In the past week, 4 domestic new drugs have been approved for marketing

【Pharmaceutical Network Industry News】Driven by the pharmaceutical policy of "imitation and innovation" and the acceleration of new drug approval and review, the speed of domestic pharmaceutical innovation is accelerating
.
Incomplete statistics show that in the first half of 2022, the China Food and Drug Administration approved a total of 29 new drugs, including 18 chemicals, 10 biological products (covering monoclonal antibodies and vaccines) and 1 traditional Chinese medicine
.
In the second half of the year, domestic new drugs are still being approved, and in the past week, a number of new drugs have been approved for marketing
.
On October 12, two new drugs of Changzhou Siyao Pharmaceutical Co.
, Ltd.
(hereinafter referred to as Changzhou Siyao), Rejik tablets and Alek oral solution, were approved for marketing
by the State Food and Drug Administration.
It is understood that Rejik tablets are suitable for monotherapy of patients with primary Parkinson's disease, which can not only improve motor symptoms, but also have the effect of protecting nerves and delaying the progression of
the disease.
Alec oral solution is a first-line antipsychotic recommended by domestic and foreign medication guidelines, which can be used for adolescents and adults with schizophrenia and can effectively treat more patients with
mental disorders.
On October 9, according to the State Food and Drug Administration, Jiangsu Kangyuan Pharmaceutical Co.
, Ltd.
's Class 3.
2 new traditional Chinese medicine dispersion cold and wet granules was approved for marketing for epidemics
caused by cold, dampness and depression.
On October 8, the State Medical Products Administration approved the marketing
of the class I innovative drug dogliatin tablets (trade name: Hua Tangning) declared by Hua Medicine Technology (Shanghai) Co.
, Ltd.
(hereinafter referred to as Hua Medicine).
According to public information, the approved dopagliatin acts on glucokinase targets in glucose storage and export organs such as islets, intestinal endocrine cells and liver, and improves blood glucose homeostasis imbalance
in patients with type II.
diabetes.
It is worth noting that this is the world's first glucokinase activator drug approved for the treatment of adult type II diabetes
.
It can reshape the body's blood glucose homeostasis and has the potential to
achieve diabetes relief at the source.
On the whole, in fact, the number of innovative drugs approved by local enterprises in recent years is rising, which is much higher than the figure
of the past ten years.
Data show that from 2008 to 2018, 41 Class 1 new drugs were approved for marketing in China, of which 10 were approved in 2018; In 2019, 12 domestic Class 1 innovative drugs were approved for marketing
.
In 2022, incomplete statistics show that China's NMPA approved a total of 32 new drugs
in the first half of the year.
Including 1 traditional Chinese medicine, 3 vaccines, 8 biological drugs and 20 chemical drugs
.
In addition to the growing number, from the perspective of treatment areas, the distribution of domestic new drugs approved treatment areas is also increasingly rich, including tumors, viruses, chronic diseases, immune systems and rare diseases
.
In this regard, the industry believes that under the background of the continuous improvement of national review and approval policies and the influx of a large amount of capital, China's pharmaceutical industry is developing rapidly, and the development of new drugs has entered a new era
.
The industry expects that as domestic pharmaceutical companies gradually enter the innovation harvest period, the number of domestic new drugs will continue to grow, and the distribution of domestic new drug treatment fields will become more and more abundant
.
In the future, more new treatment options
will be provided for the majority of patients.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.