What kind of innovative tumor drugs do patients need?

(Health Times reporter Wang Yongwen) "The research and development of anti-tumor drugs, from determining the direction of research and development to carrying out clinical trials, should implement the concept of taking clinical needs as the core and carry out clinical value-oriented research and development of anti-tumor drugs

Once this news was released, it ushered in a continuous decline in pharmaceutical-related stocks

There are almost no domestic innovative tumor drugs in the market

After the release of "I'm Not the God of Medicine" in July 2018, it attracted attention to the plight of cancer patients.

Two months later, Fruquintinib was independently developed by Hutchison Whampoa Pharmaceuticals with complete intellectual property rights.

With the launch of a batch of domestically-made innovative drugs such as fruquintinib and teriprizumab injection, the tumor medications faced by tumor patients such as Lu Yong have gradually been resolved.

But at the same time, a new problem has come again: it is not that no medicines are available, but that the research and development of new medicines are homogenized

The problem of homogenization research and development of oncology innovative drugs is outstanding

According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer of the World Health Organization in January this year, China has 4.

Behind the huge number of patients hides a huge oncology drug market.

"There are 87 companies that do PD-1 and PD-L1 monoclonal antibodies, and there are nearly 180 that claim to have PD-1 and PD-L1.

Relevant industry insiders also analyzed to the Health Times reporter that the situation of PD-1/PD-L1 getting together and homogenized research and development not only occupied a large number of patients participating in clinical trials, but also caused the gradual influx of capital to become a bubble, and at the same time The research and development of higher-value, source-innovative drugs cannot obtain capital, lack the motivation for innovation, and cannot find innovative drugs with better efficacy for patients

"In 2020, nearly 80% of the clinical researches will belong to the clinical research of innovative drugs, but this "innovation" is an innovation with quotation marks

What kind of innovative drugs do cancer patients need?

Compared with the dilemma faced by "I am not the God of Medicine", cancer patients have more new drugs available, but more new drugs, as Professor Li Jin said, are just "reconstructed" innovations, but look ahead.

"Innovative drugs are to be able to do faster and better than others on the premise of solving unmet clinical needs

The CDE draft for comments focuses on the patient-centered concept throughout drug development, emphasizes clinical value-oriented development of anti-tumor drugs, attaches importance to the matching and accuracy of therapeutic drugs and patients, and encourages development to satisfy unsatisfied Innovative drugs (First in class) that are clinically needed to reduce clinical research that has no obvious expected curative effect and may cause patients to lose curative effect and miss the opportunity to receive effective treatment

"The "Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value" issued by the Drug Evaluation Center of the State Food and Drug Administration once again emphasized this concept.

Looking ahead to the future development of innovative Chinese oncology drugs, Dr.
Yang Wei believes that we must first persist in innovation and gradually establish our own ability to develop First-in-class/Best-in-class innovative drugs; secondly, we must focus on differentiated targets and avoid targets.
The homogeneity brought about by the clustering of points has increased the overall competitive advantage of the domestic pharmaceutical field; in addition, attention must be paid to the construction of resources, and the support of relevant talents and platforms is needed from drug research and development to listing
.

Reference materials:

① 2021-07-11-The public account is the same as "Professor Li Jin: The best way is not to approve the clinical trial, not to approve the listing after the clinical trial is completed.
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