Original research drugs, that's what it is

This is the 5262nd article of Da Yi Xiao Hu

In December 2024, the results of the 10th batch of national centralized drug procurement were announced, and no original research drugs won the bid, which attracted widespread attention from the whole society. Regarding original research drugs, the most concerned issues of everyone are explained in this article.

1. What is an original drug?

Original research drugs are original new drugs that have been approved for marketing after screening thousands of compounds and rigorous clinical trials. They are original, first developed and marketed drugs. Original research drugs usually enjoy a certain period of patent protection when they are marketed. During this period, the research and development pharmaceutical company has exclusive rights to the drug, and other pharmaceutical companies cannot produce the same drug.

2. How are original drugs developed?

The research and development of original drugs is difficult, time-consuming and expensive. Since the beginning of the 21st century, the average research and development time for an original drug has taken more than 10 years, and the average research and development cost has reached billions of dollars. The research and development process is an extremely complex process, mainly involving the following stages:

1. Drug discovery and preclinical research

For specific details, please refer to the article "What is new drug development? What steps and processes are required besides clinical trials?"

(II) Clinical trial stage (Phase I to Phase III clinical trials)

If the results of preclinical studies are satisfactory, the drug will enter the clinical trial stage. This stage is divided into three stages: Phase I clinical trials mainly evaluate the safety and tolerability of the drug; determine the recommended dosage, and preliminarily evaluate its effectiveness and pharmacokinetic parameters. Phase II clinical trials further evaluate the efficacy and safety of the drug, optimize the dosage, and determine the best dosage selection for Phase III trials; Phase III clinical trials verify the efficacy and safety of the drug in a larger patient population, and are also the most critical stage in determining whether the drug can be marketed.

(III) Regulatory approval

After completing all necessary clinical trials and obtaining data, pharmaceutical companies will submit a new drug application to the drug review agency in their country. The drug review agency will review all relevant data and ultimately determine whether the drug can be approved for marketing.

(IV) Phase IV clinical trial

Also known as post-marketing research, it refers to research conducted after the drug is marketed, focusing on the actual use of the drug and its long-term safety, with a wide range of patient groups as the research subjects.

Although original drugs have gone through rigorous research and development and clinical trial stages, and their effectiveness and safety have been verified, it does not mean that they are absolutely effective. In individual treatment, a certain proportion of patients may not respond well to original drugs. In addition, the effect of the drug may be affected by many factors, including individual differences in patients, the severity of the disease, other combined drugs, and patient compliance.

3. Why are original drugs usually more expensive?

Due to factors such as high R&D costs, long R&D cycles, and patent protection, the price of original research drugs is usually higher. Multinational pharmaceutical companies invest billions to tens of billions of dollars each year in the research and development of original research drugs, including the salaries of scientific researchers, laboratory equipment, clinical trial costs, etc., which constitute the high cost basis of original research drugs. For example, during the COVID-19 outbreak, Pfizer invested 30,000 people and $2 billion to develop a COVID-19 vaccine. During the patent protection period, original research drugs enjoy market exclusivity, and other pharmaceutical companies are not allowed to imitate the drug during this period, allowing original research drug manufacturers to recover R&D costs and make profits, while also promoting the sustainable development of innovative drugs.

4. Are original drugs, innovative drugs, and imported drugs all the same?

Original research drugs and innovative drugs are essentially the same, both referring to new drugs with independent intellectual property rights. However, original research drugs are not necessarily imported drugs, but may also be innovative drugs developed by Chinese domestic pharmaceutical companies. In recent years, the research and development of innovative drugs by Chinese domestic pharmaceutical companies has developed rapidly, bringing many original research drugs to Chinese patients; on the other hand, although most imported drugs are original research drugs, some are also generic drugs.

5. Is it becoming increasingly difficult to prescribe imported original drugs in hospitals?

Under the background of the centralized procurement policy, imported original drugs are often at a relative disadvantage in the centralized procurement bidding due to their high prices, making it difficult for them to win the bid, and their chances of entering public hospitals have been greatly reduced. Some multinational pharmaceutical companies that are unwilling to "trade price for volume" are adjusting their strategies, and some have shifted their business focus from public hospitals to out-of-hospital markets such as pharmacies and private hospitals.

Author: Pfizer (China) Research and Development Co., Ltd.

Zhang Yiqiong, Oncology Clinical Development Department