7 star drugs in 2019

Close to the end of 2019, review the star medicine of this year< br / > No< br / > 1 < br / > amg-510 - the hope of the whole village < br / > amg-510 is unexpected and reasonableAmg-510, as the first candidate drug of KRAS G12C to enter the clinical practice after more than 30 years of Industrial Research on Ras pathway, is as popular at this year's ASCO conference as a Qinghua University student who suddenly came out of a small village hidden in the mountains< br / > ras gene family is the earliest human carcinogenic gene with the highest mutation probabilityIt has three members: KRAS, NRAS and HRASAmong them, KRAS mutation is the most popular, accounting for 85%Ras protein has always been considered as the target of "no medicine", because the surface of Ras protein is smooth without small molecule binding pocketAMG 510 can play a role by binding to the hidden grooves on the surface of KRAS protein, which can irreversibly bind to the cysteine on the mutated KRAS protein, thus making KRAS go into a state of inactivationAt the time of data release of asco2019 conference, AMG 510 enrolled 35 patients with KRAS G12C mutation who had received at least 2-line treatment in the past, including 14 patients with NSCLC, 19 patients with CRC and 2 patients with other types of tumorsAmong the 10 assessable NSCLC patients, 5 had partial remission, 4 had stable disease, and the disease control rate reached 90%One patient who got PR continued to improve after reading the data, and got complete remission in the 18th weekOf the 18 evaluable CRC patients, 13 were stableWhen the data of esmo2019 conference was released, amg510 was included in 76 solid tumor patients with KRAS G12C mutationAmong the 13 NSCLC patients whose curative effect can be evaluated (dosage 960mg / D), 7 cases were partially relieved, 6 cases were stable, the disease control rate was 100%, and the curative effect was equivalent to that beforeBut in 12 patients with CRC whose curative effect can be evaluated, only one patient had partial remission, 10 patients had stable disease, and the disease control rate was 92%Although the curative effect of amg510 on NSCLC is considerable, the curative effect of amg510 on colorectal cancer is concerned by investors < br / > considering that the number and time of patients in the group after 2-line severe treatment and observation are not sufficient, we can keep attention and expectation on the follow-up data of amg510 There is no doubt that amg510 is a milestone It seems that you can see the way to solve the problem of mutated tumor of KRAS from its body, and it also makes the backlog of investment enthusiasm after PD-1 find a new outlet Many KARs concept projects started development after amg501 Up to now, nextpharma has included 22 KRAS related projects The mutation rate of < br / > KRAS was 97% in solid tumors, especially in pancreatic cancer The incidence of KRAS G12C mutation in NSCLC, colorectal cancer and other solid tumors was about 13%, 3% - 5% and 1% - 2%, respectively There are about 30000 newly diagnosed patients with KRAS G12C mutation cancer in the United States every year, and the market is still very attractive < br / > No < br / > 2 < br / > olapari - the next magic drug < br / > lynparza (olapari) is listed as the most concerned star drug in 2019 In addition to its remarkable sales results with ovarian cancer and breast cancer indications, it has also made significant breakthroughs in the field of pancreatic cancer and prostate cancer, greatly broadening the market boundary of PARP inhibitors < br / > during the ASCO conference in June this year, the phase III Polo study published positive results Olapalin, as a first-line maintenance therapy, was used in patients with BRCA + metastatic pancreatic cancer after platinum chemotherapy Compared with placebo, olapalin doubled the progression free survival time (7.4 vs 3.8 months), reduced the risk of disease progression by 47% (HR 0.53), and doubled the progression free survival rate in one year (33.74% vs 14.5%), The 2-year progression free survival rate doubled (22.1% vs 9.6%) < br / > metastatic pancreatic cancer has a rapid deterioration rate, with the lowest 5-year survival rate among all cancers It is known as the "king of cancer" For many years, the mainstream treatment plan is gemcitabine based chemotherapy drug combination Olapalin can be maintained after the patients receive the first chemotherapy to control the disease, significantly delay the time of disease deterioration or recurrence, and increase the proportion of patients who can receive second-line treatment It is a major breakthrough in the maintenance treatment of pancreatic cancer for more than 20 years < br / > during this year's ESMO conference, detailed data of prospective phase III profound research results were presented In the cohort a with BRCA1 / 2, ATM, cdk12 and other DNA homologous recombination repair (HRR) defect related gene mutations, olapalin can significantly prolong the imaging progression free survival (RPFS, 7.4 vs 3.6 months), Reduce the risk of disease progression or death by 66% The median RPFS was also significantly prolonged (5.8 vs 3.5 months) and the risk of disease progression and death was reduced by 51% in cohort B carrying any of the other 12 broad HRR mutations The significance of < br / > profound study is that it not only proves that olapari has a good effect on the patients with mcrpc who have undergone the new endocrine therapy, but also suggests that HRR defect related gene mutation is a benefit marker for prostate cancer patients to receive PARP inhibitors, which also accelerates the clinical treatment of prostate cancer from the era of chemotherapy to the era of targeted treatment < br / > in fact, there are gene mutations related to HRR defects in many types of tumors, which means that the way to expand the indications of olapari is still wide The research results related to DNA repair mechanism won the Nobel Prize in chemistry in 2015 Olapali, as the world's first PARP inhibitor, was supposed to usher in a high light moment at the end of 2014 Unfortunately, at that time, tumor immunotherapy such as PD1 and car-t was in a positive trend, and the industry did not pay enough attention to PAPR inhibitors, Even AstraZeneca's own development priority for olapali may be behind that of drug I But with the deeper understanding of immunotherapy, PARP inhibitors have returned to the center of vision Not only the global project transactions of PARP inhibitors are frequent, but also the spicy mosadon is deeply bound to the joint development of olapari with drug K Will olapali become the next antitumor drug? < br / > No < br / > 3 < br / > inclisiran - lowering blood fat is beyond imagination < br / > traditionally, hyperlipidemia, a chronic disease, needs to take medicine every day to control the progress of the disease and the occurrence of complications It's thankful that you can reduce the number of times of taking medicine from twice a day to once a day Can you imagine a patient with hyperlipidemia who is treated every six months? Isn't it the same as not getting sick? If this lipid-lowering drug is on the market, how can those statins survive? How do the manufacturers who develop the new drug think of reducing the intensity of patients' drug demand so low? < br / > the medicine company, which focuses on developing revolutionary cardiovascular disease therapies, was just acquired by Novartis in late November for us $9.7 billion Inclisiran, which is expected to be given twice a year, is an RNA interference therapy Please remember their names < br / > at the esc2019 conference in early September, the complete data of the first critical phase III orion-11 study administered by inclisiran every six months was first published The results showed that for the patients whose LDL-C level could not be controlled by the maximum tolerable dose of statins, 300 mg inclisiran was injected subcutaneously twice a year, the LDL-C level in the control group of inclisiran was reduced by 54% after placebo correction in the 17th menstrual period, and the time average LDL-C in the control group of inclisiran was reduced by 50% after placebo correction in the 3rd-18th menstrual period < br / > at the meeting of AHA in early November, orion-10 research results were published, For the primary end point, placebo adjusted LDL-C levels were reduced by 58% in the 17th menstrual period and 56% in the time average LDL-C level in the placebo adjusted inglisiran group from the 3rd to 18th menstruation < br / > the target of inclisiran is PCSK9, which has very clear mechanism and efficacy evidence However, compared with the two currently marketed PCSK9 antibody drugs, inclisiran is much cheaper in production cost, and is significantly better than PCSK9 monoclonal antibody which needs to be administered every two weeks or once a month in the number of times of administration Moreover, for patients whose blood lipid level cannot be controlled by statins, Inclisiran can also reduce LDL-C by another 50% It's really exciting to think about this "black technology" drug beyond imagination < br / > No < br / > 4 < br / > aducanumab - the victory of the data statistician < br / > If only because of the phase III clinical failure, the market value of Biogen has shrunk 15 billion dollars overnight, aducanumab may not be listed as the star drug in 2019 After all, there are too many dead souls buried in the a β field, and no one else will be surprised Surprisingly, who would have thought that aducanumab could come back from the dead? < br / > on October 22, aducanumab, who had been sentenced to death in our hearts for seven months, was announced by Biogen that it would submit its listing application to FDA in early 2020 Overnight, Biogen's market value soared by another 10 billion dollars, to recover the lost land < br / > the drug or the drug, the test is the test, but the data is not the previous data < br / > the basis for the previously announced failure of two phase III trials of aducanumab, code named engage and emerge, was made by the independent data monitoring committee After the analysis of the interim data, they believed that aducanumab had no effect on Alzheimer's disease and mild cognitive impairment caused by mild Alzheimer's disease dementia, and it is likely to be difficult to reach the primary efficacy end point < br / > to help Biogen see the light of hope in the dark is their own company's medical data statisticians After analyzing the larger data set, they found that in a clinical trial called emerge, AD patients treated with high-dose aducanumab significantly reduced their cognitive ability score (cdr-sb) by 23% at week 78 compared with the control group, reaching the primary end point In addition, the high-dose group of aducanumab also showed the effect of continuous reduction compared with placebo in other secondary end points The image data also showed that the burden of amyloid plaques in the treatment group of aducanumab at the 26th and 78th weeks was significantly lower than that in the placebo group After getting the latest analysis conclusion, Biogen communicated with FDA and announced the decision to submit NDA < br / > although Biogen announced the specific reasons for the reversal of emerge test results at the Alzheimer's clinical trial meeting in early December, the industry still doubts whether the FDA session will approve the listing of aducanumab But no matter what the final result is, the value of medical data statistical analysts has been highlighted in this new drug development war to conquer Alzheimer's disease < br / > No < br / > 5 < br / > zebotinib - the new height of Chinese innovative drugs < br / > zebotinib is approved by FDA, which is expected, but it can be three months ahead of the scheduled approval period (2020 / 2 / 27), or more or less than you expected According to an insider, the original Commission: FDA went to the clinical center to check, zero major find < br / > looking back on the journey of Chinese pharmaceutical enterprises to the sea, from APIs to preparations, from imitation to innovation, from me too to fast follow, the efforts of several generations have finally brought the first FDA approved original new drug born in China, which is a breakthrough of Chinese new drug from 0 to 1, with milestone significance No matter how rare and hard the American biotech model of Baiji Shenzhou is to be replicated in China, zebutini, which carries many expectations, really represents a new level of Chinese innovative medicine After taking the difficult first step, I believe that more breakthroughs will follow < br / > back to zebotinib itself, FDA approval is only the first step to success How to sell an original new drug in the United States is Baiji