What happened?

On July 2, the Drug Evaluation Center (CDE) of the State Drug Administration issued the notice on publicly soliciting opinions on the guiding principles of Clinical value-oriented Clinical Research and Development of antineoplastic drugs.

On the day of the announcement, the share prices of A-share CXO companies fluctuated sharply. The policy document became a hot topic in the pharmaceutical industry over the weekend.

The market tends to think that the changes in BSC selected in clinical controlled trials will affect the prosperity of CXO in the future. Because this change will directly reduce the possibility that drugs developed by me-too will be put on the market in the future, thus affecting the number of new drug companies' products and reducing the number of orders available to CXO.

What does the policy document say?

The market discussion focused on the principles of control drug selection established in this document, which focused on the following two points:

1) try to provide subjects with the best treatment / drugs in clinical practice, and should not choose treatments that are uncertain in safety and effectiveness or have been replaced by better drugs in order to improve the success rate and efficiency of clinical trials.

2) New drug research and development should provide patients with better treatment choice as the highest goal. When non-optimal treatment is selected as control, even if the clinical trial achieves the preset research goal, it can not show that the experimental drug can meet the actual needs of clinical patients, or can not prove the value of the drug to patients.

Wall Street Institute of WisdomThink:

Aiming at 1), the policy document actually solves the clinical ethical problems and puts forward a bottom line thinking, which requires that the patients in the control group should be given no less than the recommended treatment of the existing standards.This opinion draft institutionalizes some of the parts that originally belonged to the category of ethics.To ensure that the patients in the control group who participated in the clinical trial received reasonable treatment. Relevant patient-centered drug development (patient focused drug development,PFDD) documents are also being drafted, including FDA in the United States.

In view of 2), the constraints of the policy documents on pharmaceutical companies are further clarified.The clinical control group of the new drug is required to compare with the recommended treatment in the existing standards, so as to ensure the benefit to the patients after the drug is put on the market.. In fact, this is the requirement in practice, but some pharmaceutical companies have previously obtained listing permits through loopholes, which will be curbed in the future.

The document is literally limited to this, but in fact, the new development guidelines do bring some changes to the industry, both for innovative pharmaceutical companies adopting me-too and CXO.

For innovative pharmaceutical companiesIt is good for the companies with fast development progress and those with slow development progress.The key variable is whether the standard recommended treatment for indications changes during phase 3.。

For example: now the first-line recommended treatment for liver cancer is PD-L1+, so now the clinical control group of first-line drug phase 3 for liver cancer is PD-L1+, which may not be sorafenib in the previous control. Well, at present, the companies whose indications for liver cancer have entered the third phase of the clinic may be positive, and if they do not enter, they will face the replacement of the control group in the future. on the one hand, they have higher requirements for the efficacy of clinical drugs, on the other hand, the cost of purchasing PD-L1+ in clinic is also several times higher than that of sorafinib.

For CXO enterprises: it is also a head company that is divided and has strong ability to benefit resources.The key variable is the ability to accelerate development and accelerate clinical progress.。

For example, a head CXO company said in a survey that the company's preclinical development time can be shortened by 3-6 months, and the clinical time can be further shortened. It is clear that CXO, which has rapid development and clinical capabilities, will get more orders for the future market environment that counts against time.

I want to emphasize one point here.There is a common misunderstanding about me-too drugs in the market.Me-too itself is a kind of "new drug" developed on the basis of the original drug and after evading the chemical structure patent of the latter, it may be better or worse, but it is not absolute.

Since it is a "new drug", it means that the clinical use of me-too drugs is consistent with the existing requirements.It is necessary to compare the curative effect with the standard recommended drugs.. The new guidelines themselves will not require "head-to-head" clinical treatment with the original drug, unless the drug is already on the market and standard recommended treatments are available.

Me- to type drug development is mainly used to avoid patent restrictions. The essence of excessive competition in domestic me-too drugs is that the IP environment is not very strict, coupled with the strong imitation ability of domestic pharmaceutical companies and a large amount of short-term capital invested in a certain field, resulting in excessive competition. With the continuous improvement of the policy, this kind of situation will be effectively alleviated in the future through the spontaneous clearing of the market.

Coincidentally, later on the 4th, the State Drug Administration and the State intellectual property Office jointly issued the "measures for the implementation of the Mechanism for early settlement of Drug Patent disputes (for trial implementation)," and some new policies have also emerged on drug patent issues.

Overall, the guiding principles document may have caused an over-interpretation of the market.Wall Street Institute of WisdomIt is believed that the next stage of development of the innovative drug and CXO industry should therefore usher in structural differentiation rather than simply being bad.

At the same time, we can see that the formulation of policy documents is constantly promoting the marketization of innovative drugs, and drugs with poor efficacy will be eliminated in the market application.