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Advantages in clinical needs

The modified new drug has obvious clinical advantages. A modified new drug is an upgrade and modification of a drug already on the market, which emphasizes "superior efficacy". Compared with the drug is modified, it has obvious clinical advantages such as enhancing efficacy, reducing side effects, and improving patients' medication compliance.

1. Help to improve the efficacy of drugs. For example, the leuprelin microsphere structure makes the active ingredient of the drug not easily degraded by the enzyme, improving the stability of the drug and significantly improving the efficacy.

2. Reduce the frequency of medication and enhance patient compliance. For example, the super-long-acting preparation of metabolite prodrug for risperidone metabolites is injected intramuscular once every 3 months and only needs to be injected 4 times a year, which greatly reduces the number of administration number and enhances the medication compliance of patients compared with the conventional dosage form of daily administration.

3. Reduce side effects and improve safety. For example, paclitaxel albumin nanoparticles utilize nanoparticle technology to bind drugs to human blood albumin to form particles with a diameter of 130 nm. The incidence of allergic reaction is very low, and the blood toxicity, gastrointestinal toxicity and neurotoxicity are lower than paclitaxel injection and paclitaxel liposome.

Advantages in drug development

In terms of pharmacoeconomics, modified new drugs have the advantages of low risk, low input, long life cycle and high return.

1. Compared with new molecular entities, the development risk of modified new drugs is lower and the input cost is also lower.

In terms of R&D risk, the research and development success rate of modified new drugs is about 3.6 times of new molecular entities, and the research and development risk is significantly lower than new molecular entities.

In terms of capital and time investment, the development of a new molecular entity drug requires a large number of pre-clinical studies and clinical studies to prove safety and efficacy of the drug. The average research and development cost of a new drug is 1.2 billion US dollars, lasting 10 to 15 years, and modified new drugs may refer to approved drugs or published literature, avoiding a large number of repeated experiments and greatly reducing the research and development cost and time. The new preparation, for example, costs an average of only $50 million and lasts only 3 to 4 years.

2. Compared with generic drugs, modified new drugs have high technical or patent barriers, long life cycle and high rate of return.

Compared with generic drugs, whether it is structural improvement, dosage form improvement, new compound preparations or new indications, modified new drugs have certain technical or patent barriers, such as liposomes, microspheres, nanoparticles and other processes are complex and difficult to BE or need clinical validation. However, modified new drugs have a surveillance period of 3 to 4 years compared with generic drugs, the life cycle is significantly longer, and the rate of return is also significantly increased.