There were 167 varieties of Class 1 new drugs applied in China in the first half of this year, involving 129 pharmaceutical enterprises and research institutions. According to Insight database, 29 pharmaceutical enterprises applied for more than 2 new drug varieties, wherein, Hengrui Medicine topped with a total of 6 applications for Class 1 new drug varieties.

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上半年1类新药申请品种排行榜TOP6
恒瑞医药 辉瑞 基石药业 绿叶制药 中国生物制药 中国医药集团 |
Top 6 by Number of Applications for Class 1 New Drug Varieties in the First Half of the Year Hengrui Medicine Pfizer CStone Pharmaceuticals Luye Pharma Sino Biopharmaceutical China National Pharmaceutical Group |
2 Class 1 new drugs applied for production
Hengrui Medicine had 2 Class 1 new drug varieties applied for production in the first half of 2018, separately, Class 1 new chemical drug: remimazolam tosylate and its preparation, and Class 1 biological product for treatment: camrelizumab for injection, with the former being the first Class 1 new drug applied for production in China this year.
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Pharmaceutical product name |
Acceptance No. |
Acceptance date |
Priority review |
Handling state |
|
Remimazolam Tosylate |
CXHS1800001 |
March 21 2018 |
Having significant therapeutic advantages over existing treatment means |
Under review and approval |
|
Remimazolam Tosylate for Injection |
CXHS1800002 |
March 21 2018 |
Under review and approval |
|
|
Camrelizumab for Injection |
CXSS1800009 |
April 23, 2018 |
Under review and approval |
Remimazolam tosylate
The marketing application for the Class 1 new drug remimazolam tosylate accepted by CDE on March 21 includes two acceptance numbers: CXHS1800001 (API) and CXHS1800002 (injection). This drug in development belongs to benzodiazepines, and is a short-acting GABAa receptor agonist that is applicable to the intravenous general anaesthesia in selective operations.
Remimazolam tosylate and its preparation were included in the list of the 28th batch of registration applications of pharmaceutical products to be included in the priority review procedure published by CDE on April 23 upon "having significant therapeutic advantages over existing treatment means", and are now "under review and approval". The industry is generally optimistic about the future market of remimazolam tosylate and considers the drug to have the potential to become a RMB 1 billion/2 billion blockbuster variety.
Camrelizumab for injection
Camrelizumab for injection is a humanized anti-PD-1 monoclonal antibody that is applicable to the treatment of relapsed/refractory classical Hodgkin lymphoma patients who have received at leas...










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