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The American Annual Meeting of Hematology (ASH) is one of the largest and most comprehensive international academic conferences in the field of hematology in the world.
The 63rd ASH Annual Meeting in 2021 will be held online and offline simultaneously from December 11th to 14th
.
The results of a phase Ib clinical study (NCT03951623) evaluating the safety and preliminary efficacy of HMPL-523 in adult patients with primary immune thrombocytopenia (ITP) will be reproduced in the form of an oral report during the ASH annual meeting in 2021.
Pound announced
.
Yimaitong invited the main researcher of the study, Professor Yang Renchi from the Hospital of Hematology, Chinese Academy of Medical Sciences, to be interviewed to share the latest research progress
.
Interview with Professor Yang Renchi It is recommended to check Yimaitong in Wifi environment: ITP is still an incurable disease so far.
Could you please talk about the current status of ITP treatment? What are the domestic and foreign guidelines for the standardized treatment of adult patients with ITP? What are the unmet medical needs in terms of treatment? Professor Yang Renchi ITP, as an autoimmune disease, has strong heterogeneity and is still incurable so far
.
Domestic and international guidelines recommend first-line therapy includes: corticosteroids, intravenous gamma globulin
.
Second-line therapy comprising: thrombopoietin (TPO) receptor agonist, rituximab and spleen tyrosine kinase (of Syk) inhibitors fostamatinib the like
.
Although there are many treatments with different mechanisms of action, the treatment of ITP is still a difficult problem
.
If medication is used for too long, especially glucocorticoids for too long, it will cause many treatment-related adverse reactions (TRAE) such as steroid-type diabetes, steroid-type hypertension, osteoporosis, femoral head necrosis, thrombosis and infection
.
Therefore, there are still a large number of patients who do not respond well to existing treatments, and there is an urgent need for new treatment methods that are safe and effective and can reduce the economic burden of patients
.
Yimaitong: As a new type of Syk inhibitor, HMPL-523 is expected to solve the unmet treatment needs of adult patients with ITP
.
The results of a phase 1b clinical study of HMPL-523 were announced during the 2021 ASH conference
.
As the main investigator, would you please introduce the background, research design, and status of the patients enrolled in the study? Professor Yang Renchi HMPL-523 is a new and highly selective small molecule oral inhibitor.
Its mechanism of action is different from that of TPO receptor agonists and rituximab.
It is expected to become a promising ITP therapy
.
Especially for patients with refractory ITP, HMPL-523 has shown the effect of increasing platelet count and good safety in the study
.
Based on previous research results, in order to further verify the efficacy and safety of HMPL-523 before marketing, we conducted this multi-center, double-blind, placebo-controlled Phase Ib study, including a dose escalation phase and a dose expansion phase
.
The target population of the study is adult patients with primary chronic ITP who have received at least one ITP treatment and have poor efficacy
.
The enrolled patients were randomly divided into the HMPL-523 treatment group and the placebo treatment group at a ratio of 3:1 for 8 weeks of treatment
.
After evaluation, he received 16-week open-label HMPL-523 treatment, with a total treatment duration of 24 weeks
.
In the dose escalation phase, the study designed 4 dose groups of 100 mg qd, 200 mg qd, 300 mg qd, and 400 mg qd, and each dose group enrolled 8 patients
.
According to research verification, 300mg qd has been determined as the recommended dose for the expansion phase
.
Another 12 patients were enrolled in the dose extension treatment group to further evaluate the safety and preliminary efficacy of this dose group
.
Yimaitong: Based on the results of the Phase 1b clinical study of HMPL-523, please talk about the efficacy and safety of HMPL-523 in the treatment of adult ITP patients? What are the highlights of HMPL-523 compared with the currently commonly used therapeutic drugs in clinical practice? Professor Yang Renchi’s research results show that among the 4 dose groups of HMPL-523, the 300mg qd treatment group (including the double-blind treatment group and the open-label treatment group) has a particularly outstanding efficacy, with an overall response rate (ORR) of 80%, sustained The response rate (DRR) is 40%
.
In terms of safety, the most common TRAE in the HMPL-523 treatment group was elevated liver enzymes, but they were all grade 1
.
During treatment, there were no abnormally elevated platelet counts, thromboembolic events, severe bleeding-related TRAEs, and discontinuations caused by TRAEs
.
The results of the Phase Ib study have shown good efficacy and safety, but it is necessary to expand the population to conduct Phase III clinical trials to provide more detailed and reliable data support for the marketing of the drug
.
Current studies have confirmed that HMPL-523 is still effective for some patients who are ineffective in TPO or TPO-RA treatment or who relapse after treatment, and has good safety, stable platelet response, and low risk of thrombosis
.
Yimaitong: Based on the results of a phase 1b clinical study of HMPL-523, a phase III study (NCT05029635) of HMPL-523 for the treatment of adult patients with ITP was recently launched in China
.
As the main investigator, would you please introduce the basic situation of the HMPL-523 Phase III study? And the current patient recruitment situation? Professor Yang Renchi's HMPL-523 Phase III study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HMPL-523 in the treatment of adult patients with ITP
.
The primary endpoint of the study is DRR, and the secondary endpoints and exploratory endpoints include ORR, TRAE incidence, and the improvement of patients' quality of life
.
The study plans to recruit 180 patients
.
Adult patients with primary ITP who have received at least one anti-ITP drug treatment ineffective or relapsed after treatment will be enrolled
.
The first subject has already received dosing treatment on October 27, 2021
.
Yimaitong: Could you talk about the impact of the emergence of HMPL-523 on the domestic ITP treatment pattern? What are your prospects for HMPL-523 in the treatment of ITP in the future? In addition to ITP, what is the application prospect of HMPL-523 in other diseases? Professor Yang Renchi’s HMPL-523 has a different mechanism of action from the existing domestic drugs for the treatment of ITP.
If it can be successfully marketed in China in the future, for chronic adult ITP patients, especially the use of second-line treatment options such as TPO receptor agonists or rituximab It is a new choice for patients with poor efficacy
.
And based on the results of the current phase Ib study, the patients enrolled in the clinical study can obtain good curative effect and controllable safety after treatment with HMPL-523
.
In addition to ITP, HMPL-523 has a number of studies on blood system related diseases carried out in China, the United States and Europe
.
Such as the treatment of indolent non-Hodgkin’s lymphoma (NCT02857998) and a variety of B-cell malignant tumor subtypes (NCT03779113)
.
In addition, clinical trials of HMPL-523 for the treatment of other autoimmune diseases are also planned
.
It is hoped that with the deepening of research, the scope of clinical application of HMPL-523 can be further expanded, so as to provide more patients with new treatment options
.
Summary Although there are many treatments with different mechanisms of action, the treatment of ITP is still a difficult problem
.
As a new type of Syk inhibitor, HMPL-523 is expected to solve the unmet need for treatment of adult patients with ITP
.
A phase 1b clinical study showed that for the patients enrolled in the study, HMPL-523 has a good effect, rapid onset, and high DRR
.
In terms of safety, after treatment with HMPL-523, the platelet response is stable and the risk of thrombosis is low
.
Based on the results of a phase 1b clinical study of HMPL-523, a phase III study of HMPL-523 for the treatment of adult ITP was recently launched in China, and the first patient has been enrolled for treatment
.
In addition to ITP, HMPL-523 also has a number of blood system-related diseases and other autoimmune diseases research is underway, which is expected to bring clinical benefits to more patients
.
Professor Yang Renchi, Director of the Thrombosis and Hemostasis Center, Chinese Academy of Medical Sciences (Institute of Hematology) Thrombosis and Hemostasis Center, Chief Physician, Doctoral Supervisor, Tugong Expert of the Ministry of Health, Member of the Steering Committee of the Asia-Pacific Hemophilia Working Group Enjoying the Special Government Allowance of the State Council China Medical Education Deputy Chairman of the Hemostasis and Thrombosis Branch of the Association Executive Director of the Rare Disease Branch of the Chinese Research Hospital Association Standing Member of the Thrombosis and Hemostasis Professional Committee Member of the Hematology Branch of the Chinese Medical Association Deputy Chief of the Biology Group Leader of the Chinese Rare Blood Disease Working Group Leader of the National Hemophilia Collaboration Group Chief Editor of Haemophila Chinese Edition, Haemophila, Chinese Journal of Hematology, etc.
, published 101 SCI-indexed papers as the first author or corresponding author Successively won the second prize of the National Science and Technology Progress Award, the first prize of Tianjin Science and Technology Progress Award, and the second prize of Science and Technology Progress Award of the Ministry of Education.
References: Renchi Yang, et al.
2021ASH.
Oral 16.
NP-HEM-21N03-Valid Until 2023 Dec.
This document aims to promote the communication and exchange of medical information
.
This information is only for academic reference by medical and health professionals, not for the general public, nor for advertising
.
For prescription, please refer to the drug insert approved by the State Drug Administration
.
Please do not distribute or forward this information
.
The 63rd ASH Annual Meeting in 2021 will be held online and offline simultaneously from December 11th to 14th
.
The results of a phase Ib clinical study (NCT03951623) evaluating the safety and preliminary efficacy of HMPL-523 in adult patients with primary immune thrombocytopenia (ITP) will be reproduced in the form of an oral report during the ASH annual meeting in 2021.
Pound announced
.
Yimaitong invited the main researcher of the study, Professor Yang Renchi from the Hospital of Hematology, Chinese Academy of Medical Sciences, to be interviewed to share the latest research progress
.
Interview with Professor Yang Renchi It is recommended to check Yimaitong in Wifi environment: ITP is still an incurable disease so far.
Could you please talk about the current status of ITP treatment? What are the domestic and foreign guidelines for the standardized treatment of adult patients with ITP? What are the unmet medical needs in terms of treatment? Professor Yang Renchi ITP, as an autoimmune disease, has strong heterogeneity and is still incurable so far
.
Domestic and international guidelines recommend first-line therapy includes: corticosteroids, intravenous gamma globulin
.
Second-line therapy comprising: thrombopoietin (TPO) receptor agonist, rituximab and spleen tyrosine kinase (of Syk) inhibitors fostamatinib the like
.
Although there are many treatments with different mechanisms of action, the treatment of ITP is still a difficult problem
.
If medication is used for too long, especially glucocorticoids for too long, it will cause many treatment-related adverse reactions (TRAE) such as steroid-type diabetes, steroid-type hypertension, osteoporosis, femoral head necrosis, thrombosis and infection
.
Therefore, there are still a large number of patients who do not respond well to existing treatments, and there is an urgent need for new treatment methods that are safe and effective and can reduce the economic burden of patients
.
Yimaitong: As a new type of Syk inhibitor, HMPL-523 is expected to solve the unmet treatment needs of adult patients with ITP
.
The results of a phase 1b clinical study of HMPL-523 were announced during the 2021 ASH conference
.
As the main investigator, would you please introduce the background, research design, and status of the patients enrolled in the study? Professor Yang Renchi HMPL-523 is a new and highly selective small molecule oral inhibitor.
Its mechanism of action is different from that of TPO receptor agonists and rituximab.
It is expected to become a promising ITP therapy
.
Especially for patients with refractory ITP, HMPL-523 has shown the effect of increasing platelet count and good safety in the study
.
Based on previous research results, in order to further verify the efficacy and safety of HMPL-523 before marketing, we conducted this multi-center, double-blind, placebo-controlled Phase Ib study, including a dose escalation phase and a dose expansion phase
.
The target population of the study is adult patients with primary chronic ITP who have received at least one ITP treatment and have poor efficacy
.
The enrolled patients were randomly divided into the HMPL-523 treatment group and the placebo treatment group at a ratio of 3:1 for 8 weeks of treatment
.
After evaluation, he received 16-week open-label HMPL-523 treatment, with a total treatment duration of 24 weeks
.
In the dose escalation phase, the study designed 4 dose groups of 100 mg qd, 200 mg qd, 300 mg qd, and 400 mg qd, and each dose group enrolled 8 patients
.
According to research verification, 300mg qd has been determined as the recommended dose for the expansion phase
.
Another 12 patients were enrolled in the dose extension treatment group to further evaluate the safety and preliminary efficacy of this dose group
.
Yimaitong: Based on the results of the Phase 1b clinical study of HMPL-523, please talk about the efficacy and safety of HMPL-523 in the treatment of adult ITP patients? What are the highlights of HMPL-523 compared with the currently commonly used therapeutic drugs in clinical practice? Professor Yang Renchi’s research results show that among the 4 dose groups of HMPL-523, the 300mg qd treatment group (including the double-blind treatment group and the open-label treatment group) has a particularly outstanding efficacy, with an overall response rate (ORR) of 80%, sustained The response rate (DRR) is 40%
.
In terms of safety, the most common TRAE in the HMPL-523 treatment group was elevated liver enzymes, but they were all grade 1
.
During treatment, there were no abnormally elevated platelet counts, thromboembolic events, severe bleeding-related TRAEs, and discontinuations caused by TRAEs
.
The results of the Phase Ib study have shown good efficacy and safety, but it is necessary to expand the population to conduct Phase III clinical trials to provide more detailed and reliable data support for the marketing of the drug
.
Current studies have confirmed that HMPL-523 is still effective for some patients who are ineffective in TPO or TPO-RA treatment or who relapse after treatment, and has good safety, stable platelet response, and low risk of thrombosis
.
Yimaitong: Based on the results of a phase 1b clinical study of HMPL-523, a phase III study (NCT05029635) of HMPL-523 for the treatment of adult patients with ITP was recently launched in China
.
As the main investigator, would you please introduce the basic situation of the HMPL-523 Phase III study? And the current patient recruitment situation? Professor Yang Renchi's HMPL-523 Phase III study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HMPL-523 in the treatment of adult patients with ITP
.
The primary endpoint of the study is DRR, and the secondary endpoints and exploratory endpoints include ORR, TRAE incidence, and the improvement of patients' quality of life
.
The study plans to recruit 180 patients
.
Adult patients with primary ITP who have received at least one anti-ITP drug treatment ineffective or relapsed after treatment will be enrolled
.
The first subject has already received dosing treatment on October 27, 2021
.
Yimaitong: Could you talk about the impact of the emergence of HMPL-523 on the domestic ITP treatment pattern? What are your prospects for HMPL-523 in the treatment of ITP in the future? In addition to ITP, what is the application prospect of HMPL-523 in other diseases? Professor Yang Renchi’s HMPL-523 has a different mechanism of action from the existing domestic drugs for the treatment of ITP.
If it can be successfully marketed in China in the future, for chronic adult ITP patients, especially the use of second-line treatment options such as TPO receptor agonists or rituximab It is a new choice for patients with poor efficacy
.
And based on the results of the current phase Ib study, the patients enrolled in the clinical study can obtain good curative effect and controllable safety after treatment with HMPL-523
.
In addition to ITP, HMPL-523 has a number of studies on blood system related diseases carried out in China, the United States and Europe
.
Such as the treatment of indolent non-Hodgkin’s lymphoma (NCT02857998) and a variety of B-cell malignant tumor subtypes (NCT03779113)
.
In addition, clinical trials of HMPL-523 for the treatment of other autoimmune diseases are also planned
.
It is hoped that with the deepening of research, the scope of clinical application of HMPL-523 can be further expanded, so as to provide more patients with new treatment options
.
Summary Although there are many treatments with different mechanisms of action, the treatment of ITP is still a difficult problem
.
As a new type of Syk inhibitor, HMPL-523 is expected to solve the unmet need for treatment of adult patients with ITP
.
A phase 1b clinical study showed that for the patients enrolled in the study, HMPL-523 has a good effect, rapid onset, and high DRR
.
In terms of safety, after treatment with HMPL-523, the platelet response is stable and the risk of thrombosis is low
.
Based on the results of a phase 1b clinical study of HMPL-523, a phase III study of HMPL-523 for the treatment of adult ITP was recently launched in China, and the first patient has been enrolled for treatment
.
In addition to ITP, HMPL-523 also has a number of blood system-related diseases and other autoimmune diseases research is underway, which is expected to bring clinical benefits to more patients
.
Professor Yang Renchi, Director of the Thrombosis and Hemostasis Center, Chinese Academy of Medical Sciences (Institute of Hematology) Thrombosis and Hemostasis Center, Chief Physician, Doctoral Supervisor, Tugong Expert of the Ministry of Health, Member of the Steering Committee of the Asia-Pacific Hemophilia Working Group Enjoying the Special Government Allowance of the State Council China Medical Education Deputy Chairman of the Hemostasis and Thrombosis Branch of the Association Executive Director of the Rare Disease Branch of the Chinese Research Hospital Association Standing Member of the Thrombosis and Hemostasis Professional Committee Member of the Hematology Branch of the Chinese Medical Association Deputy Chief of the Biology Group Leader of the Chinese Rare Blood Disease Working Group Leader of the National Hemophilia Collaboration Group Chief Editor of Haemophila Chinese Edition, Haemophila, Chinese Journal of Hematology, etc.
, published 101 SCI-indexed papers as the first author or corresponding author Successively won the second prize of the National Science and Technology Progress Award, the first prize of Tianjin Science and Technology Progress Award, and the second prize of Science and Technology Progress Award of the Ministry of Education.
References: Renchi Yang, et al.
2021ASH.
Oral 16.
NP-HEM-21N03-Valid Until 2023 Dec.
This document aims to promote the communication and exchange of medical information
.
This information is only for academic reference by medical and health professionals, not for the general public, nor for advertising
.
For prescription, please refer to the drug insert approved by the State Drug Administration
.
Please do not distribute or forward this information
.
