injection received the "Drug Registration Certificate" issued by the State Food and Drug Administration and was approved for marketing
.
Essomeprazole sodium for injection is used in low-risk patients
with gastroesophageal reflux disease and bleeding from acute gastric or duodenal ulcers.
In 2007, the original research of AstraZeneca AB for injection essomeprazole sodium was approved for marketing in China, the trade name is "Naixin/Nexium", the specification is 40mg
.
Up to now, essomeprazole sodium has been approved
in many countries and regions around the world.
According to the information on the website of the State Food and Drug Administration, there are a total of 60 approval numbers for essomeprazole sodium for injection in China, involving Qilu Pharmaceutical, Chia Tai Tianqing and other enterprises
.
East Sunshine Pharmaceutical On the same day, East Sunshine Pharmaceutical announced on the Hong Kong Stock Exchange that the company's independent research and development product aspart insulin 30 injection has been approved by the China National Medical Products Administration and approved for marketing
.
This product is a premixed insulin containing 30% soluble insulin aspart and 70% protamine insulin
aspart.
The product is currently a commonly used drug in the mainstream insulin intensive regimen, which is mainly used to control postprandial blood glucose in diabetic patients, and is suitable for patients
who receive oral hypoglycemic drugs but still have poor blood sugar control.
It is reported that East Sunshine Medicine has invested a total of about 116,475,300 yuan
in research and development on this drug.
The successful marketing approval of this product will benefit the expansion of the Group's business in the field of endocrinology and metabolic therapy and further enrich the Group's product portfolio
.
Haisco Haisco announced on November 8 that the company has recently received the "Acceptance Notice" issued by the State Medical Products Administration, and the marketing authorization application of the company's innovative drug HSK16149 capsules has been accepted
.
According to the announcement, HSK16149 capsules are Class 1 new drugs with independent intellectual property rights developed by the company, which are intended for the treatment
of peripheral neuropathic pain.
The indication declared by Haisco this time is diabetic peripheral neuralgia, and clinical research
on other indications for peripheral neuropathic pain will continue in the future.
HSK16149 Another phase III double-blind study in Chinese postherpetic neuralgia patients is progressing normally
.
Haisco said that if the marketing authorization application of HSK16149 capsules can be successfully approved, it will be able to accumulate more rich and valuable experience for the research and development of innovative drugs, and play a positive role
in the establishment of the company's academic brand.
Conclusion Under the background of the continuous improvement of national review and approval policies and the influx of a large amount of capital, China's pharmaceutical industry is developing rapidly, and the development of new drugs has entered a new era
.
The industry expects that as domestic pharmaceutical companies gradually enter the innovation harvest period, the number of domestic new drugs will continue to grow, and the treatment field will become more and more abundant
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.