Since the founding of new China, especially since the reform and opening up for more than 40 years, the pharmaceutical industry has made great efforts and the whole pharmaceutical industry has undergone a great change. It is a great history of struggle, both in the history of Chinese medicine and in the history of world pharmaceutical. We can find out the experience and practice of promoting foreign trade and cooperation in the past decades by deeply sensing the temperature of industrial changes. It not only sketched the troubles of the whole industry growth and the difficulties of transformation, but also recorded the self evolution process of the international hard internal skill training of the pharmaceutical industry. In the new era, China's pharmaceutical industry is developing from high speed to high quality. The internationalization of Chinese pharmaceutical industry will be in a new stage of development. In recent five years, domestic innovative drugs have been reported fast, and Chinese leading innovation enterprises have begun to usher in a wave of harvest period. Some enterprises have even made breakthroughs in the way of entering the world Top50. We can't help but ask, how far is China from the birth of pharmaceutical enterprises?

The gap is rapidly shortened in the future

To answer this soul question, we need to make a rational comparison between the head pharmaceutical enterprises and the pharmaceutical enterprises in China.

The top 50 list of 2020 global pharmaceutical enterprises published by the magazine of pharmaceutical manager of the United States, Roche ranked the top with revenue of 48.247 billion dollars in 2019, and four pharmaceutical enterprises in China were listed. Yunnan Baiyao (ranked 37), China biopharmaceutical (ranked 42), Hengrui Pharmaceutical (ranked 43), Shanghai medicine (ranked 48), respectively, had revenue of 4.284 billion dollars, 3.373 billion dollars, 3.321 billion dollars $2.875 billion. Although the revenue of Chinese pharmaceutical companies is still more than 10 times larger than that of Roche, from the previous list, only China biopharmaceuticals (ranked 42) and Hengrui Pharmaceutical (No. 48) are listed. By this year, a total of 4 Chinese enterprises are listed. It is clear that the scale of pharmaceutical enterprises in China is expanding rapidly, and it is believed that more Chinese enterprises will be on the list in the future.

The surging power of these enterprises is closely related to the importance and investment in R & D. According to korui Weian data, the R & D expenditure of listed biomedical companies (excluding large pharmaceutical companies) ranked top 100 by market value increased 35% compared with the previous year. With the help of capital, the rising star, Baiji Shenzhou invested 927million dollars in R & D in 2019, ranking among the top 10 R & D expenditures of global biopharmaceutical companies. Meanwhile, the R & D investment of China biopharmaceutical and Hengrui pharmaceutical in 2020 top 50 list of global pharmaceutical enterprises is: 347 million US dollars and 518million dollars respectively, and Chinese enterprises are striving to catch up with each other in R & D investment.

To judge the level of pharmaceutical innovation in a country, two indicators are used internationally to measure: the proportion of research and development products before and after the market in the world and the proportion of new drugs after the market. At present, China's contribution rate of R & D products accounts for 7.8% of the global proportion before listing, which is at the same level as that of traditional pharmaceutical powers such as the UK; The contribution rate of China is 4.6% in the proportion of new drugs after listing in the world. Chinese pharmaceutical companies are speeding up in the long-term innovation run.

Of course, the competitiveness of pharmaceutical enterprises is also reflected in the global operation capacity, risk resistance capacity, growth capacity and other aspects. And these capabilities of Chinese enterprises and pharmaceutical enterprises also exist gap. Although there is still a gap between us and pharmaceutical enterprises, our leading pharmaceutical enterprises have shown their own vanguard and determination. With the development of new drugs, the distance between China and the world will be reduced.

Good ecology is the fertile land for enterprises to take off

To narrow the gap between Chinese pharmaceutical enterprises and pharmaceutical enterprises, it is inseparable from the healthy development of the ecosystem.

The optimized policy environment nourishes the sustainable development of enterprises. In recent years, the national macro strategy has changed from "generic pharmaceutical strategy" to "innovative drug strategy", and has issued a series of new policies and achieved results in the new drug related links such as new drug research and development, drug review, medical insurance, intellectual property protection and so on. The ecological environment of pharmaceutical innovation has been optimized, and the enthusiasm for R & D innovation of Chinese medicine has been ignited“ It's a good time. " During the dialogue with some representatives of international enterprises, they expressed full confidence in the rise of Chinese pharmaceutical industry in the new era.

The return of high-tech talents adds impetus to development. In recent years, the domestic policy has inspired the medical innovation and the huge market volume in China, which has triggered a strong "sea return tide", and a group of overseas talents have returned to China for entrepreneurship around the millennium. The real global new drug research and development needs high-end talents who have worked abroad for many years and have rich experience to lead. More importantly, returnees return has promoted the gradient growth of domestic talents, which promotes the understanding and accumulation of advanced medical technology. Returnees with transnational enterprise management experience, such as Lu Xianping, Chenli and wujinzi, have injected great energy into the internationalization of Chinese pharmaceutical industry.

Capital is a new driving force to promote pharmaceutical enterprises to become pharmaceutical enterprises“ 2015 is a major turning point. "This year is regarded by many as the first year of drug policy reform. Various favorable policies have been issued, which shape the investment highland of China's pharmaceutical industry, and the investment in new drugs in capital market is in a boom. Since the IPO was restarted in 2009, it has been increasing at the rate of asset securitization of dozens of pharmaceutical enterprises every year. "Since 2001, he has gone through a very painful financing process since he returned to China and started his business in 2001. Once, even the employee salary was unable to be paid, which directly caused the core personnel to leave the company. The innovation of enterprise financing environment has only been gradually improved in recent years."

In 2018, the Hong Kong Stock Exchange proposed "allow biotech companies that have not yet made profits or have no income to be listed in Hong Kong". In 2018, Geli pharmaceutical became a successful global listed non-profit biomedical enterprise of the Hong Kong stock exchange, with a financing of US $400million. In 2019, the Shanghai Stock Exchange also launched science and technology innovation board to serve scientific and technological innovation enterprises, which also gave a strong focus on pharmaceutical innovation.

The pharmaceutical innovation ecology, such as industrial policy, international talents and capital, is constantly optimized and perfected, and has burst into infinite vitality.

Innovation layout of global vision to move the future

The optimization of environment makes Chinese pharmaceutical enterprises more and more confident. To turn this confidence into action, the core point is that the products must have international competitiveness. Product force is the foundation of the birth of pharmaceutical enterprises. The number of new drug research and development in China is greatly increased than before. Both traditional large pharmaceutical enterprises and "new generation" innovative biopharmaceutical companies are actively transforming and laying out the future. With the outbreak of China's indigenous innovation, the international status of China's pharmaceutical industry has been rapidly promoted.

The pharmaceutical industry in China has undergone qualitative changes gradually: "during the Tenth Five Year Plan period, China's pharmaceutical innovation is in the bud stage. Although dozens of new drugs have been approved for listing, there are few original drugs of real significance“ During the 11th Five Year Plan and the 12th Five Year Plan, a series of new drug R & D encouraging policies were launched by national major new drug creation projects. A large number of overseas talents returned to China for entrepreneurship, which gave birth to the prosperity of domestic pharmaceutical innovation. Heavy weight new drugs, represented by ektini, apatini and sidabbenamine, have been published successively“ Since the 13th five year plan, the new drug review policy has changed the innovation ecology, and the R & D pattern from "China new" to "global new" has gradually formed, and a large number of innovative products have emerged. According to statistics, 38 new drugs of class I were approved in China from 2008 to 2018. Among them, nine new drugs of category I have been approved in 2018, accounting for 1/4 of the total approved drugs in recent 10 years, and rosastah, which is listed globally, has been approved. China's innovative drugs have made great progress in quantity and quality.

We are pleased to see that there are a number of potential enterprises in China, which have already been the top 50 elite club of pharmaceutical enterprises in the world. In recent years, many enterprises have shown their vitality in internationalization and are stepping on the journey of becoming an enterprise. As one of the representative enterprises, Baiji Shenzhou, whose zebotini was approved by the US FDA in 2019, is a Chinese independent R & D anti-cancer innovative drug approved for listing in the United States. The main clinical support data for the drug submission to NDA came from a multicenter clinical trial in China, which was unimaginable in the past.

In 2015-2019, the clinical trials conducted by Chinese enterprises overseas are growing, and the willingness of enterprises to go out and participate in global competition is becoming stronger and stronger. In addition, there are also enterprises' new drug projects directly choose to carry out clinical practice abroad. For example, GM CSF target drug independently innovated by Tianjing biology took the lead in conducting a phase I clinical trial in the United States in 2019, and returned to China for declaration after obtaining clinical data. The activity of Chinese enterprises in overseas clinical trials has increased.

Note: Overseas refers to other countries and regions besides mainland China, China Hongkong and Chinese mainland Taiwan. Chinese enterprise refers to the company headquartered in China

Source: clarivate Corellis, clinical trial starts from January 1, 2015 to December 31, 2019

In these clinical projects, biopharmaceutics are given great promise. Some people say that China's pharmaceutical innovation, with its advantages of later development, has overtaken in a new round of biomedical innovation, becoming a small gap with pharmaceutical enterprises. In 2020, COVID-19 swept the globe, and the results of phase II clinical trials of the new recombinant crown vaccine (adenovirus vector), led by academician Chen Wei, were announced. This is the global phase II clinical trial data of the new crown vaccine. The study showed that 99.5% days after the single inoculation of the recombinant coronal vaccine, 99.5% of the subjects produced specific antibodies, and 89% of the subjects produced a specific cellular immune response, which is expected to provide a "dual protection response" to the human body against COVID-19 infection. According to who, 133 new crown vaccines are being studied in the world, and the fast-moving vaccines come from China.

Nowadays, bio medicine has become the focus of the global pharmaceutical industry competition. Once upon a time, biopharmaceutics were regarded as patents of pharmaceutical companies. Because of its various and complex preparation links, the quality system requires very high, and it is not easy to meet international standards. Before 2018, China's biopharmaceutical drug industry was still a blank. However, this pattern was broken by the approval of the US Trogarzo FDA, which was created by Zhongyu new drug and the innovative AIDS therapy of biological production of medicine. This is the first sterile biological preparation produced in China and approved by FDA to be listed in the United States. In June 2020, the EU order of Fuhong Hanlin hlx02 (tetorzumab for injection) successfully completed the pre delivery inspection and packing work, and officially embarked on the journey to the European market. This is a "Chinese" mAb biological similar drug approved by the EU.

After China joined ICH, the form of independent innovative drugs going to sea is becoming more and more abundant and diversified. The international multicenter phase III clinical trial of the first-line treatment of liver cancer by carrierizumab and apatinib mesylate, which was independently developed by Hengrui pharmaceutical, was carried out in the United States, Europe and China. The time of listing of PD-1 in China market of Jun Shi biological is only half a year from that of multinational enterprises. Such progress has never been a feat in the history of drug research and development in China.

In other words, Chinese companies have begun to have the basic outlines of pharmaceutical companies.

The path and strategic choice of enterprises

World enterprises are the symbol of national core competitiveness and independent innovation ability. Since joining ICH, the number of cases of innovation drugs fully developed in China has been authorized to overseas companies and listed overseas for sale. Some enterprises have distributed the first in class new drugs in the world, which has been in the same PK as that of multinational pharmaceutical enterprises. The goal of Chinese pharmaceutical companies to become one of the world's pharmaceutical companies may break through in the first half of the new decade. If we look forward, powerful enterprises are also laying out new targets and new mechanism only in class new drugs.

"The further we go, the more depends on the development of basic research and the development of transformational medicine." Some experts believe that most Chinese enterprises have obtained comparative competitive advantages, while pharmaceutical enterprises grasp the continuous competitive advantage. The state is putting forward concrete measures from optimizing the original innovation environment, strengthening the original orientation of national science and technology plan, strengthening the training of basic research talents, innovating scientific research methods and means, strengthening the original innovation of national key laboratories, and enhancing the independent innovation ability of enterprises, and so on, and helping to seize the leading scientific research commanding point in key areas.

To analyze this kind of sustainable competitive advantage, pharmaceutical enterprises have three common characteristics worth learning:

First, we need core fist products, that is, the real profitability of enterprises should be excellent. Taking xiumeile, known as "the king of medicine", as an example, since its marketing in 2003, the accumulated sales revenue of single products has exceeded $150billion. Therefore, the scale profitability is the foundation of the enterprise formation. The innovation "black horse" like Geely ranks in the top ten in the world for more than 30 years. It has put forward its competitive innovative products in the fields of hepatitis C and other fields, and rewrites the treatment process of human major diseases with the advanced concept. From the above clinical trial layout, Chinese enterprises are storing force.

Second, we should have the ability to control standards and rules, which is an important performance of the world enterprises to be strong. At present, Chinese enterprises are accelerating the progress from meeting standards and meeting standards to formulating standards. This requires them to combine technology innovation and standardization construction closely, and accelerate the transformation of technological innovation achievements to international standards. Compared with European and American multinational pharmaceutical enterprises for a century, China has been making innovative drugs for a short time. And from the perspective of global biological sequence patent application, although China occupies the leading position in the application of biological sequence patent, corerwian data shows that among the top 10 inventors in the global patent application number, there are 8 Chinese academic institutions, but their patents are only applied in China, and the applications for entering other countries are relatively few. The top 10 patent applicants in the second place are mainly large / bio pharmaceutical companies based in North America. This is a place that Chinese enterprises need to pay special attention to. The ability to lead standards and rules is the sharpener to earn discourse power.

Third, the operation and risk resistance capability. This year's new crown test will test the resilience of enterprises. For example, the supply chain and industrial chain brought by API are the secret weapons of enterprises whether they can recover and recycle quickly in the crisis. At present, the countries play 5g technology, and Huawei's Qilin chip and Hongmeng system show great ability to fight against risks. Because of the changes of global economic situation, enterprises should constantly improve their global business capabilities, calmly respond to external environment changes and realize sustainable development capabilities.

Innovation is the core power of the future development of pharmaceutical industry. Looking globally, China's leading pharmaceutical companies continue to make efforts in innovation and development, such as 3.896 billion yuan of Hengrui's net profit of 5.328 billion yuan in 2019. It is not difficult to predict, with the acceleration of independent R & D innovation in China, the internationalization of Chinese medicine will be more and more high.

In the new decade, it is an important task for Chinese enterprises to cultivate enterprises and enhance international competitiveness, and also the responsibility given by the times. The world is facing great changes in the past century, especially the impact of COVID-19 on the world governance system. Pharmaceutical enterprises in China still need to practice their internal skills. Both API enterprises and pharmaceutical enterprises must clearly understand their advantages and disadvantages, support by independent innovation, aim at the front and the cutting-edge of industry development, forge core competitiveness and pursue them. We believe that a number of pharmaceutical enterprises will appear in China in the near future.