CDE: The research and development standards of new anti-tumor drugs need to be improved in the pharmaceutical industry led by CXO.

On July 2, CDE issued the "Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value.
" Documents The standards for research and development of new anti-tumor drugs have been raised
.

A "blood case" triggered by a guiding principle

The focus of everyone’s discussion was mainly on the choice of control drugs when conducting randomized controlled studies.
The above-mentioned "Guiding Principles" pointed out that when positive drugs are selected as the control group, "the subjects should be provided with the best treatment methods/drugs in clinical practice as much as possible.
It should not be used to improve the success rate and efficiency of clinical trials and choose treatments that are uncertain in safety and effectiveness, or have been replaced by better drugs.
” “When there is BSC (best supportive care), BSC should be preferred As a control, not a placebo", this expression has aroused great attention from the market
.

As soon as the policy came out, the CXO industry began to show a downturn, and the entire pharmaceutical sector plummeted!

Image source: Wind

According to analysis by industry insiders, part of the reason is that since March, the share price of the pharmaceutical sector has risen a lot, and the valuation is already very high, showing a large bubble component.

A little bit of trouble may puncture the bubble and cause a sharp drop; and One is the "Guiding Principles" issued by CDE last Friday, clarifying that new drug development should provide patients with better treatment options as the highest goal

Forcing companies to accelerate innovation, CXO may be wrongly killed

Regarding the "Guiding Principles" last Friday, many brokerages have also interpreted it from various aspects to predict the possible future impact on the entire pharmaceutical industry
.

Zhongjin Medicine stated that the guiding principles encourage in-depth understanding of the needs of patients on the basis of further improving the effectiveness and safety of oncology drugs, guiding drug development, and detailing various requirements
.

They believe that this principle will further promote the standardization of domestic oncology drug clinical research and lay a solid foundation for further aligning with the clinical standards of developed countries

Regarding the improvement of the standard of the control group, Zhongjin Medicine believes that this has put forward higher requirements for the development of me-too drugs with the same target or mechanism in the clinical progress.

In the true sense, the value of FIC and BIC will be more affirmed and improved.
Support

They believe that the introduction of the document will help to further concentrate resources on high-quality innovative pharmaceutical companies and leading CXOs
.

For innovative pharmaceutical companies, companies with high-efficiency drug development or high-quality varieties with BIC potential will receive more attention; for CXO companies, companies with a relatively high domestic business may have short-term performance impact; in the long-term, Domestic CXO companies will benefit from the upgrade of the overall industrial chain of innovative drugs and the sustained development of participating in global competition to a greater extent

The Haitong Securities team stated that the "Guiding Principles" basically clarified the attitude of not supporting "me-worse".

Although some such projects will no longer be approved, the current leading pharmaceutical companies and biotech new projects have basically been separated from this.

CITIC Construction Investment stated that the "Guiding Principles" emphasized "clinical value".
Me too drugs also have clinical value, such as improving efficacy, safety, or reducing patient burden, but it does not encourage excessive investment leading to "high-level repetition".

.

They believe that the long-term benefits of innovative drug companies and differentiated companies
.

This is because the draft for comment releases more resources for truly valuable innovations, while avoiding homogenized competition caused by "high-level duplication"

As for the CXO track, because innovation is the definite direction, the proportion of R&D investment in the pharmaceutical industry continues to rise; on the other hand, FIC and BIC are more difficult, and the top CXO and CXO enterprises with distinctive service capabilities have more obvious advantages, so CXO The industry continues to be optimistic

Some organizations also said that some self-media over-reported negative sentiments such as the dramatic changes in the research and development of new drugs like me too, which in turn triggered market concerns about the prosperity of the CXO sector.

Original title: CDE is a guiding principle, the standards for the development of new anti-tumor drugs should be improved, and the pharmaceutical industry led by CXO has killed.