The big era of generic drugs is coming!

To say that the key policies of the pharmaceutical industry in the past two years, the consistency evaluation of generic drugs is certainly one of them. But what I want to say today is not a generic drug in the general sense, but an improved generic drug, which is often referred to as a new class of drugs, also known as new or improved new drugs.

The second class of new drugs is a new class of chemical drugs after the reform of China's chemical drug classification in 2016, referring to improved new drugs that are not listed at home or abroad. Class 2 new drugs are drugs that are optimized on the basis of known active ingredients, their structure, dosage form, formulation process, route of administration, indications, etc., and have obvious clinical advantages.

In 2016, the State Food and Drug Administration at that time encouraged the reform of the Drug Registration Regulations in 2007 to encourage the creation of new drugs, and formulated the “Chemical Drug Registration Classification Reform Work Plan” (No. 51 of 2016), that is, people The No. 51 text, often referred to, redefines the classification of drugs. (A detailed list of the 2 types of new drugs approved for clinical and approved production since April 1, 2016 is turned to the end of the article)

Expected 2025

China's two types of new drug market will reach 276 billion yuan

According to BCC research results, the market for DDS (Drug Delivery System) in the world in 2015 was about $178.8 billion, accounting for about 17% of the global pharmaceutical market.

Compared with developed countries, China's new preparation industry market is relatively small. In 2014, China's new preparations accounted for about 3.8% of the total pharmaceutical market, and the market size was 47.3 billion yuan. By 2017, it is estimated to have exceeded 70 billion yuan, about 4.5%.

It is expected that under the impetus of many factors, China's new formulation in 2025 will account for 10% of the pharmaceutical market. According to the growth rate of China's pharmaceutical market in recent years, we expect the compound annual growth rate in the next few years to be 7%. In 2025, the pharmaceutical market will reach 2.7 trillion yuan. The market size of the new formulation is expected to reach 276 billion yuan.

Why do you say

The big era of new formulations is coming?

 A number of national policies support 2 new types of preparations, and the intensity is constantly increasing

The pharmaceutical market is a policy-oriented market, so the development of such drugs is inseparable from policy support.

The improved new drug has improved the dosage form of common drugs, and has obvious clinical advantages by improving the efficacy and reducing side effects.

In February 2016, the Premier of the State Council presided over the State Council executive meeting to deploy and promote the innovation and upgrading of the pharmaceutical industry. The meeting decided to aim at the urgent needs of the masses and strengthen R&D and innovation of the original research drugs, the first generic drugs, Chinese medicines, new preparations, and high-end medical devices.

In March 2016, the improved new drug was defined as a class 2 new drug in China's chemical drug classification reform, giving a monitoring period of 3 to 4 years, emphasizing clinical value, distinguishing it from low-level modifiers and routes of administration. Strong support for the development of innovative formulations.

In December 2017, the priority review comments will include advanced formulation technologies, innovative treatments, and drug registration applications with significant therapeutic advantages in the priority review. At the same time, innovative formulations such as controlled release and release are explicitly supported in various policies.

In 2018, the "Intellectual Property Protection Key Support Industry Catalogue" included long-acting, slow-release, targeted and other new preparations into the key intellectual property support industries.

There is huge demand in the market

The number of patients with chronic diseases increases, the incidence of adverse drug reactions is high, and medication compliance is poor, so the demand for improved drugs is urgent.

The world's chronic diseases have become the number one killer. In recent years, China's disease spectrum has also undergone tremendous changes. The number of chronic patients in China continues to rise, and the trend of young people is obvious. The China Cardiovascular Disease Report 2017, released in early 2018, shows that the prevalence and mortality of cardiovascular disease in China is still on the rise. The estimated number of cardiovascular diseases is 290 million, including 13 million strokes, 11 million coronary heart disease, 5 million pulmonary heart disease, 4.5 million heart failure, 2.5 million rheumatic heart disease, 2 million congenital heart diseases, and high blood pressure. 270 million.

A set of data shows that by 2030, the burden of major chronic disease myocardial infarction, stroke, diabetes, and chronic obstructive pulmonary disease is expected to increase by nearly 50% or more on a current basis. Recently, China's first "Blue Book on Health Management (2018)" shows that the number of chronic diseases in China is around 300 million, and the chronic disease burden of people under 65 is 50%.

Adverse drug reactions remain high. According to the National Monitoring Report on Adverse Drug Reactions released during the year, the National Adverse Drug Reaction Monitoring Network received 1.429 million adverse drug reactions/incident reports in 2017, including 433,000 new and serious adverse drug reactions/incident reports. 30.3% of the total number of reports in the same period, we can see that the side effects of drugs are still a huge challenge in the treatment of diseases. Among them, the proportion of chemicals is as high as 82.8%.

Some drugs are inconvenient to use, and patients' medication compliance is poor. There are a lot of literature data showing that some diseases, especially those chronic drugs that need to take drugs for a long time, are less than 20%. Drug non-compliance is prevalent throughout the world and has a high incidence. The World Health Organization survey shows that about 50% of patients worldwide have medication non-compliance. Our survey shows that about 46% of patients do not take the prescribed dose. In addition, medication adherence is directly related to the course of treatment, dosage, cost, etc., and the improved drug is beneficial to improve patient compliance by improving drug compliance, reducing dose and frequency of administration.

Substituting huge market space for the same generic product

After the introduction of the improved new drug, it will quickly replace the common dosage form. Usually, after the introduction of the modified new drug, the common dosage form is quickly replaced. The sales need to be relatively stable in 4 to 5 years (the growth rate is less than 20%), and the sales of the innovative preparation products after the stabilization account for more than 70%.

R&D costs are relatively low and risk is low

Compared with the new molecular entity, the improved new drug has a lower risk of research and development and a lower input cost. In terms of R&D risk, according to a BIO report, the statistical analysis of the success rate of new drug clinical development in 2006-2015 shows that the probability of a new molecular entity from clinical phase I to successful approval is 6.2%, and the non-chemical entity is 22.6. %, the development rate of non-chemical entities (including improved new drugs) is about 3.6 times that of new molecular entity drugs, which shows that the risk of research and development of improved new drugs is significantly lower than that of new molecular entities.

In terms of capital and time investment, the development of a new molecular entity drug requires extensive preclinical studies and clinical studies to demonstrate drug safety and effectiveness, according to data from the Pharmaceutical Research and Development Association of the United States (PhRMA), including R&D failures. The average R&D cost of a new drug is $1.2 billion, which lasts 10-15 years. The average cost of a new drug is only $0.5 billion, which lasts 3-4 years.

Therefore, under the stimulus of the policy, the number of declared two types of innovative preparations in China has increased significantly since 2017. In addition, in terms of technology, China also has a certain foundation for new formulation innovation. In recent years, China has focused on strengthening research on international advanced dosage forms and related excipients such as osmotic pumps, microporous membranes, long-term slow release, targeting, and timing pulses. Established a number of new formulation technology platforms in China, including laser perforated osmotic pump controlled release tablets, sustained release microparticles, sustained release suspensions, bioadhesive preparations, transdermal preparations, long-acting injection microspheres, and injection lipids. The plastids, etc., and designed and manufactured the corresponding equipment and production lines.

Nearly two years

Strong research and development of these two types of drugs in these enterprises in China

Since the publication of the "Chemical Drug Registration Classification Reform Work Plan" in March 2016, domestic enterprises have 61 applications for approval of clinical and approved production of 21 types of drugs, involving more than 40 products.

Among them, Zhengda Tianqing, Kelun Pharmaceutical, Kexin Bicheng and Haizheng Pharmaceuticals approved the clinical and approved production acceptance of more than 3 new drugs, and there are 10 enterprises of 2 new drugs approved for clinical and approved production. There are two acceptance numbers.