he development of Chinese medicine: a hundred years of magnificent history, a unique world to change the world
A hundred years of vicissitudes, ups and downs.
One hundred years may be just a fleeting moment in the vast history, but the hundred years since the founding of the Communist Party of China have witnessed the vicissitudes of China in a hundred years, led the great changes of the Chinese nation in a hundred years, and achieved the glory of a century in Chinese history.
In all walks of life, hundreds of boats are competing for success, and they are in full bloom.
China's pharmaceutical industry is no exception, and has undergone earth-shaking changes in the past.
Let us touch the pulse of the era of innovation and change in China's pharmaceutical industry, and perceive the past, present and future of China's pharmaceutical industry.
1. The chaos is not divided, and the cracks are for survival
Like most national industries and commerce, China's pharmaceutical industry also sprouted in the absurd and humiliating but turbulent era of the late Qing Dynasty and the early Republic of China.
Since the Opium War opened the door of China, foreign capital and commodities have been driven straight in.
British merchants Lao Tak Kee and Watsons Pharmacy are blooming everywhere, almost sweeping the capital cities of China.
Western pharmacies are all making a lot of money, and the Japanese "Ren Dan" can almost be described as flooding.
The power of the "Treaty of Shimonoseki" allowed foreign businessmen to obtain the privilege of opening factories in China, and foreign businessmen took the opportunity to expand the former western pharmacy into a pharmaceutical factory.
The "Shidezhi Pharmaceutical Factory" opened in 1900 was the first foreign pharmaceutical factory since the late Qing Dynasty.
If it is profitable, there will naturally be stories of unwillingness to be left behind.
In response to the government's call to "learn skills from barbarians to control barbarians", many national capitalists invested in building factories.
In 1912, Huang Chujiu founded Longhu Company, Shanghai's first western medicine factory with national capital, on Hankou Road, specializing in the production and sales of "Dragon and Tiger Pill".
The advertisement of Longhu Rendan, "You must be prepared for travel, you must be prepared for home, the king of first aid, and the treasure of helping the world" is overwhelming, which can be said to be the first of its kind for pharmaceutical companies.
The counterfeit version of "Rendan" once became a symbol of domestic products, and the Japanese businessmen were even so annoyed that they sued the Western medicine company Longhu for trademark infringement.
In this age of humiliation, providing for one's family is the sole purpose of the struggle for survival.
Painkillers from foreign companies, when they land in China, they become Zhitongsan, Antongdan, Huishengfang...; the same oil is even more varied, such as Panacea Oil, Ruyi Oil, Zizi Oil, Cross Oil, Baicao Oil, Baoxin Oil, and Wind-dispelling Oil …
If one name doesn’t work, change to another name and continue to sell it. Everything remains the same, as long as it can make money.
At this time, drug dealers and pharmaceutical factories, as long as they are alive, are more important than anything else.
Talking about ambition and helping the world for the people seems a little pale and powerless.
2. Survival in a crisis, stand up for morality
When the nation is in crisis, some people bow their heads, some people live in peace, some people stay away from right and wrong, and of course some people sacrifice their lives to face national disasters. The medical field is no exception.
The rise of the May Fourth Movement awakened the sleeping lion.
"Boycott Japanese products and advocate domestic products" resounded through the sky. Qin Runqing, then chairman of the Shanghai Money Industry Association, put forward the important proposition that "business should also be patriotic".
On the one hand, the national pharmaceutical industry smelled the opportunity for business boom, and on the other hand, it was inspired by patriotic ideas.
Xiang Songmao of Wuzhou Pharmacy Co., Ltd. shouted angrily: "Sell foreign products, but pick up the rest of the soup. We must make new medicines to compete with them."
In 1921, Wuzhou Guben Soap Factory was formally established. By 1931, Wuzhou Pharmacy had 17 branches and 55 joint ventures, with more than 100 kinds of products worth nearly 10 million yuan, becoming the largest pharmaceutical company in China at that time.
Early site of Wuzhou Pharmacy
Image source: Shanghai Nianhua
Like Wuzhou, the national pharmaceutical companies at this time all have the ideal of "saving the country through industry", and they are not afraid of power and march forward.
After 1920, pharmaceutical factories in Shanghai, Guangzhou and other big cities sprung up like mushrooms, and a large number of national enterprises with market competitiveness emerged, such as Wuzhou, Zhongfa and Xinya Pharmaceutical Factory in Shanghai, He Jigong and Huang Baoshan Pharmaceutical Factory in Guangzhou, and Tianjin Pharmaceutical Factory. Zhongxi, Weidimin Pharmaceutical Factory, etc.
In 1924, there were only 93 ethnic pharmaceutical factories founded by Chinese people. By 1936, the number had grown to more than 300 in major provincial capitals.
Shooting the head bird, Xiang Songmao's life is like bright fireworks, frozen in the moment of blooming. Unfortunately, he was captured by the Japanese army. However, he denounced the enemy chieftain and died for his country with awe-inspiring righteousness.
Mr. Xiang wrote with his life that "it is better to live with few desires to support one's life, but to live up to one's life on major festivals; to run a family within one's means, and to treat one's righteousness as a thousand dollars", which inspires entrepreneurs to go forward and succeed.
At the time of saving the nation, the national pharmaceutical company is like a copper pea that cannot be steamed, cooked, pounded, fried, or cracked, and it only needs a drop of rain and dew to break through the ground.
3. Among the mountains, there are ups and downs
There has never been an industry that is always smooth sailing. Only after going through ups and downs and standing still can it show its true qualities as a hero. The backbone of the pharmaceutical industry is not in vain.
In 1937, the Japanese invaders set foot on the land of China, and the flames of war broke out.
The Japanese army's three-all policy of "killing, robbing, and burning" almost swept away the industries and commerce of all major nationalities.
During the war years, medicines were most in short supply. The importance of the pharmaceutical industry is self-evident, and the Japanese army will naturally not let go of the nascent national pharmaceutical industry.
At the beginning of the outbreak of the Anti-Japanese War, the artillery fire of the Japanese army almost shattered the entire national pharmaceutical industry.
Wild fire, in spring.
With the help of the Chinese Communist Party and the patriotic united front, the pharmaceutical industry has gone deep into the hinterland or survived in foreign concessions.
The skyrocketing price of medicines has naturally attracted speculative capital from all walks of life in order to hoard them for profit.
With the help of capital, the pharmaceutical industry quickly recovered. Some well-equipped pharmaceutical factories began to research and produce chemical raw materials, such as glucose for injection and various sulfonamide antibiotics.
On August 15, 1945, Japan announced its unconditional surrender. The soul-stirring eight-year war of resistance finally brought peace and tranquility.
The vigorous song of "Returning Hometown in Triumph" resounded all over the land of China.
All walks of life have put in all their strength, and they are about to do a big job to ease the grievances of eight years.
However, for the national pharmaceutical industry, a bigger test is still to come.
The Pacific War ended hastily due to Japan's rapid defeat. The military medicines hoarded by the allies headed by the United States are useless and have to be piled up in major ports in the Far East.
The exquisite self-interest of capitalism is aimed at China, which is waiting to be rebuilt.
A large number of remaining military drugs flooded into the Chinese pharmaceutical market, and domestic bureaucratic capital also took the opportunity to fan the flames and vigorously advocated the import of Western medicine. At one time, 80% of the medicines on the market were imported products.
To describe it in today's words, this is blatant dumping.
However, China at that time was incapable of anti-dumping.
National pharmaceutical companies unable to compete rapidly declined and closed down one after another. More than 70% of the national pharmaceutical companies have been delisted, and there are less than 200 pharmaceutical factories left, and the survivors can only be in a semi-standstill state.
The Chinese pharmaceutical industry, which survived the War of Resistance, was severely dumped by the Allied Forces.
At this time, the medical industry realizes that living to death can be more tenacious. Even though the road ahead is full of difficulties and obstacles, a real fighter is one who has the confidence to get out of the trough and the courage to move forward without fear.
4. Self-reliance and self-sufficiency
In 1949, New China was established, mountains and rivers were rebuilt, and national industry hit the upper reaches of the water, and the waves suppressed flying boats, but they encountered the blockade of Western imperialism.
The biggest "achievement" of the Western imperialist blockade and embargo policy is to force New China to establish a complete, systematic, comprehensive and independent industrial system.
This is one of the important roots of the formation of the independent, self-reliant, self-sufficient industrial system and economic development strategy of New China. It is against this background that China's pharmaceutical industry officially started again.
After the ravages of war and the dumping of the Allied forces, the lack of medical care and medicine is a true portrayal of the founding of New China.
Raw material shortage, backward technology, outdated equipment, weak foundation...
At this time in New China, medicines were more expensive than gold, and medicines were hard to find. There was a folklore: gold has a price but medicine is priceless.
Our great leader Chairman Mao said back then, "Block it, block it for ten or eight years, and all problems in China will be solved."
It is under this wise and confident judgment that China's pharmaceutical industry has launched a national plan.
In 1950, the National Pharmaceutical Industry Professional Conference established the policy: "The development of raw materials is the mainstay, supplemented by preparations", and the research and development of antibiotics, sulfonamides and other epidemic drugs will be the focus.
"Self-reliance and hard work" has always been the glorious tradition of the Communist Party. Relying on the transformation of enemy counterfeit pharmaceutical factories and dilapidated factories, more than 90 kinds of main chemical raw materials were produced in just three years of economic recovery, with an annual output of 99 tons.
The story we are familiar with: Shanghai Pharmaceutical Factory’s auto repair workshop produced the first batch of crystalline penicillin; Northeast Pharmaceuticals, the cradle of the chemical pharmaceutical industry, produced a batch of rodenticides, insecticides and drinking water disinfectants such as Liuliu and Qingshuilong… Later, pharmaceutical people set up one monument after another.
The development of Chinese medicine: a century-old history of turmoil, a unique world to change the world (Figure 2)
1958 Vitamin C production line
Source: E drug manager
In 1953, with the start of the "First Five-Year Plan", the focus of the construction of the pharmaceutical industry shifted to antibiotics, chemically synthesized specific drugs and related chemical intermediates.
The North China Pharmaceutical Factory, once the largest antibiotic production plant in Asia, was completed and put into operation, completely ending the history of our country's dependence on imports of penicillin and streptomycin.
The development of Chinese medicine: A hundred years of magnificent history, a world of change (Figure 3)
Early North China pharmaceutical factory site
Source: Fenghuang Hebei-City Memory Special Page
Penicillin, which used to be more expensive than gold, has been reduced to only a few cents a bottle.
The large-scale production of antibiotics has made many diseases disappear in China, such as pneumonia, meningitis, and tuberculosis.
As a result, many Chinese believe that diseases can be cured fundamentally, and the average life expectancy in China has also been greatly increased. The "curse" of premature death in backward areas is gone forever.
In 1964, my country piloted a pharmaceutical industry trust to implement unified management, unified accounting, and unified distribution of personnel, finance, and materials. The profits of the national pharmaceutical industry were uniformly handed over to the national treasury by the trust.
The development of Chinese medicine: a century-old history of turmoil and turmoil, a unique world to change the world (Figure 4)
during the pilot pharmaceutical trust
Source: Xinhua News Agency
In addition, with the successive promulgation of laws and regulations such as "Administrative Measures for the Manufacturing of Pharmaceutical Devices" and "Regulations on the Administration of Finished Medicines", the quality of medicines has been guaranteed, and the production, output value and profits of medicines have doubled.
Under the national planning system, the main varieties of antibiotics, sulfonamides, and endemic drugs are basically self-sufficient, getting rid of the backward situation of relying on imports of raw materials.
Under the unified leadership of the Party Central Committee, the departments of medicine, health and health commissions and other departments in various regions have flexed their muscles and adhered to the policy of facing the countryside and the people. The expensive medicines in the past have developed into common medicines for urban and rural medical care.
In 1967, the total output value of China's pharmaceutical industry reached 7.2 billion yuan, and the output of six major chemical drugs exceeded 13,000 tons.
Struggling for the liberation and happiness of the people has always been the original aspiration of the Communist Party of China, and it has always been the mission of the Communist Party of China to put people's health in a priority development strategy.
The pharmaceutical industry has gone from decline to prosperity, from small workshops to a complete system, and from lack of doctors and medicines to meeting the needs of basic medicines. This is the great practice of China's pharmaceutical industry gradually becoming independent.
5. The story of spring, the introduction of Western learning to the East
"The spring thunder awakens the inside and outside of the Great Wall, and the spring light warms both sides of the river." The story of spring quickly resounds from the small border of the South China Sea to the land of China. "Emancipate the mind and seek truth from facts", the chief designer re-steered the Chinese giant with the wisdom and calmness that has gone through thousands of years. China is at a crossroads, and so is China's pharmaceutical industry.
Ten years of turmoil caused the pharmaceutical industry, which was on the right track, to encounter Waterloo again. Pharmaceutical factories were set up indiscriminately, drugs were produced indiscriminately, and shoddy manufacturing... Chaos arose and development stagnated.
Maybe there will always be troubles and opportunities in the growth of any industry. The long wait of ten years finally ushered in a turning point.
In 1978, the Third Plenary Session of the Eleventh Central Committee of the Party sounded the clarion call for reform and opening up.
The development of Chinese medicine: a century-old history of turmoil and turmoil, a unique world to change the world (Figure 5)
Old Objects of Reform and Opening Up Exhibited in the National Museum
Source: Xinhua News Agency
The establishment of the State Administration of Medicine has realized the unified management of the pharmaceutical industry in the true sense.
The successive release of various relevant policies has brought about great changes in the appearance of my country's pharmaceutical production.
How to deal with the relationship between "reform" and "opening up", and how to deal with the relationship between "bringing in" and "going out" has become the first important proposition of the State Administration of Medicine.
For these two groups of relationships, both hands must be grasped and both hands must be hard.
Lin Dong, director of the Foreign Affairs Bureau of the State Administration of Medicine at the time, set his sights on Japan, which has a deep relationship with China and a willingness to cooperate and win-win.
The signing of the "Sino-Japanese Friendship Treaty" and the promulgation of the "Sino-Foreign Joint Venture Law" greatly accelerated the process of negotiation and cooperation.
In 1980, Lin Dong and Otsuka Akihiko signed three documents respectively on behalf of China and Japan, the "Contract for the Joint Venture of China Otsuka Pharmaceutical Co., Ltd.", the "Technical Cooperation Contract" and the "Articles of Association of China Otsuka Pharmaceutical Co., Ltd."
China Pharmaceutical Industry Corporation and Otsuka Pharmaceutical Co., Ltd. of Japan invested in the establishment of a joint venture company - China Otsuka Pharmaceutical Co., Ltd., and the first joint venture pharmaceutical company in New China was born.
The development of Chinese medicine: a century-old history of turmoil and turmoil, a unique world to change the world (Figure 6)
China Otsuka Pharmaceutical Ribbon Cutting Ceremony
Source: E drug manager
A flower blooming alone is not spring, but a hundred flowers blooming together makes the garden full of spring. Under the guidance of emancipating the mind, China's pharmaceutical industry ushered in the story of spring, the grass grows and the warblers fly.
In 1981, China National Pharmaceutical Foreign Trade Corporation was established, establishing an international exchange platform;
In 1982, Sino-US Shanghai Bristol-Myers Squibb Pharmaceutical Co., Ltd. was jointly established by the US Bristol-Myers Squibb Company, China National Pharmaceutical Foreign Trade Corporation and Shanghai Pharmaceutical Industry Corporation, becoming the first Sino-US joint venture pharmaceutical company and the first to pass FDA certification;
Since then, joint ventures have sprung up. From 1982 to 1995, more than half of the top 50 pharmaceutical companies in the world have set foot on the land of China. Xi’an Janssen Pharmaceuticals, Chongqing GlaxoSmithKline Pharmaceuticals, Dalian Pfizer Pharmaceuticals...
Through introduction, digestion and absorption, the national pharmaceutical industry has made considerable progress in technology, variety, dosage form, quality and scale. In addition, the GMP promotion process has been accelerated, new business concepts have been popularized, and the industrial scale has basically doubled every five years. The old look of the industry has changed.
Chinese medicine needs the world, and world medicine also needs China.
In 1983, the "vitamin C two-step fermentation production process" independently developed by the Institute of Microbiology, Chinese Academy of Sciences and Beijing Pharmaceutical Factory was transferred to Roche, Switzerland at a price of 5.5 million US dollars, achieving a "zero" breakthrough in technology export.
The first one with epoch-making significance and becoming a global blockbuster product is artemisinin.
In October 1981, at the International Artemisinin Conference sponsored by the World Health Organization and others held in Beijing, Tu Youyou made a report on "Chemical Research on Artemisinin" as the chief spokesperson, which was highly praised. The discovery of artemisinin not only adds a new antimalarial drug, but more importantly, it lies in the discovery of the unique chemical structure of this new compound, which will point out the direction for the synthesis and design of new drugs.”
In 1992, in view of the high cost of artemisinin and the difficulty of curing malaria, Professor Tu Youyou's team invented dihydroartemisinin, an "upgraded version" with 10 times the antimalarial efficacy of the former.
This is hailed as the "nemesis" of drug-resistant malaria by the international medical community. It is a drug that my country has independent intellectual property rights and is truly going global.
In October 2015, the Swedish Karolinska Institutet announced in Stockholm that Tu Youyou, a Chinese female pharmacist and chief researcher of the Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, won the 2015 Nobel Prize in Physiology or Medicine.
The spring breeze of reform revives vitality, and the open door stimulates innovation. By 1995, the national output of chemical raw materials had reached 330,000 tons, and bulk chemicals such as antibiotics and vitamins had become the main force in the international market supply, and China's modern pharmaceutical industry finally occupied a place in the world.
6. Crossing the river by feeling the stones and deepening the reform
At the beginning of the reform and opening up, Deng Xiaoping, the great chief architect of our reform and opening up, said: "The business we are doing now is a new business. Marx did not talk about it, our predecessors did not do it, and other socialist countries did not do it. Therefore, there is no ready-made experience to learn from, we can only learn by doing and explore in practice."
If you see what you are sure about, you should boldly try and make bold breakthroughs. This is the case for rural reforms and urban reforms, and the development of China's pharmaceutical industry should also be the same.
In 1983, Huabei Pharmaceutical Factory, as the first pilot unit in Hebei, took the lead in promoting the factory director responsibility system, setting a precedent in the industry.
In 1986, the Northeast Pharmaceutical Enterprise Group, with the Northeast Pharmaceutical General Factory as the leader, established a horizontal economic alliance, which was established in Shenyang as the first enterprise group in my country's pharmaceutical industry.
In 1987, Chongqing Traditional Chinese Medicine Co., Ltd. was established, becoming the first joint-stock enterprise in my country's pharmaceutical industry.
Since then, a large number of enterprise groups such as Xinhua Pharmaceutical, Guangzhou Baiyunshan, North China Pharmaceutical, and Shanghai Pharmaceutical have been established one after another, setting off a wave of "union, merger and reorganization".
At the end of the 1980s, the development of the pharmaceutical industry was unrivaled. It can be seen from the football teams undertaken by pharmaceutical companies. Clubs such as Dongyao Club, Guangzhou Baiyunshan, Guangzhou Sun God, Jilin Yatai and other clubs became popular all over the country. Pharmaceutical companies can be seen in almost all major sports events.
In 1992, Comrade Deng Xiaoping made a speech on the southern tour, and the 18 aphorisms for governing the country pushed the reform, opening up and modernization to a new stage, and the joint-stock reform of the pharmaceutical industry thus entered the fast track of rapid development.
In 1993, Harbin Pharmaceutical Group took the lead in completing the joint-stock reform and listed on the Shanghai Stock Exchange, becoming the first listed company in the national pharmaceutical industry.
The development of Chinese medicine: a century-old history of turmoil and turmoil, a unique world to change the world (Figure 7)
Harbin Pharmaceutical Group Office Building
Source: China Economic Weekly
In the initial stage of the establishment of the market economy, a large number of pharmaceutical companies seized the opportunity to enter the capital market, and the forward-looking layout won the opportunity for enterprises, such as Guangzhou Baiyunshan, Shandong Lukang, China Resources Double Crane, Humanwell Pharmaceutical, Tonghua Jinma...
At the same time, the rules and regulations of "no pharmaceutical factories below the county level" and "pharmaceutical factories can only be run by the state" were broken, and a large number of private enterprises such as Hengrui, Fosun, and Huahai came into being and developed rapidly.
In 1995, the total output value of my country's pharmaceutical industry exceeded 100 billion yuan, and there were 3,257 pharmaceutical enterprises, including 177 large-scale enterprises, and 14 enterprises were listed companies. The average annual growth rate of the pharmaceutical industry has reached 17.5%. Compared with 1978, the total output value has nearly quadrupled, doubling in an average of 4.2 years, becoming one of the fastest-growing industrial sectors in the national economy.
With the help of the spring breeze of reform, the reform dividend will be released. With reform, reorganization, and restructuring, the enthusiasm and vitality of enterprises have been greatly improved, and the Chinese pharmaceutical industry has finally ushered in a qualitative change from a quantitative change, and has completed its own difficult and brilliant remodeling.
7. Strengthen management and improve the legal system
"There is no rule without rules, and it is difficult to correct the six rhythms without the five tones." In the new era of reform and opening up, the construction of the legal system has been put on a new agenda, and the medical field is no exception.
In the early days of reform and opening up, problems left over from history were combined with the unhealthy trend fueled by the open policy. Drug factories were set up indiscriminately, drugs were manufactured and sold illegally, counterfeit and shoddy drugs were received, and kickbacks were accepted.
In 1978, the State Administration of Medicine was formally established, ending the situation of "headless" and "multiple" supervision of medicine.
In 1979, the State Council approved and forwarded the "Report on the Rectification of Pharmaceutical Factory Work in the Nation" by eight ministries and commissions including the Ministry of Health, and carried out a comprehensive rectification of pharmaceutical production units across the country from top to bottom.
In 1984, the first "Drug Administration Law" was promulgated and officially implemented in July 1985.
In addition, since the first edition of "Chinese Pharmacopoeia" was published in 1953, several editions have been revised successively. In 1985, the Ministry of Health expanded the Pharmacopoeia Committee to clarify the guiding ideology and principle requirements for compiling the Pharmacopoeia.
Since then, the State Council and the Ministry of Health have successively formulated and promulgated more than 20 drug management measures, including the first "Good Manufacturing Practice for Drugs".
The prototype of the first system of drug management in my country has emerged, stepping out of the era of "no law to follow" in the pharmaceutical industry.
In 1991, the State Administration of Medicine established the "GMP Implementation Committee" to carry out GMP compliance.
In 1994, the Ministry of Health established the "China Drug Certification Committee" to carry out "GMP certification". GMP certification is a mandatory requirement for pharmaceutical companies.
In the same year, the licensed pharmacist qualification system came into effect, stipulating that all enterprises engaged in drug production and business activities must have personnel with corresponding licensed pharmacist qualifications in their key positions.
On the basis of the improvement of laws and regulations, the drug inspection institutions have been gradually improved and the supervision network has been fully covered. By 1994, my country had 1,600 drug administration agencies, 1,953 drug inspection institutes, and 11,200 drug supervisors. Large-scale national drug supervision and assurance system.
During the transition period of the disintegration of the planned economy and the rise of the market economy, the pharmaceutical industry is also undergoing transformation from absolute monopoly to relative competition and disorderly competition, with unprecedented speed and geometric growth in revenue. The construction of the rule of law is an important guarantee for a smooth transition.
8. The chaos of approval documents makes it difficult to see a doctor
Haste makes waste, everything cannot be accomplished overnight. The rapid economic and social development has naturally brought about the challenges of accompanying effects. As a high value-added industry, the pharmaceutical industry is the epitome of the accompanying effect of rapid development since the reform and opening up.
At the end of the 1990s, the only channel for ordinary people to prescribe and buy medicines was public hospitals, followed by a unique group of "medical representatives", whose goal was "income is king".
Selling with gold has become the consensus of the industry, but the drug prices are inflated, and it is the patients who pay the bill, and the common people suffer unspeakably.
About 60% of the income of public hospitals across the country comes from the price difference between purchase and sale of medicines, and the problem of "supporting doctors with medicines" has not been resolved for a long time.
If you mess around, great rule will come.
In 1998, the State Council merged the original drug regulatory functions of the State Administration of Medicine, the State Administration of Traditional Chinese Medicine and the Pharmaceutical Administration Bureau of the Ministry of Health, and reorganized the State Drug Administration.
At the age of 54, Zheng Xiaoyu took office as the first director.
The drug access certificate and GMP certification are the weights that Director Zheng grasps with both hands.
The original intention of using the power of approval to regulate drug access and ensure the quality of drugs is good, and the path is also clear.
However, absolute power without regulation can easily breed corruption, and the entire regulatory system can easily be dragged into the quagmire of crazy power rent-seeking.
During the three years from 1999 to 2002, only more than 1,000 enterprises passed the GMP certification. However, in 2003, 5,000 companies passed the certification, and in 2004, before the deadline set by Director Zheng, 6,000 pharmaceutical companies passed the certification threshold.
The approval of new drugs is even more crazy. During the period when Director Zheng monopolized power, the State Food and Drug Administration accepted 10,009 "new drug" applications in 2004 alone, while the US Food and Drug Administration only accepted 148 applications in the same period. In 2005, the Food and Drug Administration approved 11,086 applications for drug registration, 80% of which were generic drugs.
New drug approval and GMP certification are useless, and the resulting approval transactions cast a huge shadow over the entire pharmaceutical system, so that people talk about "imitation".
The pharmaceutical market is full of chaos, fake and inferior drugs are rampant, and it is difficult and expensive to see a doctor, which has reached an unprecedented level since the founding of the People's Republic of China.
What ignited this chaos was the Leucin A injection incident of Qiqihar Second Pharmaceutical Co., Ltd.
At the end of 2006, Premier Wen called for a thorough investigation of the violations of laws and disciplines of the Zheng Group.
In 2007, Director Zheng was executed, and relevant persons were severely punished. Since then, the "wide-entry" management has come to an end
The deepening reform of Chinese medicine has been put on the agenda, and a narrow door has been erected above the rushing torrent.
Facts have shown that if the cage of the system is not tightened, as long as the door is slightly opened, it is easy for people to try their best to take advantage of loopholes. Only strict supervision and investigation can cut off the chain of interests.
Nine, cut off circulation, quality first
"The people are supreme, life is supreme, and we will do our best to ensure the quality and safety of medicines." This is the solemn promise of the party and the state to the people.
Several years after Director Zheng resigned, medical reform was the core of the policy, focusing on solving the problems of expensive medical treatment and subsisting on medicines, stabilizing and protecting the medical insurance fund, focusing on both industries and hospitals, and formulating many policies.
During this period, the circulation industry was staggering forward. In the rhythm of strong state-owned enterprises’ continuous deployment, hospital pharmacies began to be entrusted, and they were beaten “small, scattered, and chaotic” every now and then. They each looked for more living space, but they still did not get rid of the extensive and chaotic inertia.
Standing in the spotlight again, originating from the southeast.
In May 2010, Fujian Province officially implemented the two-invoice system starting from the seventh standard of basic medicines; in February 2012, Sanming medical reform started; after achieving results, it was introduced to the whole country by the former National Health and Family Planning Commission in October 2014 as a model.
The two-invoice system was first selected and implemented as a breakthrough in medical reform.
The "misfortunes never come singly" is that in 2013, GlaxoSmithKline (China) was "suspected of serious commercial bribery and tax-related crimes" by the Ministry of Public Security, and in 2016 the Shandong vaccine case broke out.
The chaos in the distribution of medicines has brought about sharp pains. The country took the courage to "scrape the bone to cure the poison" and learned from the painful experience.
In April 2016, the state issued the "Key Tasks for Deepening the Reform of the Medical and Health System in 2016", requiring eight provinces to pilot the two-invoice system policy in the field of medical circulation.
In May 2016, the former State Food and Drug Administration issued the "Announcement on Rectifying Illegal Operations in the Field of Drug Circulation (2016 No. 94)", commonly known as the most stringent "Ten Circulation Articles" in history.
In January 2017, the National Health and Family Planning Commission issued the "Implementation Opinions on Implementing the "Two-Invoice System" in Drug Procurement in Public Medical Institutions (Trial Implementation)", announcing the beginning of the nationwide "Two-Invoice System".
In addition, policy combinations such as the linkage of the three medicines, the cancellation of bonuses, and the proportion of medicines followed closely behind.
In the field of quality supervision and assurance, until 2008, the market share of generic drugs in my country was as high as 98%. Suffering from the situation of various types of generic drugs and uneven quality, the country made up its mind to redeploy, and the curtain of consistency evaluation officially opened.
In 2012, the State Council promulgated the "National Drug Safety 12th Five-Year Plan", which clearly proposed for the first time to carry out quality consistency evaluation of generic drugs.
In 2016, the State Food and Drug Administration implemented the "Opinions on Consistency Evaluation of the Quality and Efficacy of Generic Drugs" issued by the General Office of the State Council, and designated 289 basic drug varieties to complete the consistency evaluation by the end of 2018.
In November 2018, the fifth meeting of the Central Committee for Comprehensively Deepening Reform reviewed and approved the "Pilot Plan for Centralized Drug Procurement Organized by the State". On November 15, the Joint Purchasing Office composed of delegated representatives from the 11 pilot regions issued the "Centralized Drug Procurement Document in 4+7 Cities".
Since then, the most difficult, time-consuming, and significant generic drug consistency evaluation + mass purchase has swept the country.
Avoiding diseases and avoiding medical treatment will only nourish the legacy of carbuncle, which will be hard to return. Take out the courage to scrape the bone to treat poison, find the focus of the disease, prescribe the right medicine, and perform the operation well, in order to remove putrefaction, promote muscle growth, strengthen tendons and bones. The elastic index has been ten years, and the curve of reincarnation is a spiral, which is almost ancient for a person, but as far as the Chinese pharmaceutical industry is concerned, it has just begun "the devil's weight loss training", and the goal of "slimming" is a lean and strong trunk.
10. Driven by innovation, the dream of a strong country
General Secretary Xi Jinping pointed out that "the Chinese people are striving to realize the Chinese dream of the great rejuvenation of the Chinese nation. To realize the Chinese dream of the great rejuvenation of the Chinese nation is to realize the prosperity of the country, the rejuvenation of the nation, and the happiness of the people." We will strive hard to become a world-class pharmaceutical company and develop into a "medical power".
In 2008, the "National Major New Drug Creation" science and technology special project was launched, with unprecedented funding intensity and wide coverage.
Driven by the special project for new drug creation, the development of innovative drugs has entered the "fast lane". Chemical drugs and biological drugs have been followed up to partially catch up.
A large number of powerful innovative pharmaceutical companies have risen, Hengrui, Qilu, Hansoh, Betta, Innovent, Junshi, BeiGene...
The development of Chinese medicine: a century-old history of turmoil and turmoil, a unique world to change the world (Figure 8)
BeiGene goes public in Hong Kong
Source: BeiGene official website
Innovative drugs have been launched one after another with remarkable achievements, such as Icotinib, Conbercept, Chidamide, Apatinib, EV71 HFMD Vaccine, Ebola Vaccine, Benaglutide Injection, Malic Acid Ninofloxacin, Antofloxacin Hydrochloride, Anlotinib…
The launch of these blockbuster drugs not only fills the gap in domestic innovative drugs, but also makes an outstanding contribution to the realization of import substitution and alleviating the difficulty and cost of medical treatment.
The development of new formats in the pharmaceutical industry also promotes the rapid development of contract research and development (CRO), contract manufacturing (CMO), contract research and development and production (CDMO), etc., to achieve efficient resource utilization and value sharing.
On the other hand, the long-standing problems of "many" drug registration applications and "slow" review have become stumbling blocks for the development of innovative drugs.
At the beginning of taking the helm, Director Bi Jingquan, who was later affectionately called "Grandpa Bi" by the medical community, showed the determination to "destroy the old and establish the new", committed to "solving many difficult problems that have been wanted to be solved for a long time but have not been solved, and many things that were wanted to be done in the past but were not solved. Great job done."
In August 2015, the State Council's "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" was promulgated, and a new round of drug review and approval reform in my country kicked off.
In February 2016, the State Food and Drug Administration issued the "Opinions on Implementing Priority Review and Approval for Solving the Backlog of Drug Registration Applications", on the one hand, to speed up the review to solve the backlog; on the other hand, to open up a "green channel" for innovative drugs and clinically urgently needed drugs priority review.
In June 2016, the General Office of the State Council issued the "Notice on Printing and Distributing the Pilot Program of the Drug Marketing Authorization Holder System", officially launching the pilot program in 10 provinces and cities including Beijing, Guangdong, and Shandong, and officially promoting it nationwide by December 2019.
In 2016, the former National Health and Family Planning Commission organized the first batch of national medical insurance drug negotiations, and since then, medical insurance negotiations have become normalized. The innovation of the shortlisted conditions, the shortening of the waiting period, and the price reduction negotiation of drugs in the catalog have gradually made breakthroughs, and the dynamic changes of the medical insurance catalog are more in line with the characteristics of innovation.
In June 2017, the State Food and Drug Administration officially became a member of the International Human Drug Registration Technical Coordination Conference (ICH), which means that it is gradually in line with the highest international standards.
In April and November 2018, the state launched the Hong Kong Stock Exchange’s New Deal and the Shanghai Stock Exchange’s Science and Technology Innovation Board to open up financing channels and alleviate the time-consuming and difficult-to-profit situation of new drug research and development.
In June 2019, the National Health Insurance Administration, the Ministry of Finance, the National Health Commission, and the State Administration of Traditional Chinese Medicine issued the "Notice on Printing and Distributing the List of National Pilot Cities for Payment According to Disease Diagnosis Related Groups", and DRGs entered the trial operation demonstration stage.
As of 2020, the development of my country's innovative drug industry can be said to have all the necessary elements. The quadruple resonance of policies, industries, talents, and capital will jointly boost the industry into a golden period of development. track.
The prosperity of the country, the rejuvenation of the nation, and the happiness of the people are the beautiful pictures outlined by the Chinese Dream. There is also a deeply rooted dream of health in the hearts of every Chinese.
Looking back at the century-old history, we have gone through the great journey of the Chinese nation from independence and self-improvement to pioneering and enterprising, from arduous entrepreneurship to pragmatic innovation, and from humble beginnings to daring to be the first.
Looking forward to the future, China's pharmaceutical industry is developing vigorously, and every person in the industry will follow suit and work hard to realize the great rejuvenation of the Chinese nation.
I would like to use this article to celebrate the 100th birthday of the Communist Party of China!
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