The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

May 03, 2017 Source: CCTV Finance

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According to the latest data released by the National Cancer Center, the number of new cancer cases in China reached 4.29 million in 2015, and the number of deaths reached 2.81 million. At present, cancer has become the number one cause of death among Chinese residents. With the development of science and technology, many new cancer treatment drugs have emerged in recent years. It is particularly gratifying that in recent years, domestic scientific research enterprises have increased the independent research and development of anticancer drugs, and some new anticancer drugs with the latest international technology have entered the clinical trial stage.

200,000 US dollars a year of self-funded treatment will have domestic drugs, cancer patients in China have new hope

In the office of the Department of Gastroenterology, 307 Hospital of the Beijing Academy of Military Medical Sciences, Director Xu Jianming is examining the first-phase clinical trial of an anticancer drug PD-1 monoclonal antibody.

Xu Jianming, director of the Department of Digestive Oncology, 307 Hospital of the Academy of Military Medical Sciences: This lymph node is so large, the shortest path is 1.2 cm, the longest path is 1.9 cm, the original shortest path is 3.0 cm, and the longest path is 3.9 cm. Is a patient with a better effect.

The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

Director Xu Jianming told CCTV Finance that about one-sixth of the digestive cancer patients in his department are undergoing clinical trials of PD-1 monoclonal antibody. Most of these cancer patients are currently unable to undergo traditional methods such as surgery and chemotherapy. Treatment, cancer has really become a terminal illness in their body, the PD-1 monoclonal antibody drug in clinical trials in the hospital is the patient who has almost been sentenced to death, and now the only hope.

The so-called PD-1 is a hot target for tumor immunotherapy, and PD-1 monoclonal antibody binds to PD-1 in the human body to stimulate and enhance the body's own immune system, thereby inhibiting tumor growth and even eliminating cancer cells. .

The clinical study of PD-1 in the United States has been 10 years old. In 2014, the US FDA approved the listing of two PD-1 monoclonal antibodies. At present, the new anti-cancer drug PD-1 monoclonal antibody has shown efficacy in many cancers such as melanoma, non-small cell lung cancer and bladder cancer, and more than 500,000 people worldwide have been treated.

According to current clinical trials, PD-1 monoclonal antibody can control cancer progression in 50% of patients with skin cancer, cure 10% of patients with skin cancer; for stubborn non-small cell lung cancer, it can also control 24% of patients. effect. At present, the clinical efficacy of cancers such as gastric cancer, breast cancer, blood cancer, head and neck cancer, intestinal cancer and brain tumors is also being tested in clinical trials.

Although this new anticancer drug has achieved a staged victory in the fight against cancer, in order to allow more patients to use the anticancer drug PD-1 monoclonal antibody, the first encounter is the high price. In the United States, this treatment costs about $200,000 a year. Secondly, this new anticancer drug will have different effects among different individuals, and its side effects need to be judged in combination with clinical research. However, in China, the current cancer treatment in hospitals relies on traditional treatments such as chemotherapy. Most doctors in China have never been exposed to this new drug, and most cancer patients are even more unaware.

The hospital where Director Xu Jianming is located is already a medical institution with a certain level of medical care in China. When talking about cancer treatment work for many years, his biggest feeling is that there are few anticancer drugs, and today, with the domestic PD-1 The monoclonal antibody drug entered the clinical trial, and he told CCTV Finance, which made him see a new weapon against cancer.

Xu Jianming: The median survival of liver cancer may generally be that patients who cannot undergo surgery may generally be around 10 months. Then, if you have this medicine, your life expectancy will be significantly extended.

The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

The PD-1 monoclonal antibody, which has been regarded as a star-resistant drug by the global medical community, has begun to be made in China. This has given Xu Zhiming an attending doctor who has seen more hopes for cancer, and this exciting medical innovation, Who is doing the research?

In Suzhou, CCTV Finance met Yu Dechao, the founder of Jiangsu Xinda Bio-Pharmaceutical Co., Ltd., and the National Experts of the “Thousand Talents Program” of the Central Organization Department. It is the company he led, which has developed a world-class PD-1 monoclonal antibody drug, and is currently conducting clinical trials in 307 hospitals affiliated to the Academy of Military Medical Sciences.

Yu Dechao, Chairman of Cinda Biopharmaceutical Suzhou Co., Ltd.: If the chemical is a bicycle, the monoclonal antibody is equivalent to our Boeing 777 and Boeing 747.

The world's latest anticancer drug can also be used to replace millions of imported drugs in China.

Although it is easy to compare, in order to produce the 747 in this biopharmaceutical, Yu Dechao has been studying it for more than 20 years.

In 1989, Yu Dechao successfully obtained a doctoral degree in molecular genetics from the Chinese Academy of Sciences. After graduation, he went to the postdoctoral station of the University of California to study medicinal chemistry. At that time, it was the period of vigorous development of the US bio-pharmaceutical industry, which made Yu Dechao contact with the world's most advanced research and development work of biopharmaceuticals for the first time, but also made him deeply understand the difficulty of developing a new monoclonal antibody.

Yu Dechao: If you look for such an antibody, you have to screen it out step by step in a method of 1 billion or even 10 billion in an antibody library. To make a monoclonal antibody into a medicine, we initially estimate that there are at least 1000 steps, and each of the 1000 steps may be wrong.

Yu Dechao said that anticancer drugs for biological agents are not only difficult to develop, but also more complicated to manufacture. With his talents, Yu Dechao's research career in the United States is smooth and smooth. For 20 years, he has gone from an ordinary researcher in the laboratory to the company's vice president of research and development. But when Yu Dechao talked with relatives and friends in his hometown in the United States and heard news of some relatives and friends dying because of certain diseases, the anti-cancer drug made in China was always the heart of his heart.

Yu Dechao: I feel that many of the diseases that can be cured in the United States have no medicine in China.

In 2006, Yu Dechao returned to China to start research and development of anticancer drugs. In 2011, Yu Dechao founded Cinda Biopharmaceutical Co., Ltd. and began to focus on the development of cutting-edge monoclonal antibodies.

CCTV Finance "Half-hour Economy" learned that in the United States, such as lung cancer, melanoma, etc., the use of PD-1 drugs for treatment, the annual cost of about 200,000 US dollars.

In China, imported PD-1 drugs are used at their own expense, and 200,000 US dollars is converted into RMB about 1.4 million, which is a treatment cost that ordinary cancer patients cannot afford. This also means that the world's latest anti-cancer drugs are almost out of touch with Chinese cancer patients. It is the biggest wish of researchers for Chinese cancer patients to enjoy the world's most advanced anticancer drugs at affordable prices.

Despite the difficulties in developing new anti-cancer drugs, and even filled with unpredictable "luck" variables, in 2013, Yu Dechao decided to develop a star product in biopharmaceuticals, PD-1 monoclonal antibody, but this prudent decision was It came to opposition from some investors.

Yu Dechao: The biggest concern is that you have been established for a few years. Your company may not have this ability in terms of technical ability, technical level and knowledge level.

The Chinese must develop a world-class PD-1 anticancer drug. Under the insistence of Yu Dechao and the R&D team, the company's board of directors finally agreed to develop PD-1 monoclonal antibody. It takes about several billion yuan to develop a new drug. Yu Dechao hopes to cooperate with the American pharmaceutical company Lilly to promote the research and development process. Unexpectedly, the other party put forward strict R&D and production standards, which made Yu Dechao spend more than three years and spend hundreds of millions of yuan. In order to be able to align with international production standards, and to prove China's ability to develop and produce biopharmaceuticals, Yu Dechao handed over the sky-high tuition fee.

Yu Dechao: We passed the audit of Lilly Company in September 2016. We are very proud. We may be the first production line in China that has passed the GMP standard audit of major international companies.

In 2015, with excellent technology, China's Cinda Bio and the Eli Lilly and Company, which has a history of more than 140 years of pharmaceutical production, reached a comprehensive strategic cooperation. This also means that the development of Chinese anticancer drugs has officially gained the recognition of American counterparts.

Anti-cancer new drugs transnational research and development Chinese pharmaceutical companies show China speed

In a report in April 2017, the Wall Street Journal of the United States pointed out that "China has long been a supplier of cheap raw materials and generic drugs in the world, and is now emerging as a major producer of important new drugs such as biotech drugs. According to the United States. According to the latest data from relevant departments, China is currently ranked second in the world in terms of the number of biotherapeutic clinical trials, second only to the United States."

Indeed, in China, not only the Cinda that has just been seen, but also the PDI monoclonal antibody research for cancer treatment in many companies in China has entered the clinical trial stage. Running with the sickness and fighting the terminal illness, China's speed has already made us see more hope.

At a laboratory in San Francisco, USA, Dr. Wu Hai, a Chinese scientist, is busy with his colleagues in the early development of monoclonal antibodies against cancer drugs. Their candidate antibodies will be handed over to the parent company in Shanghai for clinical trials and industrial development of cancer treatment.

Wu Hai, Chief Scientific Officer of Shanghai Junshi Biomedical Technology Co., Ltd.: After the work here, we will go outside to do real antibody screening work, but this step is very important, because once the hybridoma can't grow up, or If the growth fails, the outside work will be meaningless.

Speaking of cancer, these two words are in the heart of Wuhai, it is a pain forever. In 1996, when Wu Hai’s mother died of cancer, this grief also prompted him to invest in the development of anticancer drugs.

In 2012, Wuhai returned to China and founded Shanghai Junshi Biological Co., Ltd. with his companions to focus on the development of anticancer drugs such as PD-1 monoclonal antibody. Wuhai then established this research and development platform in San Francisco.

Wuhai: Our North American point is currently doing early research and delivering the earliest ammunition to the parent company. Currently, we are working on a project with 11 antibody projects, and 10 antibody projects are started in San Francisco.

In the production line of Wujiang District, Suzhou. Antibodies developed by US laboratories are here for process development and production. At present, Wuhai's R&D team has two projects that have been established as major national drug innovation projects. Among them, the anticancer drug PD-1 monoclonal antibody is undergoing Phase I clinical trial at the Cancer Hospital of Chinese Academy of Medical Sciences.

Shi Yuankai, deputy dean of the Cancer Hospital of the Chinese Academy of Medical Sciences: Even if the imported drugs are listed in China, its price is definitely not affordable for ordinary people. If domestic drugs are listed, its price is definitely cheaper than imported drugs. A lot, so it can benefit the majority of ordinary patients in China.

A little mouse needs 50,000 dollars! New drug research and development test China's strength

Monoclonal drug therapy is widely used in tumors, autoimmune diseases, viral infections, osteoporosis, cardiovascular and cerebrovascular diseases because of its targeting, low toxicity and good curative effect. However, the development of monoclonal antibody drugs has the characteristics of high cost, difficulty, and limited production capacity, and has extremely high requirements for the technology and capital of R&D companies. There is still a big gap between the research and development of monoclonal antibody in China and the international advanced level.

Internationally, the scale of “bioreactors” is often used as one of the criteria to measure the industrial level of a country's biopharmaceuticals. The total size of the United States is about 1.3 million liters, South Korea is about 570,000 liters, and China has only 50,000 liters, less than 4% of the United States.

Zhang Zhuobing, deputy general manager of Shanghai Junshi Biomedical Technology Co., Ltd.: The manufacturing process just said that the equipment is all people's. In the technical process, like the medium, like some analytical methods, the reagents analyzed are all foreign.

In order to be in line with international standards in drug research and development, this group of Chinese researchers has set up two laboratories in San Francisco and Maryland in the United States, responsible for the research and development of drug front-end.

At Shanghai Junshi's Cancer Immunology Laboratory in Maryland, USA, Yao Sheng, one of the founders of Junshi, is responsible for the development of targets for oncology drugs. Yao Sheng told CCTV Finance that "the economy is half an hour", most people in the body have tumor cells and immune cells in battle all the time. The work here is to find help by observing the interaction between cells and proteins. The method by which immune cells fight cancer cells.

There are about 6,000 human cell membrane receptor proteins known at present, and the relationship between different tumors and these receptors can be said to be ever-changing. Randomly searching for useful targets can be found in the needles of the sea. Junshi is also actively collecting many A biological sample of a patient who has overcome cancer, looking for new antibodies to fight cancer.

Yao Sheng, deputy general manager of Shanghai Junshi Biomedical Technology Co., Ltd.: Now we have found some patients with tumors that have subsided in our patients. We have found that they often have some beneficial antibodies produced by themselves. It is very unique, other patients are not, so through this platform, we can find out what these antibodies are.

In the animal laboratory of Suzhou Xinda Biological, mice for the production of human monoclonal antibody were raised. These mice are similar in appearance to the general experimental mice, but in order to become an animal for the production of monoclonal antibodies, these mice must be genetically engineered to carry genes that produce human antibodies. . This is also the most basic condition for the development of anticancer drugs.

Yu Dechao, Chairman of Cinda Biopharmaceutical Suzhou Co., Ltd.: I bought a mouse for 50,000 US dollars. This mouse can't be reproduced. It won't breed. He has already disposed of it for you.

In 2013, when Cinda Bio began to develop anti-cancer drug PD-1 monoclonal antibody, it faced the embarrassing situation that it could not find a mouse for animal model in China.

Yu Dechao: At that time, there was no such thing in 2013, so if you take this medicine, the clone you selected will not work. There is no way to judge.

In order to solve this animal pharmacodynamic problem, two years ago, Yu Dechao hired an expert with more than 20 years of experience from the United States to help Cinda Bio to develop its own animal model. The mice they use now are a valuable achievement in two years.

Yu Dechao: We can now proudly say that it should be in the domestic animal model, I guess it is not one of the best, the best.

The manufacture of anticancer drugs in China is not only a little bit of completion in research and development, but also at the forefront of biopharmaceutical manufacturing workshops in the world of drug development. Chinese scientists are also stepping closer to world-class levels.

Yu Dechao: In the United States, the entire cost of such a drug costs hundreds of thousands of dollars a year. This cost is not available to most Chinese people. So one of our goals is to change this situation. We initially estimated that because the specific drugs did not come out, it is not easy to say how much, but the initial planning should not be a year's cost, for example, should not exceed 100,000.

Half an hour of observation: the speed of China running for life

In fact, we all know that there is no absolute medicine in the world. The process of human and disease resistance is an eternal topic. A sudden illness is often the most difficult pain for a family. The process of drug development is actually the process of racing against time. The scientists who have just discovered the drugs have actually become famous, but the motivation for running for life has returned to the motherland and took up anticancer drugs. R&D work.

In the financial sector, the development of new drugs is a very risky industry. The investment of hundreds of millions of yuan is very likely to be lost. But it is this courage and responsibility that human beings will have more on the road to fighting disease. Ways and hopes.

Since 2006, the state has intensively introduced a series of support policies in the field of bio-pharmaceuticals. At present, some drugs have entered the clinical trial stage. Once the domestic anti-cancer drugs are successfully developed, those imported anti-cancer drugs worth hundreds of thousands of yuan will be more For the economy, more effective Chinese manufacturing, for the benefit of patients, for the benefit of one family, we thank this speed of life for China, praise this real China manufacturing.

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