FDA approves 19 BLA applications for multiple heavy-duty targeted drugs to be approved for market!

2020 is coming to an end, this year, although the new crown pneumonia epidemic swept the world, but the FDA for the development and approval of new drugs have not been affected in any way, but the good news comes out frequently, a number of heavy new drugs approved for the market! As one of the world's leading pharmaceutical industry markets, the United States has a strong pharmaceutical market to support innovation, coupled with a strict review and evaluation system, the FDA's annual approval of new drugs has become the world's new drug research and development "barometer."
, with the wide application of monoantic drugs and the development of new targets, biological drugs have been paid more and more attention.
1: In recent years, the FDA has approved BLA applications (source: Pharmacopoeic U.S. Listed Drugs Database) This year the FDA approved a total of 19 BLA applications, including 11 new molecular entities and 9 orphan drugs.
19 biologics are from Horizon, Lundbeck Lingbei, Sanofi, Cis Bio, Immunomedics, Jansen, Hospira, Mylan, Viela Bio, Lilly, Genentech, ENDO GLOBAL AESTHETICS, GlaxoSmithKline, Noor and Nord, Regeneron and Y-MABS THERAPEUTICS.
Figure 2: 2020 FDA Approves BLA Application (Source: Pharmaceutical Intelligence U.S. Listed Drugs Database) Table 1: 2020 FDA Approves Biologics 1.Tepezza: Orphan Drug, IGF-1R Target Monoantigen.
January 21, the FDA approved HORIZON THERAPEUTICS' teprotumumab for the treatment of thyroid eye disease.
thyroid eye disease, also known as Graves eye disease, is a self-immune-related disease.
Teprotumumab is the first drug specifically approved for thyroid eye disease and is an important milestone in the treatment of thyroid eye disease.
2.Vyept: it's CGRP single resistance.
February 21, the FDA also approved Lingbei's eptinezumab for preventive treatment of migraines.
the CGRP target competition has been fierce, after the FDA has approved Amgen Novarma's erenumab, Teva's Freemanezumab and Lilly's galcanezumab three of the same target monoantigen, not only that, the FDA approved Biohaven's oral CGRP inhibitor Rimegegantepant at about the same time.
3.Sarclisa: Orphan medicine, CD38-oriented cell dissolution antibodies.
March 2, the FDA approved Sanofi's ISATUXIMAB, a combination of pomadamide and dexamysund for multiple myeloma (MM) treatments that have previously received more than two therapies, including pomadamine and protease inhibitors.
fda had approved another CD38 antibody, daratumumab, before isatuximab was approved.
, isatuximab clinical trials for a variety of lymphoma and leukemia treatments are proceeding in an orderly manner.
4.Pulmotech MAA:the polymerized albumin at the same time.
5.Trodelvy: The first antibody-coupled drug (ADC) approved to target TRAP-2.
April 22, the FDA accelerated approval of Immunomedics' sacituzumab govitecan for the treatment of adult patients with metastasis triple negative breast cancer who have received at least two therapies in the past.
addition to triple-yin breast cancer, Sacituzumab's development of adaptive diseases includes rectal cancer, prostate cancer, stomach cancer and other solid tumors, is one of the most noteworthy "heavyweight bombs" in 2020.
6. Darzalex Faspro: Orphan medicine, subsurfaced injections containing Daratumab (a CD38-directed cell dissolution antibody) and hyalurase for the treatment of multiple myeloma in adults.
7.Nyvepria: A biosynthic drug from Amgen's Neulasta (pegfilgrastim, Pfeisting), a white blood cell growth factor used to reduce the incidence of infection in patients with non-myelin malignancies.
8.Semglee: Insulin glycelin injections, off-skin injections, a long-acting human insulin similarity, used to improve blood sugar control in adults and children with type 1 diabetes and adults with type 2 diabetes.
first approved in the United States in 2000.
the drug was first submitted as a new drug application (NDA) and then as a Biologics Application (BLA).
9.Uplizna: Orphan Drug, a CD19-oriented cell dissolution antibody.
June 11, the FDA approved VILA BIO's inebilizumab for optic neurospinal cord disease (NMOSD) that is positive for water channel protein 4 (AQP4) antibodies.
addition to NMOSD, this product is also developing kidney transplantation, severe muscle weakness and other self-immune diseases, but the market potential to develop into a heavy bomb is small.
10.Semlee: The FDA approves the use of Semglee™ (insulin glycelin injections) in vials and pre-installed pens to control high blood sugar levels in adults with type 2 diabetes and adults and children with type 1 diabetes.
Semglee has the same amino acid sequence ® Sanofi Lantus and is approved for the same adaptive disorder.
11.Lyumjev: A new type of quick-acting insulin used to improve blood sugar control in adult diabetics.
12.Phesgo: A subsurfic injection made up of a combination of Pertuzumab, Trastuzumab, and hyalurogenic acidase hyaluronidase-zzxf to treat adult her2-positive breast cancer patients who have spread to other parts of the body, as well as early HER2-positive breast cancer adult patients.
13.Hulio: Biosynthics for Shomeile (Adamo Monoanti).
,000-year-old company, AbbVie, has been the world's top-ranked company by sales for many years, with $19 billion in 2019.
will not be available in the U.S. until 2023 because of AbbVie's tight patent protection for Mylan/Concorde.
14.Qwo: A combination of bacterial collagenase used to treat medium to severe cells in the hips of adult women.
15.Monjuvi: Orphan drug, a CD19-oriented cell dissolution antibody.
July 31, the FDA accelerated approval of MorphoSys' tafasitamab in association with lynamide to treat adult patients with relapsed or incurable diffuse large B-cell lymphoma (DLBCL).
16.Blenrep: Orphan drug, a B-cell mature antigen (BCMA)-guided antibody and micro-tube inhibitor binding.
August 5, the FDA accelerated approval of GSK's ADC drug belantamab mafodotin for the treatment of adult patients with recurring/refractic multiple myeloma (MM) who have received at least four treatments in the past.
only about 10,000 MMs worldwide receive four-line treatment, GSK is conducting earlier drug trials.
17.Enspryng: Orphan drug, a lebinocyte median-6 (IL-6) subject antagonist.
August 14, the FDA approved gene teksatralizumab for the treatment of AQP4-positive optic neurospinal cord disease.
is the second NMOSD product approved in 2020.
18.Inmazeb: Orphan Drug, a research three-antibody cocktail therapy (atoltivimab, maftivimab and odesivimab-ebgn), is the first drug approved for treatment of Ebola infection in adults and children.
19. Danyelza: Orphan drug, is a humanized monoclonal antibody that targets glycoside lipids (GD2), which is highly expressed in a variety of neurosurgery tumors and sarcoma.
FDA-approved treatment in a joint treatment with granulocyte-macrophage cluster stimulation factor (GM-CSF) for children (1 year and older) and adult patients with relapsed/refractory high-risk neuroblastoma who have shown partial remission, mild relief, or stable disease in previous treatments.
Danyelza has been awarded priority review qualifications, orphan drug eligibility, breakthrough therapy and rare pediatric disease status by the FDA.
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