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[Pharmaceutical Network Industry News] Recently, Yuandong Bio's 3-type generic listing application for vigabatrin powder has entered the "approval" process and is expected to be approv.
vigabatrin powder is a highly effective drug for the treatment of infantile spas.
At present, only imported products have been approved, and the domestic pharmaceutical company Zhongyuandong Bio is the exclusive application for generic listi.
Public information shows that vigabatrin is an analog of γ-aminobutyric acid (GABA) and has antiepileptic effe.
The drug can be used as adjunctive therapy in patients who have not responded to other antiepileptic drugs, especially those with partial seizures (mainly used to control complex partial seizure.
This medicine may also be used in babies with West syndrome (infantile spasm.
vigabatrin was developed by Sanofi and launched in the United States in 201 It is one of the very few FDA-approved treatments for infantile spasms (IS) and some adults with complex partial seizures (CPS) whose seizures cannot be controlled despite multiple epilepsy therapi.
) is one of the effective dru.
It is estimated that more than 10,000 newborns in China suffer from infantile spasms each year, requiring effective disease manageme.
For the families of these patients, vigabatrin will meet a pressing medical ne.
The industry believes that if Yuandong Bio's vigabatrin powder can be successfully approved, it will usher in a huge market development spa.
However, it should be noted that in China, as of June 2021, in addition to Yuandong Biology, Shanghai Aokeda Biology and .
Reddy from India have also successively submitted listing applications for the import of “Vigrenoic Acid Powder” in CategoryAnd it is included in the priority review process on the grounds that it "complies with rare disease and children's drugs", and the competition in this market is expected to become more and more fierce in the futu.
In fact, for a long time, there has been a shortage of medicines for children in Chi.
Therefore, the country has formulated a series of policies in recent years, including strengthening the allocation of medicines for children in hospitals, bidding and purchasing directly on the Internet, encouraging research and development, and giving priority to review, e.
, to encourage manufacture.
Increase the research and development and production of medicines for childr.
For example, at the end of September, the state issued the "China Children's Development Outline (2021-2030)" to encourage the research, development and production of children's medicines, and to speed up the application and approval of children's medicin.
He also proposed to "explore the formulation of a national list of essential medicines for children, and update the list of banned medicines for children in a timely mann.
"At present, data shows that under the influence of a series of policies, the research and development and review and approval of children's medicines have shown a significant growth moment.
Since the beginning of this year, a number of children's medicines have been approved for marketing and producti.
For example, recently, Shi Siyao announced that its wholly-owned subsidiary Shijiazhuang Siyao's cefaclor dry suspension and metronidazole tablets had been approv.
In addition, stiripentol dry suspension has been included in the list of priority review varieties, which is the first time that the group's declared products have been included in such a list, and it is also an exclusive domestic applicati.
This product is a rare disease drug that meets the physiological characteristics of children, and is mainly used to treat severe muscle tremor in children with epilep.
On April 11, Renfu Pharmaceutical also announced that its holding subsidiary Yichang Renfu has recently received the "Notice of Acceptance" for the production of clobazam tablets approved and issued by the State Food and Drug Administration, which means that the domestic production of this variety is register.
The work has entered the review sta.
The company stated that it will actively promote the follow-up related wo.
It is understood that clobazam tablets can be used to treat refractory epilepsy in childr.
It is a rare disease drug and is suitable for the combined treatment of epileptic seizures in patients with Lennox-Gastaut syndrome (LGS) aged 2 years and abo.
There is no such active ingredient approved in Chi.
Listed for sa.
In general, from the perspective of recent years, many pharmaceutical companies have begun to have the will to accelerate their deployment in the field of rare disease drugs for children under the multiple benefi.
In the future, as more and more pharmaceutical companies focus on the fields of children's pharmaceuticals and health, the industry expects that the development momentum of exclusive and new varieties will also be very rapid, benefiting more children's patien.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
vigabatrin powder is a highly effective drug for the treatment of infantile spas.
At present, only imported products have been approved, and the domestic pharmaceutical company Zhongyuandong Bio is the exclusive application for generic listi.
Public information shows that vigabatrin is an analog of γ-aminobutyric acid (GABA) and has antiepileptic effe.
The drug can be used as adjunctive therapy in patients who have not responded to other antiepileptic drugs, especially those with partial seizures (mainly used to control complex partial seizure.
This medicine may also be used in babies with West syndrome (infantile spasm.
vigabatrin was developed by Sanofi and launched in the United States in 201 It is one of the very few FDA-approved treatments for infantile spasms (IS) and some adults with complex partial seizures (CPS) whose seizures cannot be controlled despite multiple epilepsy therapi.
) is one of the effective dru.
It is estimated that more than 10,000 newborns in China suffer from infantile spasms each year, requiring effective disease manageme.
For the families of these patients, vigabatrin will meet a pressing medical ne.
The industry believes that if Yuandong Bio's vigabatrin powder can be successfully approved, it will usher in a huge market development spa.
However, it should be noted that in China, as of June 2021, in addition to Yuandong Biology, Shanghai Aokeda Biology and .
Reddy from India have also successively submitted listing applications for the import of “Vigrenoic Acid Powder” in CategoryAnd it is included in the priority review process on the grounds that it "complies with rare disease and children's drugs", and the competition in this market is expected to become more and more fierce in the futu.
In fact, for a long time, there has been a shortage of medicines for children in Chi.
Therefore, the country has formulated a series of policies in recent years, including strengthening the allocation of medicines for children in hospitals, bidding and purchasing directly on the Internet, encouraging research and development, and giving priority to review, e.
, to encourage manufacture.
Increase the research and development and production of medicines for childr.
For example, at the end of September, the state issued the "China Children's Development Outline (2021-2030)" to encourage the research, development and production of children's medicines, and to speed up the application and approval of children's medicin.
He also proposed to "explore the formulation of a national list of essential medicines for children, and update the list of banned medicines for children in a timely mann.
"At present, data shows that under the influence of a series of policies, the research and development and review and approval of children's medicines have shown a significant growth moment.
Since the beginning of this year, a number of children's medicines have been approved for marketing and producti.
For example, recently, Shi Siyao announced that its wholly-owned subsidiary Shijiazhuang Siyao's cefaclor dry suspension and metronidazole tablets had been approv.
In addition, stiripentol dry suspension has been included in the list of priority review varieties, which is the first time that the group's declared products have been included in such a list, and it is also an exclusive domestic applicati.
This product is a rare disease drug that meets the physiological characteristics of children, and is mainly used to treat severe muscle tremor in children with epilep.
On April 11, Renfu Pharmaceutical also announced that its holding subsidiary Yichang Renfu has recently received the "Notice of Acceptance" for the production of clobazam tablets approved and issued by the State Food and Drug Administration, which means that the domestic production of this variety is register.
The work has entered the review sta.
The company stated that it will actively promote the follow-up related wo.
It is understood that clobazam tablets can be used to treat refractory epilepsy in childr.
It is a rare disease drug and is suitable for the combined treatment of epileptic seizures in patients with Lennox-Gastaut syndrome (LGS) aged 2 years and abo.
There is no such active ingredient approved in Chi.
Listed for sa.
In general, from the perspective of recent years, many pharmaceutical companies have begun to have the will to accelerate their deployment in the field of rare disease drugs for children under the multiple benefi.
In the future, as more and more pharmaceutical companies focus on the fields of children's pharmaceuticals and health, the industry expects that the development momentum of exclusive and new varieties will also be very rapid, benefiting more children's patien.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
