Business Club December 27th 2010 The fruitful biomedical sector is thrilled. In October, the bio-industry was included in a strategic emerging industry to make the bio-pharmaceutical industry a better future.
As of December 22, the biopharmaceutical sector achieved a “speculative expedition†of the Shenwan Industrial Classification gain of 34.51%. During the same period, the Shanghai and Shenzhen 300 Index rose only 1.61%.
Biological products benefit most
On October 18, the State Council announced its decision on accelerating the cultivation and development of strategic emerging industries, and pointed out that in the bio-industry area, "the development of biotechnology drugs, new vaccines and diagnostic reagents, chemical drugs, and modern drugs for the prevention and treatment of major diseases will be vigorously developed. The large variety of innovative drugs such as traditional Chinese medicines will raise the level of the biomedical industry, accelerate the development and industrialization of advanced medical equipment, medical materials and other biomedical engineering products, and promote the development of scale."
Ai Jian Securities analyst Lin Xingqiu said in an interview with the "Financial Business" of the First Financial Daily that biologicals are included in strategic emerging industries, and the direct benefit of biological products is the industry.
According to the industry classification of Shenyin Wanguo, the biomedical sector is generally divided into six sub-sectors: chemical pharmaceuticals, biological products, medical devices, pharmaceutical and commerce, Chinese medicine, and medical services.
In the biomedical sector, as of December 22, biological products rose the lowest this year, only 17.58%, far behind medical devices (93.09%), medical services (80.63%). Aijian Securities was most optimistic about the biological products sub-sector in 2011. In 2010, the biological products industry saw the smallest increase. This year's performance was the fastest and the valuation was relatively reasonable.
Vaccines are an important category in biological products. According to data provided by Lin Xingqiu, the global vaccine market was 19.2 billion U.S. dollars in 2008, 22.1 billion U.S. dollars in 2009, and is expected to grow to 34 billion U.S. dollars in 2012. The growth rate of the vaccine market is much higher than that of the entire pharmaceutical industry, and China is the largest In terms of production and consumption countries, in general, there is a huge growth potential for vaccines in China. Listed companies can focus on hualan bio (002007) and Tiantan (600161. SH).
The prospects of listed companies in the fields of diagnostic reagents and genetic testing also make people "expect". "The new medical reform advocates 'prevention from disease', focusing on early stage prevention rather than late stage treatment. It provides ample space for the development of biological product companies (diagnostic reagents, genetic testing, and vaccines)." Guo Fanli, Advisor, Pharmaceutical Industry Researcher, China Investment Group Say. According to him, diagnostic reagents are newly emerging industries, such as those that can be used to diagnose premarital diseases. He suggested focusing on Kehua Bio (002022.SZ) and Daan Gene (002030.SZ) in the diagnostic reagent industry.
Chemical drugs increase added value
In the area of ​​chemical pharmaceuticals, Lin Xingqiu suggested to pay attention to Hengrui Pharmaceutical (600276. SH) and Hisun Pharmaceutical (600267. SH). Hisun Pharmaceutical has gone overseas to seek US Food and Drug Administration (FDA) certification, and has developed to export higher-margin preparations.
Chemical pharmaceuticals are not technically high compared to biological products. Vitamins belong to the chemical and pharmaceutical industry. China is the country with the largest amount of vitamin production. VC and VE production accounts for more than 70% of the world's total, but its technical content is relatively low, and most of them are exported. Northeast Pharmaceutical (000597.SZ), Zhejiang Pharmaceutical (600216.SH), and North China Pharmaceutical (600812.SH) are large companies that produce chemical drugs.
Zhang Lihe, an academician of the Chinese Academy of Sciences, said in an interview with the media that many of China's raw material medicine exports are actually exported according to chemical raw materials, but India has long ago used the raw material drug production base to demonstrate its process according to the requirements of the US FDA. Therefore, according to the drug export, it is much higher than the added value of China. In recent years, India has imported a large amount of raw material medicine from China, made it into medicine and preparations, and exported it to countries including China, and obtained a very high price difference.
In terms of modern Chinese medicine, Guo Fanli proposed to pay attention to Yunnan Baiyao (000538. SZ), Tong Ren Tang (600085. SH), Kangmei Pharmaceutical (600518.SH), Dong E Ejiao (000423. SZ) and so on.
There are only a handful of companies in the medical device sub-sector of the SW Medical Biopharmaceuticals segment, only 10 of them. “In the past, we couldn’t make large and medium-sized medical devices. We did some middle-to-low-end medical devices. Nuclear magnetic resonance and CT devices were monopolized by large multinational companies. Domestic enterprises mainly engaged in medium-sized devices such as B-mode ultrasonography and color ultrasonography. The small apparatus," said Guo Guozhong, director of the Center for the Transformation of Chinese Medical Science and Technology Achievements, said in an interview with this newspaper.
The BOCI International report stated that it is optimistic about the rapid expansion of Yu Yue Medical (002223.SZ) in the low-end medical device market, and is optimistic about Jiu An Medical (002432 SZ), Yang Pu Medical (300030 SZ) and Lepu Medical (300003). (SZ) Export and Import Substitution Process for Mid-range Medical Equipment Materials.
Lin Xingqiu believes that in 2011, it may also pay attention to listed companies whose drugs are selected as basic drugs in the country but have separate pricing rights, such as Yunnan Baiyao and Ma Yinglong (600993.SH).
R&D capability is the key
R&D capability is a powerful edge for listed companies in the future. "Enterprises must have the ability to research and develop new drugs. In general, they must have a certain amount of new drug reserves. If they do not, there will be limited space for future development," said Lin Xingqiu.
The research and development process for new drugs in biopharmaceutical companies is generally based on the development of drugs at the laboratory stage, and then into the preclinical toxicity efficacy test (in mice or other animals), and then the relevant data reported to the State Food and Drug Administration, to get clinical After the approval, clinical trials are conducted on healthy persons or patients. After the efficacy is confirmed, the drug can be produced and marketed only with the permission of the regulatory authority.
Three phases of clinical trials are required. Phase I is an experiment of safety. Recruitment of healthy volunteers is used as an experiment. Normally, 30 to 40 people are used. The purpose is mainly to test safety. If safety is good, phase II is allowed. The number of people in phase II is about 200, and the main purpose is to explore the efficacy. If there is curative effect and the side effects are relatively limited, then phase III is allowed. Phase III is the determination of efficacy. After the efficacy is determined, it will be reported to the Food and Drug Administration. If it is feasible, the Food and Drug Administration will issue a formal production approval.
“The industry chain is very long. It takes 10 years or more from the start of R&D to go public. The time for generic drugs will be shorter.†Guo Fanli said that overall, domestic large companies have invested less, foreign organisms. Pharmaceutical companies, at least 15% to 20% of annual sales, are used as R&D funds, and there are very few domestic companies that can use 1% of funds.
Guo Fanli further stated that many large companies have financial strength, but are unwilling to do research and development, large companies have paved the way for a long time, brand awareness has been established, investment in R&D funding may not be a problem, but if the long development cycle fails, It is also a blow to the accumulation of previous brands; although small businesses really want to innovate, but they do not have the financial strength and R&D strength, they are trapped in the “did not want big companies to do, and small businesses can’t do it†gap with foreign countries. Bigger and bigger.
Lin Xingqiu pointed out that at present, domestic listed companies with relatively good R&D performance include Hengrui Medicine and Tasly (600535.SH). An innovative drug named "Ragogliptin" developed by Hengrui Pharmaceuticals has been approved for the first phase of clinical trials in the United States. In August of this year, Tasly announced that its flagship product, Compound Danshen Dripping Pills, has completed Phase II clinical trials in the United States and confirmed safe and effective. It is about to enter phase III trials. "Tishri is a very good company in the modernization of Chinese medicine."
However, the high valuation of the biopharmaceutical industry has also made some analysts cautious. A securities analyst believes that the valuation of pharmaceuticals is high, and he suggests focusing on such leading companies as Yunnan Baiyao and Hengrui Pharmaceutical. “The market has always been highly concerned, and when the industry is at risk, leading stocks are more insurance than small stocks.â€
As of December 22, the biopharmaceutical sector achieved a “speculative expedition†of the Shenwan Industrial Classification gain of 34.51%. During the same period, the Shanghai and Shenzhen 300 Index rose only 1.61%.
Biological products benefit most
On October 18, the State Council announced its decision on accelerating the cultivation and development of strategic emerging industries, and pointed out that in the bio-industry area, "the development of biotechnology drugs, new vaccines and diagnostic reagents, chemical drugs, and modern drugs for the prevention and treatment of major diseases will be vigorously developed. The large variety of innovative drugs such as traditional Chinese medicines will raise the level of the biomedical industry, accelerate the development and industrialization of advanced medical equipment, medical materials and other biomedical engineering products, and promote the development of scale."
Ai Jian Securities analyst Lin Xingqiu said in an interview with the "Financial Business" of the First Financial Daily that biologicals are included in strategic emerging industries, and the direct benefit of biological products is the industry.
According to the industry classification of Shenyin Wanguo, the biomedical sector is generally divided into six sub-sectors: chemical pharmaceuticals, biological products, medical devices, pharmaceutical and commerce, Chinese medicine, and medical services.
In the biomedical sector, as of December 22, biological products rose the lowest this year, only 17.58%, far behind medical devices (93.09%), medical services (80.63%). Aijian Securities was most optimistic about the biological products sub-sector in 2011. In 2010, the biological products industry saw the smallest increase. This year's performance was the fastest and the valuation was relatively reasonable.
Vaccines are an important category in biological products. According to data provided by Lin Xingqiu, the global vaccine market was 19.2 billion U.S. dollars in 2008, 22.1 billion U.S. dollars in 2009, and is expected to grow to 34 billion U.S. dollars in 2012. The growth rate of the vaccine market is much higher than that of the entire pharmaceutical industry, and China is the largest In terms of production and consumption countries, in general, there is a huge growth potential for vaccines in China. Listed companies can focus on hualan bio (002007) and Tiantan (600161. SH).
The prospects of listed companies in the fields of diagnostic reagents and genetic testing also make people "expect". "The new medical reform advocates 'prevention from disease', focusing on early stage prevention rather than late stage treatment. It provides ample space for the development of biological product companies (diagnostic reagents, genetic testing, and vaccines)." Guo Fanli, Advisor, Pharmaceutical Industry Researcher, China Investment Group Say. According to him, diagnostic reagents are newly emerging industries, such as those that can be used to diagnose premarital diseases. He suggested focusing on Kehua Bio (002022.SZ) and Daan Gene (002030.SZ) in the diagnostic reagent industry.
Chemical drugs increase added value
In the area of ​​chemical pharmaceuticals, Lin Xingqiu suggested to pay attention to Hengrui Pharmaceutical (600276. SH) and Hisun Pharmaceutical (600267. SH). Hisun Pharmaceutical has gone overseas to seek US Food and Drug Administration (FDA) certification, and has developed to export higher-margin preparations.
Chemical pharmaceuticals are not technically high compared to biological products. Vitamins belong to the chemical and pharmaceutical industry. China is the country with the largest amount of vitamin production. VC and VE production accounts for more than 70% of the world's total, but its technical content is relatively low, and most of them are exported. Northeast Pharmaceutical (000597.SZ), Zhejiang Pharmaceutical (600216.SH), and North China Pharmaceutical (600812.SH) are large companies that produce chemical drugs.
Zhang Lihe, an academician of the Chinese Academy of Sciences, said in an interview with the media that many of China's raw material medicine exports are actually exported according to chemical raw materials, but India has long ago used the raw material drug production base to demonstrate its process according to the requirements of the US FDA. Therefore, according to the drug export, it is much higher than the added value of China. In recent years, India has imported a large amount of raw material medicine from China, made it into medicine and preparations, and exported it to countries including China, and obtained a very high price difference.
In terms of modern Chinese medicine, Guo Fanli proposed to pay attention to Yunnan Baiyao (000538. SZ), Tong Ren Tang (600085. SH), Kangmei Pharmaceutical (600518.SH), Dong E Ejiao (000423. SZ) and so on.
There are only a handful of companies in the medical device sub-sector of the SW Medical Biopharmaceuticals segment, only 10 of them. “In the past, we couldn’t make large and medium-sized medical devices. We did some middle-to-low-end medical devices. Nuclear magnetic resonance and CT devices were monopolized by large multinational companies. Domestic enterprises mainly engaged in medium-sized devices such as B-mode ultrasonography and color ultrasonography. The small apparatus," said Guo Guozhong, director of the Center for the Transformation of Chinese Medical Science and Technology Achievements, said in an interview with this newspaper.
The BOCI International report stated that it is optimistic about the rapid expansion of Yu Yue Medical (002223.SZ) in the low-end medical device market, and is optimistic about Jiu An Medical (002432 SZ), Yang Pu Medical (300030 SZ) and Lepu Medical (300003). (SZ) Export and Import Substitution Process for Mid-range Medical Equipment Materials.
Lin Xingqiu believes that in 2011, it may also pay attention to listed companies whose drugs are selected as basic drugs in the country but have separate pricing rights, such as Yunnan Baiyao and Ma Yinglong (600993.SH).
R&D capability is the key
R&D capability is a powerful edge for listed companies in the future. "Enterprises must have the ability to research and develop new drugs. In general, they must have a certain amount of new drug reserves. If they do not, there will be limited space for future development," said Lin Xingqiu.
The research and development process for new drugs in biopharmaceutical companies is generally based on the development of drugs at the laboratory stage, and then into the preclinical toxicity efficacy test (in mice or other animals), and then the relevant data reported to the State Food and Drug Administration, to get clinical After the approval, clinical trials are conducted on healthy persons or patients. After the efficacy is confirmed, the drug can be produced and marketed only with the permission of the regulatory authority.
Three phases of clinical trials are required. Phase I is an experiment of safety. Recruitment of healthy volunteers is used as an experiment. Normally, 30 to 40 people are used. The purpose is mainly to test safety. If safety is good, phase II is allowed. The number of people in phase II is about 200, and the main purpose is to explore the efficacy. If there is curative effect and the side effects are relatively limited, then phase III is allowed. Phase III is the determination of efficacy. After the efficacy is determined, it will be reported to the Food and Drug Administration. If it is feasible, the Food and Drug Administration will issue a formal production approval.
“The industry chain is very long. It takes 10 years or more from the start of R&D to go public. The time for generic drugs will be shorter.†Guo Fanli said that overall, domestic large companies have invested less, foreign organisms. Pharmaceutical companies, at least 15% to 20% of annual sales, are used as R&D funds, and there are very few domestic companies that can use 1% of funds.
Guo Fanli further stated that many large companies have financial strength, but are unwilling to do research and development, large companies have paved the way for a long time, brand awareness has been established, investment in R&D funding may not be a problem, but if the long development cycle fails, It is also a blow to the accumulation of previous brands; although small businesses really want to innovate, but they do not have the financial strength and R&D strength, they are trapped in the “did not want big companies to do, and small businesses can’t do it†gap with foreign countries. Bigger and bigger.
Lin Xingqiu pointed out that at present, domestic listed companies with relatively good R&D performance include Hengrui Medicine and Tasly (600535.SH). An innovative drug named "Ragogliptin" developed by Hengrui Pharmaceuticals has been approved for the first phase of clinical trials in the United States. In August of this year, Tasly announced that its flagship product, Compound Danshen Dripping Pills, has completed Phase II clinical trials in the United States and confirmed safe and effective. It is about to enter phase III trials. "Tishri is a very good company in the modernization of Chinese medicine."
However, the high valuation of the biopharmaceutical industry has also made some analysts cautious. A securities analyst believes that the valuation of pharmaceuticals is high, and he suggests focusing on such leading companies as Yunnan Baiyao and Hengrui Pharmaceutical. “The market has always been highly concerned, and when the industry is at risk, leading stocks are more insurance than small stocks.â€
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