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In September, a total of 14 new drugs were approved for marketing
in China, the United States and Europe.
Among them, the United States approved 8 new drugs for marketing, and 6 global new drugs (see table for details); EU approves 6 paragraphs; No new drugs have been approved
in China.
in China, the United States and Europe.
Among them, the United States approved 8 new drugs for marketing, and 6 global new drugs (see table for details); EU approves 6 paragraphs; No new drugs have been approved
in China.
The United States approved 8 new drugs for marketing
According to the Pharmadigger database, eight new drugs were approved in the United States in
September.
Among them, Spesolimab, Daxibotulinumtoxin A, Eflapegrastim, Deucravacitinib, Terlipressin and Elivaldogene autotsemcel were approved
for the first time in the world.
September.
Among them, Spesolimab, Daxibotulinumtoxin A, Eflapegrastim, Deucravacitinib, Terlipressin and Elivaldogene autotsemcel were approved
for the first time in the world.
Spesolimab-sbzo (trade name: Spevigo), developed by Boehringer Ingelheim, is the world's first and only drug
approved specifically for the treatment of generalized pustular psoriasis (GPP).
Unlike plaque psoriasis, GPP is a rare and potentially life-threatening neutrophil skin disease characterized by widespread outbreaks of painful aseptic pustules
.
Because the disease is so rare, identifying symptoms can be challenging and can lead to delays
in diagnosis.
Spesolimab blocks activation of the interleukin-36 receptor (IL-36R), which has been shown to be associated
with the pathogenesis of GPP.
The approval of Spesolimab is based on a pivotal EFFISAYIL-1 Phase II clinical trial
.
The results of the trial showed that patients treated with Spesolimab had significantly fewer pustules than those
treated with placebo.
Previously, the drug had obtained orphan drug designation and priority review status
in the United States.
approved specifically for the treatment of generalized pustular psoriasis (GPP).
Unlike plaque psoriasis, GPP is a rare and potentially life-threatening neutrophil skin disease characterized by widespread outbreaks of painful aseptic pustules
.
Because the disease is so rare, identifying symptoms can be challenging and can lead to delays
in diagnosis.
Spesolimab blocks activation of the interleukin-36 receptor (IL-36R), which has been shown to be associated
with the pathogenesis of GPP.
The approval of Spesolimab is based on a pivotal EFFISAYIL-1 Phase II clinical trial
.
The results of the trial showed that patients treated with Spesolimab had significantly fewer pustules than those
treated with placebo.
Previously, the drug had obtained orphan drug designation and priority review status
in the United States.
Daxibotulinumtoxin A (trade name: Daxxify), developed by Revance Pharmaceuticals, is the world's first and currently the only long-acting peptide formulation neuromodulator for the treatment of moderate to severe glabellar lines
.
Patients only need to be injected twice a
year.
The drug approval is based on a phase III clinical trial
called SAKURA.
The results of the trial showed that after receiving Daxibotulinumtoxin A injection, the severity of glabellar wrinkles improved in 98% of the subjects; The median duration was up to 6 months, and some patients maintained improvement even at 9 months
.
In December 2018, Fosun Pharma reached a cooperation agreement with Revance on Daxibotulinumtoxin A to obtain the right to
commercialize Daxibotulinumtoxin A in the Chinese market.
At present, Fosun Pharma is conducting two phase III clinical trials
of the drug for the treatment of isolated neck dystonia and moderate to severe glabellar lines.
.
Patients only need to be injected twice a
year.
The drug approval is based on a phase III clinical trial
called SAKURA.
The results of the trial showed that after receiving Daxibotulinumtoxin A injection, the severity of glabellar wrinkles improved in 98% of the subjects; The median duration was up to 6 months, and some patients maintained improvement even at 9 months
.
In December 2018, Fosun Pharma reached a cooperation agreement with Revance on Daxibotulinumtoxin A to obtain the right to
commercialize Daxibotulinumtoxin A in the Chinese market.
At present, Fosun Pharma is conducting two phase III clinical trials
of the drug for the treatment of isolated neck dystonia and moderate to severe glabellar lines.
Eflapegrastim (trade name: Rolvedon) is the first novel long-acting granulocyte colony-stimulating factor (G-CSF) approved by the U.
S.
Food and Drug Administration (FDA) developed by Spectrum Pharmaceuticals to stimulate the proliferation process by binding to G-CSF receptors expressed on granulocyte progenitor cells, allowing them to eventually produce functionally activated neutrophils
in the bone marrow.
Most chemotherapy-induced neutropenia results in delayed chemotherapy administration, reduced chemotherapy dose, or premature termination
of chemotherapy.
Eflapegrastim's approval is based on two phase III clinical trials called ADVANCE and RECOVER, which have a similar safety profile compared to active comparators and are non-inferior in shortening the duration of chemotherapy-induced severe neutropenia
.
S.
Food and Drug Administration (FDA) developed by Spectrum Pharmaceuticals to stimulate the proliferation process by binding to G-CSF receptors expressed on granulocyte progenitor cells, allowing them to eventually produce functionally activated neutrophils
in the bone marrow.
Most chemotherapy-induced neutropenia results in delayed chemotherapy administration, reduced chemotherapy dose, or premature termination
of chemotherapy.
Eflapegrastim's approval is based on two phase III clinical trials called ADVANCE and RECOVER, which have a similar safety profile compared to active comparators and are non-inferior in shortening the duration of chemotherapy-induced severe neutropenia
.
Deucravacitinib (trade name: Sotyktu) is the world's first and currently the only approved oral selective tyrosine kinase 2 (TYK2) allosteric inhibitor developed by Bristol-Myers Squibb for the treatment of adult patients with
moderate to severe plaque psoriasis.
Psoriasis is a common chronic, systemic immune-mediated disease
.
Up to 90% of people with psoriasis have plaque psoriasis, which is characterized by well-demarcated, round or oval plaques, often covered with silvery-white scales
.
THE APPROVAL OF THE DRUG IS BASED ON THE RESULTS
OF TWO PIVOTAL PHASE III CLINICAL TRIALS, POETYK PSO-1 AND POETYK PSO-2.
For patients with moderate to severe plaque psoriasis, Deucravacitinib is superior to placebo and Apremilast
.
moderate to severe plaque psoriasis.
Psoriasis is a common chronic, systemic immune-mediated disease
.
Up to 90% of people with psoriasis have plaque psoriasis, which is characterized by well-demarcated, round or oval plaques, often covered with silvery-white scales
.
THE APPROVAL OF THE DRUG IS BASED ON THE RESULTS
OF TWO PIVOTAL PHASE III CLINICAL TRIALS, POETYK PSO-1 AND POETYK PSO-2.
For patients with moderate to severe plaque psoriasis, Deucravacitinib is superior to placebo and Apremilast
.
Terlipressin (trade name: Terlivaz) is the world's first FDA-approved therapy to improve kidney function in adult patients with hepatorenal syndrome (HRS), developed
by Mallinckrodt.
HRS is an acute and life-threatening condition that is common in patients with
advanced liver disease.
HRS is divided into rapidly progressive types, which cause acute renal failure and usually require hospitalization, and chronic, which progresses
over weeks to months.
Terlipressin is a synthetic analogue of endogenous vasopressin, has a vasoconstrictor and antibleeding pharmacological effect, reduces blood flow to the liver and portal venous pressure
.
THE APPROVAL IS BASED ON THE RESULTS
OF A PHASE III CLINICAL TRIAL CALLED CONFIRM.
Patients with rapidly progressive HRS achieved significantly higher HRS reversal with Terlipressin than in the placebo group
.
by Mallinckrodt.
HRS is an acute and life-threatening condition that is common in patients with
advanced liver disease.
HRS is divided into rapidly progressive types, which cause acute renal failure and usually require hospitalization, and chronic, which progresses
over weeks to months.
Terlipressin is a synthetic analogue of endogenous vasopressin, has a vasoconstrictor and antibleeding pharmacological effect, reduces blood flow to the liver and portal venous pressure
.
THE APPROVAL IS BASED ON THE RESULTS
OF A PHASE III CLINICAL TRIAL CALLED CONFIRM.
Patients with rapidly progressive HRS achieved significantly higher HRS reversal with Terlipressin than in the placebo group
.
Omidenepag isopropyl (trade name: Omlonti) is a selective prostaglandin E2 receptor (EP2) agonist developed by Santen Pharmaceuticals, which simultaneously increases the outflow of aqueous humor from the trabecular mesh and uveal sclera to exert the effect
of reducing intraocular pressure.
The drug was approved for marketing
in Japan in 2018.
of reducing intraocular pressure.
The drug was approved for marketing
in Japan in 2018.
Sodium phenylbutyrate/taurursodiol (oral fixed-dose formulation of sodium phenylbutyrate and taurine diol, trade name: Relyvrio) is the first treatment developed by Amylyx Pharmaceuticals to significantly delay the progression of ALS and prolong patient survival in a randomized, placebo-controlled clinical trial
.
The therapy improves the health of intracellular mitochondria and endoplasmic reticulum, thereby delaying the death
of nerve cells.
The drug was approved for conditional marketing
by Canada's drug regulatory authority in June this year.
.
The therapy improves the health of intracellular mitochondria and endoplasmic reticulum, thereby delaying the death
of nerve cells.
The drug was approved for conditional marketing
by Canada's drug regulatory authority in June this year.
Elivaldogene autotsemcel (trade name: Skysona) is the first gene therapy
developed by Bluebird Biologics to treat early cerebral adrenodystrophy.
Adrenal leukodystrophy (ALD) is a rare X-linked metabolic disorder that mainly affects males
.
The approval of the drug is based on a phase II/III clinical trial called ALD-102 and a phase III clinical trial
of ALD-104.
Based on the findings, patients treated with Elivaldogene autotemce had an estimated 72% survival without major dysfunction within 24 months of the first symptom onset (neurological function score NFS≥1), which is about 1.
6 times higher
than that of untreated patients.
developed by Bluebird Biologics to treat early cerebral adrenodystrophy.
Adrenal leukodystrophy (ALD) is a rare X-linked metabolic disorder that mainly affects males
.
The approval of the drug is based on a phase II/III clinical trial called ALD-102 and a phase III clinical trial
of ALD-104.
Based on the findings, patients treated with Elivaldogene autotemce had an estimated 72% survival without major dysfunction within 24 months of the first symptom onset (neurological function score NFS≥1), which is about 1.
6 times higher
than that of untreated patients.
The EU approved 6 new drugs for marketing
According to the Pharmadigger database, a total of 6 new drugs were approved in the EU in September, and no new drugs
were approved for the first time in the world.
were approved for the first time in the world.
Tezepelumab (trade name: Tezspire) is the first and only EU-approved biologic drug
for the treatment of severe asthma that is not limited by phenotype or biomarkers.
TSLP is an epithelial cytokine produced in response to pro-inflammatory stimuli, such as pulmonary allergens, viruses, and other pathogens, which is expressed in the airways of patients with asthma and is associated with
disease severity.
Tezepelumab, a TSLP monoclonal antibody drug, was approved based on the results of a clinical trial called PATHFINDER: Tezepelumab was statistically and clinically significant
in reducing the average annual rate of asthma exacerbations in patients with severe, uncontrolled asthma compared to placebo.
The drug was first approved by the FDA in
December 2021.
for the treatment of severe asthma that is not limited by phenotype or biomarkers.
TSLP is an epithelial cytokine produced in response to pro-inflammatory stimuli, such as pulmonary allergens, viruses, and other pathogens, which is expressed in the airways of patients with asthma and is associated with
disease severity.
Tezepelumab, a TSLP monoclonal antibody drug, was approved based on the results of a clinical trial called PATHFINDER: Tezepelumab was statistically and clinically significant
in reducing the average annual rate of asthma exacerbations in patients with severe, uncontrolled asthma compared to placebo.
The drug was first approved by the FDA in
December 2021.
Vutrisiran (trade name: Amvuttra) is a subcutaneous RNAi therapy
developed by Alnylam Pharmaceuticals.
The approval is based on a phase III clinical trial
called HELIOS-A.
The results showed that the drug significantly improved the signs and symptoms of hATTR amyloidosis, and the manifestations of polyneuropathy stopped or reversed
in more than 50% of patients.
Vutrisiran was previously approved by the FDA in
June 2022.
developed by Alnylam Pharmaceuticals.
The approval is based on a phase III clinical trial
called HELIOS-A.
The results showed that the drug significantly improved the signs and symptoms of hATTR amyloidosis, and the manifestations of polyneuropathy stopped or reversed
in more than 50% of patients.
Vutrisiran was previously approved by the FDA in
June 2022.
Voclosporin (trade name: Lupkynis) is an oral calcineurin inhibitor
developed by Otsuka Pharmaceutical.
Lupus nephritis, an immune complex caused by systemic lupus erythematosus (SLE) involving the kidneys, is a major comorbidity and cause of
death in SLE.
Vocl ospor in is an analogue of cyclosporine A, which binds to cyclophilin A to form a heterodimeric complex, which in turn binds to and inhibits calcineurin, blocks IL-2 expression and T cell-mediated immune response, stabilizes kidney function
.
The drug was first approved by the FDA in
January 2021.
developed by Otsuka Pharmaceutical.
Lupus nephritis, an immune complex caused by systemic lupus erythematosus (SLE) involving the kidneys, is a major comorbidity and cause of
death in SLE.
Vocl ospor in is an analogue of cyclosporine A, which binds to cyclophilin A to form a heterodimeric complex, which in turn binds to and inhibits calcineurin, blocks IL-2 expression and T cell-mediated immune response, stabilizes kidney function
.
The drug was first approved by the FDA in
January 2021.
Fosdenopterin (trade name: Nulibry) is the first cPMP substrate replacement therapy
developed by Origin Biosciences.
Molybdenum cofactor A deficiency (MoCD) is a very rare autosomal recessive disorder caused
by disruption of molybdenum cofactor (MoCo) synthesis, which is essential for sulfite oxidase (SOX) activity.
Fosdenopterin can replace cPMP and allow the MoCo synthesis step to continue, eliminating sulfites while activating MoCo-dependent enzymes, reducing central nervous system symptoms, and thus reducing mortality
in patients with type A MoCD.
The drug was first approved by the FDA in
February 2021.
developed by Origin Biosciences.
Molybdenum cofactor A deficiency (MoCD) is a very rare autosomal recessive disorder caused
by disruption of molybdenum cofactor (MoCo) synthesis, which is essential for sulfite oxidase (SOX) activity.
Fosdenopterin can replace cPMP and allow the MoCo synthesis step to continue, eliminating sulfites while activating MoCo-dependent enzymes, reducing central nervous system symptoms, and thus reducing mortality
in patients with type A MoCD.
The drug was first approved by the FDA in
February 2021.
The fixed-dose antibody combination therapy of Relatlimab and Nivolumab (trade name: Opdualag) is a fixed-dose combination developed
by Bristol-Myers Squibb.
The product was first approved by
the FDA in March 2022.
by Bristol-Myers Squibb.
The product was first approved by
the FDA in March 2022.
Faricimab (trade name: Vabysmo) is a bispecific antibody developed by Roche that targets both vascular endothelial growth factor A (VEGF-A) and angiopoietin 2 (Ang-2) signaling pathways
.
Faricimab was first approved by the FDA in
January 2022.
.
Faricimab was first approved by the FDA in
January 2022.
