The domestic innovative drug industry is ushering in a period of opportunity!

Since the beginning of this year, a series of policies favorable to the development of innovative drugs are being intensively introduced
.
For example, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Technical Guidelines for Clinical Pharmacology of Innovative Drugs" (hereinafter referred to as "Guiding Principles"
.
The document covers the foreword, the purpose and role of clinical pharmacology of innovative drugs, and clinical pharmacology).
The overall plan of pharmacological research, research content and research timing, research methods, overall considerations of research design, basic considerations of innovative chemical and biological products, regulatory considerations, acronyms and meanings, and references include 10 sections, It aims to provide suggestions for key issues such as the research content, research timing, overall design and other key issues of clinical pharmacology research in the development of
innovative drugs.
The domestic innovative drug industry is ushering in a period of opportunity! (Source: Pharmaceutical Network) The industry believes that a series of favorable policies It will promote the better development of China’s innovative medicine industry
.
According to the author’s understanding, in fact, under the general trend of China’s pharmaceutical innovation, domestic pharmaceutical companies and pharmaceutical companies such as Hengrui and Fosun Pharma have begun to usher in an intensive harvest period.
Companies’ performance in innovation in recent years has been remarkable
.
For example, Hengrui currently has 8 innovative drugs approved for marketing
.
Hengrui Pharmaceuticals has more than 100 innovative drugs (including new drugs introduced through cooperation).
(Excluding new indications for the development of new drugs on the market) are in the clinical application and above stage, of which 81 are Class 1 new drugs; in addition, many blockbuster innovative drugs are also about to enter the harvest period
.
In addition, BeiGene has been innovating in recent years.
In fact
, it has also gained a lot .
At present, it has promoted 11 drug candidates into the clinic, including BTK inhibitor zebutinib, PD-1 antibody drug tislelizumab, and PARP inhibitor pamipali 3
The company’s prospectus has previously shown that as of November 4, 2021, in addition to commercialized drugs and declared drug candidates, the company has 36 drug candidates in clinical research phase, and more than 50 drug candidates are under development.
A preclinical research project
.
On the whole, analysts believe that the development of China’s pharmaceutical industry has entered the product-side logic, and the internationalization of innovative products has also begun.
In the future, a large number of innovative pharmaceutical companies will show strong explosiveness.

.
However, it should be noted that under the good development situation of domestic innovative drugs, some shortcomings are gradually becoming prominent
.
For example, some popular tracks at present, with the increasing number of companies entering the game, the phenomenon of "involution" has begun to emerge
.
Taking the PD-1 product as an example, data shows that as of November 2021, 6 domestically-made PD-1 models have been approved for listing in China, 4 models have entered medical insurance, and 3 models are in the production stage
.
In addition, according to incomplete statistics, there are currently 657 registrations of PD-1/PD-L1 clinical trials in China
.
It is worth mentioning that there are 183 products in the phase 3 clinical stage that are not differentiated significantly, and most of the targets are the same
.
It is worth noting that, in order to avoid homogeneous competition, in addition to policies that have begun to combat ineffective innovation, pharmaceutical companies have also begun to continuously increase the intensity of R&D investment, to do differentiated innovations, and to find new indications instead of Crowded in a "shortcut" track
.
In addition to homogenization, because the research and development of innovative drugs is not easy, risks and benefits coexist
.
Therefore, it is obvious that in recent years, in the process of developing innovative drugs, more and more pharmaceutical companies have begun to decide to terminate research and development
.
For example, Fosun Pharma announced recently that its holding subsidiary Wanbang Biochemical Pharmaceutical Group Co.
, Ltd.
has decided to terminate the clinical trials and follow-up development of the new class 1 drug Vanggliflozin.
) Is in phase I clinical trials
.
However, the industry also said that the research and development of pharmaceutical companies has always been a risky activity
.
Under the background that innovative R&D has become the general trend in the industry, it is expected that clinical R&D will encounter high R&D costs, long R&D cycles, and low R&D success rates.
This will also force companies to speed up thinking and exploration, and how to ensure that the value of science is increased.
At the same time, how fast and cost-effective innovation can be achieved, further improving the innovation quality of pharmaceutical companies, and improving innovation capabilities
.
In addition, it should be noted that with the increasing prosperity of innovative drugs, the R&D and commercial production needs of pharmaceutical companies have begun to continue to expand, which is placing higher requirements on the speed and flexibility of production line construction.

.
At the same time, the upstream pharmaceutical equipment field will also face more and more new challenges
.
For example, in the case of increasingly fierce market competition, for innovative drug companies, once their products gain market access, they need to accelerate the process of product commercialization, which will also affect equipment production capacity and stable supply.
Put forward higher requirements
.
Post-Edition In short, driven by policies, talents and capital factors, pharmaceutical innovation is ushering in a good opportunity that has never been seen before
.
But if you want to truly make innovative drugs and usher in a broader market, pharmaceutical companies need to be updated, faster, or differentiated, and have more clinical value, in order to occupy a place in the market
.
Pharmaceutical equipment companies, if they want to "share a piece of the pie" under the tide of innovation of pharmaceutical companies, they also need to strengthen innovation investment and continue to upgrade equipment to continuously meet the various needs of pharmaceutical companies
.