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On November 7, Jinxing Pharmaceutical announced that the Center for Drug Evaluation of the State Food and Drug Administration has accepted its application for the marketing of omecamtiv mecarbil, which is used to treat heart failure (HFrEF)
with reduced ejection fraction 。 According to public information, Omecamtiv mecarbil is a first-in-class selective small molecule cardiomyosin activator, developed by Cytokinetics, a licensing partner of Minxing Pharmaceutical, which can directly target the contraction mechanism of the heart, bind and increase the number of
myomyosin head regions that interact with actin during contraction.
According to Jinxing Pharmaceutical, the drug is expected to bring more treatment options
to HFrEF patients in China.
On November 4, Qilu Pharmaceutical's improved new drug risperidone oral dissolved film was declared for marketing, which is used for the treatment of schizophrenia or bipolar disorder
.
It is understood that in 2021 and 2022, Qilu Pharmaceutical began to usher in the harvest period of oral lytic film products, and among the declared oral lytic film products, aripiprazole oral lytic film, olanzapine oral lytic film, memantine hydrochloride oral lytic film, montelukast sodium oral lytic film, tadalafil oral lytic film were approved for marketing, and risperidone oral lytic film has also been declared for marketing
recently.
In addition to the application for listing of a number of new drugs, on November 6, the self-developed clonidine hydrochloride sustained-release tablets (trade name: Lidinger) independently developed by Lipin Pharmaceutical (Xiamen) Co.
, Ltd.
also held a national listing meeting in Xiamen, marking the official national batch listing
of the product.
ADHD is one of the most common neurobehavioral disorders in childhood and
adolescence.
Under the continuous guidance of the provincial drug administration and other relevant departments and the innovative research and development of enterprises, the product was registered and approved by the State Food and Drug Administration on June 30 this year (Sinopharm H20223470), which is currently the exclusive approved new drug for the treatment of attention deficit hyperactivity disorder (ADHD) in children, and belongs to the three classes of chemicals registered by the State Food and Drug Administration
.
With the rise of pharmaceutical innovation in recent years and the advancement of review and review, it can be clearly found that domestic new drugs are accelerating their market
.
Incomplete statistics show that in the past five years (2016 to 2021), China has launched a total of 280 new drugs, focusing on the three major diseases of
oncology, cardiovascular system and digestion/metabolism.
On the whole, although there are still various problems in the research and development of new drugs in China, China is currently accelerating the transformation from generic drugs to innovative drugs, and the number of new drugs in China is growing and the application range is becoming wider and wider
.
The industry believes that the quantitative change of China's new drugs in the future may cause qualitative changes, which will accelerate the high-quality development of
China's pharmaceutical industry while bringing more and better choices for clinical treatment drugs.
However, it should be noted that while setting off a "wave of innovation" in the industry, pharmaceutical companies also need to pay attention to curbing excessive enthusiasm for research and development, and do not insist on only developing "hot" targets; It is necessary to pay attention to the research situation of various "targets" in the world, calmly layout, combined with the talent reserve of pharmaceutical companies, in order to find the research and development direction suitable for their own enterprises and continue to help
the development of the industry.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.