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Recently, according to the official website of NMPA, the listing application (acceptance number: CYHS2000257, 258) of the 4 generic drug "lurasidone hydrochloride tablets" in Jiangsu Hausen has been changed to "under approval" status, and it is expected to be approved for listing this month.
The second domestically produced company was approved, and the author predicts that the indication is schizophrenia
.
Lurasidone is a schizophrenia drug, the original research has entered medical insurance
Figure 1 Source: NMPA official website
Figure 2 Source: NMPA official website
The original research entered China Medical Insurance
The original research entered China Medical InsuranceThe original research Lurasidone hydrochloride (Urasidone HCl, trade name: Latudal/Rosuda) is an atypical (second-generation) antipsychotic drug developed by Sumitomo Pharmaceuticals.
It is a combination of dopamine (D2) and serotonin (5-HT2A, 5 -HT7) receptor antagonist
.
In October 2010, the drug was approved by the FDA for the first time.
It has been approved for 3 indications: ①Treatment of schizophrenia in adults and adolescents (13-17 years old); ②Single-drug treatment of adults and adolescents (10-17) Years old) Depressive episodes of bipolar type I affective disorder; ③As an adjuvant therapy of lithium or valproate, it is used to treat depressive episodes of bipolar type I affective disorder in adults
.
In January 2019, the drug was approved for marketing in China for the treatment of adult schizophrenia, and successfully entered the 2020 national medical insurance during the 2020 medical insurance negotiations
As of the end of 2020, Roshuda has been approved for marketing in 27 countries and regions around the world.
With its comprehensive characteristics of efficacy, safety, and tolerability, Roshuda is recommended by many international treatment guidelines
.
After querying the IMS database, the global sales of lurasidone hydrochloride tablets in 2019 were approximately US$3.
Hisun won the first imitation
Hisun won the first imitationAccording to the official website of CDE, a total of 5 companies have submitted applications for the listing of lurasidone hydrochloride tablets for generic drugs.
Among them, Hisun Pharmaceuticals submitted the first application for listing and was approved for listing in April 2021 and became the first imitation for the spirit.
Schizophrenia
.
In addition, Hausen and Yang Zijiang speculate that they have also submitted a listing application for bipolar I disorder
(Source: CDE official website)
Schizophrenia is a chronic disease with a high recurrence rate.
In addition to positive symptoms such as hallucinations, delusions, and speech disturbances, as well as negative symptoms such as reduced emotional expression or lack of motivation, it is often accompanied by poor memory, concentration, and execution.
Such as cognitive dysfunction and emotional symptoms such as restlessness and depression
.
As time goes by, various symptoms appear, and life and employment will become more and more difficult
Note: The original text has been deleted
