Where do the dreams of preparation exports come true?
As the largest exporter of APIs and the world's largest producer of generic drugs, the export of pharmaceutical preparations is the dream of the entire industry, and it is also the country’s encouraging focus for the next five years. For a long time to come, China's preparations should be dominated by generic drugs. The optimal route for China's pharmaceutical exports will be based on the existing global advantages of the Chinese pharmaceutical industry.
China has a sound industrial chain in the fields of antibiotics, vitamins and other products, and has a global discourse; raw materials for Chinese medicines such as anti-tumor and hypertension are supplied globally; China's biotechnology level is closest to that of developed countries. These three major advantages correspond to the category of formulations, is expected to become the ultimate goal to achieve the dream of China's pharmaceutical exports.
Antibiotics: the most global supply base
At present, the leading varieties of western medicines for export in China are penicillins, cephalosporins, vitamins, and anti-infectives. According to customs data, in 2011, the cumulative export value of penicillins, cephalosporins, and other anti-infective drugs in China reached US$558 million, accounting for 25.65% of China's Western medicine exports.
It can be found that the largest category of pharmaceutical products exports is China's most discourse-like varieties of APIs in the world. The biggest advantage of the export of this category is that China has the world's largest production capacity and the most complete supporting industrial chain. For example, 7ACA, the raw material for cephalosporin synthesis, will have a theoretical total domestic production capacity of more than 15,000 tons.
Currently, Sinopharm, Sinopec Pharmaceutical Trading Co., and Jiangshan Pharmaceutical, which are currently leading Western drug product exporters, have the advantage of export rankings based on their well-established industrial chain of raw material drugs, such as penicillin of Sinopharm; Novo Pharmaceuticals such as Amoxicillin.
After many rounds of industrial upgrading, the quality of Chinese medicine has been qualitatively improved. Developing countries are more sympathetic to Chinese medicine and Asia has become the largest market. In 2011, preparations exported to Asia accounted for 35% of the total formulation export value, but the share decreased by 8.7%, mainly due to the expansion of the share of developed countries' formulation exports. In 2011, exports of Western medicine, Oceania, Europe and Latin America accounted for 17.7%, 17.6% and 9.0% of the total export value, respectively, the year-on-year increase was as high as 783.6%, 66.3% and 40.3%. At the same time, the four major export markets for Western medicine preparations are Australia, the United States, Hong Kong, and South Korea, both of which are developed countries and regions.
This also shows that under the pressure of increasing medical expenses and R&D costs, the demand for China's generic drugs from developed countries is growing.
At present, the possibility of exporting cephalosporin preparations, anti-infectives, and vitamins, and other advantageous varieties has been taken seriously by companies with industrial chain advantages such as Hua Yao, Shi Yao, Zhejiang Pharmaceutical, and so on. Under the constraints of supporting policies, there are still a large number of antibiotic competitors followed.
However, it is still important to note that overseas sales in the past were mainly government purchase orders or purchases by overseas distributors. The sales channels and operating capabilities of local companies overseas were very weak. The enthusiasm and the degree of emphasis of the enterprises were not enough. This directly restricted the export of pharmaceutical preparations. The rapid growth. In addition, we should also pay attention to differentiated competition and be alert to the vicious competition that these varieties have caused by overcapacity in the API industry.
Expanding sales channels will become the main task for the export of anti-infective pharmaceutical companies. Can cooperate with foreign companies to become their OEM supplier, borrow other people's brands, sell their own products, gradually establish their own brand; can also be FDA or EU EDQM certification, and to Southeast Asia, South America and other countries and regions And actively respond to WHO and EU certifications, and expand government procurement orders.
Specialist Drugs: The Most Rapid Growth Potential Category
In the export of western medicines, the second tier is anti-tumor, anti-hypertension and hypolipidemic products. In recent years, the domestic raw materials for these categories have developed rapidly. For example, Sartan drugs are the world's largest antihypertensive drug with total sales of more than US$23 billion. Under the leadership of pharmaceutical companies such as Huahai Pharmaceutical, it has developed into a global supplier of large variety, developed by Huahai Pharmaceutical. Sartan potassium tablets have been approved for listing in the United States; Hisun Pharmaceutical's anti-tumor and statins drug substances and preparations have also received orders from more than a dozen multinational companies.
Such specialty preparations will become the most promising category for Chinese chemical pharmaceutical preparations exports, and will also be the most likely varieties for China to enter the pharmaceutical markets of developed countries in Europe and the United States. The development potential of future specialty preparations is based on several points:
First, our country's raw materials have already had a good foundation. At present, specialty raw material companies such as Hisun, Huahai, Haixiang, and Jingxin have achieved a certain reputation internationally. Over the years, overseas operations have formed rich experience and good reputation. The industrial chain and technological level of related products are global. Leading. Such as drug declaration, preparation of examination and approval documents, clinical trial design, product sales channel construction, and ensuring low cost, these foundations provide an important guarantee for future formulation transformation.
At present, these companies are extending to the downstream products of the relevant industrial chain to expand their production capacity. Among them, Hisun Pharmaceutical and Huahai Pharmaceutical have been licensed to market in the high-end drugs market in the United States and the European Union, and sales of related products in countries such as the European Union have achieved very good performance.
The second is that global pharmaceuticals have entered the non-patent era in an all-round way, and between 2011 and 2015, US$77 billion worth of medicines will face patent cliffs that have lost their property rights protection. This will bring infinite imagination to specialty specialty generics. In recent years, raw material drug companies with Chinese characteristics have constantly adjusted the product structure in accordance with the expiration date of product patents. The local R&D leaders such as Hengrui, Xiansheng, Hua Yao and other generic pharmaceutical companies are equally committed to patent expired products and will soon expire. The pharmaceutical companies with Chinese characteristics have strong strength in the development of raw material medicines and preparations corresponding to blockbuster patented products.
The third is the transfer of generic pharmaceutical production capacity of multinational companies. In the environment where the speed of patented medicines is slowed down and global medical costs are compressed, the production strategy of multinational companies for generic drugs in China is already very obvious. The varieties they are concerned with must be high-end refractory diseases such as cancer, hypertension, and diabetes. . Part of it is promoted as a domestic market, and the other part is used as an OEM order to re-export trade to other countries. With the improvement of product quality control technology capabilities, China has the opportunity to become the largest generic pharmaceutical manufacturing and supply base on the basis of abundant raw materials and huge production capacity.
At present, in addition to the dozens of companies that originally focused on the export of specialty APIs, a large number of pharmaceutical manufacturers, such as Shanghai Pharmaceutical, Hyundai Pharmaceutical, and North China Pharmaceutical, are also developing specialty APIs. The goal is to use APIs. The intervention will open up the global supply chain, and then develop into the high-end formulation field.
Biosimilars: The closest to international standards
Biopharmaceuticals are the fastest-growing category of current sales, and the closest to China's pharmaceuticals and international high-end levels.
At present, China's biopharmaceutical industry has achieved certain development. According to the statistics, up to now, the country has approved the listing of 13 types of 25 382 genetic engineering drugs and genetic engineering vaccine products of different specifications. There are more than 200 biopharmaceutical companies producing biopharmaceuticals, and there are more than 100 biopharmaceuticals in the country; The research and development of antibody drugs is hot, with 5 companies in the sales stage, 8 in the clinical stage, and 15 preclinical/invested investments.
Although most of these products that are already on the market or under development are biosimilars, they do not prevent them from developing into competitive products. The biosimilar field is also the most important area for the future development of biopharmaceuticals in China.
In the context of the development of generic drugs as the development strategy of global pharmaceutical companies, the development of biosimilar drugs is the goal of all pharmaceutical companies. In particular, in the next five years, the world's potentially worthy $59 billion worth of biopharmaceuticals will lose patent protection. From 2012 to 2020, the biologics market is expected to grow at an annual rate of $1 billion.
This set of data is enough to make all businesses crazy. The pace of biosimilars for multinational companies has accelerated. In the environment where relevant special projects encourage the development of products such as genetic engineering drugs, monoclonal antibody drugs, vaccines, and diagnostic reagents, it is not too late for China to join the team with its current level of biotechnology.
The demand for biosimilar drugs in developed countries in Europe and America is rapidly increasing, and overseas biosimilar drug approval procedures are also being simplified. A few days ago, FDA issued the draft three guiding principle documents for the development of biosimilar drugs, which includes products such as vaccines, blood and blood components, gene therapy, tissues, and proteins.
At present, a large number of local companies have focused on the development of biological agents, North China Pharmaceutical's recombinant human albumin, rabies vaccines, Livzon, Hisun, and so on.
However, the main demand for biosimilar drugs is concentrated in developed markets such as Europe and the United States, and relevant experts encourage local companies to directly develop and market their products overseas, which is more effective in terms of product approval and market expansion. At present, a large number of companies are strengthening cooperation with multinational corporations to develop products. Their target markets include overseas markets, and local companies also hope to rapidly push their products to the international market through the influence of multinational corporations in the world.
For specific species, biosimilar drugs such as monoclonal antibodies, TNFα receptor inhibitors, and long-acting protein drugs are promising in the industry.
As the largest exporter of APIs and the world's largest producer of generic drugs, the export of pharmaceutical preparations is the dream of the entire industry, and it is also the country’s encouraging focus for the next five years. For a long time to come, China's preparations should be dominated by generic drugs. The optimal route for China's pharmaceutical exports will be based on the existing global advantages of the Chinese pharmaceutical industry.
China has a sound industrial chain in the fields of antibiotics, vitamins and other products, and has a global discourse; raw materials for Chinese medicines such as anti-tumor and hypertension are supplied globally; China's biotechnology level is closest to that of developed countries. These three major advantages correspond to the category of formulations, is expected to become the ultimate goal to achieve the dream of China's pharmaceutical exports.
Antibiotics: the most global supply base
At present, the leading varieties of western medicines for export in China are penicillins, cephalosporins, vitamins, and anti-infectives. According to customs data, in 2011, the cumulative export value of penicillins, cephalosporins, and other anti-infective drugs in China reached US$558 million, accounting for 25.65% of China's Western medicine exports.
It can be found that the largest category of pharmaceutical products exports is China's most discourse-like varieties of APIs in the world. The biggest advantage of the export of this category is that China has the world's largest production capacity and the most complete supporting industrial chain. For example, 7ACA, the raw material for cephalosporin synthesis, will have a theoretical total domestic production capacity of more than 15,000 tons.
Currently, Sinopharm, Sinopec Pharmaceutical Trading Co., and Jiangshan Pharmaceutical, which are currently leading Western drug product exporters, have the advantage of export rankings based on their well-established industrial chain of raw material drugs, such as penicillin of Sinopharm; Novo Pharmaceuticals such as Amoxicillin.
After many rounds of industrial upgrading, the quality of Chinese medicine has been qualitatively improved. Developing countries are more sympathetic to Chinese medicine and Asia has become the largest market. In 2011, preparations exported to Asia accounted for 35% of the total formulation export value, but the share decreased by 8.7%, mainly due to the expansion of the share of developed countries' formulation exports. In 2011, exports of Western medicine, Oceania, Europe and Latin America accounted for 17.7%, 17.6% and 9.0% of the total export value, respectively, the year-on-year increase was as high as 783.6%, 66.3% and 40.3%. At the same time, the four major export markets for Western medicine preparations are Australia, the United States, Hong Kong, and South Korea, both of which are developed countries and regions.
This also shows that under the pressure of increasing medical expenses and R&D costs, the demand for China's generic drugs from developed countries is growing.
At present, the possibility of exporting cephalosporin preparations, anti-infectives, and vitamins, and other advantageous varieties has been taken seriously by companies with industrial chain advantages such as Hua Yao, Shi Yao, Zhejiang Pharmaceutical, and so on. Under the constraints of supporting policies, there are still a large number of antibiotic competitors followed.
However, it is still important to note that overseas sales in the past were mainly government purchase orders or purchases by overseas distributors. The sales channels and operating capabilities of local companies overseas were very weak. The enthusiasm and the degree of emphasis of the enterprises were not enough. This directly restricted the export of pharmaceutical preparations. The rapid growth. In addition, we should also pay attention to differentiated competition and be alert to the vicious competition that these varieties have caused by overcapacity in the API industry.
Expanding sales channels will become the main task for the export of anti-infective pharmaceutical companies. Can cooperate with foreign companies to become their OEM supplier, borrow other people's brands, sell their own products, gradually establish their own brand; can also be FDA or EU EDQM certification, and to Southeast Asia, South America and other countries and regions And actively respond to WHO and EU certifications, and expand government procurement orders.
Specialist Drugs: The Most Rapid Growth Potential Category
In the export of western medicines, the second tier is anti-tumor, anti-hypertension and hypolipidemic products. In recent years, the domestic raw materials for these categories have developed rapidly. For example, Sartan drugs are the world's largest antihypertensive drug with total sales of more than US$23 billion. Under the leadership of pharmaceutical companies such as Huahai Pharmaceutical, it has developed into a global supplier of large variety, developed by Huahai Pharmaceutical. Sartan potassium tablets have been approved for listing in the United States; Hisun Pharmaceutical's anti-tumor and statins drug substances and preparations have also received orders from more than a dozen multinational companies.
Such specialty preparations will become the most promising category for Chinese chemical pharmaceutical preparations exports, and will also be the most likely varieties for China to enter the pharmaceutical markets of developed countries in Europe and the United States. The development potential of future specialty preparations is based on several points:
First, our country's raw materials have already had a good foundation. At present, specialty raw material companies such as Hisun, Huahai, Haixiang, and Jingxin have achieved a certain reputation internationally. Over the years, overseas operations have formed rich experience and good reputation. The industrial chain and technological level of related products are global. Leading. Such as drug declaration, preparation of examination and approval documents, clinical trial design, product sales channel construction, and ensuring low cost, these foundations provide an important guarantee for future formulation transformation.
At present, these companies are extending to the downstream products of the relevant industrial chain to expand their production capacity. Among them, Hisun Pharmaceutical and Huahai Pharmaceutical have been licensed to market in the high-end drugs market in the United States and the European Union, and sales of related products in countries such as the European Union have achieved very good performance.
The second is that global pharmaceuticals have entered the non-patent era in an all-round way, and between 2011 and 2015, US$77 billion worth of medicines will face patent cliffs that have lost their property rights protection. This will bring infinite imagination to specialty specialty generics. In recent years, raw material drug companies with Chinese characteristics have constantly adjusted the product structure in accordance with the expiration date of product patents. The local R&D leaders such as Hengrui, Xiansheng, Hua Yao and other generic pharmaceutical companies are equally committed to patent expired products and will soon expire. The pharmaceutical companies with Chinese characteristics have strong strength in the development of raw material medicines and preparations corresponding to blockbuster patented products.
The third is the transfer of generic pharmaceutical production capacity of multinational companies. In the environment where the speed of patented medicines is slowed down and global medical costs are compressed, the production strategy of multinational companies for generic drugs in China is already very obvious. The varieties they are concerned with must be high-end refractory diseases such as cancer, hypertension, and diabetes. . Part of it is promoted as a domestic market, and the other part is used as an OEM order to re-export trade to other countries. With the improvement of product quality control technology capabilities, China has the opportunity to become the largest generic pharmaceutical manufacturing and supply base on the basis of abundant raw materials and huge production capacity.
At present, in addition to the dozens of companies that originally focused on the export of specialty APIs, a large number of pharmaceutical manufacturers, such as Shanghai Pharmaceutical, Hyundai Pharmaceutical, and North China Pharmaceutical, are also developing specialty APIs. The goal is to use APIs. The intervention will open up the global supply chain, and then develop into the high-end formulation field.
Biosimilars: The closest to international standards
Biopharmaceuticals are the fastest-growing category of current sales, and the closest to China's pharmaceuticals and international high-end levels.
At present, China's biopharmaceutical industry has achieved certain development. According to the statistics, up to now, the country has approved the listing of 13 types of 25 382 genetic engineering drugs and genetic engineering vaccine products of different specifications. There are more than 200 biopharmaceutical companies producing biopharmaceuticals, and there are more than 100 biopharmaceuticals in the country; The research and development of antibody drugs is hot, with 5 companies in the sales stage, 8 in the clinical stage, and 15 preclinical/invested investments.
Although most of these products that are already on the market or under development are biosimilars, they do not prevent them from developing into competitive products. The biosimilar field is also the most important area for the future development of biopharmaceuticals in China.
In the context of the development of generic drugs as the development strategy of global pharmaceutical companies, the development of biosimilar drugs is the goal of all pharmaceutical companies. In particular, in the next five years, the world's potentially worthy $59 billion worth of biopharmaceuticals will lose patent protection. From 2012 to 2020, the biologics market is expected to grow at an annual rate of $1 billion.
This set of data is enough to make all businesses crazy. The pace of biosimilars for multinational companies has accelerated. In the environment where relevant special projects encourage the development of products such as genetic engineering drugs, monoclonal antibody drugs, vaccines, and diagnostic reagents, it is not too late for China to join the team with its current level of biotechnology.
The demand for biosimilar drugs in developed countries in Europe and America is rapidly increasing, and overseas biosimilar drug approval procedures are also being simplified. A few days ago, FDA issued the draft three guiding principle documents for the development of biosimilar drugs, which includes products such as vaccines, blood and blood components, gene therapy, tissues, and proteins.
At present, a large number of local companies have focused on the development of biological agents, North China Pharmaceutical's recombinant human albumin, rabies vaccines, Livzon, Hisun, and so on.
However, the main demand for biosimilar drugs is concentrated in developed markets such as Europe and the United States, and relevant experts encourage local companies to directly develop and market their products overseas, which is more effective in terms of product approval and market expansion. At present, a large number of companies are strengthening cooperation with multinational corporations to develop products. Their target markets include overseas markets, and local companies also hope to rapidly push their products to the international market through the influence of multinational corporations in the world.
For specific species, biosimilar drugs such as monoclonal antibodies, TNFα receptor inhibitors, and long-acting protein drugs are promising in the industry.
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