What is the impact of the newly promulgated new crown clinical guidelines in China on the research and development of new crown drugs?

Author: Crayon Piggy

Recently, in response to the prevention and control of the new coronavirus, CDE (China Ministry of Disease Control) issued the "Technical Guidelines for Clinical Trials of New Drugs for Novel Coronavirus Pneumonia", which formulated a series of guidelines for the research and development and marketing standards of new coronavirus drugs

The global new crown epidemic is developing rapidly, and there is a precedent for the new crown drug incentive policy

In the context of the rapid development of the global new crown epidemic, especially the United States, which is the most affected by the new crown epidemic, the demand for new crown drugs is undoubtedly the largest.

The FDA’s pre-IND (pre-IND) guidance for COVID-19 drugs focuses on guiding drugmakers through the pre-IND process, providing feedback to drugmakers, and helping them move their products into clinical trials in a fast and efficient manner

The FDA said earlier, “To facilitate this, we urge sponsors to submit a pre-IND meeting request to allow early and thorough review and discussions between the sponsor and the FDA so that subsequent INDs can be reviewed more expeditiously.

The FDA's guidance for the development of drugs and biological products for the treatment or prevention of COVID-19, which aims to determine the safety and efficacy of drugs and biological products for the treatment or prevention of COVID-19.

The guidelines open the door for decentralized or platform clinical trials, but also emphasize that randomized, placebo-controlled, double-blind clinical trials with a superiority design are strongly recommended to evaluate drugs for the treatment or prevention of COVID-19

Compared with the "Technical Guidelines for Clinical Trials of New Drugs for Novel Coronavirus Pneumonia" recently released by CDE, there are many similarities compared with the two guidelines issued by the FDA earlier

For example, applicants are also encouraged to communicate closely with reviewing regulatory agencies; randomized, placebo-controlled, double-blind clinical trials with superiority design are also recommended to evaluate drugs for the treatment or prevention of COVID-19, but also provide exploratory clinical trials.

Overall, the documents issued by the CDE and the guidelines issued by the FDA strongly support and encourage the research and development of new crown-related drugs, but in contrast, the CDE documents are more cautious and conservative, which is related to the more effective control of the new crown epidemic in China.

CDE has made heavy blows recently, and domestic epidemic prevention and control has entered a new stage?

In response to the new crown epidemic drugs, the recent heavy news from CDE can be said to be intensive.

Based on the current situation of prevention and control at home and abroad, the mutation of the new coronavirus has the characteristics of weakened toxicity but significantly stronger infectivity.

Countries are racing against time, what are the global new crown drug investment opportunities?

Judging from the global marketed drugs, there are currently 3 blockbuster drugs on the market, namely Merck's Molnupiravir, Pfizer's Paxlovid and Tengsheng Biopharma's Ambavirumab injection and romisevirumab injection

At present, there are many different types of new crown treatment drugs in the late stage of development around the world, such as new coronavirus neutralizing antibodies mainly for mild to moderate patients, anti-cytokine receptor/neutralizing antibodies mainly for severe patients, Small molecule new crown drugs for moderate and severe patients (including RNA polymerase inhibitors, JAK inhibitors, AR antagonists, 3CL protease inhibitors, etc.

In addition to the above-mentioned three listed special drugs, there are currently many different types of new crown treatment drugs in the late stage of development around the world.

In addition, Paxlovid is facing capacity pressure in the short term, and the high-volume process industry chain is expected to generate huge benefits

At the same time, CDMO companies Proton and Asymchem have recently disclosed that they have received large orders, and it is speculated that they are all orders from Pfizer's Paxlovid from details such as amount and time

What can be seen is that the global market for new crown drugs is huge, and small molecule drugs may become the main weapon against the new crown
.
In addition, the short-term release of new crown drug production capacity is expected to bring a large number of orders to CDMO companies.
In the short term, both sectors have good prospects
.

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