May 2020 Global Approval of New Drugs Profile: 5 Japan, 1 India, USA

In May 2020, the world's first new drug approvals were mainly in the United States, Japan and IndiaThe U.SFood and Drug Administration (FDA) approved five new molecular substance drugs (NMs) for the treatment of non-small cell lung cancer, Serpercatinib for the treatment of RET mutation-related non-small cell lung cancer/thyroid myelin cancer/thyroid cancer; Ripretinib for the treatment of gastrointestinal interstitial tumors; Fluororadiol F 18 for breast cancer diagnosis; and Floratifortpir F18 for Alzheimer's disease diagnosisJapan has approved Remdesivir for the treatment of new coronary pneumonia;Capmatinib Hydrochloride has been approved by the FDA for the use of metexosome 14 jump mutation sylated non-small cell lung cancer adult patientsThe drug was originally developed by Incyte, after which Novartis signed a global research and development license agreement with Incyte and successfully went on sale with a product called Tabrecta ®The drug is still in the second phase of research on the treatment of glioblastoma, liver cancer, melanoma, and clinical phase I/II studies for the treatment of colorectal cancer and head and neck cancerNSCLC is a malignant tumor of lung tissue, accounting for about 90% of lung cancerMETex14 is the driving gene of metastatic non-small cell lung cancer (mNSCLC) and plays a key role in lung cancer metastasisAbout 3 to 4% of nSCLC patients had METex14 exon mutationsThere are about 4,000 to 5000 mNSCLC patients in the United States each yearIn general, patients with the METex14 mutation have a poor prognosis and often have bone metastasis, liver metastasis, and brain metastasisTabrecta ® is a targeted Met kinase inhibitor that blocks the downstream signaling pathway for cancer cell proliferation by inhibiting the phosphorylation of Met moleculesTabrecta ® was approved on the basis of a multi-center, non-random, open-label, multi-queue clinical phase II trial (NCT02414139)97 patients with MET exosome jump lung cancer were treated with 400 mg medication until tumor progression or unacceptable toxic side effects occurredThe results showed that the total remission rate was 68% for 28 patients who had not been treated, with a median remission period of 12.6 months, and 69 patients who had been treated had a total remission rate of 41% and a median remission period of 9.7 monthsc-Met is now a hot cancer target, with The Listing of Crizotinib (Pfizer), Cabozantinib (Takeda) and Tepotinib (Merck), and the success of Capmatinib further increasing competition in the fieldSelpercatinib was approved by the FDA on May 8, 2020 for the treatment of adult NSCLC patients with metastatic RET gene fusion, adults with advanced or metastatic RET gene mutations of thyroid myelin cancer and pediatric patients over 12 years of age, as well as adults with advanced or metastatic RET gene fusion who require systemic treatment and radioactive iodine incontiningThe drug was developed by Loxo Oncology (ALil subsidiary) and is called Retevmo®RET kinase mutation mainly includes fusion, activation point mutation, leading to over-activated RET signal and uncontrolled cancer cell proliferationRET fusion accounts for about 2% of NSCLC and 10 to 20% of thyroid cancerRET point mutations account for about 60% of circulating thyroid myelin cancer and about 90% of hereditary thyroid myelin cancerCancer cells with RET fusion positive or point mutations are highly dependent on the RET kinase signaling pathway and are sensitive to targeting small molecule inhibitorsSelpercatinib is a kinase inhibitor that inhibits wild-type and multi-mutant RET isomers and performs tumor suppression by interfering with THE RET signaling pathwaySelpercatinib was approved on the basis of a multi-center, open-label, multi-queue test (LIBRETTO-001, NCT03157128)1) RET fusion-positive NSCLCincluded 105 patients who had been treated in the past and received 160 mg of medication twice a dayThe results showed a total mitigation rate of 64% and a median mitigation period of 17.5 monthsFor 39 patients who had not been treated, the total remission rate was 85%2) thyroid myelin cancerpatients who had received Cabozantinib/Vandetanib treatment in the past 55 patients, with a total remission rate of 69%, median remission period has not been evaluated;3) the total ret-positive thyroid cancerthe total remission rate of patients who have been treated in the past (N-19) was 79%, the median remission period was 18.4 months, and the overall remission rate of the untreated patient group (N-8) was 100%, and the median remission period has not been evaluated Ripretinib has been approved by the FDA on May 15, 2020 for the treatment of adult patients with advanced gastrointestinal interstitial oma (GIST), developed and sold by Deciphera Pharma, a product called Qinlock ® GIST is a tumor that affects the digestive tract and occurs mainly in the stomach and small intestine There are about 4,000 to 6,000 new cases in the United States each year, with similar rates in Europe and other regions GIST is induced by a series of mutations, about 80% of KIT kinase mutations and PDGFR alpha kinase mutations of about 6% Current drugs cannot yet target a wide range of targets, with a five-year lifetime of about 48% to 90% Ripretinib is a tyrosine kinase inhibitor that can target KIT kinases combined with wild, primary and secondary mutations, platelet derivative factor receptor A kinase (PDGFR alpha), etc., to perform tumor inhibition Ripretinib's approval is based on an international multicenter, randomized, double-blind, placebo-controlled clinical Phase III trial (NCT03353753) 129 GIST patients who had previously received the treatment of imatinib, sunitinib, or regorafenib entered the Ripretinib group (N-85) and the placebo group (N-44) The median PFS in the treatment group was 6.3 months, the placebo group was 1.0 months, and the risk ratio was 0.15 (p 0.001) The median OS was 15.1 months in the treatment group and 6.6 months in the placebo group, with a risk ratio of 0.36 Fluoroestradiol F 18 was approved by the FDA on May 20, 2020 and is developed and marketed by Zionexa on a product called Cerianna ® The drug is approved for ER-positive recurrent or metastatic breast cancer as a radiomarker contrast ingenual agent In addition, the drug is still in the clinical phase III phase of PET imaging for hard fibroids (invasive fibroids) breast cancer is the world's highest incidence of female cancer, with an annual incidence rate of 128.5 per 100,000 in the United States, a mortality rate of 20.3 per 100,000, and about 12.9 percent of women will be diagnosed with breast cancer According to 2017 data, 3.6 million women in the United States have breast cancer Of these, ER-positive is about 80%, which is of great significance for clinical diagnosis the clinical results of Cerianna ®, 85 patients were assessed, biopsy positive of 47 patients, 36 imaging positive cases; Cerianna ® as a new type of targetER breast cancer diagnostic reagent, will provide clinicians with more diagnostic data to support clinical decision-making Flortaucipir F 18 has been approved by the FDA for radiology of Alzheimer's disease (AD) on May 28, 2020 The drug was originally developed by Siemens and later licensed to Avid Radiopharms (Lilly Subsidiary) with a product called Tauvid ® Alzheimer's disease (AD) is a progressive disease that early manifests itself as memory loss and is one of the top 10 fatalities in the United States According to the CDC, there were 5 million AD patients in the United States in 2014, with an estimated 14 million cases by 2060 Currently, AD diagnosis is usually based on a pathological diagnosis of the brain after death, and three amyloid-based diagnostic reagents have been approved The approval of Flortaucipir F 18 is based on two clinical trials In test 1, the detection sensitivity of 64 patients was 92% to 100%, and the specificity was 52% to 92% In Test 2, the consistency was evaluated by Fleiss' kappa, resulting in 0.87 (95% CI: 0.83, 0.91), and the laboratory-evaluated Fleiss' kappa analysis results were 0.82 (95% CI: 0.75, 0.88) Tauvid ® is the first diagnostic drug to target Tau protein, competing with the Vizamyl ®/Amyvid ®/Alzavue ® based on amyloid protein testing Currently, all four diagnostic reagents are F-18 markers Developed by Gilead, Redsiwe was approved by JAPAN on May 8, 2020 for the treatment of the New Coronary Pneumonia Virus Infection (SARS-CoV-2), a product called Vekry ® According to the latest WHO statistics, SARS-CoV-2 has caused more than 6 million infections and 367,000 deaths worldwide (May 31, 2020) Of these, 1.76 million were infected in the United States and more than 100,000 died In view of the high infection capacity of the new coronavirus, multi-country upgrade early warning quarantine measures The study showed that angiosuppressant-converting enzyme ACE2, as an invasive receptor for the new coronavirus, was similar to SARS infection U.S NIH clinical trial (NCT04280705), the Reedsewe group recovered about 31 percent faster than the placebo group ( p 0.001), the median recovery time in the treatment group was 11 days, and the placebo group had 15 days The mortality rate was 8.0% in the Redsiwe treatment group, while the mortality rate in the placebo group was 11.6% (p-0.059) In another SIMPLE trial, the safety and efficacy of patients admitted to critical COVID-19 were assessed for 5 or 10 days in Redsewe The results showed that patients in the 5-day and 10-day groups were more similar in clinical improvement (ratio: 0.75 (95% CI: 0.51-1.12)) May 1, 2020, Redsewe received fda emergency use approval for the treatment of the new coronal pneumonia virus infection (SARS-CoV-2) On May 26th the NHS agreed to allow Redseweto to treat patients with severe pneumonia in the new crown Centhaquine, developed by Pharmazz, was approved for sale in India on 14 May 2020 for the treatment of hemorrhagic shock, a product called Lyfaquin ® At present, the drug is still in the clinical stage of postoperative pain and cardiac arrest Centhaquine increases blood pressure and heart transfusion by stimulating alpha epinephrine receptor 2B, which increases blood pressure and heart transfusion, and promotes arterial dilation and tissue infusion by inhibiting alpha epinephrine receptor 1 Clinically, the treatment with Centhaquine can significantly reduce mortality, blood lactic acid, and increase the mean arterial pressure, blood pressure, and heart transfusion