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Recently, the NMPA website showed that Dongyang Sun Pharmaceutical "Insulin Glargine Injection" was approved for listing
.
Insulin glargine is one of the types of centralized insulin procurement.
A total of 4 companies have been approved before, including the original research company Sanofi and 3 domestic companies: Ganli Pharmaceutical, Tonghua Dongbao and United Laboratories
.
Among them, Dongyang Sunshine is the fourth domestic product approved
.
It is worth mentioning that the CDE website on the same day showed that Hengrui's SHR3680 tablet listing application has been included in the priority review and started to be publicized.
It will be used to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden
.
In addition, on October 22, Sihuan Pharmaceutical also issued an announcement stating that the China National Medical Products Administration has accepted the New Drug Application (NDA) for Anaprazole Sodium Enteric-Coated Tablets
.
It is reported that Anaprazole sodium enteric-coated tablets is a new drug listing application submitted by Xuanzhu Biological, a subsidiary of Sihuan Pharmaceutical
.
The industry believes that many new drugs are about to be launched, mainly because major pharmaceutical companies are increasing their investment in research and development of new drugs, and innovative results have begun to emerge
.
According to statistics, from 2018 to 2020, there are 32 new drugs (excluding imported drugs, new indications, and vaccines) approved for marketing in China for the first time
.
In the first half of this year alone, 15 Class 1 new drugs have been approved for marketing
.
In addition, this year's approval of domestically produced innovative drugs is also showing a blowout trend
.
For example, there are 27 innovative drugs that have passed the review in January-September, including cyclopofol injection, enovervirin tablets, hytropopapaethanolamine tablets, hyperimibe tablets, savotinib tablets, and injection Levo Ornidazole Phosphate Disodium and other blockbuster drugs
.
Under the current trend of innovation, analysis believes that in the future, as relevant departments continue to introduce supporting policies in strengthening clinical trial data verification and accelerating the review and approval of innovative drugs, the development of China's innovative drug industry may further accelerate
.
It is understood that in recent years, the State Food and Drug Administration has actually been working hard to speed up the examination and approval work, and is also continuing to promote the entry of new drugs into medical insurance.
.
For example, on May 17, 2018, the State Food and Drug Administration in conjunction with the Health and Health Commission issued the "Announcement on Optimizing Drug Registration Review and Approval Matters", which greatly simplified the approval procedures for new drugs listed overseas
.
Applicants do not need to apply for clinical trials, but can directly apply for listing with overseas trial data, and the time to market the drug will be accelerated by 1-2 years
.
On September 18, 2020, the National Medical Insurance Administration issued the "2020 National Medical Insurance Drug Catalogue Adjustment Passed Formal Review of the List of Nominated Drugs", 171 drugs were in the period from January 1, 2015 to August 17, 2020 New drugs approved for marketing
.
As early as in the 2019 medical insurance catalog adjustment, 70 drugs that were newly launched in recent years and have high clinical value have been included in the national medical insurance drug catalog through negotiations
.
In general, with the current favorable national policies and the continuous investment of pharmaceutical companies, China's new drug research and development has entered a golden age
.
At the same time, it is also ushering in more intense market competition
.
In this regard, the industry believes that in the future, only products with real clinical value can stand out and become blockbuster products
.
However, it is not an easy task to truly improve the R&D and innovation capabilities of domestically-made innovative drugs.
In addition to continuously increasing investment in innovative R&D, pharmaceutical companies must also vigorously cultivate pharmaceutical talents with original awareness and ability, improve the talent training mechanism, and formulate Appropriate development strategies can build an independent and controllable drug innovation system and promote the further development of enterprises and industries
.
.
Insulin glargine is one of the types of centralized insulin procurement.
A total of 4 companies have been approved before, including the original research company Sanofi and 3 domestic companies: Ganli Pharmaceutical, Tonghua Dongbao and United Laboratories
.
Among them, Dongyang Sunshine is the fourth domestic product approved
.
It is worth mentioning that the CDE website on the same day showed that Hengrui's SHR3680 tablet listing application has been included in the priority review and started to be publicized.
It will be used to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden
.
In addition, on October 22, Sihuan Pharmaceutical also issued an announcement stating that the China National Medical Products Administration has accepted the New Drug Application (NDA) for Anaprazole Sodium Enteric-Coated Tablets
.
It is reported that Anaprazole sodium enteric-coated tablets is a new drug listing application submitted by Xuanzhu Biological, a subsidiary of Sihuan Pharmaceutical
.
The industry believes that many new drugs are about to be launched, mainly because major pharmaceutical companies are increasing their investment in research and development of new drugs, and innovative results have begun to emerge
.
According to statistics, from 2018 to 2020, there are 32 new drugs (excluding imported drugs, new indications, and vaccines) approved for marketing in China for the first time
.
In the first half of this year alone, 15 Class 1 new drugs have been approved for marketing
.
In addition, this year's approval of domestically produced innovative drugs is also showing a blowout trend
.
For example, there are 27 innovative drugs that have passed the review in January-September, including cyclopofol injection, enovervirin tablets, hytropopapaethanolamine tablets, hyperimibe tablets, savotinib tablets, and injection Levo Ornidazole Phosphate Disodium and other blockbuster drugs
.
Under the current trend of innovation, analysis believes that in the future, as relevant departments continue to introduce supporting policies in strengthening clinical trial data verification and accelerating the review and approval of innovative drugs, the development of China's innovative drug industry may further accelerate
.
It is understood that in recent years, the State Food and Drug Administration has actually been working hard to speed up the examination and approval work, and is also continuing to promote the entry of new drugs into medical insurance.
.
For example, on May 17, 2018, the State Food and Drug Administration in conjunction with the Health and Health Commission issued the "Announcement on Optimizing Drug Registration Review and Approval Matters", which greatly simplified the approval procedures for new drugs listed overseas
.
Applicants do not need to apply for clinical trials, but can directly apply for listing with overseas trial data, and the time to market the drug will be accelerated by 1-2 years
.
On September 18, 2020, the National Medical Insurance Administration issued the "2020 National Medical Insurance Drug Catalogue Adjustment Passed Formal Review of the List of Nominated Drugs", 171 drugs were in the period from January 1, 2015 to August 17, 2020 New drugs approved for marketing
.
As early as in the 2019 medical insurance catalog adjustment, 70 drugs that were newly launched in recent years and have high clinical value have been included in the national medical insurance drug catalog through negotiations
.
In general, with the current favorable national policies and the continuous investment of pharmaceutical companies, China's new drug research and development has entered a golden age
.
At the same time, it is also ushering in more intense market competition
.
In this regard, the industry believes that in the future, only products with real clinical value can stand out and become blockbuster products
.
However, it is not an easy task to truly improve the R&D and innovation capabilities of domestically-made innovative drugs.
In addition to continuously increasing investment in innovative R&D, pharmaceutical companies must also vigorously cultivate pharmaceutical talents with original awareness and ability, improve the talent training mechanism, and formulate Appropriate development strategies can build an independent and controllable drug innovation system and promote the further development of enterprises and industries
.
