9.7 Subjective open-ended questions (As long as the answers are valid, 3 to 30 wealth points will be rewarded) (Pharmaceutical Engineering Technology section)
Thread Content
Open-ended question (any valid answer earns 3 to 30 wealth points) (Answers must be submitted within 48 hours). What is the future of the pharmaceutical industry in China? This is a very complex issue, so let me first provide some background information: 1. The environmental protection drive in China is unstoppable, and the active pharmaceutical ingredients industry generates large amounts of waste, with complex compositions. 2. China’s economic level is rising, labor costs are high, and there is a tendency in various regions to relax GMP standards. 3. According to the laws of development, industries that are highly polluting and energy-intensive tend to shift from developed regions to less developed ones. 4. However, the United States is now making efforts to attract or coerce manufacturing industries to return there. 5. The costs associated with periodic GMP upgrades, environmental improvements, and automation upgrades are very high. What are your forward-looking insights and opinions on this issue for our industry? (I am personally very optimistic about this industry.)Since 1997, the pharmaceutical industry has seen a steady rise in its importance within the national economy. The proportion of its main economic indicators to the total industrial output has been showing a consistent upward trend. The pharmaceutical industry accounts for a small proportion of the national economy; its scale, measured in terms of assets, is only 2%–3%. Even its efficiency indicators, which are relatively higher, are only 3%–4%. It is one of the industries that contribute to stable economic benefits in China, but it does not belong to the category of key industries. The pharmaceutical industry is closely related to the daily lives of the general populace; it is a special industry dedicated to preventing and treating diseases, promoting rehabilitation and health care, and improving the overall quality of the nation. It plays a positive and irreplaceable “guardian” role in ensuring the healthy and sustainable development of the national economy. III. Three important standards for pharmaceutical quality management Quality is the lifeblood of drugs; drugs whose quality cannot be guaranteed can, in a sense, be considered poisons. They not only fail to treat diseases but also delay treatment and put patients’ lives at risk. To carry out effective quality management in a pharmacy, it is necessary to continuously identify and address shortcomings, and three standards must be mastered. These three standards form the basis for other tasks; if this fundamental work is not done properly, it becomes difficult to ensure the quality of drugs, and thus it is hard to achieve the ultimate goal of making things convenient for customers and ensuring the safe and effective use of medications by the public. 1. Purchase acceptance criteria. Pharmacies in a chain network do not have a purchasing process; they simply receive deliveries from the headquarters and verify them using delivery tracking sheets and retail allocation orders. When purchasing medicines, individual pharmacies should pay attention to verifying the qualifications of the suppliers and the staff involved, and obtain relevant documents, including copies of the supplier’s drug distribution license, business license, and GSP or GMP certification – all of which must be stamped with the supplier’s official seal ; For the sales staff of the supplier, a copy of their ID card, a copy of their graduation certificate, and the original power of attorney should be requested ; There is also a quality assurance agreement signed by both parties. Only when all the above information is complete can a contract be signed and the procurement process proceed. By conducting thorough qualification reviews, it can be seen that entities unable to provide all the aforementioned documents generally have poor creditworthiness; stores should refrain from doing business with such entities. When accepting pharmaceuticals, it is necessary to conduct a visual inspection of each batch against the actual goods. Items such as the product name, specifications, batch number, quantity, date of manufacture, expiration date, manufacturer, and approval number must be checked. Any products with abnormal appearances must not be accepted into the store. 2. In-store maintenance standards. Medicines that pass the testing upon leaving the factory can enter the distribution chain. The most important task in this distribution process is proper storage and maintenance; if proper care is not taken, medicines that were once qualified may become substandard. Some medications need to be stored at 4–6°C; either too high or too low temperatures can cause changes in the physical or chemical properties of these medications, resulting in them losing their therapeutic effect and becoming substandard products ; Some medications need to be stored in a light-proof, airtight container ; Some need to be stored at room temperature; high temperatures can pose a danger. High-concentration hydrogen peroxide solutions will decompose rapidly when exposed to strong light, leading to an explosion. Therefore, proper maintenance of medicines is not only necessary to prevent the presence of substandard drugs, but it is also an essential requirement for ensuring operational safety. Regular maintenance is essential; quality control personnel must be aware of the storage conditions required for each type of medication, and they should store or display these medications in the appropriate areas in strict accordance with those requirements. The relative humidity inside the store should be maintained between 45% and 75%, and measures must be taken if it is either too high or too low. If the temperature is too high, some suppositories may easily melt; if it’s too low, some liquids may freeze or crack ; In high humidity, drugs that are prone to absorbing moisture will absorb water and decompose ; When the humidity is too low and the environment is too dry, drug packaging such as aluminum-plastic packaging tends to crack and develop edges; separation occurs between the aluminum-plastic material and the PVC sheet, allowing the tablets and capsules to be exposed to the air, which makes them prone to contamination and deterioration. Therefore, proper maintenance is essential; otherwise, drugs that are of qualified quality can become substandard due to inadequate maintenance, causing harm to patients. This will also inevitably affect the store’s reputation, resulting in both reputational and financial losses. 3. Classification display, after-sales service standards. Drug display should not only be aesthetically pleasing and convenient but also meet quality management requirements. The products in the store should be displayed separately at the following levels. First of all, drugs and non-drugs should be separated; non-drugs generally include foods, cosmetics, medical devices, sanitary materials, etc. Traditional Chinese medicine decoction pieces in pharmaceuticals should be placed in separate containers, while other medications (prescription and over-the-counter) should be classified further. Prescription and non-prescription drugs are further categorized and displayed separately as oral and topical medications. Topical medications are further separated and displayed as those that easily absorb odors and those that do not. Hazardous materials are substances that can ignite or explode, or possess corrosive, irritating, and highly toxic properties when exposed to external factors such as light, heat, air, moisture, or impact. For example, substances such as nitroglycerin, turpentine, sulfur, camphor, potassium permanganate, trichlorfon, and formalin solutions cannot be displayed; only their empty packaging may be shown. Prescription drugs must be sold only upon presentation of a prescription. Pharmacists must review the prescription; in cases where there are drug incompatibilities or the dosage does not meet requirements, they must refuse to dispense the medication. When necessary, the original prescribing physician must make corrections and sign the prescription, or issue a new one, before the medication can be sold. When selling OTC drugs, salesclerks should provide customers with proper medication guidance and inform them of precautions, so that the customers can use the drugs appropriately. IV. The competitive strategy for Chinese pharmaceutical companies to build national brands The internationalization of China’s pharmaceutical industry is a process by which local enterprises adapt to international standards and market rules. Survival of the fittest, elimination of the weak. In the competitive environment of economic globalization, domestic companies involved in various stages of the pharmaceutical industry value chain need to make strategic adjustments in the following areas if they wish to establish their own national brands on the world stage: 1. Thoroughly analyze the characteristics of Chinese consumers’ demands regarding pharmaceutical products, in order to identify market opportunities that not only align with the company’s development goals but also address the unmet needs of these consumers. Although the Chinese pharmaceutical market has great potential, without effective segmentation to identify the existing needs, market opportunities will remain with those competitors who are good at understanding consumers. 2. Chinese pharmaceutical enterprises need to establish a long-term development goal of “sustainable growth”. In the context of the WTO, Chinese domestic enterprises, facing established and experienced multinational companies, need to consider the long-term development of their businesses, with competition rising from a tactical level to a strategic one. The most prominent issue is determining how to position oneself within the new landscape; for example, do pharmaceutical companies need to pursue forward or backward integration? Should it act as a \"processing factory,\" making full use of its advantages in technology development and manufacturing? Do pharmaceutical intermediaries need to explore new business models? Is it through self-operated terminals, or by leveraging capital operations to achieve effective control over the terminals? The answers to these questions directly affect a company’s position in the new market landscape. 3. Chinese pharmaceutical companies particularly need the business models and marketing strategies of multinational pharmaceutical brands. The strategic re-planning in China’s pharmaceutical industry is directly related to the competitive pressure from multinational pharmaceutical companies. Only by actively participating in this process of change can one gain a favorable competitive position. Based on the current situation, multinational pharmaceutical companies, just like in other industries, dominate the high-end market in China and reap substantial profits. The financial performance of the biopharmaceutical industry, dominated by multinational pharmaceutical companies, is better than that of the traditional Chinese medicine industry; the same is true for the pharmaceutical distribution sector, which is highly sought after by multinational companies. Studying and understanding the strategies of multinational pharmaceutical companies and their changes will help domestic Chinese pharmaceutical firms determine their own strategic directions. 4. Chinese pharmaceutical companies must continuously adapt to and adopt internationally recognized industry certification standards. Compliance with industry certification standards is the only way for Chinese pharmaceutical companies to gain some degree of influence. The uniqueness of the pharmaceutical industry means that consumers cannot rely on experience or preferences when choosing pharmaceutical products; instead, they must depend on rational criteria for making decisions. Over the years, multinational companies in various industries have long begun to educate Chinese consumers regarding their purchasing decisions, and Chinese consumers have started to become accustomed to using various standards, especially international standards, when making such decisions. Therefore, learning about, adapting to, and adopting internationally recognized industry certification standards is an inevitable choice for various enterprises in China’s domestic pharmaceutical sector. In short, following China’s accession to the WTO, the Chinese pharmaceutical industry is undergoing a transformation that involves a reorganization of its structure. Some of its motivations are internal, while others are external. In the pharmaceutical industry, some participants in various links of the value chain take an active role, while others play a passive role. There is a need to expand capital, as well as pressure from global competition ; There is the appeal of the huge potential in the Chinese market, as well as the drive from **standardized industry certification regulations. Local companies in China’s pharmaceutical industry need to seize potential unmet market demand opportunities, gain a thorough understanding of their multinational competitors, and adopt international certification norms and standards in order to secure a favorable position in the new market landscape. V. Problems in China’s pharmaceutical industry 1. The issue of a large number of small, fragmented, and disorganized pharmaceutical enterprises is prominent, with a lack of large-scale leading companies. There are 3,613 pharmaceutical manufacturing enterprises nationwide, of which 423 are large-scale enterprises, accounting for only 11.7% of the total. Most enterprises lack a high degree of specialization and do not have their own brands or distinctive products. Most enterprises are not only small in scale, have poor production conditions, outdated manufacturing processes, obsolete equipment, and low management levels, but they are also scattered in location; as a result, the concentration of production among these enterprises is far below that of advanced countries. In 2000, the production concentration among the 60 largest pharmaceutical companies in our country was 35.7%, while the top 20 pharmaceutical companies in the world accounted for around 60% of the global pharmaceutical market share. 2. A technology innovation system centered on enterprises has not yet been established. The foundation for new drug innovation is weak; a mechanism for the rapid industrialization of medical technology innovations and scientific achievements has not yet been fully established. Investment in medical technology is insufficient, there is a lack of new products with independent intellectual property rights in China, product updates are slow, and duplication is widespread. 97% of chemical active pharmaceutical ingredients are “generic” products. Many old products, few new products ; There are many low-quality and low-value-added products, while high-tech and high-value-added products are few ; There are many repeatedly produced varieties and few exclusive brands. Some products, such as gentamicin, paracetamol, vitamin B1, and metronidazole, are manufactured by dozens or even hundreds of companies. Even for new products, the phenomenon of repeated production is severe; for example, 34 companies produce the new class II drug levofloxacin preparations, while 35 companies manufacture clarithromycin preparations. The pace of using high-tech to transform traditional industries is slow. Most old products have low technical and economic indicators, outdated manufacturing processes, high costs, and lack international competitiveness. 3. The pharmaceutical distribution system is not yet well-developed. After the three-tier wholesale structure that emerged under the planned economy system was largely dismantled, a new and effective pharmaceutical distribution system has yet to be fully established, and illegal drug markets continue to emerge despite repeated attempts to suppress them. Coupled with years of low-level repetitive construction in the production sector, this has led to a severe oversupply of most products, chaotic distribution patterns, and formidable challenges in addressing the situation. 4. The quality and performance of medical device products are poor. Most of the medical device products that our country can produce are conventional mid-to-low-end products with low added value, while the high-tech, sophisticated medical devices and new, practical medical equipment needed in clinical practice must be imported for the most part. Conventional medical device products have a slow rate of renewal, low levels of technological advancement, and their quality does not meet the high standards required in healthcare. The rates of product repair and downtime are higher compared to similar products abroad, and the reliability of these products is unstable. 5. The formulation variety does not match the active pharmaceutical ingredient variety. China has become a major international producer of active pharmaceutical ingredients; however, there is insufficient research and development in pharmaceutical formulation technologies. The level of formulation development remains low, and the quality of most formulated products is unsatisfactory, making it difficult for them to enter the international market ; In our country, on average, one active pharmaceutical ingredient can only be used to produce three formulations, whereas abroad, one such ingredient can be used to create more than a dozen or even dozens of formulations ; The formulation technology is backward, resulting in low stability of the product quality. 6. The import and export structure of pharmaceutical products is unreasonable. Our country has yet to break away from the traditional export pattern of chemical active pharmaceutical ingredients with low added value and high pollution, as well as conventional surgical instruments, sanitary materials, and traditional Chinese medicinal materials; it continues to import expensive formulated drugs and large-scale, high-end medical equipment, while the proportion of exports of high-tech products remains low. Insufficient efforts are made to develop international markets, information channels are inadequate, and there is a slow response to information from international markets. In particular, there is a lack of awareness and mechanisms for jointly exploring international markets. VI. Development Trends in the Pharmaceutical Industry The profound impact of pharmaceuticals on human life has resulted in high growth rates and substantial profits for this industry. China’s pharmaceutical industry began to develop at the beginning of the 20th century, progressing from nothingness to a stage where modern technologies are widely used in production. Especially since the policy of reform and opening up, the development of China’s pharmaceutical industry has accelerated; the annual growth rate of production in this sector was 17.7%, which is higher than the average annual growth rate of the national industry during the same period. It is also higher than the average growth rate of major pharmaceutical-producing countries around the world over the past 30 years, making China one of the fastest-growing pharmaceutical industries in the world today. The pharmaceutical industry in our country is gradually showing economies of scale, and it features great potential as well as healthy and rapid development. The growth rate of traditional chemical pharmaceuticals will gradually slow down, while natural (traditional Chinese medicine) and biopharmaceuticals will become the main drivers of growth in this industry. Chemical drugs, natural (traditional Chinese) drugs, and biological drugs will divide the market among themselves, forming the three major emerging markets in the pharmaceutical industry of the new century – this will be the most important characteristic of China’s pharmaceutical sector in the future. 1. Chemical drugs: The rapid development of chemical drugs in China took place during the 1970s and 1980s; it was during this period that some of the most important drugs still in use today were discovered and invented. Organic compounds remain the most important source for synthesizing drugs. The invention of advanced computerized instruments, continuous improvements in separation and analysis techniques, and especially the further development of more sensitive analytical methods will lead to an improvement in the quality of chemically synthesized drugs. Chemically synthesized drugs are evolving toward greater specificity, which not only improves their efficacy but also reduces their toxic side effects. The three-dimensional structures of enzymes, receptors, and proteins will be elucidated one by one, which lays a solid foundation for the rational design of drugs using these identified biological targets, thereby enabling the development of new chemically synthesized drugs. Chemically synthesized drugs remain the most effective, most commonly used, most widely produced, and most important therapeutic agents. It is incomplete to use catchy terms such as \"returning to nature\" and \"green consumption\" to undermine the importance and utility of chemically synthesized drugs. 2. Traditional Chinese Medicine (natural medicines) Traditional Chinese medicine is a treasure of our motherland, with a long history. Especially after the founding of the People’s Republic of China, great emphasis has been placed on its development. Recently, a large-scale survey of traditional Chinese medicine and natural medicine resources has been carried out across the country, and it has been found that there are tens of thousands of plant, animal, and mineral substances that can be used as medicines, making it one of the regions with the richest such resources in the world. Many important medicinal herbs, such as Artemisia annua, milk thistle, benzoin, American ginseng, and cloves, have been successfully introduced. At present, China is conducting research on substitutes for endangered medicinal animals; substances such as artificial musk and artificial bezoar have been successfully developed. To date, more than 200 traditional Chinese medicines and natural drugs have been subject to systematic chemical studies, including commonly used ones such as ginseng, notoginseng, rhubarb, and coptis. Pharmaceutical scientists in our country have developed as many as 32 monomeric compounds from traditional Chinese medicines and natural drugs, such as reserpine, paclitaxel, and artemisinin. In recent years, new compound drugs based on traditional Chinese and natural medicines have seen rapid growth. 3. Biopharmaceuticals Biotechnology is one of the fastest-growing high-tech fields worldwide. Currently, various emerging biotechnologies are widely applied in medicine, agriculture, bioprocessing, resource development and utilization, and environmental protection, and have had a profound impact on the development of industries such as pharmaceuticals. What we often refer to these days is modern biotechnology, which includes genetic engineering, cell engineering, and enzyme engineering, among which genetic engineering is the core technology. Since biotechnology will open up broad prospects for addressing major challenges facing humanity such as food, health, the environment, and energy, it is classified as a high-tech field alongside computer microelectronics, new materials, new energy sources, and aerospace technology, and is considered to be at the core of science and technology in the 21st century. The most active area of application for biotechnology at present is the pharmaceutical industry, with biopharmaceuticals (often referring to genetically engineered drugs) regarded by investors as one of the industries with the highest potential for growth. The development of biopharmaceuticals has given rise to an unprecedentedly fierce competition in the 21st century. China’s gene engineering pharmaceutical industry began in the late 1980s. The industrialization of interferon α-1b, China’s first genetically engineered drug with independent intellectual property rights, in the Shenzhen Science and Technology Park in 1989 marked the start of significant development in the industrial production of gene-based drugs in the country. The development of gene drugs in our country has roughly gone through two stages: In the first stage, it was characterized by enterprises and institutions led by **biotechnology development centers**, scientific committees, and six major **level biopharmaceutical research institutes**, with projects focusing on hepatitis and vaccine-related products ; Phase 2: A stage of rapid development for both enterprises and institutions. During this period, many organizations were involved; **macro-control was ineffective, there was severe duplication of biological projects, and China was able to produce the major biological gene drugs that were previously available only abroad. According to incomplete statistics, more than a dozen of the world’s best-selling gene-based drugs can be produced in China, such as interferon (IFN), recombinant human growth hormone (rhGH), erythropoietin (EPO), and colony-stimulating factors (CSF). In June 2000, with the release of the draft human genome, countries around the world began to invest heavily in research on gene sequences and gene functions. China, just like developed countries, was about to enter an era of rapid development in biogenetic drugs. VII. Trends in the International Pharmaceutical Industry 1. High medical costs Due to an increasing population, an aging population, and higher expectations regarding health, the expenditure on medical care as a percentage of GDP is quite high in various countries. This is especially true in developed countries: 13.6% in the United States, 6.8% in the United Kingdom, 7.2% in Japan, 10.7% in Germany, and 2% in China. 2. High difficulty in developing new drugs The pharmaceutical industry is a high-tech industry characterized by high costs, long development cycles, high risks, and high returns – traits that are more pronounced in this industry than in others. From preclinical trials of new drugs to FDA approval, it takes an average of 12 years for each drug ; In terms of cost, it generally ranges from 250 million to 350 million dollars; such a large investment will take several years to yield a return. The success rate of the chemical compounds studied in reaching the market is extremely low, with an average probability of 1/10,000 to 1/5,000. Moreover, the average effective patent period for newly launched drugs is 5 to 7 years; if all investments cannot be recovered before the patent expires, the new drug will quickly lose its market share due to legitimate imitation by other companies once the patent expires. Therefore, the risks associated with new drug development are increasing. 3. A promising market for natural medicines As people have long been concerned about the toxic side effects of chemical drugs, and since chemically synthesized drugs prove ineffective in dealing with some of the world’s most difficult medical conditions, pharmaceutical companies around the world are turning to natural plants in an attempt to extract new drugs from them; moreover, the development costs are much lower compared to those of purely chemically synthesized drugs. The natural medicine market in the United States is growing at a rate of over 20% per year, while Japanese herbal preparations are also growing at a rate of 15%. Currently, research materials have evolved from animals and plants to insects and microorganisms. 4. The protection of pharmaceutical intellectual property is becoming globalized. Strengthening the protection of pharmaceutical intellectual property is a key measure and approach to ensuring the market success of innovative drugs. Therefore, major pharmaceutical companies attach great importance to protecting the intellectual property rights of the products they develop. The protection of these drugs is not limited to domestic markets; applications are also filed on a global scale in order to gain a foothold in the international market once the products are launched. Both developed and developing countries are stepping up efforts to protect the intellectual property rights of their own products. 5. The characteristics of global operations in the pharmaceutical industry are becoming increasingly evident. (1) Pharmaceutical companies are constantly merging and forming strategic alliances. Unlike in the past, mergers among pharmaceutical companies now take place between large firms that all possess strong capabilities. For example, the Swedish pharmaceutical company Pharmacia merged with the American company Upjohn on equal terms; similarly, Pfizer/Warner-Lambert and Pharmacia-Upjohn/Monsanto also merged. At the beginning of 2000, the two major British pharmaceutical companies, GlaxoSmithKline and Schering-Plough, announced their merger, forming the world’s largest pharmaceutical group, which would control around 7.5% of the global market. According to reports, the American company Johnson & Johnson plans to acquire Alza for $12 billion. Forming strong alliances is a key strategy for pharmaceutical companies to compete in today’s market. (2) A new landscape of cooperation is emerging. Currently, the world’s major pharmaceutical companies are expanding the scope of their collaborations through various means, so as to ensure that their products can hold a stronger position in the market. A notable feature is the cooperation with developing countries – taking advantage of their rich pharmaceutical resources and low labor costs, combined with one’s own research and development capabilities, to establish factories in those countries. This not only helps reduce costs but also enables access to markets in developing countries. The establishment of such cooperative relationships will not only help developed pharmaceutical companies maintain and expand their market share, but also enable developing countries to develop their own domestic pharmaceutical industries. 6. Widespread use of high-tech technologies With continuous innovation in science and technology, certain high-tech technologies are being used more and more often in the process of drug development. High-throughput rapid screening technologies and modern biotechnology will be widely applied. The Human Genome Project, the discovery of functional genes, and the development of bioinformatics have brought tremendous potential for drug discovery to the pharmaceutical industry. The rapid growth of a number of biopharmaceutical companies has made them an important force in the world’s pharmaceutical industry.