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On November 19, NMPA announced information on 68 drug approval documents to be obtained.
Among them, Chia Tai Tianqing's " Lurasidone Hydrochloride Tablets " was approved, becoming the fourth domestic company to be approved for listing of this product
.
At present, at least 14 domestic pharmaceutical companies have deployed lurasidone, among which Hisun Pharmaceutical, Jiangsu Hausen, and Yangzijiang have been approved for production
Zhengda Tianqing Lurasidone Hydrochloride Tablets Hisun Pharmaceutical, Jiangsu Hausen, Yangtze River
Screenshot source: NMPA official website
According to the Pharmacy Rongyun generic drug reference preparation catalog, Lurasidone Hydrochloride was originally developed for Lurasidone HCl produced by Sumitomo Pharmaceuticals, Japan , with the trade name: Latudal/Rosuda, which is an atypical (second-generation) antipsychotic drug.
Dopamine (D2) and serotonin (5-HT2A, 5-HT7) receptor antagonists
.
Screenshot source: Yaorong Cloud Database
At present, the Lurasidone Hydrochloride Tablet Roshuda originally developed by Sumitomo has been marketed in 20+ countries and regions around the world, and has been approved for multiple indications, including ①treatment of schizophrenia in adults and adolescents (13-17 years old); ② Monotherapy in adults and adolescents (10-17 years old) with bipolar type I affective disorder depressive episodes; ③As an adjuvant therapy of lithium or valproate, it is used for the treatment of adult bipolar type I affective disorder depressive episodes
.
According to estimates by Yaorongyun, global sales in 2020 will be approximately US$1.
Global sales of lurasidone hydrochloride tablets
Screenshot source: Yaorongyun Global Drug Research and Development Database
The drug landed in China in January 2019 for the treatment of schizophrenia, and then entered the 2020 national medical insurance
.
As a result, the in-hospital sales of lurasidone hydrochloride tablets have achieved leapfrog growth.
In-hospital sales of lurasidone hydrochloride tablets
Screenshot source: Yaorongyun National Hospital Sales Database
According to the statistics of Yaorongyun, there are currently a total of 6 companies that have submitted applications for the listing of lurasidone hydrochloride tablets in 4 generic categories, and 4 of them have been approved this year: Zhejiang Hisun Pharmaceutical 's first application and won the first in April this year.
Afterwards, Jiangsu Hausen, Yangtze River, and Chia Tai Tianqing were successively approved and deemed to have passed the consistency evaluation
.
Qilu Pharmaceutical, Chongqing Yaoyou Pharmaceutical, Livzon Group, Hunan Dongting Pharmaceutical, Shijiazhuang Siyao and Chenxin Pharmaceutical are in the BE trial stage
Zhejiang Hisun Pharmaceuticals Jiangsu Hausen, Yangtze River, Chia Tai Tianqing Qilu Pharmaceuticals, Chongqing Yaoyou Pharmaceuticals, Livzon Group, Hunan Dongting Pharmaceuticals, Shijiazhuang Siyao Chenxin Pharmaceuticals
Overview of the layout of Lurasidone related preparations
Data source: Yaorongyun drug review database; China clinical trial database
In addition, Jinan Benro Pharmaceutical applied for approval for a Class 3.
Jinan Benro Pharmaceutical Lurasidone Hydrochloride Capsules Guangdong Dongyang Pharmaceutical Lurasidone Delayed Release Tablets
