Industry: Pharmaceutical companies' innovation and R&D should be patient-centered and pay attention to clinical value

【Pharmaceutical Network Market Analysis】In recent years, talking about biomedical innovation, R&D "clustering" can be said to be one of the inescapable topics, pipelines mainly concentrated in tumor, immunity and other fields, among which PD-1 is particularly typical
.
According to the statistics of Southwest Securities, 85 of the world's 154 PD-1s are developed or cooperatively developed by Chinese enterprises, and it is expected that in the next 2-3 years, the number of PD-1 monoclonal antibodies listed in China will reach 15
.
The executive chairman of the China Association for the Promotion of Pharmaceutical Innovation believes that China's pharmaceutical innovation has entered the 2.
0 stage, and more emphasis is placed on clinical value-oriented, that is, solving the needs of clinical diseases, rather than following the listed drugs
.
In order to solve the problem of R&D crowding, CDE previously issued the "Clinical Value-oriented Guidelines for Clinical R&D of Antitumor Drugs", which requires that "new drug research and development should provide patients with better (more effective, safer or more convenient) treatment options as a higher goal", and "should pay attention to whether positive control drugs reflect and represent the best treatment options for target patients in clinical practice"
。 The industry believes that the guiding principle releases the logic that innovative drugs should return to their essence, which will force innovative pharmaceutical companies to innovate from the source to solve the problem of homogeneous innovative drugs, achieve differentiated layout, and promote innovation to Me-better, FirstinClass and
other directions 。 At present, some pharmaceutical companies are also gradually realizing that domestic pharmaceutical companies should lay out new and updated directions, accelerate the transformation of industry-university-research effectiveness, pay attention to clinical value, extend from anti-tumor to anti-infection, anti-aging, central nervous system and other fields, from the intersection of unmet clinical needs and new technologies that can solve problems, and find a breakthrough point
for future development.
The development of new drugs that are patient-centered and focus on clinical value is not only to solve the problem
of homogenization.
For domestic innovative drugs, with the advancement of the new medical reform policy, the competitive environment is fierce, pharmaceutical companies generally face multiple challenges, in order to seek more markets, going overseas has become a general trend
.
However, since the beginning of this year, new drugs, including Innovent Biologics and Hutchison Pharmaceutical, have suffered setbacks one after another, which has hit the confidence of the industry
.
From the perspective of the reasons, the industry believes that it is still related to not being "new" enough, "If it is an innovative drug that targets the unmet needs of patients, then going out should not be a big
problem.
" But if there are similar drugs abroad that can be replaced, then the challenge will be greater
.
"As the threshold for innovative drugs overseas continues to rise, it will also force domestic pharmaceutical companies to implement the concept of patient-centered in the research and development process
.
" At present, the way domestic pharmaceutical companies go to sea mainly includes independent overseas and license out and other borrowed "ships" to go to sea, of which license out is that Chinese pharmaceutical companies sell their overseas or global rights and interests of their products to overseas enterprises, and overseas companies are responsible for follow-up clinical development, application for listing, production and sales, etc.
, this "going to sea" method is faster and more popular
with domestic pharmaceutical companies.
According to data from Medic Cube, from 2019 to 2021, the number of license out transactions of Chinese pharmaceutical companies reached 100, with a cumulative transaction value of more than US$24 billion
.
In September this year, Fosun Pharma and innovative pharmaceutical company Kefeiping Pharma recently "joined hands", the two parties will jointly develop and exclusively commercialize Caprasheen hydrochloride by Fosun Pharma Industry worldwide, and the cooperation areas include all available indications of Kaiprashen hydrochloride oral preparations and ordinary injections
.
According to reports, this "Biopharma + Biotech" cooperation model can make up for the shortcomings in commercialization capabilities, and the shortcomings in global investment and global organizational capacity building
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.