Improved new drugs are improvements to marketed drugs, emphasizing "efficacy", with relatively high success rate, low risk, long life cycle, and rapid returns
.
At present, under the continuous advancement of medical reform and the normalization and standardization of national procurement and provincial centralized procurement, the pressure on the generic drug market has intensified, and although the return of innovative drugs is high, the research and development cycle is long and the early investment is large, which is not suitable for all domestic pharmaceutical companies to blindly participate
.
Therefore, improved new drugs are gradually becoming one of the mainstream of
global new drug research and development.
Judging from the declaration of domestic pharmaceutical companies, in recent years, this mainstream trend is also accelerating the brewing, and the outbreak period is coming
.
For example, on November 4, Qilu Pharmaceutical's improved new drug risperidone oral dissolved film was declared for marketing, which is used to treat schizophrenia or bipolar disorder
.
It is worth mentioning that in terms of improved new drugs, Qilu Pharmaceutical, which mainly focuses on oral dissolved film, has had 5 oral lytic film products on the market
before.
On October 19, Kelun Pharmaceutical's Class 2 improved new drug brepiprazole oral dissolved film obtained the implied approval for clinical trials for the treatment of schizophrenia
in adult patients.
At present, Kelun Pharmaceutical mainly has 31 new drugs in the clinical stage of declaration and above, including 19 Class 1 new drugs, 9 Class 2 improved new drugs, 3 biosimilars, covering tumor, autoimmunity, anesthesia analgesia, cardiovascular, liver disease and other disease fields, involving PD-L1, TROP-2, JAK, HER2, RET, LAG-3, CLDN18.
2 and other targets, covering small molecules, monoclonal antibodies, bispecific antibodies, ADC and other fields
。 It is understood that the reason why Kelun Pharmaceutical has achieved great results in new drugs is mainly due to the continuous increase in R&D investment, and its R&D expenses have reached 1.
204 billion yuan
in the first three quarters of 2022.
On September 20, HealthYuan issued an announcement that the company recently received the approval and issuance of the "Drug Clinical Trial Approval Notice" on XYP-001 by the State Medical Products Administration, and agreed to carry out clinical trials
of this product for idiopathic pulmonary fibrosis.
XYP-001 is an improved new drug developed by Health Element Layout, which is intended to be used for the treatment of idiopathic pulmonary fibrosis (IPF).
In addition to the continuous listing of improved new drugs, the overall growth of China's improved new drug market is also gradually accelerating, from 2016 to 2021, the market size has increased from 261.
4 billion yuan to 389.
7 billion, and is expected to exceed the 400 billion mark
in 2022 。 It is worth mentioning that in order to continue to promote the development of this market, the state has also issued a series of favorable policies, such as the State Food and Drug Administration issued the "Technical Guidelines for Clinical Trials of Modified New Drugs of Chemical Drugs (Draft for Comments)" in 2020; On September 3, 2021, under the deployment of the State Medical Products Administration, the Drug Review Center organized and formulated the "Technical Guidelines for Clinical Trials of Improved New Drugs for Children (Trial)".
.
.
The industry believes that a series of policies are encouraging innovative preparations and improved new drugs to enter the fast lane
.
In the future, pharmaceutical companies in many fields, such as liposomes, microspheres, oral soluble films, micelles, transdermal patches, etc.
, may also usher in more new breakthroughs
.
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