China's new cancer patients every 8 minutes
Professor Luo Yongzhang of Tsinghua University's School of Life Sciences: In 2015, there were about 4.3 million new cancer cases in our country, and the number of deaths was 2.8 million, which means that the average number of new cancer patients per minute was already more than 8 people.
Luo Yongzhang, a professor at Tsinghua University's School of Life Sciences, threw out a series of cold, hard cancer numbers at the start of this April 22 symposium on new cancer markers. The World Health Organization predicts that in 2020, there will be 20 million new cases of cancer worldwide and 12 million deaths due to cancer. Finding effective means of cancer treatment and monitoring is the direction that many scientists around the world are working towards. However, in reality, how to detect cancer in time has been troubling the medical community at home and abroad.
Luo Yongzhang: So why is it that once a tumor is detected, it's mostly in the middle or late stages, that's the first question I'm asking. The second, as we all know, is that more than 90 percent of malignant tumors eventually die of metastasis, but if they can be detected early, the cure rate can be as high as 95 percent.
Major breakthrough! A drop of blood can measure cancer
Ninety percent of early cancers can be cured, while late cancers are nine times more likely to die. Tumors are secretive, and although early tumors are good to be cured, they are often easy to be detected in the late stage due to the lack of obvious symptoms. Late-stage tumors have already metastasized and spread, which is very difficult to be cured. Luo Yongzhang saw this fact painfully when he first graduated from university in the 1980s.
Luo Yongzhang: After graduating from college, one of my classmates was found to have cancer, and it was pancreatic cancer, and he died less than six months after the operation. So before this classmate of mine passed away, I hope I can study a major related to oncology.
The death of a close classmate due to cancer y stimulated Luo Yongzhang, who changed his major from undergraduate chemistry to biology during his studies in the U.S. From then on, he began a career of fighting against cancer. 1998, a fortuitous opportunity prompted Luo Yongzhang to return to China and develop a new anticancer drug called Endo, which has brought the price of medicines down dramatically. However, the problem of early detection of tumors has also been plaguing Luo Yongzhang. The existing medical community, used to detect cancer tumor markers, are unstable problems, it is difficult to timely detection of potential danger. How exactly can we find a fast track to timely detection of tumors? For more than two decades, Luo Yongzhang and his team have been searching for an answer.
In fact, as early as 1989, academics have found that heat shock protein 90α in human body can be a marker for tumor discovery, more than two decades, research teams from all over the world have published more than 10,000 research papers around this protein, and produced three American academicians and three European academicians, but no research results have been transformed into products. 2009 Luo Yongzhang team began to intervene in the research, and through recombinant proteins, the research team has been able to find a fast channel for timely detection of tumors. In 2009, Luo Yongzhang's team began to intervene in the research and artificially produced the structurally stable heat shock protein 90α through recombinant protein large-scale preparation technology, which is equivalent to their freedom to "manufacture" this protein. On this basis, they also independently developed a reagent kit specialized in the detection of heat shock protein 90α. Patients only need to take a drop of blood, which can be used for monitoring cancer conditions and evaluating treatment effects.
Luo Yongzhang: Take a person's blood, later put it inside this box, interact with the antibody, and see the color change, so that you can quantitatively detect the amount of natural HSP90α.
In 2013, Luo Yongzhang's team, together with eight hospitals, including the Cancer Hospital of the Chinese Academy of Medical Sciences, collected 2,036 enrollment samples and completed the world's first clinical trial of heat shock protein 90α as a marker for lung cancer. It proved for the first time in the world that heat shock protein 90α, is a brand new tumor marker. At present, our self-developed Hsp90α quantitative test kit has passed the clinical trial validation, obtained the national certificate of the third and highest category of medical devices, and passed the European Union certification, approved to enter the Chinese and EU markets.
The research of Luo Yongzhang's team has caused a sensation in the international medical community, with a special letter of congratulations from Dr. James Watson, the discoverer of the DNA double helix and Nobel Prize winner. Published in 2009 in the Proceedings of the National Academy of Sciences of the United States of America, it has attracted widespread attention and citations from international peers. The State Food and Drug Administration (SFDA) soon approved it for disease monitoring and efficacy evaluation of lung cancer patients. This is the first product in the world to use human Hsp90α for clinical use in the 24 years since its discovery.
After lung cancer, Luo Yongzhang's team completed a clinical study on liver cancer in 2016, demonstrating, for the first time in the world, that heat shock protein 90α can be used in liver cancer patients, and has now been approved for use in the clinic by the State Food and Drug Administration. In addition to the monitoring of liver and lung cancers, thanks to the heat shock protein 90α detection technology, doctors can get timely information when some cancers metastasize to two organs, the liver and the lungs, so that they can make the best treatment plan.
Cancer "magic mirror" by the state licensing, but met the threshold of promotion
Luo Yongzhang team developed a can detect the heat shock protein 90 alpha kit, and this kit is just a laboratory product, to make it serve millions of patients must realize its industrialization, this process is not simple.
In 2008, Progeny and Tsinghua University*** established the National Engineering Laboratory for Anti-tumor Protein Drugs, which is the first national engineering laboratory approved by the National Development and Reform Commission at Tsinghua University. In the company's laboratory, the head of the R&D center, Li Michuan, showed us the heat shock protein 90α kit that has been mass-produced. The whole process of using the kit to detect human heat shock protein 90α takes only 3 hours, and there is no high technical threshold. However, it is not easy to standardize the mass production of the kit.
Yantai Prodigy Biotechnology Development Co., Ltd. general manager Cui Dawei: In the field of biopharmaceuticals, in fact, the beginning of the laboratory research many times will be successful, but when it comes to the real mass production, that is, we are called to amplify the experiments, it is very likely to encounter difficulties.
In 2009, David Cui went to Yantai to set up a heat shock protein 90α kit factory. To transform the scientific research in the laboratory into products, the first and foremost is the technical amplification of the problem. Laboratory research on heat shock protein 90α antibody demand is small, do not need to keep it stable for too long. To mass-produce the kit, David Cui had to make the heat shock protein 90α solution stable enough to ensure a long sales period. In order to stabilize the heat shock protein 90α solution for mass production, David Cui spent a year developing a protective solution system for heat shock protein 90α. This allowed them to make the product effective for more than a year. And the highest level abroad can only maintain stability for six months.
The heat shock protein 90α kit went from the lab to the factory and then from the factory down the production line, the R&D and production team had a bumpy ride. However, whether heat shock protein 90α can really be a demon-masking mirror of cancer, the most important thing is still need to be clinically tested, so how does the heat shock protein 90α test actually work?
The middle-aged man whose blood is being collected is a cancer patient. He was diagnosed with advanced lung cancer in 2014. Surgery and chemotherapy followed, and he was in desperate need of an effective tumor test to keep up with changes in his condition. When he happened to learn about the heat shock protein 90α testing technology, he had a variety of tumor tests including it. Today, he came to the Physical Examination Center to check his heat shock protein 90α value.
Patient: by the time in September did it again, this time from the operation has been 9 months, this time all the other conditions are still showing normal. Like CE1, Ca125 tumor markers, these are normal, but the 90 alpha went to more than 100, 120 something. This is not normal.
In addition to the abnormal value of heat shock protein 90α, other tumor markers are shown to be normal, coupled with no other reaction, so that the patient did not attract much attention. But to his surprise, by 2015, the other tumor marker indicators were also abnormal.
Cancer patient: has been to 2015, this time the CT has been obvious problems, the body can also feel the bad feeling. Then this time began to take medicine. At that time was in the CT and a few other six months in advance, 90a reflected, if I had the knowledge of this at that time, should be alert, earlier intervention.
Now, after active treatment, this patient's condition has been controlled. Using a variety of means to detect changes in his body has become a must for him.
PATIENT: By June 2016, the 90a had dropped back down to the 60s, as the CT showed it was also good.
Clinical data show that in lung cancer, the traditional tumor marker CEA sensitivity is only 54%, with a compliance rate of 66%; while the heat shock protein 90α has a sensitivity of 72%, with a compliance rate of 75%, which is significantly better than CEA. while in liver cancer, the traditional marker AFP has a sensitivity of 53%, with a compliance rate of 74%; while the heat shock protein 90α has a sensitivity of 93% and the compliance rate is 92%.
Wang Huaqing, director of the Cancer Research Institute of Tianjin People's Hospital, said: Heat shock protein 90α has been found to be much better than the markers commonly used in the clinic in basic experiments as well as in non-small cell lung cancer and liver cancer.
While steadily advancing the detection of lung and liver cancers, Luo's team is also actively testing the feasibility of heat shock protein 90α for other cancers. Currently, internal trial data from Progeny show that the sensitivity of heat shock protein 90α on diffuse large B-cell lymphoma, reached 73 percent.
Huaqing Wang: In the lymphohematologic system, that is, in the malignant lymphoma research that I am engaged in, there are also very good seeds in the basic experiments. It is sensitive and specific. We feel that this is undoubtedly a major discovery, then the Chinese people led by us to carry out such research, not only for our benefit in China, but also for the world, in the early diagnosis and treatment of cancer, can make our contribution, we think it is very valuable.
The effectiveness of heat shock protein 90α in detecting liver and lung cancers has been fully verified in the clinic, and the effectiveness test for other cancer detection is also advancing steadily. In the eyes of outsiders, the prospect of heat shock protein 90α application should be a bright one, while David Cui believes that the good times are far from over. Right now, although the heat shock protein 90α detection technology has obtained the national license, but the promotion of a relatively short period of time, sales are not large. The Yantai factory of Progeny, often "three days fishing, two days sunshine net".
Cui Dawei: Now the overall sales are still not big enough, this is also a piece of our urgent need to develop, we are now because of the sales are not enough, so our plant is not continuous in the production of our production once about two months can be supplied to three to four months of use.
During the shutdown, employees at the Progeny kit factory had to spend their time maintaining machines and producing training. The huge investment in research and development in the early stage, while the production and sales volume is insufficient, making it impossible to reduce production costs. Right now, the average price of heat shock protein 90α test in the hospital is about 300 yuan. While other tumor tests, such as CA series, the average price is only 80, 90 yuan. In addition, because Progeny has not yet applied for the procedures into the medical insurance, patients in the hospital to test heat shock protein 90α, can not enjoy medical insurance.
Cui Dawei: we do than some of the existing markers to be expensive, the first piece is that we are now the initial R & D investment is huge, this is one aspect. The second piece of our market is not open, our average cost of amortization will be very high, so this is also a piece of, as we promote the market, then we will certainly cost price more and more down, this way then will be conducive to more people to use our product.
The production line can not give full play to the capacity, holding a golden bowl but can not find sales. Right now, the company is doing promotion one province at a time. They have passed the price approval of 13 provinces and cities, and are in the process of admission to more than 100 hospitals.
Luo Yongzhang: I call for a gift to parents, the best is to give the gift of a medical examination, which is the most important, so that people can be early detection, and then treatment, nip the tumor in the bud, early detection is a person's life, late detection is what medicine can not help.
Half-hour observation: more "world firsts" are needed in the fight against cancer
As the saying goes, 90% of early cancers are curable, while late cancers are deadly. Early detection is the most effective way to treat cancer. We are very pleased that Luo Yongzhang team after years of unremitting efforts, for China to get a cancer detection in the field of the world's first, this is a full of gold "world first", we hope that the pace of its promotion can be a little faster, so that the Chinese manufacturing can be a little more. A little more of this "world's first" can win a little more time for millions of cancer patients, and give birth to one more point of hope.