2020 Top 10 New Innovative Drugs Available Worldwide

In 2020, the approval of innovative drugs worldwide is in a state of blowout, including several heavyweight anti-tumor innovative drugs, including THELOXO-292 (Retevmo), the first innovative 4-line treatment for advanced gastrointestinal mesothelioma (GIST), the first bile tube cancer targeting therapy (Pemigatinib).
rapid development of medical science and technology has brought new hope to mankind.
, the world's first oral MET inhibitor - Tepotinib General Name: Tepotinib Product Name: Tepmetko Original Research: Merck Date: March 25, 2020 (MHLW, Japan) Adaptation: For the treatment of non-removable, MET exon 14 jump mutation late stage or recurrence Non-Small Cell Lung Cancer (NSCLC) Patients On March 25, 2020, Japan's Ministry of Health, Labour and Mantle (MHLW) approved Merck's Tepotinib listing for the treatment of patients with late-stage or relapsed non-small cell lung cancer (NSCLC) that cannot be removed, met exon 14 jump mutations.
Tepmetko became the world's first oral MET inhibitor to be approved for the treatment of patients with advanced NSCLC with the MET gene mutation.
As an oral MET kinase inhibitor, Tepmetko is powerful and highly selective in suppressing cancer-causing signals caused by MET gene changes, including METex14 jump changes, MET amplification, and OVERexpression of MET proteins, with the potential to improve the prognostication of treatment for invasive tumor patients carrying these specific MET changes.
in addition to being used in clinical trials for NSCLC patients, Tepmetko is also treating patients with hepatocellular carcinoma in Phase 2 clinical trials.
previously, it had been awarded a breakthrough therapy by the FDA.
2nd, the world's first RET inhibitor - Selpercatinib General Name: Selpercatinib Product Name: Retevmo Original Research: Lilly Launch Date: May 8, 2020 Adaptation: Adult Transferability RET fusion positive non-small cell lung cancer (NSCLC) patients≥ adults and pediatric patients with systemic or relapsed RET mutated thyroid myeloma (MTC) at age ≥ require systemic treatment; age≥ adult and pediatric patients who are 12 years of age and have advanced or metastatic RET fusion-positive thyroid cancer require systemic treatment and are incurable to radioactive iodine (radioactive iodine, if appropriate), May 8, 2020, FDA approved The targeted anticancer drug Retevmo (selpercatinib, 40mg and 80mg capsules) of Loxo Oncology, a subsidiary of Eli Lilly, is used to treat tumors in specific genes (re-arranged genes during transfection). , RET gene) there are 3 types of tumor patients with genetic changes (mutation or fusion): non-small cell lung cancer (NSCLC), thyroid myelin-like cancer (MTC), and other types of thyroid cancer.
Retevmo is a selective RET kinase inhibitor that blocks RET kinases and prevents cancer cells from growing.
this approval is based on the total mitigation rate (ORR) and remission duration (DOR) of the Phase I/II clinical study LIBRETTO-001, the data show that Retevmo's efficacy is significantly better than that of the multi-target RET targeted drug currently approved (e.g. cabodinib, van der Thani, etc.) is not as effective as the RET-targeted drug BLU-667 (Pralsetinib) in study, or will become a first-line recommendation for RET-positive patients.
, the FDA has granted Retevmo Orphan Drug Eligibility (ODD), Breakthrough Drug Qualification (BTD), and Priority Review Eligibility.
, the first drug approved specifically for cancer patients with RET gene changes, was originally discovered by Loxo Oncology, a U.S. oncology precision drug development company, that Lilly acquired Loxo Oncology in January 2019 for $8 billion, the largest in a series of Deals by Lilly to expand its cancer treatment business.
, the first antibody association (ADC) drug targeting TRAP-2 - Trodelvy Generic name: sacituzumab govitecan-hziy Product Name: Trodelvy Original Research: Immunomedics Company Launch Date: April 22, 2020 Adaptation: At least 2 previously accepted On April 22, 2020, the FDA accelerated the approval of the antibody-coupled drug Trodelvy (sacituzumab govitecan-hziy) developed by Immunomedics one and a half months in advance for the treatment of adult patients with metastasis triple-yin breast cancer who had previously received at least two treatments.
, the FDA awarded sacituzumab govitecan a breakthrough therapy.
Trodelvy is the first FDA-approved antibody-coupled drug to treat triple-yin breast cancer and the first antibody-coupled drug to target Trap-2 (human nourishment layer cell surface antigen 2);
, Trodelvy has been approved for clinical practice in China.
Trodelvy consists of two parts: the target drug part Trap-2 antibody and the chemotherapy drug part SN-38 (similar to Ilithican).
Trop-2 is expressed in breast cancer, cervical cancer, colorectal cancer, kidney cancer, liver cancer and many other tumor cell surface, the expression rate of Trap-2 in patients with triple-yin breast cancer is as high as 90%, but the expression is limited in normal tissue.
Therefore, Trodelvy can target the active metabolite govitecan (SN-38) of the clinically commonly used chemotherapy drug Ilitican to solid tumor lesions by specific targeting Trap-2 monoantigen Sacituzumab, playing a chemical toxic killing effect.
, the world's first bile tube cancer target drug - Pemigatinib Common name: Pemigatinib Product Name: Pemazyre Original Research: Incyte Company Launch Date: April 17, 2020 Adaptation Symptoms: Patients with localized advanced or metastatic bile tube cancer who have been treated in the past with fibroblast growth factor recipient 2 (FGFR2) fusion or rearm April 17, 2020, FDA accelerates approval of Incyte The company Pemigatinib, which treats patients with localized advanced or metastatic bile tube cancer who have previously been treated with fibroblast growth factor recipient 2 (FGFR2) fusion or rearm, is approved at a 5-longer time than scheduled A month and a half ahead of the approval date on March 30th, the world's first bile tube cancer targeted therapy, showed that Pemigatinib treatment had an objective remission rate of more than 30% for patients with FGFR2 fusion/rearm, and a disease control rate of more than 80%, And the effect is fast and long-lasting.
the progress of its domestic listing, Cyda Bio has reached a strategic partnership with Pemigatinib's research and development drug company Incyte in December 2018 to develop and commercialize Pemigatinib in China, including Hong Kong/Macau and Taiwan.
March 4, 2020, Xinda Bio completed the first drug giving of Pemigatinib in China, becoming an important milestone in Pemigatinib's entry into the Chinese market.
, the first drug to treat PH1 - Oxlumo General Name: Lumasiran Product Name: Oxlumo Original Research: Alnylam Pharmaceutical Company Date: November 23, 2020 Adaptation: For the treatment of the original On November 23, 2020, the FDA announced the approval of the RNAi drug Oxlumasiran (Oxlumo) for the treatment of type 1 primary oxalic aciduria (PH1).
is the first FDA-approved treatment for the rare disease PH1 and the third RNAi treatment approved in nearly three years.
PH1 is an extremely rare disease that affects people of all ages and is characterized by excessive production of heralic acid, which can lead to end-stage kidney disease (ESKD) and other systemic complications.
is the first drug approved for PH1 and the only treatment that has been shown to reduce harmful oxalic acid levels.
approval of Oxlumo will have a meaningful clinical impact on PH1 patients.
the United States, Oxlumo has been awarded the FDA's pediatric rare disease qualification for PH1, Orphan Drug Qualification (ODD), breakthrough Drug Qualification (BTD).
in the EU, Oxlumo has been granted ODD, Priority Drug Qualification (PRIME).
, the first 4-line treatment for advanced gastrointestinal mesothelioma (GIST) innovative therapy - Qinlock Common name: ripretinib Product name: Qinlock Original research: Deciphera Pharmaceuticals Launch date: May 15, 2020 Adaptation: Late gastrointestinal tract In patients with mesothelioma (GIST), the FDA announced on May 15, 2020 that it has approved the launch of the protein kinase inhibition Qinlock tablet, becoming the first innovative treatment dedicated to 4-line treatment of advanced gastrointestinal mesothelioma (GIST).
the drug's allergy to GIST adult patients, who have been treated with more than three protein kinase inhibitors, including imatinib.
Ripretinib is a tyrosine kinase inhibitor that inhibits KIT primary cancer gene-like gene-like genosine kinase (KIT) and plate plate-derived growth factor subject A (PDGFRA) kinases, including wild, primary and secondary mutations.
Ripretinib can also inhibit other kinases in-body, such as PDGFRB, TIE2, VEGFR2 and BRAF.
Over the past 20 years, there has been significant progress in the development of GIST therapies, including four FDA-approved targeted therapies - imatinib in 2002, schoiniinib in 2006, regofinib in 2013 and Avaprini in early this year - but some patients have not responded well to these drugs, and Liptinib's approval offers a new treatment option for these GIST patients.
approval is based primarily on INVICTUS Phase III clinical research data.
results showed that Ripretinib was able to improve the progressive survival of GIST patients with four lines and above, and the tolerance was generally better.
, First Ebola Therapy - Inmazeb Generic Name: Atoltivimab, maftivimab and odesivimab-ebgn Commodity Name: Inmazeb Original Research: Regenerative Dollars Date: October 14, 2020 Adaptation: For the treatment of infections caused by the Zaire Ebolavirus, which can be used for adults and children infected with the virus, Including newborns of mothers who tested positive for infection On October 14, 2020, the FDA approved Inmazeb (atoltivimab, maftivimab, odesivimab-ebgn, formerly known as REGN-EB3) for the treatment of infections caused by the Zaire Ebolavirus virus, which can be used in adults and children infected, including newborns of infected mothers who have tested positive for infection. This is the first fdatic drug approved by the U.S. FDA to treat Ebola virus infection.
inmazeb was developed by Regenerative Meta, which targets glycoproteins on the surface of the Ebola virus.
this glycoprotein, by combining with a subject on the cell surface, causes the virus to fuse with the host cell membrane, allowing the virus to enter the cell.
Inmazeb is a mixture of three all-human IgG1 monoantibodies developed using VelociSuite® rapid reaction technology, which bind to the glycoprotein at the same time, blocking the virus's attachment and entry into cells.
, Inmazeb was granted orphan drug eligibility in the United States and the European Union, and breakthrough drug eligibility (BTD) in the United States.
8, the first low-grade urethra cancer drug therapy - Jelmyto Generic name: mitomycin Product Name: Jelmyto Original Research: UroGen Pharmaceuticals Date: April 17, 2020 Adaptation: For treatment On April 17, 2020, the FDA approved the listing of Jermyto (Silk Riftmycin Gel) developed by UroGen Pharma for the treatment of low-level upper urinary tract skin cancer (UTUC).
Jermyto is the first and only non-surgical treatment option approved for LG-UTUC.
Jelmyto, which consists of fissromycin, a chemotherapy drug, and sterile gels, was developed using UroGen's proprietary slow-release RTGel™ technology, an alkylated drug that inhibits DNA transcription into RNA, stops protein synthesis and deprives cancer cells of the ability to multiply.
has been awarded fast-track eligibility by the FDA, orphan drug eligibility, priority review eligibility and breakthrough therapy.
, the first drug to treat neurofibromatosis - Koselugo Generic name: Selumetinib Product Name: Koselugo Original Research: AstraZeneca and MSD Launch Date: April 13, 2020 Adaptation