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    Home > Medical News > Latest Medical News > [in-depth analysis] although pyrrolidine is good, can it be the best choice?

    [in-depth analysis] although pyrrolidine is good, can it be the best choice?

    • Last Update: 2018-08-17
    • Source: Internet
    • Author: User
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    The author: Liu Qian (micro signal drugmagic) was approved to go public on Monday, which caused great acclaim in the pharmaceutical industry As a class 1.1 new drug researched and developed locally, it is also reasonable to get special approval as a "major special project" and obtain very beautiful data in phase III clinical practice As an oral anti-Her-2 drug, there is no doubt that pyrrolidine has great clinical value But Mr Qian's focus is on its commercial value, which is the sales prospects after the IPO The manufacturer of pyrrolidine has a very strong comprehensive strength in the field of cancer Another drug of pyrrolidine has broken the industry record in just a few years since it was launched on the market, which naturally makes everyone full of expectations on whether pyrrolidine can reach a new high Whether the sales volume of new drugs with good clinical data is good or not must be analyzed before we know According to the mechanism of action, pyrrolidine is a highly targeted drug, which can only be used in HER-2 receptor positive patients Although many solid tumors have HER-2 positive expression, only breast cancer and gastric cancer have commercial significance Because gastric cancer is generally found late, many patients can not do pathological biopsy, the detection rate and positive rate of HER-2 are significantly lower than that of breast cancer Apatinib is a multi-target inhibitor of anti VEGF, which can play a role in many major solid tumors, such as lung cancer, gastric cancer, colorectal cancer and liver cancer Moreover, the drug does not need specific detection, so it is widely used in clinical practice Pyrrolidine is a lot more focused, its main battleground is breast cancer Breast cancer is also a high incidence rate of malignancy Theoretically, it has great market potential The annual sales volume of trastuzumab is about 3000000000, the key is how much it can get Breast cancer treatment market is generally divided into new adjuvant treatment, postoperative adjuvant treatment and late rescue treatment according to the clinical process Because trastuzumab has moved forward to adjuvant and new adjuvant treatment, there is a large space for HER-2 positive late breast cancer market Currently, imported lapatinib is also available The approval of pyrrolidine was based on a study of advanced breast cancer compared with lapatinib, although the PFS and orr indicators such as pyrrolidine were significantly better However, lapatinib is a small potato in the breast cancer market Its head-to-head effect is lost to trastuzumab, so it is only used for patients with trastuzumab ineffective treatment Its annual sales volume in China is less than 100 million, and it is not enough to give pyrrolidine in full Rapid approval of pyrrolidine versus lapatinib is an effective way to speed up the listing, but to truly capture a commercially significant market, it has to compete head to head with a stronger competitor Because breast cancer has a long survival period and many patients can be treated with tumor resection, doctors' prescriptions are greatly affected by evidence-based medical evidence such as the total survival period It is more difficult to use super indications than other solid tumors In the next 6-12 months, the same product of pyrrolidine, lenatinib, will be launched in China The former is almost the same as pyrrolidine, but has more diarrhea side effects The latter is an upgraded version of trastuzumab In 2020, kadcyla (t-dm1), a heavy bomb from Roche, proved to be more effective than trastuzul and lapatinib in the treatment of advanced breast cancer And pyrrolidine also needs to prove that its efficacy is better than trastuzumab, or that its efficacy is equivalent to lenatinib and Roche's patozumab, so as to curb the competition of other new drugs with the advantages of oral administration and low side effects The preliminary clinical data of pyrrolidine is good, but the heavyweight clinical data are much less than those of the above products, especially the head-to-head comparison data with lenatinib, patozumab and her2-adc are lacking Because there are too many new tumor drugs, the head to head test is of great significance: because of the differences between the design of the test and the patients in the group, it is not rigorous to draw a conclusion by comparing the data of different drugs in different clinical trials There is no doubt that the market of advanced breast cancer treatment is very crowded, and because the survival period is short and limited by the ability to pay, it is estimated that the market size of HER-2 drugs in the advanced breast cancer market is only 1 / 5-1 / 6 of the adjuvant treatment, the real key market is the postoperative adjuvant market Because of bed turnover and doctors' concept, the number of new adjuvant therapy for breast cancer is far less than that of adjuvant therapy and the medication cycle is short, so it will not become the main position of anti HER-2 treatment Trastuzumab is undoubtedly the dominant market in the postoperative auxiliary market In the past 18 years since its launch, its popularity has been eating doctors and patients, especially after the price cut of 65% last year, its sales volume has grown rapidly There are three opportunities for pyrrolidine in the adjuvant Market: the follow-up treatment one year after trastuzumab treatment (similar to lenatinib), the combination treatment of trastuzumab for 1-2 years (similar to patozumab), or a more aggressive attempt to replace trastuzumab in an all-round way What kind of market strategy the manufacturer adopts can be seen from its clinical research strategy that it does not seem to follow the way of similar products coming to nalantine (maybe it is thought that Chinese doctors and patients are not used to sequential treatment after trastuzumab), but rather the way of combining with trastuzumab, and so on The advantage of patozumab in adjuvant therapy is mainly reflected in the high-risk patients with positive lymph nodes, and pyrrolidine can select a wider population If the effect is similar to that of patozumab, pyrrolidine may seize the market of non high-risk patients in adjuvant therapy Because it was used in combination with trastuzumab after the operation, which was equivalent to blocking the opportunity of the follow-up treatment of lenatinib in a disguised way, and it was really quite brilliant However, trastuzumab is the core drug of such triple adjuvant therapy In addition to the treatment concept of seeing doctors, plus or without pyrrolidine, it is also subject to the patient's ability to pay As a "small three" market will not be large, at least with trastuzumab is not an order of magnitude Is it easier to maintain trastuzumab after one year? The answer is No the average medication cycle of trastuzumab patients is 6 months How many patients can change pyrrolidine after one year? In order to be as large as trastuzumab, pyrrolidine must be the core drug of adjuvant therapy, and it should be used as a head-to-head adjuvant therapy test with trastuzumab In view of the good curative effect and long survival period of adjuvant therapy for breast cancer, in order to shake the position of trastuzumab, there must be a very large-scale clinical trial (refer to the Hera trial 5100 cases followed up for 8 years) Although more than 500 million yuan has been spent on research and development before the launch of pyrrolidine, it will cost more to do a single adjuvant clinical trial, and hundreds of millions of dollars were spent on the challenge of trastuzumab in that year by lapatinib But only negative results were obtained It has been said that pyrrolidine has the advantages of small oral and side effects, but it is always used in combination with chemotherapy, patients always need to receive intravenous infusion treatment, it is not important to take anti-Her-2 orally In addition, trastuzumab has been on the market for 18 years, and Chinese doctors and patients also have rich experience in dealing with side effects The price of pyrrolidine hasn't come out yet, but last year, after trastuzumab was greatly reduced into the medical insurance, the self paid part of patients was less than 2000 yuan per month, so it's difficult for pyrrolidine as a new drug to go to PK price Besides, it's very difficult for hospitals to separate and develop new drugs Pyrrolidine can only be purchased at their own expense In addition to the new drugs mentioned above, there are several analogues of trastuzumab to be launched in the breast cancer market Although they are competing for the market of the original trastuzumab, they will indirectly affect the use of pyrrolidine The current clinical data of pyrrolidine is indeed promising, but its clinical drug use object is much narrower than that of the same elder martial brother, and the competition varieties in the main battlefield are very crowded, resulting in less unmet clinical needs of breast cancer, so it can't gallop like the same elder martial brother in various tumors In addition, the strength of the main competitive products is superior, and the current tumor drug negotiation and collection system suppress the price of new drugs The competition faced by pyrrolidine is a little cruel If pyrrolidine could go on the market half a year earlier, it would be a chance to overtake in a corner if the supply of trastuzul was cut off Of course, there are not so many if all the heavy bombs have to be knocked out by themselves.
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