Experts in the industry support: Where is the direction of drug research and development in China?

　　China is a major producer of bulk pharmaceuticals in the world, and it is also a major consumer of pharmaceuticals. However, at present, the chemical drugs produced in China lack independent intellectual property rights, 97% of which are generic drugs, which are at a disadvantage in international competition. In this regard, relevant experts have put forward suggestions on the future research and development direction and product structure adjustment of Chinese pharmaceutical companies.

 

　　Adjust the variety structure and engage in "three-dimensional crossover"

Nowadays, people are conscious of health and improving their quality of life. With the acceleration of public health system construction, the improvement of disease prevention and control system, the strengthening of rural medical and health infrastructure and the establishment of a new cooperative medical system, it is a medical economy. The rapid development has provided a favorable market opportunity. The consumer market has also undergone new changes: the consumption area extends from the city to the countryside, the consumer objects are further broadened, the consumption choices are more extensive, the consumption purpose is expanded from disease prevention and treatment to fitness and puzzle, consumption is new, natural and therapeutic. it is good. In addition, the comprehensive promotion of urban workers' basic medical insurance system and the acceleration of the aging population will increase the demand for pharmaceutical products.

The multi-level nature of drug demand and market requires diversity and multi-layered drug development. However, Li Lannian, executive chairman of the China Chemical and Pharmaceutical Industry Association, said that although China has become a major producer of bulk pharmaceuticals in the world, it has a considerable amount of exports. However, the low level of duplication of some varieties of production has not changed fundamentally. Some enterprises have not combined with the adjustment of variety structure in the transformation of GMP (Good Manufacturing Practice), but simply expanded production capacity, and the investment has not been rewarded, resulting in fund precipitation and equipment idle, which has intensified the contradiction of insufficient production capacity utilization. . Product assimilation is serious, market competition and price competition are fierce.

　　Wang Xiaoliang, director of the Institute of Materia Medica of the Chinese Academy of Medical Sciences, believes that market-oriented production is crucial. Among the more than 1,000 new drugs being developed in various countries, there are more than 400 new biological drugs for cancer, 26 for Alzheimer's disease, and more than 100 kinds of drugs for heart disease, myocardial infarction, AIDS, and psychosis. There are 25 kinds of diabetes drugs.

　　The structural adjustment of the varieties of local enterprises should be based on the frequency of occurrence of population diseases in China. At the structural level, there are more “three-dimensional intersections” to minimize “plane collisions”, especially to reduce low-level repetition. Combined with the needs of China's pharmaceutical market, hepatitis drugs, cirrhosis drugs, anti-tumor drugs, anti-diabetes and complications drugs, cardiovascular drugs, etc. should be the direction of enterprise research and development. As a developing country, anti-infective drugs are still one of the most demanding varieties in the market. With the advancement of society and increased competition, the market for psychiatric treatment drugs will continue to increase, and this field has always been a weakness in the development of innovative drugs in China. In developed countries, antidepressants have become the most popular drugs. One.

 

　　Pay attention to secondary development and strengthen formulation research

Shen Huifeng, a researcher at the Shanghai Pharmaceutical Industry Research Institute, believes that due to the increasing risk of new drug investment and the demand for new drug development in the world, the development of new drugs has slowed down. Under the premise of people's continuous development of new drugs, drug development has entered the era of preparation. And drug release technology (DDS) is the main theme of this era.

Since the drug release technology can maintain a stable drug level within the scope of treatment, prolong the action time, can be released to the tissue or organ of the disease, and can be quantitatively released according to the pharmacokinetic principle, which can better meet the needs of medical and patients. Therefore, the application range of DDS technology is very wide, and there is a great development in the aspects of cardiovascular diseases, respiratory diseases, analgesics, malignant tumors, etc., which require lifelong medication, large dosage, high drug toxicity or pathogenicity. In addition, digestive system medications, certain anti-infectives are also suitable for the production and use of controlled release formulations. The use of DDS technology will change the medical price-performance ratio of old drugs, and the public who need health care will receive higher medical service levels from old products that have expired patents.

However, there is still a big gap between China's technology and the pharmaceutical industry in developed countries. It is far from meeting the needs of the domestic market. China still spends a lot of money every year to import expensive preparations. Therefore, it is necessary to strengthen domestic pharmaceutical companies. Release technology research. This strategy not only meets the needs of the continuous development of the pharmaceutical market, but also greatly improves the efficacy of drugs, reduces side effects, and it is also crucial to implement differentiated marketing strategies for pharmaceutical companies to obtain premium profits.

 

　　Current major drug release technologies include:

 

　　Slow release preparation

　　In recent years, the development of polymer materials has promoted the preparation of slow-release preparations and the development of new varieties. There are more than ten different types of sustained-release dosage forms for oral sustained-release preparations, such as skeletal, gel, and sustained-release pellets. , coated type, multi-layer sustained release, stomach retention tablets, etc.

　　Oral instant disintegration/disintegration tablets (FDDTs)

　　FDDTs disintegrate and dissolve quickly in saliva without water, and some tablets dissolve quickly in saliva for a few seconds or rapidly disintegrate in the mouth. The invention mainly comprises an lyophilized method for preparing an intraoral immediate release tablet, a molded tablet for preparing an intraoral immediate release tablet, and a direct compression tablet for preparing an oral rapid collapse.

 

　　PEGylated drug delivery system

　　PEG is a polymer compound and a protein-polypeptide drug that is PEGylated and can carry a large amount of water molecules, thereby increasing the volume by 5 to 10 times. The original water-insoluble protein-polypeptide can not only improve the dissolution after PEG treatment. Sexuality can also improve mobility, prolong drug action, and reduce side effects. According to foreign estimates, the world sales of only PEGylated interferon preparations will reach 1.5 billion to 2 billion US dollars in the next 5 years, while the market sales of PEGylated old drugs will eventually reach 10 billion yuan, and its market prospects are very bright.

　　Oral mucoadhesive drug delivery system

　　In recent years, mucoadhesive administration has attracted the attention of researchers, because it has better characteristics than conventional administration, and the drug stays at the administration site for a long time, so that the preparation is in close contact with the mucosa and can control the release of the drug. To improve the bioavailability by changing the mucosal properties of the local administration, promoting the absorption of the drug.

 

　　Inhaled drug delivery system

　　The market for inhaled drug delivery systems was $11.7 billion in 2000, with sales forecasting more than $22.6 billion in 2005 and $35.2 billion in 2010. The market potential is very large. The proportion of people who use inhalants in China is small. With the increase of drug use level and the application of inhalants in the treatment of systemic diseases such as lung cancer, the domestic market will expand rapidly.

 

　　Nano drug delivery technology

　　Water-insoluble drugs have poor solubility, such as reducing their particle volume, which increases their surface area and enhances solubility.

　　According to market analysis, the new drug delivery system is still based on oral sustained-release preparations. The technologies for rapid release of oral drug delivery products in the market mainly include immediate release technology, oral controlled release technology, oral compound preparation and taste masking technology. . Shen Huifeng believes that while strengthening the research on drug delivery system, it is necessary to strengthen the research and development and application of pharmaceutical excipients to adapt to the development of new drugs and dosage forms.