Industry experts support: where is the direction of drug research and development of Chinese enterprises?

China is a major producer of bulk drugs and a major consumer of drugs in the world. However, at present, the chemical drugs produced in China lack independent intellectual property rights, of which 97% are generic drugs, which are at a disadvantage in international competition. In this regard, relevant experts put forward suggestions on the future R&D direction and product structure adjustment of Chinese pharmaceutical enterprises.
Adjust the variety structure and make more "grade separation"
Nowadays, people are more and more aware of valuing health and improving the quality of life. In addition, the construction of the public health system has been accelerated, the disease prevention and control system has been improved, the rural medical and health infrastructure has been strengthened, and the new cooperative medical system has been established, providing a favorable market opportunity for the rapid development of the pharmaceutical economy. There have also been new changes in the consumer market: the consumption area has been extended from cities to rural areas, the consumption target has been further expanded, the consumption choice has been more extensive, the consumption purpose has been expanded from disease prevention and treatment to fitness and intelligence, and the consumption is new, natural and effective. In addition, the comprehensive promotion of the basic medical insurance system for urban workers and the acceleration of the aging process of the population will increase the demand for medical products.
The multi-level nature of drug demand and market requires diversified and multi-level drug development. However, Li Shunnian, Executive Chairman of China Chemical Pharmaceutical Industry Association, proposed that although China has become a major producer of bulk drugs in the world at present, it has a considerable number of exports. However, the low-level duplication of production of some varieties has not been fundamentally changed. Some enterprises did not combine the transformation of GMP (Good Manufacturing Practice) with the adjustment of variety structure, but simply expanded production capacity. The investment did not get a return, resulting in capital precipitation and idle equipment, which aggravated the contradiction of insufficient utilization of production capacity. The product convergence is serious, and the market competition and price competition are fierce.
Wang Xiaoliang, director of the Institute of Medicine of the Chinese Academy of Medical Sciences, believes that it is crucial for enterprises to be market-oriented in production. Among the more than 1000 new drugs being developed in various countries, there are more than 400 new biological drugs for cancer, 26 for Alzheimer's disease, more than 100 for heart disease, myocardial infarction, AIDS, and psychosis, and 25 for diabetes.
The variety structure adjustment of local enterprises should be based on the frequency of disease occurrence in China's population. At the structural level, there should be more "vertical crossing" to minimize "plane collision", especially to reduce low-level duplication. In combination with the demand of China's pharmaceutical market, hepatitis drugs, liver cirrhosis drugs, anti-tumor drugs, anti diabetes and complication drugs, cardiovascular drugs, etc. should be the R&D direction of enterprises. As a developing country, anti infective drugs are still one of the most demanded varieties in the market. With social progress and intensified competition, the market of psychotherapeutics will continue to grow, and this field has always been a weak point in the research and development of innovative drugs in China. In developed countries, antidepressants have become one of the most popular drugs.
Attach Importance to Secondary Development and Strengthen Preparation Research
Shen Huifeng, a researcher at the Shanghai Institute of Pharmaceutical Industry, believes that the development of new drugs has slowed down relatively due to the increasing risk of new drug investment and significantly increased requirements internationally. On the premise that people continue to develop new uses of old drugs, drug research and development has entered the era of preparation, and drug delivery technology (DDS) is the theme of this era.
Because the drug release technology can maintain a stable drug level within the allowable range of treatment, extend the action time, and can be released to the diseased tissues or organs in a targeted manner, and can be released in a regular and quantitative manner according to the principle of pharmacokinetics, which can better meet the needs of medical treatment and patients, DDS technology has a wide range of applications, such as cardiovascular disease, respiratory disease, pain relief Malignant tumors have made great progress. In addition, digestive system drugs and some anti infectives are also suitable for the production and use of slow and controlled release preparations. The use of DDS technology will change the medical price performance ratio of old drugs, and the public who need health care will get a higher level of medical service from the old products with expired patents.
However, compared with the pharmaceutical industry in developed countries, this technology in China still has a big gap, which is far from meeting the domestic market demand. China also spends a lot of money on importing expensive pharmaceutical products every year, so it is necessary to strengthen the research on drug release technology of domestic pharmaceutical enterprises. This strategy not only meets the needs of the continuous development of the pharmaceutical market, but also will greatly improve the drug efficacy and reduce side effects. It is also crucial for pharmaceutical manufacturers to implement differentiated marketing strategies and obtain premium profits.
At present, the main drug release technologies include:
Slow and controlled release preparation
In recent years, the development of polymer materials has promoted the development of preparation technology and new varieties of slow and controlled release preparations. There are more than ten different types of slow release preparations for oral slow and controlled release preparations, such as skeleton type, gel type, slow release pellets, coated type, multi-layer slow release, stomach retention tablets, etc.
Oral instant/disintegrating tablets (FDDTs)
FDDTs can be disintegrated and rapidly dissolved in saliva without water. Some tablets can be rapidly dissolved in saliva for a few seconds or rapidly disintegrated in the mouth. It generally includes freeze-drying method for preparing oral rapid release tablets, molding tablets for preparing oral rapid release tablets, and direct compression tablets for preparing oral rapid collapse tablets.
PEG dosing system
PEG is a macromolecular compound and protein polypeptide drug, which can carry a large amount of water molecules after PEG treatment, thus increasing the volume by 5~10 times. After PEG treatment, the protein polypeptides that were originally insoluble in water can not only improve the solubility, but also improve the fluidity, prolong the drug use, and reduce the toxic and side effects. According to relevant foreign estimates, the world sales volume of only PEG interferon preparations will reach 1.5 billion to 2 billion dollars in the next five years, while the market sales volume of PEG old drugs will eventually reach 10 billion yuan, with a very bright market prospect.
Oral mucosal adhesion drug delivery system
In recent years, mucosal adhesive drug delivery has attracted the attention of researchers. Because it is superior to conventional drug delivery, the drug stays at the drug delivery site for a long time, which makes the preparation closely contact with the mucosa and can control the release of drugs. The drug delivery is localized. It can promote the absorption of drugs and improve the bioavailability by changing the properties of local drug delivery mucosa.
Inhalation release system
The market size of inhalation drug delivery system was 11.7 billion US dollars in 2000. It is predicted that the sales volume in 2005 will exceed 22.6 billion US dollars and that in 2010 will reach 35.2 billion US dollars. This market has great potential. The proportion of people who used inhalants in China is small. With the improvement of drug use level and the expansion of the application of inhalants in the treatment of lung cancer and other systemic diseases, the domestic market will expand rapidly.
Nanometer drug release technology
The solubility of water-insoluble drugs is poor. If the particle volume is reduced, the surface area will be increased and the solubility will be enhanced.
According to the market analysis, the new drug release system is still dominated by oral sustained and controlled release preparations. The rapid development technologies of oral drug release products in the market mainly include rapid release technology, oral controlled release technology, oral compound preparation and taste masking technology. Shen Huifeng believes that while strengthening the research on drug release system of preparations, it is necessary to strengthen the research and development and application of pharmaceutical excipients to meet the development needs of new drugs and dosage forms.