Entering medical insurance, welcoming the first imitation, Sumitomo Pharmaceuticals Lurasidone has mixed worries and joys

Recently, the listing application of Hisun Pharmaceutical's 4-category generic drug " Lurasidone Hydrochloride Tablets" (the relevant acceptance number is CYHS1900723) has changed its status in the NMPA to "under approval", and it is expected that it will be officially approved for the treatment of adults in the near future Schizophrenia has become the first imitation of this breed in China
.

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

At present, most of the commonly used atypical antipsychotics can control the positive symptoms, but they cannot completely solve the multi-dimensional symptoms including negative symptoms and cognitive symptoms
.
Moreover, some drugs are prone to side effects such as weight gain and abnormal glucose and lipid metabolism

Lurasidone hydrochloride (urasidone HCl, Latudal) is an atypical antipsychotic drug developed by Sumitomo Pharmaceuticals.
It has a strong affinity for dopamine (D2) and serotonin (5-HT2A, 5-HT7) receptors.
Antagonism, partial agonistic effect on 5-HT1A receptors, but almost no affinity for histamine H1 and muscarinic M1 receptors
.
Clinical studies have shown that Latudal has a good control and improvement effect on the multi-dimensional symptoms of patients with schizophrenia, and at the same time has good tolerance and compliance

Latudal was first approved in the United States in October 2010.
So far, it has been approved by the FDA for three indications, namely (1) for the treatment of adolescents (13-17 years old) and adult schizophrenia; (2) as a single Medication and as an adjuvant therapy with lithium salt or valproic acid, it is used to treat major depressive episodes associated with bipolar type I disorder (bipolar depression) in adult patients
.
(3) For the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in pediatric patients (10-17 years old)

As of the end of 2020, Latuda has been approved for marketing in 27 countries and regions around the world.
With its comprehensive characteristics of efficacy, safety, and tolerability, Latuda is recommended by many international treatment guidelines
.
According to the company's financial report, Latudal has created a total of 956.

In China, Latudal was approved for the treatment of schizophrenia in Taiwan and Hong Kong in 2016, and was approved for the treatment of bipolar type I depression in Taiwan in 2017
.
On the mainland, Latudal was approved by the NMPA in January 2019 for the treatment of adult schizophrenia under the trade name Roshuda

According to the Insight database, many domestic companies have begun to deploy the lurasidone generic drug market
.
Five companies have successively submitted generic drug listing applications (see the table below for details).

In addition to lurasidone, Sumitomo Pharmaceuticals also has an atypical schizophrenia drug in the Chinese market-Luoshan® (Lonasen®, generic name: blonanserin, bunanserin tablets)
.
The drug highly selectively blocks dopamine D2 receptor subtypes (D2, D3) and 5-HT2A receptors

       Lonasen was approved in Japan and South Korea in 2008 and 2009, and was approved in China in February 2017, and successfully entered the 2020 national medical insurance
.
According to the company’s financial report, Lonasen’s sales peaked in 2017, at approximately 12.
6 billion yen
.
At present, there are also many domestic companies in the bunanserin generic drug market.
Among them, only one company in Shijiazhuang Four Drugs submitted an application for the listing of 4 types of generic drugs (the relevant acceptance number is CYHS2100157)
.

       In addition, it is worth mentioning that Sumitomo Pharmaceuticals and Nitto Co.
, Ltd.
(Nitto) jointly developed Lonasen 's transdermal patch (trade name Lonasen Tape) was approved in Japan in June 2019, and its sales in 2019 reached 500 million yen.

.