On October 16, Zejing Pharmaceutical announced that the company's new drug application (NDA) for the treatment of medium- and high-risk myelofibrosis with jacktinib hydrochloride tablets has been accepted
.
According to reports, this is the clinical indication for the initial submission of a new drug marketing application for jacktinib hydrochloride tablets, and jacktinib is also the first domestic JAK inhibitor innovative drug to apply for new drug
marketing.
In the past two years, affected by a series of favorable policies, capital increase and other factors, the enthusiasm for the research and development of domestic innovative drugs has been high, and it has gradually entered the harvest period
.
The data shows that the number of IND applications for innovative drugs has increased year by year, including taking the field of oncology as an example, since 2019, the number of core clinical trials carried out by domestic innovative drugs has surpassed that of the United States, and reached 123 in 2020
.
In 2010~2020, a total of 1636 innovative drugs submitted IND applications for the first time, of which more than 80% of the applications came from local Chinese companies
.
In 2021, the number of declarations for domestically produced chemical drugs and domestically produced substances exceeded 200, a record high
.
According to a new research report released by Guosheng Securities, the rise of domestic innovation has accelerated
under the impetus of a good policy environment and capital.
Domestic innovative drugs have entered the harvest period, and the next few years will see more blockbuster innovative products approved for marketing
in China.
It is worth mentioning that although the domestic innovative drug industry is developing rapidly, it is also facing new challenges
.
Guosheng Securities pointed out in the research report that the time window for "pan-innovation" given by the policy is getting shorter and shorter, the medical insurance control fee is becoming stricter, the track is becoming more and more crowded, and the homogenization of domestic innovative drugs, especially targeted drug research and development, is more serious
.
The bank said that the era of innovative drug listing is a blockbuster is slowly passing, and China's innovative drug market has slowly entered the moment
from "pan-innovation" to "selected high-quality innovation".
In the future, homogenization competition for popular monoclonal antibody targets will continue to be fierce, homogenized products will gradually lose competitiveness, new technologies, scarce technology platforms, differentiated therapeutic areas, innovative drug delivery methods, etc.
may bring a better competitive pattern to enterprises, and companies with technical precipitation are expected to stand out
.
There are also views that going overseas is also a new choice
for pharmaceutical companies to avoid homogenized competition.
In recent years, in order to cope with the "involvement" of the industry brought about by the tightening of medical insurance fees, some leading pharmaceutical companies, including BeiGene, Innovent Biologics, Junshi Biologics, etc.
, have actively gone overseas through independent overseas and license-out (external licensing of a technology or patent) model to participate in international competition
.
According to incomplete statistics, since 2017, 6~8 innovative drug products in China have submitted drug marketing applications to the FDA (US Food and Drug Administration) every year; In 2021, the total transaction amount of domestic pharmaceutical companies license-out reached 13.
3 billion US dollars.
It is undeniable that it is not easy for local pharmaceutical companies to go global, and they need to face many tests, and there have been several cases
of failure of pharmaceutical companies to go abroad.
However, the current difficulties cannot stop the momentum
of domestic innovative drugs going abroad.
From the sales data of zebrutinib, the first innovative drug in China that successfully went overseas independently, the drug has been approved by the US FDA from 2012 to 2019, a total of more than seven years, and in 2021, zebrutinib achieved sales of 700 million yuan in the US market
.
In 2022, sales in the United States have reached 1.
015 billion yuan, an increase of 504.
5%
over the same period last year.
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