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[Pharmaceutical Network Industry News] April 2, 2022 is the 15th "World Autism Awareness Day".
This year's theme is "focusing on autism services, building a social security mechanism, and promoting the high-quality development of service institutions to improve People pay attention to people with autism
.
" On the 15th "World Autism Day", the current situation of drug research and development has attracted attention (Photo source: Pharmaceutical Network) Autism is also called autism, collectively referred to as autism spectrum disorder, which This disease originates in early childhood development and is a lifelong developmental disorder caused by neurological disorders affecting brain function.
Patients are mainly manifested as abnormal eye contact, delayed language function, stereotyped and repetitive behavior, and social interaction barriers
.
In 2019, there were more than 10 million autistic patients in China, of which more than 2 million were children under the age of 12
.
At present, common treatment methods for autism include social and behavioral intervention, special education, drug therapy, and psychotherapy
.
However, these methods can only relieve the suppressive symptoms, not a cure, so there is still a huge unmet need for treatment of autism patients
.
As far as the current drug market situation is concerned, there are currently no drugs targeting core symptoms of autism, such as social interaction and communication, on the market.
The commonly used drugs are mainly antipsychotics
.
In the United States, the current drugs for autism treatment, risperidone and aripiprazole, are antipsychotic drugs, not for core symptoms
.
Both drugs have been approved by the FDA as the drug of choice for the prospective treatment of irritability symptoms in adolescents with autism
.
Among them, risperidone is a drug developed by Johnson & Johnson subsidiary Janssen for the treatment of schizophrenia.
In 2006, the FDA approved Johnson & Johnson's risperidone for the treatment of irritability in children with autism from 5 to 16 years old.
It is also the first FDA-approved drug for the treatment of autism in children
.
A systematic review of risperidone showed that the drug was effective in improving "behavioral problems" in children and adolescents with autism during short-term, long-term, and discontinuation periods
.
But the disadvantage is the high recurrence rate after drug withdrawal
.
Aripiprazole is a third-generation antipsychotic drug jointly developed by Bristol-Myers Squibb and Otsuka Pharmaceuticals
.
In 2009, aripiprazole was approved by the FDA to treat irritability in children with autism
.
Comparative studies have shown that aripiprazole is as effective as risperidone in improving irritability, agitation, lethargy and social withdrawal, stereotyped behavior, hyperactivity and non-compliance, and inappropriate speech
.
However, there are adverse reactions such as weight gain, sedation, salivation, gastrointestinal vomiting and tremor
.
Domestically, the Lilac Garden Insight database shows that the original research product risperidone was approved to enter China in 1999, and the approved indications include autism and mental retardation in addition to schizophrenia
.
In addition, the drug marketing application of aripiprazole for tic disorder and autism indications was also accepted by the State Food and Drug Administration on July 1, 2021, and has been included in the priority review and approval
.
In addition, there are 17 drugs under development in the world, including drugs for the treatment of autism, which have entered the clinical stage, of which 3 are in Phase III clinical trials, 1 failed Phase III clinical trials, 7 are in Phase II clinical trials, and 6 are in Phase I clinical trials , and 5 are in the preclinical research and drug discovery stage
.
The R&D companies involved include Roche, Hepalink, Yamo Pharmaceuticals, Novartis,
etc.
In terms of the progress of products under development, Roche's vasopressin 1a (V1a) receptor antagonist Balovaptan, a drug for the core symptoms of autism, was once hoped for, but the drug failed after entering phase III clinical trials
.
At present, the fastest progress is Curemark's new drug CM-4612 for autism, which is being applied for new drug marketing in the United States
.
The data show that CM-4612 is a candidate drug for the treatment of autism by improving digestive function, to correct the defects caused by insufficient digestive enzymes in such children, and increase the concentration of essential amino acids in the blood, so as to alleviate autism core symptoms and associated symptoms
.
With the acceleration of drug research and development and the continuous progress of medical technology, I believe that in the future, it will provide new ideas and options for the treatment of more autistic patients, and let them "from the stars" enter the colorful world
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
This year's theme is "focusing on autism services, building a social security mechanism, and promoting the high-quality development of service institutions to improve People pay attention to people with autism
.
" On the 15th "World Autism Day", the current situation of drug research and development has attracted attention (Photo source: Pharmaceutical Network) Autism is also called autism, collectively referred to as autism spectrum disorder, which This disease originates in early childhood development and is a lifelong developmental disorder caused by neurological disorders affecting brain function.
Patients are mainly manifested as abnormal eye contact, delayed language function, stereotyped and repetitive behavior, and social interaction barriers
.
In 2019, there were more than 10 million autistic patients in China, of which more than 2 million were children under the age of 12
.
At present, common treatment methods for autism include social and behavioral intervention, special education, drug therapy, and psychotherapy
.
However, these methods can only relieve the suppressive symptoms, not a cure, so there is still a huge unmet need for treatment of autism patients
.
As far as the current drug market situation is concerned, there are currently no drugs targeting core symptoms of autism, such as social interaction and communication, on the market.
The commonly used drugs are mainly antipsychotics
.
In the United States, the current drugs for autism treatment, risperidone and aripiprazole, are antipsychotic drugs, not for core symptoms
.
Both drugs have been approved by the FDA as the drug of choice for the prospective treatment of irritability symptoms in adolescents with autism
.
Among them, risperidone is a drug developed by Johnson & Johnson subsidiary Janssen for the treatment of schizophrenia.
In 2006, the FDA approved Johnson & Johnson's risperidone for the treatment of irritability in children with autism from 5 to 16 years old.
It is also the first FDA-approved drug for the treatment of autism in children
.
A systematic review of risperidone showed that the drug was effective in improving "behavioral problems" in children and adolescents with autism during short-term, long-term, and discontinuation periods
.
But the disadvantage is the high recurrence rate after drug withdrawal
.
Aripiprazole is a third-generation antipsychotic drug jointly developed by Bristol-Myers Squibb and Otsuka Pharmaceuticals
.
In 2009, aripiprazole was approved by the FDA to treat irritability in children with autism
.
Comparative studies have shown that aripiprazole is as effective as risperidone in improving irritability, agitation, lethargy and social withdrawal, stereotyped behavior, hyperactivity and non-compliance, and inappropriate speech
.
However, there are adverse reactions such as weight gain, sedation, salivation, gastrointestinal vomiting and tremor
.
Domestically, the Lilac Garden Insight database shows that the original research product risperidone was approved to enter China in 1999, and the approved indications include autism and mental retardation in addition to schizophrenia
.
In addition, the drug marketing application of aripiprazole for tic disorder and autism indications was also accepted by the State Food and Drug Administration on July 1, 2021, and has been included in the priority review and approval
.
In addition, there are 17 drugs under development in the world, including drugs for the treatment of autism, which have entered the clinical stage, of which 3 are in Phase III clinical trials, 1 failed Phase III clinical trials, 7 are in Phase II clinical trials, and 6 are in Phase I clinical trials , and 5 are in the preclinical research and drug discovery stage
.
The R&D companies involved include Roche, Hepalink, Yamo Pharmaceuticals, Novartis,
etc.
In terms of the progress of products under development, Roche's vasopressin 1a (V1a) receptor antagonist Balovaptan, a drug for the core symptoms of autism, was once hoped for, but the drug failed after entering phase III clinical trials
.
At present, the fastest progress is Curemark's new drug CM-4612 for autism, which is being applied for new drug marketing in the United States
.
The data show that CM-4612 is a candidate drug for the treatment of autism by improving digestive function, to correct the defects caused by insufficient digestive enzymes in such children, and increase the concentration of essential amino acids in the blood, so as to alleviate autism core symptoms and associated symptoms
.
With the acceleration of drug research and development and the continuous progress of medical technology, I believe that in the future, it will provide new ideas and options for the treatment of more autistic patients, and let them "from the stars" enter the colorful world
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
