Medical Network November 30, Li Wei loves his wife Havin. In August last year, he wrote on Weibo: "The AIDS vaccine is all there. Is the cancer vaccine far behind?" Just one month after Li Wei died of cancer, a major breakthrough! Yesterday, the US FDA officially listed "broad spectrum" anticancer drugs, the cure rate is as high as 75%! The article "screening friends circle, let some people exclaim that the era of cancer can be cured has come.
Some media said that on November 26, Loxo Oncology and Bayer announced that the FDA (United States Food and Drug Administration) approved the joint development of the anti-cancer drug Vitrakvi (common name Larotrectinib). It is reported that this is the first "broad spectrum" anticancer drug unrelated to the type of tumor, which can effectively fight various cancers driven by a single rare gene mutation.
In layman's terms, this medicine is very effective for patients carrying certain genes, and the magic is that no matter what kind of cancer the patient gets, just carry this gene and you can cure it!
Then the question comes, is "effective treatment" equivalent to "cure"? What is the working principle? When can domestic patients be used? How to price? In order to solve various doubts, the reporter of "Daily Economic News" interviewed many insiders.
Objective response is not equal to cure
"The significance of the approval of the new drug is that the FDA approved the drug for the first time according to the tumor signal transduction target, which means that the new drug does not need to consider the area where the cancer occurs. Regardless of the cancer type, as long as the NTRK gene is fused, the drug can be used. Healing.†Han Baohui, a professor at the Shanghai Chest Hospital , told the “Daily Economic News†reporter that this opened a new door for the treatment of refractory tumor diseases and provided a new possibility.
Bai Yuezong, director of the strategic marketing department of Shanghai Ideas Medical Laboratory Co., Ltd. pointed out that "there are many variant forms of the NTRK gene, but only the patient's variant form is 'fusion', and he uses this medicine to be effective."
He explained to reporters the principle of action of this drug: tumor cells are all normal cells, normal cells grow to a certain extent, they will naturally apoptosis, NTRK gene is involved in regulating cell proliferation, after the gene mutation, the cells will not be Controlled to replicate, forming a tumor. The newly approved drug can enter the inside of the tumor cells, stop its infinite proliferation, and slowly let it die. This is targeted therapy with minimal side effects. Traditional chemotherapy is a kind of cytotoxic therapy, "killing one thousand, self-destruction of eight hundred", the side effects are relatively large.
It is reported that this new drug has been carried out in three clinical trials, including "basket test" for various cancers such as melanoma, thyroid cancer, lung adenocarcinoma, colon cancer, and gastrointestinal stromal tumor.
Bai Yuezong told the reporter of "Daily Economic News" that the medical efficiency after taking the drug is called the objective response rate. If the patient takes this drug, the tumor can be significantly reduced, which means that the response is reduced; if the tumor area is reduced by more than 30%, Objective response; some patients have taken medication, the tumor is completely invisible, it is called complete response.
Although the objective response rate of the newly listed clinical trial of this drug is above 75%, the “cure rate†referred to in many articles is not accurate. Tumors are difficult to cure, and the time is long or short, and most of them will recur. This is also a problem of drug resistance that some people are worried about.
“All targeted drugs are almost resistant, but I understand that the second generation of clinical trials for drug-resistant products has been launched,†Bai Yuezong said.
Detection technology is not yet popular in China
"NTRK is the first targeted pan-tumor therapy, so it is necessary to detect whether the gene is mutated and cannot be used blindly." Bai Yuezong said that the detection of gene "fusion" is more complicated, the most accurate and comprehensive method is to do RNA. The sequencing of (ribonucleic acid), patients need to take a part of the tumor tissue, do RNA sequencing, through this test to know whether the patient has the gene fusion of NTRK. If it is "fusion," the patient's use of this drug is very efficient; if not, it is almost ineffective.
So, what stage is the current domestic genetic testing technology developed?
Bai Yuezong told the reporter of "Daily Economic News" that the fusion detection of NTRK is not common in China. Commercial testing companies can do this by doing genetic sequencing, but it must be measured by RNA, and now mainstream testing is done with DNA. DNA can be detected a little, but not comprehensive, so it is still necessary to wait for the commercialization of RNA sequencing technology.
"This technology is currently available in China, but it is still in the laboratory development stage, and there is no commercialization." Bai Yuezong explained that this gene sequencing is not like a microscope, there is a microscope-like thing to look at. That's it. It has a number of steps, first to get the patient's tumor tissue specimens, use a whole set of biological methods to extract the RNA inside, and then do the sequencing. After sequencing, the bioinformatics analysis will be carried out, and finally the test report will be issued. It takes about 3 to 5 days to complete a complete process. If you add logistics, the time will be longer.
Applicable patient population is small
As the first NTRK inhibitory drug, is it only effective for patients with NTRK gene fusion? What is the proportion of such patients? In response, many interviewed experts told the Daily Economic News reporter that NTRK gene fusion is not common.
Bai Yuezong said: "We don't currently have data on the Chinese population, because few Chinese tumor patients have done fusion sequencing of this gene. Currently, NTRK patients are found in 18 tumors abroad, but the proportion is not high. There are some special Patients with cancer, like fibrosarcoma patients, have a higher proportion of NTRK gene fusion, which may be tens of percent. However, some large tumors, such as lung cancer, stomach cancer, and intestinal cancer, carry less than 5% or even more. low."
Han Baohui pointed out that according to the cancer incidence rate data of this kind of gene mutation, there are NTRK-like gene mutations in about 2000-3000 patients in the United States; there are about 10,000 cases in China, and the probability of this gene mutation in lung cancer is about 0.5. %. Among the cancers involved in the study data, children with soft tissue sarcoma have a higher probability of mutations in this type of gene, followed by parotid tumors.
"If lung cancer patients detect the fusion of this gene, the drug can be 80% effective. If it is detected that it does not carry this gene fusion, and there is no other gene mutation available, then only traditional The chemotherapy method, survival rate and treatment status will be much worse." Bai Yuezong said.
Domestic is expected to be clinical trial next year
So, how can people in need in China use the drug most quickly?
"Domestic patients need to test this drug first to see if they carry this gene fusion. Although our domestic genetic testing technology has not yet reached commercial level, I believe that if there is a need for medicine, there will be someone. Willing to invest, the technology will soon mature. We were not able to commercialize before, but the market demand is not big." Bai Yuezong said.
Bai Yuezong told the Daily Economic News reporter: "According to Bayer insiders, they may start clinical trials in China in the first half of next year, and patients who are eligible for clinical trials will be able to use the drug for free."
The reporter noted that the new version of the Drug Administration Law Article 39 stipulates that the import of drugs must be reviewed by the drug regulatory department of the State Council. After examination and confirmation that it meets the quality standards, it is safe and effective before it can be approved for import and issued to imported drugs. Register a certificate. A small amount of drugs that are urgently needed by medical units or imported by individuals for personal use shall be subject to import procedures in accordance with relevant state regulations.
It is worth noting that Loxo Oncology announced the price of the new drug: adult capsule purchase cost: 32,800 US dollars (about 230,000 yuan), 30 days of use; children's oral liquid formula costs: starting at 11,000 US dollars per month , calculated based on the patient's surface area.
So, will this new drug continue to maintain such a high price in China? In this regard, Wang Zhen, deputy director of the Public Policy Research Center of the Chinese Academy of Social Sciences, told the reporter of the Daily Economic News that pricing is mainly a business matter. As to whether the drug can enter the medical insurance, it is necessary to look at the efficacy of the drug, the results of the pharmacoeconomic evaluation, and the affordability of the medical insurance fund. Given the company's R&D investment, the price of this drug is certainly not too cheap.
Liu Zhengyu, secretary-general of Beijing New Sunshine Charity Foundation, said that if the drug enters the medical insurance catalogue, it needs to negotiate with the government for price. The specific pricing depends on the outcome of the negotiations.
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