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

　　China is a major global producer of raw pharmaceutical materials and an even larger consumer of medicines. However, the chemical drugs produced domestically currently lack independent intellectual property rights, with 97% being generic drugs, placing China at a disadvantage in international competition. In response, relevant experts have proposed suggestions for the future R&D direction and product structure adjustment of Chinese pharmaceutical companies.

 

Adjust product structure with more "three-dimensional crossovers"

　　Nowadays, people increasingly value health and improving quality of life. Coupled with the accelerated construction of the public health system, the improvement of disease prevention and control systems, the strengthening of rural medical and health infrastructure, and the establishment of new cooperative medical systems, favorable market opportunities have been created for the rapid development of the pharmaceutical economy. New changes have also appeared in the consumer market: consumption areas have extended from cities to rural areas, consumer groups have broadened, choices have become more diverse, and consumption purposes have expanded from disease prevention and treatment to fitness and cognitive enhancement. Consumers seek novelty, natural products, and effective treatments. Additionally, the comprehensive promotion of the basic medical insurance system for urban employees and the accelerated aging of the population will increase demand for pharmaceutical products.

　　The multi-level nature of drug demand and the market requires diversity and multi-level development in drug development. However, Li Shunnian, Executive President of the China Chemical Pharmaceutical Industry Association, pointed out that although China has become a major global producer of raw pharmaceutical materials and exports a considerable amount, the low-level duplication of some product types has not fundamentally changed. Some companies have expanded production capacity during GMP (Good Manufacturing Practice) upgrades without integrating product structure adjustments, resulting in unreciprocated investments, capital lock-up, idle equipment, and exacerbated underutilization of production capacity. Product homogenization is severe, with intense market and price competition.

　　Wang Xiaoliang, Director of the Institute of Materia Medica, Chinese Academy of Medical Sciences, believes that market-oriented production is crucial for enterprises. Currently, among over 1,000 new drugs being developed worldwide, more than 400 are biopharmaceuticals for cancer, 26 for Alzheimer's disease, over 100 for heart disease, myocardial infarction, AIDS, and mental illnesses, and 25 for diabetes.

　　The adjustment of product structure for domestic companies should be based on the frequency of diseases in China's population, with more "three-dimensional crossovers" at the structural level and minimizing "flat collisions," especially reducing low-level duplication. Considering China's pharmaceutical market demand, drugs for hepatitis, liver cirrhosis, anti-tumor, anti-diabetes and its complications, and cardiovascular drugs should be the focus of enterprise R&D. As a developing country, anti-infective drugs remain among the most demanded products. With social progress and intensified competition, the market for psychiatric drugs will also expand, although this field has been a weak point in China's innovative drug development. In developed countries, antidepressants have become one of the best-selling drugs.

 

Emphasize secondary development and strengthen formulation research

　　Shen Huifeng, a researcher at Shanghai Institute of Pharmaceutical Industry, believes that internationally, due to increasing risks and demands in new drug investment, new drug development has relatively slowed. Under the premise of continuously exploring new uses for old drugs, drug research has entered the formulation era, with drug delivery systems (DDS) being the main theme of this era.

　　Because drug delivery technology can maintain stable drug levels within therapeutic ranges, extend duration of action, target release to diseased tissues or organs, and release drugs in timed and measured doses according to pharmacokinetic principles, it better meets medical and patient needs. Therefore, DDS technology has a very broad application range, with significant development in lifelong medication, large dosage, high toxicity drugs, or diseases such as cardiovascular diseases, respiratory diseases, pain relief, and malignant tumors. Additionally, digestive system drugs and certain anti-infective drugs are also suitable for producing and using sustained-release formulations. Using DDS technology can improve the medical cost-performance ratio of old drugs, allowing the general public needing healthcare to receive higher levels of medical service from patented-expired products.

　　However, compared with pharmaceutical industries in developed countries, China's technology in this area still has a large gap and cannot meet domestic market demand. China spends a large amount annually on importing expensive formulation products. Therefore, it is necessary to strengthen research on drug delivery technology in domestic pharmaceutical companies. This strategy not only adapts to the continuously developing pharmaceutical market but also greatly improves drug efficacy, reduces side effects, and is crucial for pharmaceutical companies to implement differentiated marketing strategies and obtain premium profits.

 

Currently, the main drug delivery technologies include:

 

　　Sustained-release formulations

　　In recent years, the development of polymer materials has promoted the preparation technology and development of new types of sustained-release formulations. Oral sustained-release formulations include more than a dozen different types, such as matrix type, gel type, sustained-release pellets capsules, coated type, multi-layer sustained-release, and gastric retention tablets.

Oral fast-dissolving/disintegrating tablets (FDDTs)

　　FDDTs can disintegrate and rapidly dissolve in saliva without water; some tablets dissolve quickly in saliva within seconds or rapidly disintegrate in the oral cavity. They are generally prepared by freeze-drying to make oral fast-release tablets, molding to make oral fast-release tablets, or direct compression to make oral fast-disintegrating tablets.

　　

　　PEGylated drug delivery systems

　　PEG is a polymer compound that, when conjugated with protein-peptide drugs through polyethylene glycolylation, can carry a large number of water molecules, increasing volume by 5 to 10 times. Proteins and peptides originally insoluble in water can have improved solubility, enhanced fluidity, prolonged drug action, and reduced toxicity and side effects after PEGylation. According to foreign estimates, in the next five years, the global sales of PEGylated interferon preparations alone will reach 1.5 to 2 billion USD, and the market sales of PEGylated old drugs could eventually reach 10 billion RMB, indicating a very promising market outlook.

Oral mucosal adhesive drug delivery systems

In recent years, mucosal adhesive drug delivery has attracted researchers' attention due to its advantages over conventional administration. Drugs have prolonged retention time at the administration site, allowing close contact between the formulation and mucosa and controlled drug release. This localizes drug delivery, promotes drug absorption by altering local mucosal properties, and improves bioavailability.

　　

　　Inhalation drug delivery systems

　　The inhalation drug delivery system market was valued at 11.7 billion USD in 2000, with sales predicted to exceed 22.6 billion USD by 2005 and reach 35.2 billion USD by 2010. This market has huge potential. The proportion of inhaler users in China was relatively small, but with improved medication standards and expanded use of inhalers in treating systemic diseases such as lung cancer, the domestic market will rapidly expand.

 

　　Nanoparticle drug delivery technology

　　Water-insoluble drugs have poor solubility; reducing their particle size can increase surface area and enhance solubility.

　　According to market analysis, the current new drug release systems are still mainly oral immediate and sustained-release formulations. The rapidly developing technologies in the oral drug release product market mainly include rapid-release technology, oral controlled-release technology, oral compound formulations, and taste-masking technology. Shen Huifeng believes that while strengthening research on drug release systems in formulations, it is necessary to enhance the research and application of pharmaceutical excipients to meet the needs of new drug and dosage form development.