May 2020 Global Approval of New Drugs Profile: 5 In the United States, 1 in Japan, 1 in India.

Capmatinib Hydrochloride Capmatinib Hydrochloride has been approved by the FDA for the treatment of met exosome 14 jump mutation synthase non-small cell lung cancer adult patients.
the drug was originally developed by Incyte, and Novartis has signed a global lying license agreement with Incyte for successful lying on the market, 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/2 studies for the treatment of colorectal cancer and head and neck cancer.
NSCLC is a malignant tumor of lung tissue, accounting for about 90% of lung cancer.
METex14 is the driving gene of metastatic non-small cell lung cancer (mNSCLC) and plays a key role in lung cancer metastasis. About 3 to 4% of patients in
NSCLC had meTex14 exon mutations.
about 4,000 to 5000 mNSCLC patients in the United States each year.
, patients with THE METex14 mutation have a poor prognosis and often have bone metastasis, liver metastasis, and brain metastasis.
Tabrecta ® is a met-targeted kinase inhibitor that blocks downstream signaling pathways for cancer cell proliferation by inhibiting the phosphorylation of Met molecules.
Tabrecta ® was approved on the basis of a multi-center, non-random, open-label, multi-queue clinical Phase II trial (NCT02414139).
included in the MET exoon-jumping lung cancer patients 97 people, received 400 mg of drug treatment until the tumor progression or unacceptable toxic side effects.
trial 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 months.
c-Met is now a hot cancer target, with the listing of Crizotinib (Pfizer), Cabozantinib (Takeda), Tepotinib (Merck), and the success of Capmatinib further increasing competition in the field.
Selpercatinib Selpercatinib 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 patients with advanced or metastatic RET gene fusion in patients with general treatment and radioactive iodine fusion positive thyroid cancer and children over 12 years of age.
the drug was developed by Loxo (Lilly subsidiary) and is ® retevmo.
RET kinase mutation mainly includes fusion, active point mutation, leading to over-activated RET signal and uncontrolled proliferation of cancer cells.
RET fusion accounts for about 2% of NSCLC and 10 to 20% of thyroid cancer.
RET point mutation accounts for about 60% of the circulating thyroid myelin cancer and about 90% of hereditary thyroid myelin cancer. Cancer cells that
RET fusion positive or point mutation are highly dependent on the RET kinase signaling pathway and are sensitive to targeting small molecule inhibitors.
Selpercatinib is a kinase inhibitor that inhibits wild types and various mutant RET isomers and performs tumor suppression by interfering with THE RET signaling pathway.
Selpercatinib was approved on the basis of a multi-center, open-label, multi-queue trial (LIBRETTO-001, NCT03157128).
1) RET fusion-positive NSCLC was included in 105 previously treated patients who received 160 mg of medication twice a day. the results of the
showed a total mitigation rate of 64% and a median mitigation period of 17.5 months.
the total remission rate was 85% for 39 patients who had not been treated.
2) Thyroid myelin cancer with RET mutation s55 patients treated with Cabozantinib/Vandetanib, with a total remission rate of 69%, median remission period has not been assessed, 88 patients who have not received previous treatment, a total remission rate of 73%, median remission period of 22 months.
3) RET fusion-positive thyroid cancer The overall remission rate of patients who were 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 had not been evaluated.
Ripretinib Ripretinib has been approved by the FDA on May 15, 2020 for the treatment of adult patients with advanced gastrointestinal interstitial interstitial (GIST) treatment with three kinase inhibitors, developed and sold by Deciphera Pharma, a product called ®.
GIST is a tumor that affects the digestive tract and occurs mainly in the stomach and small intestine.
about 4,000 to 6,000 new cases each year in the United States, with similar rates in Europe and elsewhere.
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 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-derived factor receptor A kinase (PDGFR alpha), etc., to perform tumor inhibition.
Ripretinib was approved on the basis of an international multicenter, randomized, double-blind, placebo-controlled clinical Phase III trial (NCT03353753).
included 129 GIST patients who had previously received imatinib, sunitinib or regorafenib treatment, and entered the Ripretinib group (N-85) and the placebo group (N-44) at 2:1. 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.lt;0.001). The
treatment group had 15.1 months of OS and the placebo group 6.6 months with a risk ratio of 0.36.
Fluoroestradiol F 18 Fluororadiol F 18 was approved by the FDA on May 20, 2020 and developed and listed by Zionexa for ® Cerianna.
the drug as a radiation marker contrasting agent approved for ER-positive recurrent or metastatic breast cancer.
, 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.
2017 data show that 3.6 million women in the United States have breast cancer.
, ER-positive is about 80%, which is of great significance for clinical diagnosis.
the clinical results of Cerianna ®, 85 patients were assessed, biopositive in 47 patients, 36 imaging positive cases;
Cerianna ® as a new type of breast cancer diagnostic reagent targeting ER, will provide clinicians with more diagnostic data to support clinical decision-making.
Flortaucipir F 18 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 a pre-estimated 14 million cases by 2060.
At present, AD diagnosis is usually based on the patient's post-death pathology diagnosis of the brain, three amyloid-based diagnostic reagents have been approved.
Flortaucipir F 18 was approved on two clinical levels.
test 1, the detection sensitivity of 64 patients was 92% to 100%, and the specificity was 52% to 92%.
Test 2, the result was 0.87 (95% CI: 0.83, 0.91), and the laboratory-evaluated Fleiss' kappa analysis resultwased at 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.
Remdesivir Redsiwe, developed by Gilead, was approved by Japan pmDA conditions on May 8, 2020 for the treatment of the new coronal pneumonia virus infection (SARS-CoV-2), with a product called Veklury ®.
According to the latest WHO statistics, SARS-CoV-2 has caused more than 6 million infections and 367,000 deaths worldwide (31 May 2020).
, 1.76 million people have been infected in the United States and more than 100,000 have died.
in view of the high infectious capacity of the new coronavirus, multi-country escalation early warning quarantine measures.
studies have shown that angiosuppressant-converting enzyme ACE2, as an invasive receptor for the new coronavirus, is similar to SARS infection.
The U.S. NIH Clinical Trials (NCT04280705) showed that the resusivir group recovered about 31 percent faster than the placebo group (p-lt;0.001), with a median recovery time of 11 days in the treatment group and 15 days in the placebo group.
the mortality rate in the Redseve treatment group was 8.0%, while the death rate in the placebo group was 11.6% (p-0.059). in another SIMPLE trial,
evaluated the safety and efficacy of patients with severe COVID-19 hospitalizations who were given to Redsewe for 5 or 10 days.
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 26,
, nhs England agreed to Redsewe's treatment for the treatment of patients with severe pneumonia in the new crown. Centhaquine, developed by centhaquine,
was approved for sale in India on May 14, 2020, for the treatment of hemorrhagic shock, with a product called Lyfaquin ®.
, 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 in turn increases blood pressure and heart transfusion, and promotes arterial dilation and tissue infusion by inhibiting alpha epinephrine receptor 1.
clinically shown that the treatment with Centhaquine can significantly reduce mortality, blood lactic acid, and increase the average arterial pressure, blood pressure, and heart transfusion.
References 1. Drug Crossing Data: 2.Novartis Website: 3. FDA Database. 4. Drug Crossing Data: 5. Lilly's official website: 6. FDA Database. 7. Drug Crossing Data: 8. Deciphera official website: 9. FDA Database. 10. Drug crossing data: 11. NCI Data.12. Lumachi F, Santeufemia DA, Basso SM. Currentmedical treatment of estrogen-positive breast cancer. World J BiolChem. 2015;6 (3):231‐239. doi: 10.4331/wjbc.v6.i3.231 13. FDA Database . 14. 15. Drug data: 16. FDA official website: 17. FDA Database.18. Drug crossing data: 19. WHO Official Website: 20.CDC: 21. Lan J, Ge J, Yu J, et al. Structure of the SARS-CoV-2 spike-binding domain to the ACE2 Nature.2020;581 (7807): 215-220. 22. PMDA website: 2.