What Is Pharmaceutical R&D?

The first class of new drugs refers to the first class of drug registration categories stipulated in the 2007 edition of the Measures for the Administration of Drug Registration (Chinese Medicines and Natural Medicines, Biological Products) and the Chemical Drug Registration Classification Reform Work Program (Chemical Drugs), and belongs to their respective categories. Drugs within the monitoring period.

The first class of new drugs refers to the first class of drug registration categories stipulated in the 2007 edition of the Measures for the Administration of Drug Registration (Chinese Medicines and Natural Medicines, Biological Products) and the Chemical Drug Registration Classification Reform Work Program (Chemical Drugs), and belongs to their respective categories. Drugs within the monitoring period.

The "Administrative Measures for the Registration of Drugs" (2007) pointed out that the national first-class new drugs refer to the drugs that belong to the first category in the drug registration classification. Among them, the chemical drugs refer to drugs that have not been marketed at home and abroad, Chinese medicines, and natural medicines. The first category is the active ingredients and their preparations extracted from plants, animals, minerals and other substances that are not marketed in China; the biological products are the biological products that are not marketed at home and abroad.

Definition of a new class of drugs

The first class of new drugs refers to the first class of drug registration categories stipulated in the 2007 edition of the Measures for the Administration of Drug Registration (Chinese Medicines and Natural Medicines, Biological Products) and the Chemical Drug Registration Classification Reform Work Program (Chemical Drugs), and belongs to their respective categories. Drugs within the monitoring period.

The "Administrative Measures for the Registration of Drugs" (2007) pointed out that the national first-class new drugs refer to the drugs that belong to the first category in the drug registration classification. Among them, the chemical drugs refer to drugs that have not been marketed at home and abroad, and the chemical drugs are in class 1.1. For raw materials and their preparations made by synthetic or semi-synthetic methods, Class 1.2 of chemical drugs are new effective monomers and their preparations extracted from natural substances or extracted by fermentation; Chinese medicines and natural medicines are not domestically produced. Marketed active ingredients and their preparations extracted from plants, animals, minerals and other substances; biological products are biological products that have not been marketed at home and abroad. Newly released chemical drug registration classification In the newly released Announcement on the Release of the Work Plan for the Reform of Chemical Drug Registration Classification (No. 51 of 2016), the State Food and Drug Administration has adjusted the chemical drug registration classification. In the new scheme, the newly registered classification of chemicals is divided into 5 categories, of which the registered category 1 is "innovative drugs that have not been marketed at home or abroad", specifically referring to "containing new compounds with clear structure and pharmacological effects, and Clinical value of drug substances and their preparations ". In terms of content, a class of drugs in the new version of the registration classification of chemical medicines actually refers to the 1.1 and 1.2 chemical medicines in the 2007 edition of the Measures for the Administration of Drug Registration.

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Class I New Drug R & D Status

It can be seen from the above regulations that the national first-class new drugs are highly innovative and represent the highest level of drug innovation in China's drug registration classification. The development of domestic 1.1 drugs is still in its infancy. At present, domestic companies with strong R & D capabilities of Class 1.1 include Jiangsu Hengrui, Jiangsu Haosen, Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd., Dongyang Sunshine Pharmaceutical, Chia Tai Tianqing, etc., all of which have more than 5 in their product pools. Class 1.1 new drug under development or approved. Among them, cancer, cardio-cerebral vascular disease and other major disease areas, as well as monoclonal antibody drugs are still the focus of corporate R & D investment. The development of 1.1 new drugs has the characteristics of high risk and long cycle. It can be seen from the approval of 1.1 new drugs from 2010 to 2014 that the production of 1.1 new drugs is mainly concentrated in the two fields of anti-tumor and anti-infection. Among them, the research focus of anti-tumor drugs is small molecule targeted drugs, and the research focus of anti-infective drugs is antiviral treatment drugs. In addition, with the aging of China's population, diseases of the musculoskeletal system and cardiovascular system are also hotspots. For the 1.1 type of new drugs, the current general model of Chinese companies is not the original innovative drugs, but the development of Me-too drugs, that is, patents are obtained through structural modification of compounds with verified target activity, and they have become clinically developed so-called exclusive new drugs. This is, in many cases, an expensive and less effective labor. Currently, some products of the chemical 1.1 new drugs currently on the market are generally sold. For example, the first 1.1 new drug independently developed by Hengrui was launched in 2011. It is targeted at the large indication of arthritis, with sales of only 35 million RMB. ^[2]

Since 2005, there have been 28 types of exclusive varieties approved in China, including 13 types of exclusive varieties. Among these varieties, some varieties have become the leading varieties of the enterprise or the main competing varieties in similar products, such as Beta Pharma's ectinib hydrochloride, Zhengda Tianqing's magnesium isoglycyrrhizinate, etc., these varieties still have room for growth; there are some In the process of rapid growth, in the next few years, it will likely become a blockbuster variety, such as "Apatinib mesylate" of Hengrui Medicine, "Compaq Ship" of Kanghong Pharmaceutical, and Livzon Group. "Ilaprazole" and so on.

A class of new drugs:

Extinib hydrochloride : the core variety of Beda Pharmaceuticals. Extinib hydrochloride is a new generation of targeted anticancer drugs targeted by epidermal growth factor receptor kinases. It is completely original and independently developed by Chinese scientists and oncology clinical experts. The disease is advanced non-small cell lung cancer. The name of ectinib is Kemena, which has been regarded as "domestic Iressa". According to the sales data disclosed by Beda Pharmaceuticals on the market, sales revenue in 2015 reached 910 million yuan, and the market size is expected to exceed 1.2 billion yuan in terms of retail terminal prices.

Magnesium isoglycyrrhizinate : The exclusive variety of Chia Tai Tianqing, which was approved for production and sales in 2005, has now become a mature variety in the market. Magnesium isoglycyrrhizinate is a hepatocyte protectant, which has the effects of anti-inflammatory, protecting liver cell membrane and improving liver function, and is suitable for chronic viral hepatitis. Improve liver function abnormalities. At present, it has developed into one of the leading varieties of the enterprise. In 2015, it contributed nearly 2.3 billion Hong Kong dollars of sales to Chia Tai Tianqing. It is estimated that the market sales reached 2.5 billion yuan in terms of retail terminal prices. The biggest sales.

Butylphthalide : The exclusive varieties of CSPC Enbipu Pharmaceutical Co., Ltd., soft capsules and injections were approved for listing in 2005 and 2010, respectively. It is also one of the largest varieties of R & D investment in China. It is estimated that the cumulative R & D investment exceeds 500 million yuan. It is the first national class I innovative drug with independent intellectual property rights in the field of cardiovascular and cerebrovascular diseases in China. It is the result of a major project of the 1035 project of the National Science and Technology Development Center of Life Science. It has a safe single body structure and multiple pharmacological effects. Comprehensive treatment of ischemic stroke significantly reduces neurological deficits after infarction and improves the patient's ability to live. By 2015, the sales volume of the sample hospitals of the Chinese Pharmaceutical Association has reached nearly 500 million yuan, and the national sales are expected to exceed 1.5 billion yuan.

A new class of drugs may not be produced exclusively

Note that there are more than one company limited to the first class of new drugs, and the first class of new drugs may not necessarily be exclusively produced. ^[3]