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The research and development of children's medicines faces many challenges.
Under the comprehensive consideration of risks and interests, enterprises gradually turn to the blue ocean track, and the layout of children's medicines, rare diseases, etc.
RSV syncytial virus
On April 7, 2022, ARKBIFA announced that Elsavir™ achieved positive results in a multicenter Phase 3 clinical trial, meeting the primary and key secondary endpoints
The first innovative children's drug invented and developed in China and expanded to the world The first non-tumor innovative drug approved by the National Medical Products Administration (NMPA) as a "Breakthrough Therapy Variety"
Coincidentally, recently, the “King of M&A” Pfizer spent US$525 million to acquire ReViral, a Biotech company developing RSV antiviral therapy, targeting the company’s core product Sisunatovir, an oral inhibitor targeting RSV fusion proteins
RSV (Respiratory Syncytial Virus), the full name of Respiratory Syncytial Virus, is a common airborne RNA virus that mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, as well as older children and adults.
It is worth mentioning that the new coronavirus that continues to this day, the almost incurable HIV virus, and the terrifying Ebola virus are all RNA viruses
RSV infection is the leading cause of hospitalization and death due to the virus in children under five years of age worldwide
RSV infection is the leading cause of viral hospitalization and death in children under five worldwide
Currently, there is no specific antiviral drug for RSV
In the Phase III AirFLO trial, Elsavir™ significantly reduced symptom scores (p=0.
Pediatric intractable epilepsy
Pediatric intractable epilepsyRecently, Shi Siyao announced that the stiripent alcohol dry suspension of its wholly-owned subsidiary Shijiazhuang Siyao has been included in the list of priority review varieties
The domestic exclusive declaration of this product is a rare disease drug that meets the physiological characteristics of children, mainly used for the treatment of severe muscle tremor in children with epilepsy
Epilepsy is one of the more common chronic neurological disorders, affecting 1% of the world's population
Stiripentol is a new antiepileptic drug developed in France and approved by the European Medicines Agency (EMA) in 2007 for the treatment of infantile severe myoclonic epilepsy (also known as Dravet syndrome)
It is reported that stiripentol dry suspension is currently not approved by domestic companies
It is reported that stiripentol dry suspension is currently not approved by domestic companies
Stiripentol dry suspension is also "tailor-made" for children's dosing problems
Another good news came.
New Chinese medicines for children
New Chinese medicines for childrenAs of the end of March, 18 new Chinese medicines have been approved for approval in 2022, including two new medicines for children
Xiaoerxiangru Granules is a class 1.
1 new traditional Chinese medicine
.
According to public information, Xiaoer Xiangyu Ganmao Granules have obvious antibacterial, antiviral, anti-inflammatory and antipyretic effects, which can enhance the body's immunity and disease resistance.
It is a new traditional Chinese medicine for the treatment of four-season colds
.
1 traditional Chinese medicine drug
Huang's Sound Children's Spray is a 2.
1 class new traditional Chinese medicine
.
Huang's Xiangsheng Pill is a Chinese (Jiangsu) intangible cultural heritage "Huang's Laryngology" related formula, which is a national secret formula and has a good therapeutic effect on acute and chronic throat diseases
.
Relying on the innovative Chinese medicine research and development platform, Jimin Trusted R&D personnel developed an improved new drug Huang's Xiangsheng Children's Spray by changing the route of administration and dosage form on the basis of Huang's Xiangsheng Pills
.
The drug is intended to be suitable for children aged 4 to 11 years old, and it is mainly used for the treatment of acute pharyngitis and acute catarrhal tonsillitis in children
.
1 class new traditional Chinese medicine
Unlike adult medicine, traditional Chinese medicine has always been the mainstay in the field of children's medicine
.
The reason is that traditional Chinese medicine is mild in nature, has few side effects, and has an advantage in safety considerations
.
However, since the National Health and Health Commission issued the "List of Drugs for Children Encouraged to Research and Development", which gave priority to the review and approval of children's drugs, most of the children's drugs marketed by taking advantage of the policy are mainly western medicines
.
This time, the number of approvals for children's medicines and even new Chinese medicines in the field of traditional Chinese medicines has gradually increased.
In fact, it reflects that the state's support for the research and development of traditional Chinese medicines has achieved results in recent years.
It is expected that more new traditional Chinese medicines suitable for children will be launched in the future
.
Children are the future and hope of the country, and the education and service industries related to children are also booming, but the field of medicine for children is an exception
.
In a free-for-profit market, the reason is nothing more than the mismatch between costs and benefits
.
However, with the development of science and technology, the support of national policies, and the involution of popular tracks, the marginal benefit of children's drug research and development has gradually increased, and more companies will be attracted to participate in the future
.