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In August this year, the United States, the United States and the European Union approved the listing of 9 new drugs (see table for
details).
Among them, China approved 1 new drug listing, the United States approved 2, and the European Union approved 6; Many are "global new" drugs
.
details).
Among them, China approved 1 new drug listing, the United States approved 2, and the European Union approved 6; Many are "global new" drugs
.
China approved the listing of 1 new drug
In August, the repatumab independently developed by China's pharmaceutical company Shenzhou Cell Engineering Co.
, Ltd.
was approved for listing
.
The drug is used in combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) regimen for the treatment of diffuse large B-cell lymphoma
.
, Ltd.
was approved for listing
.
The drug is used in combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) regimen for the treatment of diffuse large B-cell lymphoma
.
Repatitumab is a human-mouse chimeric IgG1 anti-CD20 monoclonal antibody whose structure contains 30% of the variable region Fab of the mouse anti-CD20 monoclonal antibody, and 70% of the human IgG1 antibody stable region Fc fragment
.
The constant region sequence uses the human antibody native sequence, and valine
is used at site 219 of the heavy chain CH1 region.
This amino acid sequence is widely used in marketed antibody drugs, which can reduce the immunogenicity
of the drug as much as possible under the premise of ensuring the effectiveness of the drug.
Optizumab, Olfamumab, and Adalimumab are perfectly consistent
with the sequence of repatumab in the heavy chain constant region.
The drug was approved based on the results of its phase III clinical trial: the efficacy of repatumab-CHOP and rituximab-CHOP in the treatment of patients with initially treated diffuse large B-cell lymphoma was comparable
.
.
The constant region sequence uses the human antibody native sequence, and valine
is used at site 219 of the heavy chain CH1 region.
This amino acid sequence is widely used in marketed antibody drugs, which can reduce the immunogenicity
of the drug as much as possible under the premise of ensuring the effectiveness of the drug.
Optizumab, Olfamumab, and Adalimumab are perfectly consistent
with the sequence of repatumab in the heavy chain constant region.
The drug was approved based on the results of its phase III clinical trial: the efficacy of repatumab-CHOP and rituximab-CHOP in the treatment of patients with initially treated diffuse large B-cell lymphoma was comparable
.
The United States approved the launch of 2 new drugs
According to the data of the Pharmadigger database, a total of 2 new drugs were approved for marketing in the United States in August, namely Olipudasealpha developed by Sanofi and Betibeglogene autotemcel developed by Bluebird Biologics
.
.
Olipudasealpha is currently the world's first drug
specifically designed to treat acid sphingomyelinase deficiency (ASMD).
ASMD is an extremely rare progressive genetic disorder caused by the accumulation of sphingomyelins in various tissues due to insufficient activity of acid sphingomyelinase, and the patient's symptoms usually manifest as spleen or hepatomegaly, dyspnea, lung infection, and unusual bruising or bleeding
.
Olipudasealpha is a hydrolytic lysososomal sphingomyelin-specific enzyme replacement therapy designed to replace a lacked or defective acid sphingomyelinase
.
The approval of the drug is based on positive data from two clinical trials, ASCEND and ASCEND-Peds, in which 31 adult patients with A/B OR B-ASMD were included in the ASCEND study and 8 cases of children under 12 years of age with A/B OR B-ASMD in the ASCEND-Peds study
.
Subjects received intravenous Olipudaseal pha or placebo every two weeks for 52 and 64 weeks
, respectively.
The results of both trials showed significant improvements
in lung function and spleen volume reduction in the trial group compared with patients in the placebo group.
In addition, the drug has been approved for marketing
in Japan and the European Union in March and June this year.
specifically designed to treat acid sphingomyelinase deficiency (ASMD).
ASMD is an extremely rare progressive genetic disorder caused by the accumulation of sphingomyelins in various tissues due to insufficient activity of acid sphingomyelinase, and the patient's symptoms usually manifest as spleen or hepatomegaly, dyspnea, lung infection, and unusual bruising or bleeding
.
Olipudasealpha is a hydrolytic lysososomal sphingomyelin-specific enzyme replacement therapy designed to replace a lacked or defective acid sphingomyelinase
.
The approval of the drug is based on positive data from two clinical trials, ASCEND and ASCEND-Peds, in which 31 adult patients with A/B OR B-ASMD were included in the ASCEND study and 8 cases of children under 12 years of age with A/B OR B-ASMD in the ASCEND-Peds study
.
Subjects received intravenous Olipudaseal pha or placebo every two weeks for 52 and 64 weeks
, respectively.
The results of both trials showed significant improvements
in lung function and spleen volume reduction in the trial group compared with patients in the placebo group.
In addition, the drug has been approved for marketing
in Japan and the European Union in March and June this year.
Betibeglogene autotemcel is the world's first drug
specifically designed to treat β thalassemia patients who require routine red blood cell transfusions.
β thalassemia is a serious genetic disorder
.
Due to mutations in the gene encoding β globin, hemoglobin levels in patients are significantly reduced or even missing, requiring lifelong transfusion therapy
.
Although blood transfusions can temporarily relieve symptoms associated with severe anemia, such as fatigue, weakness, and shortness of breath, they do not treat the disease at their root and can lead to serious complications
.
Betibeglogene autotemcel is a gene therapy that genetically engineers hematopoietic stem cells isolated from patients in vitro to produce functioning β globin
.
When these hematopoietic stem cells are transfused back into the patient, they produce red blood cells with normal functions, greatly reducing the patient's need for
blood transfusions.
specifically designed to treat β thalassemia patients who require routine red blood cell transfusions.
β thalassemia is a serious genetic disorder
.
Due to mutations in the gene encoding β globin, hemoglobin levels in patients are significantly reduced or even missing, requiring lifelong transfusion therapy
.
Although blood transfusions can temporarily relieve symptoms associated with severe anemia, such as fatigue, weakness, and shortness of breath, they do not treat the disease at their root and can lead to serious complications
.
Betibeglogene autotemcel is a gene therapy that genetically engineers hematopoietic stem cells isolated from patients in vitro to produce functioning β globin
.
When these hematopoietic stem cells are transfused back into the patient, they produce red blood cells with normal functions, greatly reducing the patient's need for
blood transfusions.
The European Union approved the launch of 6 new drugs
According to the Pharmadigger database, a total of 6 new drugs were approved for marketing
in the European Union in August.
Among them, there are 3 new drugs approved for the first time in the world, they are Valoctocogene roxaparvovec, Teclistamab and Lenacapavir
.
in the European Union in August.
Among them, there are 3 new drugs approved for the first time in the world, they are Valoctocogene roxaparvovec, Teclistamab and Lenacapavir
.
Valoctocogene roxaparvovec is the world's first approved hemophilia gene therapy developed by BioMarin Pharmaceuticals
.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused
by a deletion or defect in coagulation protein factor VIII.
Hemophilia A is characterized by recurrent bleeding and its associated complications, the main complications of which are chronic hemorrhagic joint lesions that can lead to severe joint deformities
.
At present, the standard of care for severe hemophilia A is long-term lifelong intravenous infusion of coagulation factor VIII, but frequent infusions can cause great inconvenience
to patients.
Valoctocogene roxaparvovec therapy uses adeno-associated virus type 5 (AAV5) as the vector to deliver a functional copy of coagulation factor VIII, thereby helping patients restore their own coagulation factor VIII production capacity
.
The approval of the therapy is based primarily on a global Phase III clinical trial
called GENEr8-1.
The trial results showed a significant reduction
in the annual bleeding rate of subjects after a single infusion of Valoctocogene roxaparvovec compared to data from the year before enrollment.
.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused
by a deletion or defect in coagulation protein factor VIII.
Hemophilia A is characterized by recurrent bleeding and its associated complications, the main complications of which are chronic hemorrhagic joint lesions that can lead to severe joint deformities
.
At present, the standard of care for severe hemophilia A is long-term lifelong intravenous infusion of coagulation factor VIII, but frequent infusions can cause great inconvenience
to patients.
Valoctocogene roxaparvovec therapy uses adeno-associated virus type 5 (AAV5) as the vector to deliver a functional copy of coagulation factor VIII, thereby helping patients restore their own coagulation factor VIII production capacity
.
The approval of the therapy is based primarily on a global Phase III clinical trial
called GENEr8-1.
The trial results showed a significant reduction
in the annual bleeding rate of subjects after a single infusion of Valoctocogene roxaparvovec compared to data from the year before enrollment.
Teclistamb is the world's first approved BCMA/CD3 bispecific antibody drug
developed by Janssen.
BCMA is a member of the tumor necrosis factor receptor (TNF) superfamily and is highly expressed in cancer cells in patients with multiple myeloma (MM); CD3 is involved in activating the immune system to fight infection
.
Teclistamab is an IgG4 double antibody drug developed using Genmab DuoBody technology that can target both T cell CD3 and MM cell BCMA, which can redirect CD3+ T cells to BCMA-expressing myeloma cells to induce T cell immunokilling effects against target cells, and has been awarded the Priority Drug (PRIME) qualification
by the European Medicines Agency 。 Results of a phase I.
/II clinical trial called MajesTEC-1 showed that nearly half of patients with relapsed refractory MM in the included trials achieved partial or better remission; The median duration of persistent remission is about one and a half
years.
developed by Janssen.
BCMA is a member of the tumor necrosis factor receptor (TNF) superfamily and is highly expressed in cancer cells in patients with multiple myeloma (MM); CD3 is involved in activating the immune system to fight infection
.
Teclistamab is an IgG4 double antibody drug developed using Genmab DuoBody technology that can target both T cell CD3 and MM cell BCMA, which can redirect CD3+ T cells to BCMA-expressing myeloma cells to induce T cell immunokilling effects against target cells, and has been awarded the Priority Drug (PRIME) qualification
by the European Medicines Agency 。 Results of a phase I.
/II clinical trial called MajesTEC-1 showed that nearly half of patients with relapsed refractory MM in the included trials achieved partial or better remission; The median duration of persistent remission is about one and a half
years.
Lenacapavir is a new drug
developed by Gilead Sciences to treat HIV infection with medications every 6 months.
The drug is a "First-in-class" capsid inhibitor with a multi-stage mechanism of action that has no known cross-resistance to other drug classes available, providing a new treatment option
for HIV-infected patients who no longer show an effective answer to current therapies.
Lenacapavir's approval to market is based on a Phase II.
/III clinical trial
called CAPELLA.
The results of the trial showed that in nearly 80% of patients with multidrug-resistant HIV infection who had received extensive treatment, Lenacapavir in combination with the optimized background antiviral therapy regimen reached an undetectable viral load at week 52
.
developed by Gilead Sciences to treat HIV infection with medications every 6 months.
The drug is a "First-in-class" capsid inhibitor with a multi-stage mechanism of action that has no known cross-resistance to other drug classes available, providing a new treatment option
for HIV-infected patients who no longer show an effective answer to current therapies.
Lenacapavir's approval to market is based on a Phase II.
/III clinical trial
called CAPELLA.
The results of the trial showed that in nearly 80% of patients with multidrug-resistant HIV infection who had received extensive treatment, Lenacapavir in combination with the optimized background antiviral therapy regimen reached an undetectable viral load at week 52
.
Asciminib is an allosteric inhibitor developed by Novartis for ABL myristoyl pockets (STAMP) that locks BCR-ABL1 into an inactive conformation, bringing more treatment options
to patients with chronic myeloid leukemia (CML) who have received second-line treatment.
In a phase III clinical trial of CML patients who had previously received TKI, at week 24, the primary molecular remission rate of Asciminib doubled
compared to the control group Bosutinib.
The drug was first approved for marketing
by the U.
S.
Food and Drug Administration (FDA) in October 2021.
to patients with chronic myeloid leukemia (CML) who have received second-line treatment.
In a phase III clinical trial of CML patients who had previously received TKI, at week 24, the primary molecular remission rate of Asciminib doubled
compared to the control group Bosutinib.
The drug was first approved for marketing
by the U.
S.
Food and Drug Administration (FDA) in October 2021.
Developed by Eli Lilly, Lamidetam is a serotonin-1F (5-HT1F) class agonist in the trigeminal nerve pathway that has a high affinity, high selectivity, penetrates the central nervous system, relieves migraine symptoms, and has a low affinity for 5-HT1B receptors, so it does not cause vasoconstriction
.
The drug was first marketed in the United States in October 2019, becoming the first 5-HT1F receptor agonist
approved by the FDA.
.
The drug was first marketed in the United States in October 2019, becoming the first 5-HT1F receptor agonist
approved by the FDA.
Efgartigimod alfa is a neonatal Fc receptor (FcRn) antagonist developed by Argenx BV in the Netherlands, which was previously approved for marketing
in the United States in November 2021.
Fc is widely expressed throughout the body, and Efgartigimod binds to FcRn, reducing pathogenic immunoglobulin G (IgG) antibodies and blocking the IgG cycle
.
The drug was approved for the treatment of systemic myasthenia gravis
in adults who are positive for acetylcholine receptor (AChR) antibodies.
It is worth noting that China Zaiding Pharma has reached an exclusive licensing cooperation with Argenx to obtain the right to
develop and commercialize Efgartigimod in Greater China.
In July this year, the State Food and Drug Administration has officially accepted Efgartigimod's application for
the listing of new drugs in China.
in the United States in November 2021.
Fc is widely expressed throughout the body, and Efgartigimod binds to FcRn, reducing pathogenic immunoglobulin G (IgG) antibodies and blocking the IgG cycle
.
The drug was approved for the treatment of systemic myasthenia gravis
in adults who are positive for acetylcholine receptor (AChR) antibodies.
It is worth noting that China Zaiding Pharma has reached an exclusive licensing cooperation with Argenx to obtain the right to
develop and commercialize Efgartigimod in Greater China.
In July this year, the State Food and Drug Administration has officially accepted Efgartigimod's application for
the listing of new drugs in China.
In August this year, the United States, the United States and the European Union approved the listing of 9 new drugs (see table for
details).
Among them, China approved 1 new drug listing, the United States approved 2, and the European Union approved 6; Many are "global new" drugs
.
details).
Among them, China approved 1 new drug listing, the United States approved 2, and the European Union approved 6; Many are "global new" drugs
.
China approved the listing of 1 new drug
China approved the listing of 1 new drug In August, the repatumab independently developed by China's pharmaceutical company Shenzhou Cell Engineering Co.
, Ltd.
was approved for listing
.
The drug is used in combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) regimen for the treatment of diffuse large B-cell lymphoma
.
, Ltd.
was approved for listing
.
The drug is used in combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) regimen for the treatment of diffuse large B-cell lymphoma
.
Repatitumab is a human-mouse chimeric IgG1 anti-CD20 monoclonal antibody whose structure contains 30% of the variable region Fab of the mouse anti-CD20 monoclonal antibody, and 70% of the human IgG1 antibody stable region Fc fragment
.
The constant region sequence uses the human antibody native sequence, and valine
is used at site 219 of the heavy chain CH1 region.
This amino acid sequence is widely used in marketed antibody drugs, which can reduce the immunogenicity
of the drug as much as possible under the premise of ensuring the effectiveness of the drug.
Optizumab, Olfamumab, and Adalimumab are perfectly consistent
with the sequence of repatumab in the heavy chain constant region.
The drug was approved based on the results of its phase III clinical trial: the efficacy of repatumab-CHOP and rituximab-CHOP in the treatment of patients with initially treated diffuse large B-cell lymphoma was comparable
.
.
The constant region sequence uses the human antibody native sequence, and valine
is used at site 219 of the heavy chain CH1 region.
This amino acid sequence is widely used in marketed antibody drugs, which can reduce the immunogenicity
of the drug as much as possible under the premise of ensuring the effectiveness of the drug.
Optizumab, Olfamumab, and Adalimumab are perfectly consistent
with the sequence of repatumab in the heavy chain constant region.
The drug was approved based on the results of its phase III clinical trial: the efficacy of repatumab-CHOP and rituximab-CHOP in the treatment of patients with initially treated diffuse large B-cell lymphoma was comparable
.
The United States approved the launch of 2 new drugs
The United States approved the launch of 2 new drugs According to the data of the Pharmadigger database, a total of 2 new drugs were approved for marketing in the United States in August, namely Olipudasealpha developed by Sanofi and Betibeglogene autotemcel developed by Bluebird Biologics
.
.
Olipudasealpha is currently the world's first drug
specifically designed to treat acid sphingomyelinase deficiency (ASMD).
ASMD is an extremely rare progressive genetic disorder caused by the accumulation of sphingomyelins in various tissues due to insufficient activity of acid sphingomyelinase, and the patient's symptoms usually manifest as spleen or hepatomegaly, dyspnea, lung infection, and unusual bruising or bleeding
.
Olipudasealpha is a hydrolytic lysososomal sphingomyelin-specific enzyme replacement therapy designed to replace a lacked or defective acid sphingomyelinase
.
The approval of the drug is based on positive data from two clinical trials, ASCEND and ASCEND-Peds, in which 31 adult patients with A/B OR B-ASMD were included in the ASCEND study and 8 cases of children under 12 years of age with A/B OR B-ASMD in the ASCEND-Peds study
.
Subjects received intravenous Olipudaseal pha or placebo every two weeks for 52 and 64 weeks
, respectively.
The results of both trials showed significant improvements
in lung function and spleen volume reduction in the trial group compared with patients in the placebo group.
In addition, the drug has been approved for marketing
in Japan and the European Union in March and June this year.
Children and childrenspecifically designed to treat acid sphingomyelinase deficiency (ASMD).
ASMD is an extremely rare progressive genetic disorder caused by the accumulation of sphingomyelins in various tissues due to insufficient activity of acid sphingomyelinase, and the patient's symptoms usually manifest as spleen or hepatomegaly, dyspnea, lung infection, and unusual bruising or bleeding
.
Olipudasealpha is a hydrolytic lysososomal sphingomyelin-specific enzyme replacement therapy designed to replace a lacked or defective acid sphingomyelinase
.
The approval of the drug is based on positive data from two clinical trials, ASCEND and ASCEND-Peds, in which 31 adult patients with A/B OR B-ASMD were included in the ASCEND study and 8 cases of children under 12 years of age with A/B OR B-ASMD in the ASCEND-Peds study
.
Subjects received intravenous Olipudaseal pha or placebo every two weeks for 52 and 64 weeks
, respectively.
The results of both trials showed significant improvements
in lung function and spleen volume reduction in the trial group compared with patients in the placebo group.
In addition, the drug has been approved for marketing
in Japan and the European Union in March and June this year.
Betibeglogene autotemcel is the world's first drug
specifically designed to treat β thalassemia patients who require routine red blood cell transfusions.
β thalassemia is a serious genetic disorder
.
Due to mutations in the gene encoding β globin, hemoglobin levels in patients are significantly reduced or even missing, requiring lifelong transfusion therapy
.
Although blood transfusions can temporarily relieve symptoms associated with severe anemia, such as fatigue, weakness, and shortness of breath, they do not treat the disease at their root and can lead to serious complications
.
Betibeglogene autotemcel is a gene therapy that genetically engineers hematopoietic stem cells isolated from patients in vitro to produce functioning β globin
.
When these hematopoietic stem cells are transfused back into the patient, they produce red blood cells with normal functions, greatly reducing the patient's need for
blood transfusions.
Disease diseasespecifically designed to treat β thalassemia patients who require routine red blood cell transfusions.
β thalassemia is a serious genetic disorder
.
Due to mutations in the gene encoding β globin, hemoglobin levels in patients are significantly reduced or even missing, requiring lifelong transfusion therapy
.
Although blood transfusions can temporarily relieve symptoms associated with severe anemia, such as fatigue, weakness, and shortness of breath, they do not treat the disease at their root and can lead to serious complications
.
Betibeglogene autotemcel is a gene therapy that genetically engineers hematopoietic stem cells isolated from patients in vitro to produce functioning β globin
.
When these hematopoietic stem cells are transfused back into the patient, they produce red blood cells with normal functions, greatly reducing the patient's need for
blood transfusions.
The European Union approved the launch of 6 new drugs
The European Union approved the launch of 6 new drugs According to the Pharmadigger database, a total of 6 new drugs were approved for marketing
in the European Union in August.
Among them, there are 3 new drugs approved for the first time in the world, they are Valoctocogene roxaparvovec, Teclistamab and Lenacapavir
.
in the European Union in August.
Among them, there are 3 new drugs approved for the first time in the world, they are Valoctocogene roxaparvovec, Teclistamab and Lenacapavir
.
Valoctocogene roxaparvovec is the world's first approved hemophilia gene therapy developed by BioMarin Pharmaceuticals
.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused
by a deletion or defect in coagulation protein factor VIII.
Hemophilia A is characterized by recurrent bleeding and its associated complications, the main complications of which are chronic hemorrhagic joint lesions that can lead to severe joint deformities
.
At present, the standard of care for severe hemophilia A is long-term lifelong intravenous infusion of coagulation factor VIII, but frequent infusions can cause great inconvenience
to patients.
Valoctocogene roxaparvovec therapy uses adeno-associated virus type 5 (AAV5) as the vector to deliver a functional copy of coagulation factor VIII, thereby helping patients restore their own coagulation factor VIII production capacity
.
The approval of the therapy is based primarily on a global Phase III clinical trial
called GENEr8-1.
The trial results showed a significant reduction
in the annual bleeding rate of subjects after a single infusion of Valoctocogene roxaparvovec compared to data from the year before enrollment.
Standard standard.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused
by a deletion or defect in coagulation protein factor VIII.
Hemophilia A is characterized by recurrent bleeding and its associated complications, the main complications of which are chronic hemorrhagic joint lesions that can lead to severe joint deformities
.
At present, the standard of care for severe hemophilia A is long-term lifelong intravenous infusion of coagulation factor VIII, but frequent infusions can cause great inconvenience
to patients.
Valoctocogene roxaparvovec therapy uses adeno-associated virus type 5 (AAV5) as the vector to deliver a functional copy of coagulation factor VIII, thereby helping patients restore their own coagulation factor VIII production capacity
.
The approval of the therapy is based primarily on a global Phase III clinical trial
called GENEr8-1.
The trial results showed a significant reduction
in the annual bleeding rate of subjects after a single infusion of Valoctocogene roxaparvovec compared to data from the year before enrollment.
Teclistamb is the world's first approved BCMA/CD3 bispecific antibody drug
developed by Janssen.
BCMA is a member of the tumor necrosis factor receptor (TNF) superfamily and is highly expressed in cancer cells in patients with multiple myeloma (MM); CD3 is involved in activating the immune system to fight infection
.
Teclistamab is an IgG4 double antibody drug developed using Genmab DuoBody technology that can target both T cell CD3 and MM cell BCMA, which can redirect CD3+ T cells to BCMA-expressing myeloma cells to induce T cell immunokilling effects against target cells, and has been awarded the Priority Drug (PRIME) qualification
by the European Medicines Agency 。 Results of a phase I.
/II clinical trial called MajesTEC-1 showed that nearly half of patients with relapsed refractory MM in the included trials achieved partial or better remission; The median duration of persistent remission is about one and a half
years.
developed by Janssen.
BCMA is a member of the tumor necrosis factor receptor (TNF) superfamily and is highly expressed in cancer cells in patients with multiple myeloma (MM); CD3 is involved in activating the immune system to fight infection
.
Teclistamab is an IgG4 double antibody drug developed using Genmab DuoBody technology that can target both T cell CD3 and MM cell BCMA, which can redirect CD3+ T cells to BCMA-expressing myeloma cells to induce T cell immunokilling effects against target cells, and has been awarded the Priority Drug (PRIME) qualification
by the European Medicines Agency 。 Results of a phase I.
/II clinical trial called MajesTEC-1 showed that nearly half of patients with relapsed refractory MM in the included trials achieved partial or better remission; The median duration of persistent remission is about one and a half
years.
Lenacapavir is a new drug
developed by Gilead Sciences to treat HIV infection with medications every 6 months.
The drug is a "First-in-class" capsid inhibitor with a multi-stage mechanism of action that has no known cross-resistance to other drug classes available, providing a new treatment option
for HIV-infected patients who no longer show an effective answer to current therapies.
Lenacapavir's approval to market is based on a Phase II.
/III clinical trial
called CAPELLA.
The results of the trial showed that in nearly 80% of patients with multidrug-resistant HIV infection who had received extensive treatment, Lenacapavir in combination with the optimized background antiviral therapy regimen reached an undetectable viral load at week 52
.
developed by Gilead Sciences to treat HIV infection with medications every 6 months.
The drug is a "First-in-class" capsid inhibitor with a multi-stage mechanism of action that has no known cross-resistance to other drug classes available, providing a new treatment option
for HIV-infected patients who no longer show an effective answer to current therapies.
Lenacapavir's approval to market is based on a Phase II.
/III clinical trial
called CAPELLA.
The results of the trial showed that in nearly 80% of patients with multidrug-resistant HIV infection who had received extensive treatment, Lenacapavir in combination with the optimized background antiviral therapy regimen reached an undetectable viral load at week 52
.
Asciminib is an allosteric inhibitor developed by Novartis for ABL myristoyl pockets (STAMP) that locks BCR-ABL1 into an inactive conformation, bringing more treatment options
to patients with chronic myeloid leukemia (CML) who have received second-line treatment.
In a phase III clinical trial of CML patients who had previously received TKI, at week 24, the primary molecular remission rate of Asciminib doubled
compared to the control group Bosutinib.
The drug was first approved for marketing
by the U.
S.
Food and Drug Administration (FDA) in October 2021.
Medicines and medicinesto patients with chronic myeloid leukemia (CML) who have received second-line treatment.
In a phase III clinical trial of CML patients who had previously received TKI, at week 24, the primary molecular remission rate of Asciminib doubled
compared to the control group Bosutinib.
The drug was first approved for marketing
by the U.
S.
Food and Drug Administration (FDA) in October 2021.
Developed by Eli Lilly, Lamidetam is a serotonin-1F (5-HT1F) class agonist in the trigeminal nerve pathway that has a high affinity, high selectivity, penetrates the central nervous system, relieves migraine symptoms, and has a low affinity for 5-HT1B receptors, so it does not cause vasoconstriction
.
The drug was first marketed in the United States in October 2019, becoming the first 5-HT1F receptor agonist
approved by the FDA.
.
The drug was first marketed in the United States in October 2019, becoming the first 5-HT1F receptor agonist
approved by the FDA.
Efgartigimod alfa is a neonatal Fc receptor (FcRn) antagonist developed by Argenx BV in the Netherlands, which was previously approved for marketing
in the United States in November 2021.
Fc is widely expressed throughout the body, and Efgartigimod binds to FcRn, reducing pathogenic immunoglobulin G (IgG) antibodies and blocking the IgG cycle
.
The drug was approved for the treatment of systemic myasthenia gravis
in adults who are positive for acetylcholine receptor (AChR) antibodies.
It is worth noting that China Zaiding Pharma has reached an exclusive licensing cooperation with Argenx to obtain the right to
develop and commercialize Efgartigimod in Greater China.
In July this year, the State Food and Drug Administration has officially accepted Efgartigimod's application for
the listing of new drugs in China.
Medicine and medicine in the United States in November 2021.
Fc is widely expressed throughout the body, and Efgartigimod binds to FcRn, reducing pathogenic immunoglobulin G (IgG) antibodies and blocking the IgG cycle
.
The drug was approved for the treatment of systemic myasthenia gravis
in adults who are positive for acetylcholine receptor (AChR) antibodies.
It is worth noting that China Zaiding Pharma has reached an exclusive licensing cooperation with Argenx to obtain the right to
develop and commercialize Efgartigimod in Greater China.
In July this year, the State Food and Drug Administration has officially accepted Efgartigimod's application for
the listing of new drugs in China.
