CDE publicly solicits opinions on the guiding principles for the research and development of innovative anti-tumor drugs

2021-07-07 15:55:12

On July 2, 2021, CDE issued a public notice to solicit opinions on the “Guiding Principles for Clinical Research and Development of Anticancer Drugs Oriented to Clinical Values” (hereinafter referred to as the “Principles”), pointing out that the research and development of antitumor drugs, from the determination of the research and development direction, to the development of Clinical trials should implement the concept of clinical needs as the core, and carry out clinical value-oriented anti-tumor drug research and development.

Forcing pharmaceutical companies to accelerate innovation, Me better drugs are more favored by reviewers

From the perspective of clinical trial design, the “Principles” point out that when selecting positive drugs as controls for anti-tumor drugs, attention should be paid to whether the positive control drugs reflect and represent the best drug use in patients with the target indications; when planning to choose placebo or BSC (best support When BSC is used as a control drug, it should be ensured that there is no standard treatment for the indication in clinical practice; when BSC is available, BSC should be preferred as a control rather than a placebo. On the one hand, this makes Big Pharma and Biotech companies, which are committed to the research and development of Me better and first in class drugs, benefit from stronger innovation capabilities, and also makes it difficult for pharmaceutical companies to develop new drugs. On the other hand, the leading CXO companies are expected to increase the number of orders under this condition by virtue of their technical platform and reporting experience.

The cost of clinical trials increases, and the penetration rate of outsourcing is expected to increase in the long run

After the promulgation of the “Principles”, the updated research and development direction and more clinical trials with BSC as a control will increase the cost of clinical trials for pharmaceutical companies, and put forward higher requirements for clinical trial design and patient recruitment in new drug development. Innovative pharmaceutical companies with financial advantages and leading CRO companies with rich clinical trial design experience and sufficient clinical resources are expected to benefit first.

At present, the "Principles" are still in the stage of soliciting opinions and have limited impact on the research and development of new drugs that are already in clinical research.

In the short term, the “Principles” may affect the R&D investment and willingness of some pharmaceutical companies with poor innovation capabilities. But in the long run, the Matthew effect of innovative drug research and development will be more prominent, and leading pharmaceutical companies with rich pipelines will be less affected. At the same time, changes in customer structure will lead to CXOs:

1/ Long-term increase in the penetration rate of new drug R&D outsourcing

The increase in the difficulty of new drug R&D and application highlights the value of CXO’s specialized division of labor, especially CXO leading companies with an integrated platform layout will be more favored by Biotech companies.

2/ Drive the improvement of CXO concentration

The customers of leading CXO companies are often also leading innovative pharmaceutical companies, and their R&D willingness and R&D investment are more sufficient, and they are less disturbed by policies.

3/ The advantages of domestic clinical CRO companies with cost and scale advantages are more prominent

Compared with overseas clinical CRO companies, domestic companies have lower quotations and have more competitive advantages in the case of rising clinical trial costs.

6/ Driving the Accelerated Arrival of New Therapy CXO

Compared with small molecules and monoclonal antibodies, double antibodies, ADCs, and cell gene therapy are relatively in the “blue ocean” of research and development. Under the guidance of the “Principles”, more pharmaceutical companies will target these fields, and even first in class new drugs, while promoting related outsourcing industries. The prosperity of the industry, the industry leaders with extensive layout will gradually benefit.

To sum up, the top Pharma and Biotech companies with strong innovation ability are less affected by the policy, while the long-term logic of the CXO industry remains unchanged, and the penetration rate is even expected to benefit from an increase, and the first-line leading companies will further stand out.

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