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According to Evaluate Pharma's report "Evaluate Vantage 2022 Preview", FiercePharma analyzed the top ten most anticipated new drugs to be launched in 202 As of May 14, 2022, 4 models have been approved, and 1 model has been rejected due to insufficient evidence of effica.
Among the 10 new drugs, there are 4 small molecules, 3 monoclonal antibodies, 1 cell therapy, 1 RNAi therapy, and 1 polypepti.
author
0 Donanemab
0 DonanemabDeveloped by Eli Lilly, it is a humanized IgG1 monoclonal antibody that targets the deposition of specific forms of Aβ plaques (N-terminal 3-position pyroglutamination, referred to as N3pG-Aβ) , which can reduce the formation of new plaques and help clear existing plaqu.
Humanized IgG1 mAbs targeting plaques that deposit specific forms of Aβ
Aducanumab, a similar drug developed by Biogen, was approved by the FDA in June 2021, but the process was quite controversi.
Although aducanumab's performance was slightly dismal, analysts at Eli Lilly and Evercore ISI were optimistic about Donanemab , as head-to-head clinical data showed that Donanemab was more effective than aducanumab in reducing the concentration of deposited A.
But analysts at Eli Lilly and Evercore ISI are optimistic about Donanemab , as head-to-head clinical data show that Donanemab is more effective than aducanumab in reducing the concentration of deposited A.
0 Tirzepatide
Developed by Eli Lilly, it is a 39 amino acid polypeptide for the treatment of type II diabetes and obesity, which can simultaneously stimulate the receptors of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin-stimulating polypeptide (GI.
On June 25, 2021, data from a head-to-head Phase 3 clinical trial of Tirzepatide and Novo Nordisk GLP-1 blockbuster semaglutide (Ozempic) were published in the New England Journal of Medicine, and Tirzepatide was shown to reduce blood sugar levels and body weight by pesos Maglutide is more potent
Tirzepatide is more potent than semaglutide in lowering blood sugar levels and weight _ _
0 Gantenerumab
0 GantenerumabLike Lilly's Donanemab, it is a humanized IgG1 monoclonal antibody targeting Aβ, which can recruit microglia and activate phagocytosis to degrade Aβ plaqu.
The only Aβ antibody administered subcutaneousl.
The development of Gantenerumab was not so smooth either, and on December 19, 2014, Roche stopped dosing Gantenerumab after data from an interim analysis of the SCarlet RoAD trial showed that the treatment was ineffecti.
Obtained FDA breakthrough therapy designation in October 2021 , and the pivotal GRADUATE Phase III clinical trial is in progress,
0 Deucravicitinib
0 DeucravicitinibDeveloped by BMS, it is the first JAK inhibitor that selectively acts on the JH2 domain of TYK2 , can inhibit the signal transduction of IL-23, IFN α and IL-12, and will be used for the treatment of systemic lupus erythematosus and psoriasis and other autoimmune disease.
Is the first JAK inhibitor that selectively acts on the JH2 domain of TYK2
Phase II clinical trial data for psoriasis showed that compared with placebo and active control, deucravicitinib showed significant improvement in skin symptom clearance rate and quality of life indicators assessed by PASI 75 and sPGA 0/ The patient response rate was 69% , which was significantly better than the blockbuster Otezla , which is also a small molecule oral drug, and close to the IL-12/23 mAb Stelara and the drug king Humi.
The patient response rate was 69% , which was significantly better than the blockbuster Otezla , which is also a small molecule oral drug, and close to the IL-12/23 mAb Stelara and the drug king Humi.
0 Bardoxolone
Developed by Reata Pharma, it is the first Alport -related chronic kidney disease therapy targeting Nrf
It is the first Alport -related chronic kidney disease therapy targeting Nrf
Bardoxolone met its primary and key secondary objectives in the Phase III CARDINAL registration trial, but the FDA advisory committee believes that the use of glomerular filtration rate as the primary indicator in clinical trials is not as good as other indicators to confirm efficacy, and therefore questioned the drug and The progression of CKD cannot be delayed, and with a 13-0 vote against approval of Bardoxolone, the FDA also declined to approve Bardoxolone on February 2 But Reata has not given up, saying that it will maintain cooperation with the FDA and continue to promote the clinical program of Bardoxolone in the treatment of Alport syndro.
0 Tezepelumab
0 Tezepelumab Co-developed by Amgen and AstraZeneca, Tezspire is the first monoclonal antibody to consistently and significantly reduce exacerbations in a broad population of patients with severe asthma
By binding to thymic stromal lymphopoietin (TSLP), Tezepelumab blocks the interaction of TSLP with its receptor complex and inhibits multiple downstream inflammatory pathways, thereby reducing the rate of asthma exacerbatio.
Results from the PATHFINDER clinical and pivotal Phase 3 NAVIGATOR clinical trials confirm that Tezepelumab demonstrated a statistically significant and clinically significant annual asthma exacerbation rate (AAER) compared with placebo in a broad range of patients with severe uncontrolled asthma Decreased meani.
Based on this positive result, Amgen submitted a BLA to the FDA on May 10, 2021, which was approved on December 17, 2021, as an add-on maintenance therapy for the treatment of severe asthma in pediatric patients ≥12 years of age and adult patien.
Based on current clinical data, tezepelumab has shown efficacy in several severe lung diseases, and analysts believe it will have the opportunity to challenge the dominance of Sanofi's blockbuster Dupixe.
According to Evaluate Pharma, its sales in 2026 could reach $2 billi.
0 Vutrisiran
0 Vutrisiran Developed by Alnylam, it is a subcutaneous RNAi therapy for the treatment of hereditary and wild-type transthyretin amyloidosis (ATT.
Vutrisiran targets and silences transthyretin mRNA and blocks translation of wild-type and mutant transthyret.
May help reduce the deposition of transthyretin amyloid in tissues, promote the removal of amyloid deposited in tissues, and potentially restore the function of these tissu.
Compared with Alnylam's Patisiran (also an siRNA for ATTR treatment) approved in 2018 , Vutrisiran uses GalNAc delivery technology, which improves the efficacy and metabolic stability of RNAi , and reduces the frequency of dosi.
Patisiran requires every 3 weeks Vutrisiran is given as a single intravenous injection while Vutrisiran only needs to be given as a subcutaneous injection every 3 month.
Patisiran needs to be administered intravenously every 3 weeks while Vutrisiran only needs to be administered subcutaneously every 3 month.
In the Phase III HELIOS-A clinical study, Vutrisiran outperformed the placebo-controlled clinical trial of the earlier Patisiran trial, with a 46-point reduction from baseline in the patient-adjusted Neuropathy Impairment Score (mNIS+7) at month 18 , while the control group increased by 209 points, showing a higher clinical benefit, in addition to statistically significant improvements across multiple measures of quality of life, gait speed, nutritional status, and overall disabili.
Vutrisiran had submitted an NDA to the FDA in April 2021, and the FDA extended the PDUFA date by three months from April 14 this year to July 14 to conduct inspections of third-party packaging and labe.
According to Evaluate Pharma, its sales in 2026 could reach $8 billi.
0 Mavacamten
0 Mavacamten Developed by BMS, is the first FDA -approved small-molecule allosteric modulator of cardiac myosin that inhibits troponin-myosin binding and prevents muscle bridge formation, thereby improving myocardial contractility in patients with hypertrophic cardiomyopathy (HC.
Hyperfunction, thereby improving myocardial diastolic function and patient clinical outcom.
Phase III EXPLORER-HCM clinical data showed that 36% of patients using Mavacamten experienced significant improvements in oxygen consumption and cardiac function after 30 weeks, compared with 12% in the placebo group, and the clinical benefit lasted for nearly a ye.
VALOR-HCM clinical data show that increasing Mavacamten to the maximum tolerated dose of medical therapy reduces the need for surgery or interventional septal myocardecto.
Compared with traditional drugs (such as beta -blockers, calcium channel blockers, e.
), it has obvious superiority and can change the natural process of HC.
The FDA approved Mavacamten for the treatment of HCM on April 29, 202 Evaluate Pharma predicts that its sales in 2026 will reach 7 billion US dollars, which will help BMS cope with the upcoming patent cliff of 10 billion single product Eliqui.
), it has obvious superiority and can change the natural process of HC.
0 Cita-cel
0 Cita-cel Developed by Legend Bio, it is a CAR-T therapy targeting B cell maturation antigen (BCMA), containing a 4-1BB co-stimulatory domain and two BCMA-targeting antibody domains for the treatment of multiple myeloid tum.
In December 2020, Cedarquiorenza began rolling BLA submissions to the FDA, and was finally approved for the treatment of multiple myeloma on February 28, 202 The FDA approval is based on the results of the pivotal Phase Ib/II CARTITUDE-1 stu.
According to the latest data from CARTITUDE-1 presented at the 63rd ASH Annual Meeting in 2021, in 97 patients with relapsed or refractory multiple myeloma who were followed up for nearly two years, the overall response rate was 98% , strictly meaning The complete remission rate was 83% , and the two-year progression-free survival rate and overall survival rate were 61% and 74% , respectively, with Best in class potential
According to Evaluate Pharma, its sales in 2026 could reach $7 billi.
1 Adgrasib
1 Adgrasib Developed by Mirati, it is a highly selective KRAS G12C inhibitor that can covalently bind to the cysteine residue of KRAS G12C protein, maintain the inactive conformation of KRAS protein binding to GDP, and block oncogenic signali.
Inhibition of tumor cell proliferation for the treatment of NSCLC with KRAS G12C mutati.
According to data from the KRYSTAL-1 Phase II registration clinical cohort, among patients with KRAS G12C-mutant advanced NSCLC who had previously received front-line therapy (including immunotherapy and chemotherapy), the ORR of adagrasib at a median follow-up of 9 months was 43%, and the DCR was 8
Based on this data, Mirati submitted an NDA with a PDUFA date of December 14 this ye.
Adagrasib and Amgen's similar drug Sotorasib started clinical development almost at the same time, but Sotorasib progressed faster and was approved for marketing in June last ye.
In order to catch up with Sotorasib, Adagrasib is also accelerating the development of other indications such as colorectal cancer and pancreatic canc.
Better clinical benefit than Sotorasib has been shown in colorectal cancer patien.
According to Evaluate Pharma, its sales in 2026 could reach $7 billi.
main reference
Main references Main references [1] https:// https:// [2] Mintun MA et .
Donanemab in Early Alzheimer's Disea.
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Donanemab in Early Alzheimer's Disea.
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[3] https:// https:// [4] https:// https:// [5] https:// https:// [6] Wrobleski ST et .
Highly Selective Inhibition of Tyrosine Kinase 2 (TYK2) for the Treatment of Autoimmune Diseases: Discovery of the Allosteric Inhibitor BMS-98616 J Med Ch.
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Highly Selective Inhibition of Tyrosine Kinase 2 (TYK2) for the Treatment of Autoimmune Diseases: Discovery of the Allosteric Inhibitor BMS-98616 J Med Ch.
2019 Oct24;62(20):8973-899
[7] https:// https:// [8] https:// https:// [9] Spertus JA et .
Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): healthstatus analysis of a randomised, double-blind, placebo-controlled, phase 3tri.
Lanc.
2021 Jun 26;397(10293):2467 -247
Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): healthstatus analysis of a randomised, double-blind, placebo-controlled, phase 3tri.
Lanc.
2021 Jun 26;397(10293):2467 -247
[10] https:// https://
