. According to our research, the small amount of Ricardin products (more than 100 needles) sold by the company in 2007 were basically used after
liver cancer patients tried all the methods ineffectively and despaired, and so far, the efficacy has exceeded
expectations, and some hospitals have found that Ricardin is particularly effective against metastasis of the cancer cells during the process of using it.
. The research and development and Phase I clinical trial of Licatin was completed by the Fourth Military Medical University, and the Phase II and III clinical trials were completed by the Huashen Group
, which took more than 2 years and resulted in 103 clinical cases. Results from the clinical trials that have been conducted with Ricardin show that
103 patients with primary liver cancer showed significant improvement in their symptoms after 2 cycles (2 Ricardins) of treatment.
Figure 1 Licatin clinical data
Clinical remission rate (CR + PR) 8.22%
Clinical efficacy rate (CR+PR+MR) 27.40%
Clinical control rate (CR+PR+MR+SD) 86.30%
Median survival time 19 months
18 months Survival rate 51.98%
Reproduced from the research report
The treatment cost about 60,000 yuan with "Ricardin" treatment, a shot of 28,000 yuan.
Title of the article Post-intervention liver cancer
Content of the article Hello, doctor! My father has had 3 interventions since the discovery of liver cancer, the tumor control is good, AFP has dropped from 1000 to 9 now, liver function is good, ALT is 58, AST 51, bilirubin, protein are normal. But GGT288, ALP180 is a bit high, and the color of the face is a bit dark, the pores are a bit big, it seems that the liver detoxification function is not good? Is there any way to lower GGT and ALP? I'm not sure if I can do that, but I'm not sure if I can. Thank you
Response Hi, I'm sorry to reply to your message only now because the experts of the liver cancer group have gone to attend an academic conference outside. I don't know if you did Lichen planus in our hospital, if so, can you tell us your name, we can call up your father's medical records, and answer you according to the specific situation, can you?
Published: 2008-3-14
---------- from the People's Liberation Army (PLA) No. 458 medical (in Guangdong) website/index.asp
It is a pity that one of my cousins, who works in Guangzhou, was not able to use Ricardin, and his life was ruthlessly taken by liver cancer in June last year, which made his family as well as our clan heartbroken. heartbroken, because he was also a not-so-small official and our pride. According to the information of your hospital, it should be more than 6 months since the first batch of patients who used Ricardin in your hospital. How many of them are still surviving? What is the percentage of survival? Have any of them received the second injection? I really hope that you can tell the eagerly waiting patients about the real effects of Ricardin as soon as possible! Thank you!
Response Hello, the average survival time for patients diagnosed with hepatocellular carcinoma is 4.2 months, and the median survival time for patients treated with Ricardin is more than 19 months. Our center has treated more than 80 cases of liver cancer patients with Ricardin, and the effective rate is more than 60%. Ricardin can be injected in 1-6 injections. Up to now, more than ten patients in our center have received the second injection and five patients have received the third injection. Compared with traditional chemotherapeutic drugs, Ricardin has basically no side effects, with occasional transient low-grade fever and rash. The safety profile is high.
Published by jyx on 2008-3-4
----------Transferred from the website of People's Liberation Army (PLA) No. 458 Medical (in Guangdong)
Transferred to China Broadcasting Network: China independently researches and develops the first human targeted drug for hepatocellular carcinoma, Ricardin, which has been successfully launched on the market
2007-12-18 15:10:19 (Has been viewed 286 times)
CGN 07-12-17 18:37
CGCN Xi'an, Dec. 17 (Reporter Lei Kai Wang Jun Kang Weijia Correspondent Luo Liqiong) The Fourth Military Medical University held a high-quality construction results exhibition on the 17th to announce that China's independent research and development of the independent intellectual property rights of the national biological products of a new class of drugs iodomedicine injections (Ricardin)" has been approved for production and is now on the market nationwide. This is the first specific antibody-targeted drug in the world for the treatment of hepatocellular carcinoma, and also the first tumor antibody drug with complete independent intellectual property rights and new drug target in China.
Hepatocellular carcinoma is a dangerous disease with rapid progression, high mortality rate and poor therapeutic effect. There are three high incidence areas in the world, i.e., mainland China, Southeast Asia, and Africa, and according to the World Health Organization's annual health report, the incidence rate of hepatocellular carcinoma is 23.7/100,000 people. Globally, 620,000 people die of liver cancer every year, and China accounts for 45%. Only 11% of patients can receive surgical treatment, but the postoperative recurrence rate is high.
In 1987, Professor Chen Zhinan, Director of the Cell Engineering Research Center of the Fourth Military Medical University, led a group to develop antibody drugs. It has taken 20 years since the acquisition of HAb18, a monoclonal antibody specific for liver cancer and other tumors, to overcome eight key technologies, including antibody specificity screening, engineering cell preservation and subclonal quality control, targeted antigen acquisition, antibody iodine labeling technology, antibody pilot scale-up and production process, antibody and marker quality control, research on the principle of action of antibodies, and preclinical studies of antibodies and markers, and to obtain The company has also obtained 8 key technologies, including antibody light and heavy chain variable region genes and antigenic amino acid sequences, etc., and established key production technology platforms such as Metuximab preparation and cell fermentation, as well as 8 national invention patents and software copyright authorizations for antibody applications, and applied for 2 PCT international patents at the same time.
According to clinical experts, "Iodomedoximab Injection (Ricardin)" is safe and effective, which solves the fragmented antibody preparation technology for the first time, cutting the antibody with enzyme digestion and removing the Fc segment that causes non-specific binding, reducing the molecular weight of the antibody so that the targeting carrier is easy to penetrate and enter into cancerous tissues, and also The disadvantage of causing antibody immune reaction was solved. The clinical efficacy of this new drug is relatively certain, and it can be used as the first-line treatment for all stages of hepatocellular carcinoma or combined with radiotherapy and chemotherapy. The clinical effective rate of this drug is 27.4%, the clinical control rate is 86.3%, and the long-term efficacy is good, the 32-month survival rate reaches 31.03%. And it has better efficacy in anti-recurrence treatment of hepatocellular carcinoma.
Transferred to the China Broadcasting Network: Fourth Military Medical University, a series of high-quality results show press conference
2007-12-18 17:45:07 (has been viewed 637 times)
[Moderator]: Honorable friends of the press, comrades:
First of all, allow me to on behalf of the school of the Chinese Academy of Engineering, the Fourth Military Medical University, Fan Dai Ming President, Sun Changxin political commissar, to all friends of the press to participate in today's high-quality results of the series show press conference to express a warm welcome and heartfelt thanks.
Today we are mainly the fourth medical university scientific research field has three consecutive scientific research topics here to realize the breakthrough of the major achievements of the initial sex, this military force medical university is very good for the benefit of patients, our school in the recent period of time, scraping up a storm called the 500 project down to the grass-roots level, the top ten high-quality goods on the level of this level of hanging up the top and bottom of the internal and external better, how a good method, a moment our president will Tell everyone. Attending today's press conference media friends are: Xinhua News Agency, News Agency, People's Daily, People's Liberation Army Daily, Guangming Daily, Health News, Science Daily, China Youth Daily, China Education News, the Central People's Broadcasting Station, China Central Television, Phoenix TV, Shaanxi People's Radio and Television, Shaanxi Television, Shaanxi Daily, Xi'an People's Radio and Television Station, Xi'an Television, Xi'an Evening News, Sanqin Metropolis Daily. Xinhua, Sohu, China Broadcasting Network, China Western Network and so on.
Leaders and experts attending today's press conference are: academician of the Chinese Academy of Engineering, President Fan Daiming of the Fourth Military Medical University, Political Commissar Sun Changxin, Major General, Minister Wang Xi; organs, departments and affiliated hospitals related to the leadership: Yu Guoliang, Huiguoqiang, Zhao Iridium; three project leaders: Chen Zhinan, Zhang Yingqi, Jin Yan.
Friends, the Fourth Military Medical University is known for its outstanding ideological and political work, strong overall strength of the discipline and superb medical technology, as early as 1959 was identified by the Central **** as one of the country's 20 key universities. Is the country's "211 project" key construction institutions, together more than 20 years, has created a medical miracle and one after another, especially this year, the school has implemented the strategy of the real quality, blowing up a "storm of excellence", greatly advancing the construction of international advanced research-oriented military medical university process. Research-oriented military medical university process. One is the artificial skin which obtained the first five one project registration certificate of the country, later on, Prof. Jin Yan will introduce to you. The second is to obtain a national class certificate of new drugs called Ricardin, by the Department of Basic Yu Guoliang, director of the introduction; by the Department of Pharmacy Huiguoqiang, director of the introduction of a national class of new drugs recombinant reconstructive tumor necrosis factor; "five hundred projects down to the grass-roots level ten fine level," the situation, by the president of the Fan Dai Ming for the introduction of the last, and we would also like to thank the media.
[Yu Guoliang]: I published a new drug by the Fourth Military Medical University Technology Department research success, this drug belongs to the national biological products class of new drugs, it is the name of the commodity is "Ricardin".
"Ricardin" is a drug for liver cancer treatment, and I would like to briefly introduce to you five aspects of "Ricardin": its significance and market status, therapeutic effects, scientific benefits, and successful experience.
First, the significance and generation of "Ricardin". We know that China, Africa, and Southeast Asia are the three major regions in the world where liver cancer develops, and 620,000 people die of liver cancer every year, with China accounting for 45% of the total. The incidence and mortality of liver cancer is high, and surgery is the first choice of treatment, but only about 30% of the patients have the chance to have surgery. Liver transplantation is one of the radical treatments for liver cancer, however, only about 5% of liver cancer patients get liver transplantation in clinical practice. The reproduction rate of liver cancer chemotherapy for two years is also only 22% to 27%. In response to the serious problem of the relatively poor treatment of liver cancer, Prof. Chen of the technical department of our school and the group led by him started the preparation of liver cancer antibody in 1982, and with the support of the national 863 and other major projects, we finally obtained the Likertin certificate of eight core technologies through 25 years of arduous and hard work, and on the basis of which, we got the favorable cooperation from Chengdu On this basis, we got the favorable cooperation from Chengdu Huashen Group, and "Ricardin" was successfully listed in May of this year, and we would like to express our respect and gratitude to Huashen Group for its contribution.
Secondly, the market status and characteristics of "Ricardin". It is the result of entering the world's landmark industry, is the independent property rights of China's new eight drugs, it is like a biological missile penetration, "Ricardin" is the world's first eight drugs specialized in the treatment of liver cancer.
Third, the therapeutic effect of Licentin. At present, Ricardin has treated more than 800 cases of liver cancer patients, with a clinical effectiveness rate of 27.4% and a clinical rate of 86.3%. "Ricardin can also be used as a first-line drug for malignant liver cancer, or as a combination of chemotherapy, and it also has good efficacy in anti-liver cancer recurrence.
Fourth, the scientific benefits of Licarin. The research content related to Ricardin has published 45 scientific papers in international famous journals, and applied for three international patents, and the results have won the National Progress Award, and the research platform created with the traction of Ricardin has become the National 863 Xi'an Base, which has become the Antibody Engineering Science Center of our country, and the National Antibody Engineering Science Center of China. Prof. Chen, the developer of "Ricardin", has made outstanding contributions and surrendered as an academician of the Chinese Academy of Engineering with a high vote in 2007.
From the successful development of Ricardin, the experience we have gained is to grasp the most important issues to know the difficulties, adhere to the most important character of pragmatic, with the most important platform to govern the market wisdom, to grasp the best, the most important direction to make the research and industry combination. The pursuit of the most important benefits, is to benefit the people, put forward a number of good results, I hope that friends who are interested in the development of China's medical community to actively participate in our research and development, so that the results of industry, academia and research become the main point of production of our enterprises, the following please Professor Chen Zhinan continue to teach the "Ricardin" related information.
[Chen Zhinan]: Good morning, guests and friends! I continue to release the introduction of the important work of the National Biological Products "Ricardin".
Just now, Director Yu Guoliang of the Fourth Military Medical University has made a brief introduction to the incidence of liver cancer. In 2006, the Ministry of Health and the Health Statistics Information Center released that the mortality rate of liver cancer is 2.87 per 100,000, so liver cancer has been the second largest killer in our country and even in the world, and its treatment effect is relatively poor, the rate of surgical resection is less than 30%, and the rate of transplantation of liver cancer is only 5%, but both of them have an important defect, that is, liver cancer is very easy to metastasize, and the recurrence rate of one year is more than 50%. The recurrence rate in one year is more than 50%. The two-year survival rate is 22% and 22.7%, so it is very important to develop new drugs for liver cancer. In view of the current situation of the clinical needs of liver cancer, our country develops new drugs, which have two main points, one is the combination of first-line therapeutic drugs and chemotherapeutic drugs for all stages of liver cancer, especially the middle and advanced liver cancer for which the surgery and interventional therapy are ineffective.
Our first major work is that since 1982 we have obtained a number of monoclonal antibodies with independent intellectual property rights, including eight antibodies of our class I new drugs, these independent intellectual property rights of the antibody has obtained the national invention patent, authorized three, this is the HAB18 monoclonal antibody, this patent has obtained the national patent invention award, and has entered the European, Japanese, American development stage, the second work, we discovered and identified the new points of this antibody drug.
The second work is our monoclonal antibody screening human liver cancer tissue CDNA expression library, is a targeted molecule, after the necessary gene library, has gained international recognition, after a long period of research, found that it promotes cancer proliferation metastasis, we use this antibody, it can be anti-liver cancer and its metastasis.
After a lot of our research, anti-liver cancer experiments, including in vivo animal experiments. Then we determined the cancer tissue library of this molecule, the expression of this molecule in the middle of the tissue, and also again its specificity, in embryonic tissue is only 2.67, in normal tissue is only 5.18, this is reflecting a very low low, in hepatocellular carcinoma positive expression to 66.64%, so it is a marker. The third important work is that we analyzed the crystal structure of the extracellular segment of HAB18 for the first time, and we found that a new discovery has to have a certain basis, and the most important basis is that we found its structure, which has been applied for a national invention patent, and this code structure has been registered in the international code database. The blue and green colors represent the two important areas of the antibody, which are very important for binding to the antigen. The red area below is the target antigen, which is the H18G extracellular molecule, and after this molecule is bridged, we found its epitope sequence by amino acid mutation, which is a safe sequence for the antibody to target the antigen, and this work has been applied for a patent.
How did we develop this liver cancer monoclonal antibody?
The antibody is a Y-shaped antibody, there is a FC segment below, this segment is very easy to produce side effects, after entering the human body to cause the role of the antibody, we first thought of cutting off this segment, which is the monoclonal antibody, let's come to Iodine 131, after entering the human body, he is able to be highly selective to reach the site of liver cancer for the purpose of killing, the main effect of the drug like a biological missile to kill it directionally, as well as a biological missile to kill it, the main effect of the drug, it can be used to kill the liver cancer. The main effect of the drug is like a biological missile to kill it in a targeted manner, and there is also a role for a lot of highly expressed molecules on the liver cancer, he can limit the target.
The new drug was approved by the State Food and Drug Administration in 1999, and entered the clinic in 1999. After the first and second phases, the effective rate was 27.4%, but the clinical rate was 86.3%, which means that after the treatment of one additional patient, it did not expand or shrink, so the control rate is still very high. Its survival rate is outstanding, the survival rate in 24 months is 43.51%, and the survival rate in 32 months is 31.03%. The tumor was very large before treatment and gradually shrunk after treatment, shrinking by 50%. This patient's tumor was in the middle of the body and could not be removed surgically. After this treatment, the tumor disappeared from the CT scan.
This new drug we entered the clinic from 99 years, 05 years after six years of time, six years of clinical, in 05 years in April to obtain a new drug certificate of a class of biological products, 07 years in January to obtain GMP product certification, 07 years in April to obtain the production of radiopharmaceuticals, 07 years in May on the market, then to obtain the market after the expansion of application of the treatment, the rate of clinical control and the clinical efficiency has also improved than the second stage, the clinical control rate and clinical effectiveness. The clinical control rate and clinical effectiveness rate were also improved compared with that of the second phase, with the clinical control rate reaching 90.1% and the clinical effectiveness rate reaching 31%. In addition, this new drug also has an obvious characteristic, it has the effect of anti-relapse treatment, we did 60 cases, divided them into two groups, one is "Ricardin" treatment, a group is not "Ricardin" treatment, after the treatment of the pair of comparisons, by the "Ricardin" treatment, the "Ricardin" treatment was used to treat the patients. "The one-year survival rate for the group treated with Licarin was 20.62%.
Antibody production process in our university, our laboratory, it should be said that in the country is the first to carry out this work, we began such work in 2000, in the period of fifteen years, undertook a major national scientific and technological special projects, animal cells in large-scale cultivation of the Middle World Industrial Platform. This project was completed by three academies of sciences and three universities, by the Chinese Academy of Sciences, the Western Academy of Sciences, and the Academy of Military Sciences, by the Fourth Military Medical University, Jinan University, East China University of Science and Technology, which is also the country's six top units in this area of industry, academia, and research to be responsible for the completion of this project, we are as a front unit, the completion of the major projects, but also to build the production of these major projects of antibodies to the new technology platform!
There is also a class of cells through the cell fusion method, has been separated from the function of the antibody, so this class of cells, we call it engineering cells, we have established this class of animal cells engineering cells I to 300 liters of large-scale cultivation of pilot technology platform, so far in our country to do a better job there are three to five, in the 300 liters above the large-scale, in the past, we produce antibody In the past, we used mice to produce antibodies, but now we produce antibodies in line with international standards, and cooperate to set up a 3,000-liter scale engineering cell industrialization technology platform. So far, it is the first cell industrialization technology platform with more than thousands of liters, and we are also the national pilot platform, so we also shoulder some important responsibilities for technical training of colleges and universities, scientific research units and enterprises, so far, through our cooperation with 9 colleges and universities, scientific research units and 48 senior engineers and technicians, so far, it is the only one pilot base in our country.
Up to now, we have accumulated 813 cases of Iodine 131, which has been promoted in more than 30 hospitals across the country, including 17 hospitals, including the Affiliated Hospital of Tongji University in Shanghai, the First Affiliated Hospital of Xi'an Jiaotong University in China, and the Fourth Military Medical University, and the Shaanxi Cancer Hospital, etc. Four clinical trials were conducted by our Fudan University, and the first trial was conducted by our Fudan University. Now four clinical is led by our Fudan University, Shanghai Medical College, Zhongshan Hospital. This project has obtained 11 relevant patents, 11 patents have been authorized, there are two belong to the software production rights, that is, we develop cell culture related control software. There are also three PCT specialties and others have entered Europe, the United States, Japan and other countries, this project so far we have 45 articles.
Cited by the SCI 123 times won the second prize of the National Scientific and Technological Progress in 2005. We have been working on this project for 25 years, starting from 1982, the successful preparation of monoclonal antibody in 2007, the declaration of new drug in 1994, the determination in 1999, and finally the completion of this process in May this year, we have made some contributions to the industrialization of antibody drugs in our country, and again, we are very grateful to our cooperation unit, Chengdu Huashen Group, for their contribution and efforts in this regard.
Fourth Military Medical University independently researches and develops liver cancer targeting drug
Dec 17, 2007 17:25:49 Source: Xinhua News
Xinhua News, Xi'an, Dec. 17 (Xinhua Xu Zuhua, Ding Haitao) - The reporter learned from the Fourth Military Medical University on the 17th, the university independently researched and developed the specific antibody targeting drug used for treating liver cancer, iodine [131]. --Iodine [131 Ⅰ] Metuximab injection (Ricardin).
The drug was developed by a group led by Professor Chen Zhinan, director of the Cell Engineering Research Center of the Fourth Military Medical University, after 20 years. According to clinical experts, Ricardin is the first to solve the
fragment antibody preparation technology, so that the target carrier is easy to penetrate into the cancerous tissue, while at the same time solving the drawbacks of causing antibody immune response. It can be used as the first-line treatment for all stages of hepatocellular carcinoma or the combination of radiotherapy and chemotherapy.
According to the annual health report of the World Health Organization, 620,000 people die of liver cancer every year worldwide.
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