According to our investigation, a small number of Likatine products (100 needles) sold by the company in 2007 are basically in existence.
Liver cancer patients use it after all kinds of methods have been tried to be ineffective and desperate, and the curative effect is super good so far.
As expected, some hospitals also found that licardin was particularly effective in treating cancer cell metastasis.
The research and development of licatin and its clinical application in the first phase were completed by the Fourth Military Medical University, and the clinical application in the second and third phases was carried out by Huashen Group.
It took more than 2 years to complete, with clinical cases 103 cases. According to the clinical trial results of licatin,
103 the symptoms of patients with primary liver cancer were obviously improved after two cycles of treatment (2 licatin).
Chart 1 clinical data of licatin
The clinical remission rate (Cr+PR) was 8.22%.
The clinical effective rate is 27.40%.
The clinical control rate (Cr+PR+Mr+SD) was 86.30%.
The median survival time was 65438 09 months.
18 months survival rate was 5 1.98%
Transfer from research report
Primary liver cancer (HCC) is a serious disease that seriously endangers human life and health. Every year, 55% of new HCC cases occur in China. In China, the average standardized mortality rate of HCC is 14.52/65438+ million for men and 56 1/65438+ million for women. There are about 654380+ million deaths in China every year. The incidence of liver cancer is hidden, and less than 30% patients can get surgical treatment opportunities represented by hepatectomy. At the same time, the recurrence rate of liver cancer after operation is very high, and the treatment of tumor recurrence is relatively difficult. The average 6-month survival rate of patients with liver cancer after diagnosis is less than 50%, and the 5-year survival rate is only 5%.
At present, the commonly used treatment methods include TACE, absolute alcohol injection, cryotherapy, etc. Except early surgery, there are still a large number of patients who cannot get effective treatment because there is no suitable treatment. Therefore, there is an urgent need for new treatment methods and drugs to improve the overall curative effect of liver cancer treatment, which has very realistic and important clinical significance and social value.
China Broadcasting Network: China independently developed the first targeted drug for human liver cancer-Likatine, and successfully listed it.
2007- 12- 18 15: 10: 19
Wang Zhongguang 07-12-1718: 37.
Wang Zhongguang An 65438+February 17 News (Reporter, Wang Jun, Kang correspondent Luo) The excellent construction achievement exhibition held by the Fourth Military Medical University on June 17 announced that a new national biological product with independent intellectual property rights-dimethoxymonoclonal antibody injection (Likatine) was approved for production and listed nationwide. So far, this is the world's first specific antibody targeted drug specifically for the treatment of liver cancer, and it is also the first tumor antibody drug with completely independent intellectual property rights and brand-new drug targets in China.
Liver cancer is dangerous, with rapid progress, high mortality and poor treatment effect. There are three high-incidence areas in the world, namely Chinese mainland, Southeast Asia and Africa. According to the annual health report of the World Health Organization, the incidence of liver cancer is 23.7/65,438+10,000. Every year, 620,000 people worldwide die of liver cancer, with China accounting for 45%. Only 1 1% patients can receive surgical treatment, but the postoperative recurrence rate is high.
From 65438 to 0987, Professor Chen Zhinan, director of the Cell Engineering Research Center of the Fourth Military Medical University, led a research team to develop antibody drugs. It has been 20 years since the specific monoclonal antibody HAb 18 was obtained for liver cancer and other tumors. Eight key technologies have been overcome, such as antibody specific screening, engineering cell preservation and subclone quality control, target antigen acquisition, antibody iodine labeling technology, antibody pilot scale-up and production technology, antibody and marker quality control, antibody drug action principle research, and antibody and marker pre-clinical research. It has also obtained patents on key sources such as antibody light and heavy chain variable region genes and antigen amino acid sequences, established key production technology platforms such as preparation of metuximab and cell fermentation, as well as eight national invention patents and software copyright authorizations such as antibody application, and applied for two PCT international patents.
Clinical experts believe that Iminometuximab Injection (Likatine) is safe and effective. For the first time, the preparation technology of fragment antibody was solved, and the antibody was digested and cut by enzyme to remove the Fc segment that caused non-specific binding, which reduced the molecular weight of antibody, made the targeted carrier easily penetrate into cancer tissue, and solved the disadvantages of causing antibody immune reaction. The clinical efficacy of this new drug is relatively positive, and it can be used as a first-line treatment for various stages of liver cancer, and can also be used as a combination of radiotherapy and chemotherapy. The clinical effective rate is 27.4%, the clinical control rate is 86.3%, the long-term curative effect is good, and the 32-month survival rate is 365,438+0.03%. It has a good curative effect in the anti-recurrence treatment of liver cancer.
From China Broadcasting Network: Press Conference of Outstanding Achievements Series Exhibition of the Fourth Military Medical University
2007-12-1817: 45: 07 (accessed 637 times)
[Moderator]: Friends and comrades in the press:
First of all, on behalf of Academician China Academy of Engineering, President Fan of the Fourth Military Medical University and Political Commissar Sun Changxin, I would like to extend my warm welcome and heartfelt thanks to all the friends in the press for attending today's press conference on outstanding achievements.
Today, there are three scientific research projects in the research field of the Fourth Medical University, and breakthroughs in major achievements are all achieved here. This military medical university has benefited patients a lot. In recent years, there has been a storm in our school, which is called "500 Project", and the top ten products have reached the level. This level is better from top to bottom and from inside to outside. How to make a good method? Our president will tell you later. Media friends attending today's press conference include xinhua News Agency, News Agency, People's Daily, Liberation Army Daily, Guangming Daily, Health Daily, Science Daily, China Youth Daily, China Education Daily, China National Radio, CCTV, Phoenix Satellite TV, Shaanxi People's Broadcasting Station, Shaanxi Daily, xi People's Broadcasting Station, Xi Evening News, Sanqin Metropolis Daily, Xinhuanet, Sohu.com and China Radio Network.
Leaders and experts attending today's press conference are: Academician of China Academy of Engineering, President Fan of the Fourth Military Medical University, Political Commissar and Minister Sun Changxin; Relevant leaders of organs, departments and affiliated hospitals: Yu Guoliang, Hui Guoqiang and Zhao Yimin; Three project leaders:, Zhang,,.
Dear friends, the Fourth Military Medical University is famous for its excellent ideological and political work, strong overall discipline strength and superb medical technology. As early as 1959, it was identified by the central government as one of the 20 key universities in China. It is the national key construction institution of "2 1 1 project". In the past 20 years, it has created one medical miracle after another. Especially since this year, the implementation of the "excellent" strategy has greatly promoted the process of building an international advanced research-oriented military medical university. One is the artificial skin that obtained the first registration certificate of "Five One Projects" in China, which will be introduced by Professor Jin Yan later. Secondly, the new drug with the first-class national certificate is called Likatine, which was introduced to you by Director Yu Guoliang of the Ministry of Basic Education. Hui Guoqiang, director of pharmacy department, introduced the recombinant transformation of tumor necrosis factor (TNF) by a new class of national drugs. President Fan introduced the situation of "Top Ten Quality Products at the Grass-roots Level of the 500 Project". Finally, we also thank the media.
[Yu Guoliang]: The new drug I published was successfully researched by the Technical Department of the Fourth Military Medical University. This western medicine belongs to the national first-class biological products, and the product name is Likatine.
Likatine is a drug for the treatment of liver cancer. Firstly, this paper briefly introduces the significance, market position, therapeutic effect, scientific benefit and successful experience of licatin.
First, the meaning and production of "Likatine". We know that China, Africa and Southeast Asia are the three major regions where liver cancer occurs in the world. Every year, 620,000 people worldwide die of liver cancer, with China accounting for 45%. Liver cancer has a high mortality rate, and surgery is the first choice for treatment, but only about 30% of patients can be operated. Liver transplantation is one of the radical methods for liver cancer, but only about 5% of patients with liver cancer have received liver transplantation. After two years of chemotherapy for liver cancer, the fertility rate is only 22% to 27%. In view of the serious problem of relatively poor treatment of liver cancer, Professor Chen from the Department of Technology of our school and his research team began to prepare anti-liver cancer antibodies in 1982. With the support of national 863 and other major projects, after 25 years' efforts, we finally obtained Likatine certificates of eight core technologies. On this basis, we obtained the favorable cooperation from Chengdu Huashen Group, and in May this year, we "Likatine".
Second, the market positioning and characteristics of Likatine. It is the achievement of stepping into the world's landmark industry and a new type of eight drugs with independent property rights in China. It is like a penetrating biological missile. Likatine is the first eight drugs to treat liver cancer in the world.
Third, the therapeutic effect of licatin. At present, Likatine has treated more than 800 patients with liver cancer, with a clinical effective rate of 27.4% and a clinical effective rate of 86.3%. Likatine can also be used as a first-line drug for malignant liver cancer, or as a combination of chemotherapy, and it also has a good effect in preventing recurrence of liver cancer.
Fourth, the scientific benefits of Likatine. The research content related to Likatine has published 45 scientific papers in internationally renowned journals, applied for 3 international patents at the same time, and won the national progress award. The research platform established by Likatine has become the national 863 Xi 'an base and the antibody engineering science center in China. Professor Chen, a Likatine patient, surrendered himself in 2007 through an academician of China Academy of Engineering, and made outstanding contributions.
From the successful development of Likatine, we have gained such experience: we should grasp the most important problems, advance despite difficulties, adhere to the most important character of seeking truth and being pragmatic, manage market wisdom with the most important platform, and grasp the best and most important direction of combining research with industry. The pursuit of the most important interests is to benefit the people, and many good results have been put forward. We hope that friends who are interested in the development of China's medical industry will actively participate in our research and development, so that Industry-University-Research's achievements will become the main production point of our enterprise. Let's invite Professor Chen Zhinan to continue teaching about Likatine.
[Chen Zhinan]: Good morning ladies and gentlemen! I continue to publish an introduction on the important work of the national biological product "Likatine".
Just now, Director Yu Guoliang of our Fourth Military Medical University has made a brief introduction on the incidence of liver cancer. In 2006, the Health Statistics Information Center of the Ministry of Health announced that the mortality rate of liver cancer was 20.87/100000, so liver cancer has been the second biggest killer in China and even in the world. Its therapeutic effect is relatively poor, the surgical resection rate is below 30%, and the liver cancer transplantation rate is only 5%. But both of them have one of the most important defects, that is, liver cancer is very easy to metastasize, and the annual recurrence rate exceeds 50%. The two-year survival rates are over 22% and 22.7% respectively, so it is very important to develop new drugs for liver cancer. In view of the current situation of clinical demand for liver cancer, there are two main points in developing new drugs in our country. One is the combination of first-line treatment drugs and chemotherapy drugs for liver cancer in various stages, especially for advanced liver cancer that is ineffective in surgery and interventional therapy.
Our first major task is that since 1982, we have obtained a batch of monoclonal antibodies with independent intellectual property rights, including eight antibodies of our new drug. These antibodies with independent intellectual property rights have obtained national invention patents, three of which have been authorized. This is the second work of HAB 18 monoclonal antibody, which won the national patent invention award and entered the research and development stage in Europe, Japan and the United States.
The second work is to screen the CDNA expression library of human liver cancer tissue by using our monoclonal antibody, that is, targeting molecules. After the necessity of gene bank, it was recognized internationally. After long-term research, it is found that it can promote the proliferation and metastasis of cancer. We can use this antibody to resist liver cancer and its metastasis.
After a lot of research, anti-liver cancer experiments, including experiments in animals. Furthermore, we determined the cancer tissue bank of this molecule, and the expression of this molecule in the middle part of the tissue was unique, only 2.67 in embryonic tissue and 5. 18 in normal tissue. This is a very low reflection, and the positive expression in liver cancer reaches 66.64%, so it is a marker. The third important work is that we first analyzed the crystal structure of the extracellular segment of HAB 18. We found that a new discovery has a certain foundation. The most important basis is that we have found its structure and applied for a national invention patent. This code structure has been registered in the international code database. As you can see, the blue and green in this picture represent two important areas of antibodies, which are very important parts of binding to antigens. The red area below is his specific antigen, that is, extracellular molecule H 18G. After bridging this molecule, we found its epitope through amino acid mutation, that is, the safe sequence of antibody against antigen. This work has also been patented.
How did we develop this monoclonal antibody against liver cancer?
The antibody is Y-type antibody, with FC segment below, which is very easy to cause side effects. After entering the human body, it will cause antibody effect. Our first thought is to cut off this segment, which is the monoclonal antibody. Iodine 13 1. After entering the human body, it can reach the site of liver cancer with high selectivity for deliberate killing. The main drug function is targeted killing like a biological missile. There are also
We obtained clinical approval from the US Food and Drug Administration on 1999 and entered the clinic on 1999. After the first and second phases, the effective rate is 27.4%, but the clinical effective rate is 86.3%, which means that even if a patient is treated, the control rate is still high. Its survival rate is outstanding, the 24-month survival rate is 43.5 1%, and the 32-month survival rate is 3 1.03%. Before treatment, the tumor was very large, and it gradually shrank after treatment, shrinking by 50%. The patient's tumor grew in the middle part and could not be surgically removed. After such treatment, you can see that the tumor has disappeared on the CT film.
This new drug entered the clinic on 1999. After six years of clinical practice in 2005, we obtained the certificate of biological products in April 2005, obtained the GMP product certification in 1 month in 2007, produced radioactive drugs in April 2007 and went on the market in May 2007. After marketing, the clinical control rate and clinical effective rate were also improved compared with the second phase, and the clinical control reached 90.65438. In addition, this new drug has an obvious feature. Has the function of anti-recurrence treatment. We did 60 cases and divided them into two groups. One group was treated with licatin, and the other group was not treated with licatin. The one-year survival rate after licatin treatment was 20.62%.
Antibody production technology was first developed in our university and laboratory. It should be said that this work was carried out in China. We started this work in 2000, and during the Tenth Five-Year Plan period, we undertook the major national science and technology projects and the industrial platform of large-scale animal cell culture in China. This project was completed by three academy systems and three universities, by China Academy of Sciences, Western Academy of Sciences, Academy of Military Sciences, by our Fourth Military Medical University, Jinan University, East China University of Science and Technology, and by some units in Industry-University-Research, which ranks among the top six in China. As the lead unit, we have completed major projects and established a new antibody production technology platform for these major projects. If we use this new technology platform, we will use these animal cells.
There is another kind of cells that have separated the function of antibody by cell fusion, so we call this kind of cells engineering cells. We have established a pilot technology platform for large-scale culture of engineering cells I to 300 liters of such animal cells. So far, there are three or five companies that have done better in our country. Antibodies were made from mice in the past. Now we are in line with international standards and cooperate to form a scale of 3000 liters. So far, it is the first cell industrialization technology platform with the capacity exceeding 1000 liter, and ours is also a national pilot platform, so we also shoulder some important tasks of technical training for universities, scientific research units and enterprises. So far, through our cooperation with 9 universities, scientific research units and 48 senior engineers and technicians, our country is the only pilot base.
As of last month, we had 13 1 and 8 13 cases of iodine, which have been popularized in more than 30 hospitals across the country. Now this hospital is 17, including Shanghai Tongji University Affiliated Hospital, China Xi Jiaotong University First Affiliated Hospital, Fourth Military Medical University and Shaanxi Cancer Hospital. At present, there are four clinics led by Fudan University, Shanghai Medical College and Zhongshan Hospital. This project has obtained 1 1 patents, and 1 1 patents have been authorized, two of which belong to the software production right, that is, this control software related to cell culture developed by us. There are also three PCT majors, and others have also entered Europe, America and Japan. So far, we have 45 articles about this project.
Cited by SCI 123 times, won the second prize of national scientific and technological progress in 2005. We worked for 25 years, starting with 1982, successfully prepared monoclonal antibodies in 2007, applied for new drugs in 1994, and confirmed it in 1999, and finally completed the whole process in May this year. China has made some contributions to the industrialization of antibody drugs. Once again, we are very grateful to our partner Chengdu Huashen Group for its contribution and efforts in this regard.
It's a pity that my cousin who works in Guangzhou can't use Likatine. Last June, he was ruthlessly killed by liver cancer, which made his family and our people very sad, because he was also a modest official and our pride. According to the data of your hospital, it should have been more than 6 months since the first batch of patients in your hospital used Likatine. What's their situation now? How many of them are still alive? What is the survival rate? Did someone get a second shot? I really hope you can tell the expectant patients as soon as possible! thank you
Hello, generally speaking, the average survival time of patients diagnosed with liver cancer is 4.2 months, and the median survival time of patients after using licardin is more than 19 months. More than 80 patients with liver cancer were treated with licardin in our center, and the effective rate was over 60%. Likatine can be injected with 1-6 needles. Up to now, more than ten people in our center have received the second injection, and five patients have received the third injection. Compared with traditional chemotherapy drugs, licardin has basically no side effects, and occasionally has a short-term low fever and rash. High security.
Published by the sender jyx on March 4th, 2008.
-Transferred from the website of the 458th Medical College of China People's Liberation Army (in Guangdong).
Likatine, the world's first monoclonal antibody-directed drug for the treatment of primary liver cancer, also owns all intellectual property rights.
Double-effect integration: Metuximab blocked the proliferation and metastasis of hepatocellular carcinoma cell antigen Hab 18G/CD 147.
Iodine [13 1I] emits beta rays to kill liver cancer cells.
-Transferred from Chengdu Huashen Biotechnology Co., Ltd..
Application unit
1, Sichuan Cancer Hospital, Sichuan West China Hospital
2. Shandong Provincial Hospital
3. Fujian Fujian Cancer Hospital
4. Hunan Provincial People's Hospital, Hunan Cancer Hospital and Xiangya Second Hospital of Central South University, Hunan Province.
5. Shanghai Tenth People's Hospital affiliated to Tongji University, Shanghai
6. Jiangsu Jiangsu Cancer Hospital
7.Xi Tang Dou Hospital Xi First Affiliated Hospital of Jiaotong University Shaanxi Fourth Military Medical University Cancer Hospital
8. More than 80 doctors from the 458th Army of China People's Liberation Army, Guangdong.
9. China Nuclear Industry 40 1 Hospital.
10 Shengjing Hospital affiliated to Liaoning China Medical University