Biotech, which is hitting the three-inch recharge, will be cleaned up?

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Last Friday, CDE's notice of opinions on the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines" (hereinafter referred to as the "Guiding Principles") triggered a "big shock" and heated discussions in the pharmaceutical industry

The core content of the main controversy is that the "Guiding Principles" states that "the research and development of new drugs should provide patients with better treatment options as the highest goal.

Anti-tumor research and development institution "Fryer"

Fake innovative drugs welcome structural changes

It is reported that the clinical research and development of anti-tumor drugs in the past followed clinical guidelines and compared with standard therapies

According to the 2020 drug review report published by CDE, in 2020, CDE accepted 1062 category 1 innovative drugs (597 varieties), an increase of 51.

Once the "Guidelines for Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development" were published, the companies that immediately triggered the anti-tumor R&D and CRO companies or the "fry pot" of the CXO industry were directly reflected in the stock prices of related companies and CRO-related companies7 From May 5th to July 6th, the stock price "dipped"

The main reason is that from the perspective of China’s current innovative R&D pipeline, most innovative drugs are metoo-type innovative drugs.

Therefore, when the "Guiding Principles" put forward higher requirements for metoo innovative drugs, the industry market generally believes that this will directly tighten the number of orders for downstream R&D CRO companies, and the CRO or CXO industry will logically undergo fundamental structural differences.

Especially under the current boom in biopharmaceutical research and development, it is difficult to distinguish between me-too, me-better or me-worse.

Therefore, the issuance of the "Guiding Principles" is likely to be a kind of elimination of pseudo-innovative drugs, allowing me-too drugs to develop differentiatedly, instead of focusing on one popular target or pursuing only one field, especially The excessive biotech may be cleaned up, new opportunities for bigpharma

New Deal reform support

Innovative research and development will enter a new stage

However, relevant people in the industry have taken a more positive view and attitude towards the issuance of the Opinion Draft

Li Bin, the clinical vice president of Zhuhai Technolab Biotechnology Co.

He once again emphasized that the purpose of the "Guiding Principles" is not to compete, but to encourage innovation to make the design of oncology clinical research more realistic.

In addition, CRO research and development companies such as Kanglong Chemical, Kailaiying, Tigermed, etc.

Dr.