On July 2, CDE issued the “Guiding Principles for Clinical Research and Development of Antitumor Drugs Oriented by Clinical Value (Draft for Comments)”. The purpose of the “Draft for Solicitation of Comments” is to prevent poor quality drugs from taking up the approval resources of the Drug Administration and the flow of social capital to poor quality drugs or homogenized drugs.
Simply understand the core content of the “Draft for Solicitation of Comments”: according to group standards, higher requirements are put forward for the marketing of innovative anti-cancer drugs. Affected by this news, the CXO industry, led by a slump, then the entire pharmaceutical sector collectively plummeted!
Maybe the market is overreacting now, and CXO has plummeted, or maybe it's just a mistake.
The purpose is to avoid “high levels of repetition” of homogenized competition
Innovative drugs in the past: The vast majority of innovative drugs currently on the market and even under development are metoo innovative drugs. The targets are the same, the indications and efficacy are basically the same, but the structure is different: “Enterprise knowledge attempts to slightly modify the molecular structure, add and subtract groups, so that patent restrictions can be effectively circumvented without significantly reducing efficacy.”
Currently, we see that at least 100 domestic companies are developing PD-1, and another 100 companies are developing CAR-T. This must be a waste of social capital and consumption of approval resources by the State Drug Administration.
Innovative drugs after the New Deal: When there are existing BSC (best supportive treatment) on the market, BSC should be preferred as a control rather than a placebo. This has invisibly raised the standards for innovative drugs to be approved for marketing...