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Yimaike's recent hot reports ★The overall survival was significantly prolonged, and sugalimab truly achieved clinical benefits★Highlight moment|CStone's sugalimab in the treatment of stage III/IV NSCLC in the same period of "The Lancet-Oncology" Published on February 15, 2022/eMedClub News/--Recently, the Hong Kong-based innovative pharmaceutical company CStone Pharmaceuticals (02616.
HK) announced that the China National Medical Products Administration (NMPA) has approved its first-in-class precision therapy drug Tuoshu New Drug Application (NDA) for Wo® (evonib tablets) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML) harboring a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
.
This is CStone's first selective RET inhibitor Pujihua® on March 24, 2021, the first-in-class product Taijihua® on March 31, 2021, and potential best-in-class PD on December 21, 2021 -The fourth product approved for marketing after the (L)1 inhibitor Zejimet®
.
As the only IDH1 inhibitor approved in China, Tosuvo® has brought innovative precision treatment solutions to the IDH1-mutated AML patient population.
more patients worldwide
.
First-in-class IDH1 inhibitor, Tosuvo® brings good news to AML patients Acute myeloid leukemia (AML) is the most common type of leukemia in adults, with about 20,000 new cases in the United States each year, and China is expected to have new cases each year There are more than 40,000 cases, and the median age of the patients is over 60 years old
.
At present, for relatively young adult patients at home and abroad, comprehensive treatment with intensive chemotherapy and high-dose chemotherapy combined with hematopoietic stem cell transplantation can achieve better curative effects
.
But AML typically progresses rapidly, and most patients eventually become resistant to treatment or relapse, developing relapsed or refractory acute myeloid leukemia
.
IDH1 mutations can be detected in about 6%-10% of AML patients, and the mutated IDH1 enzyme can lead to up-regulation of D-2-hydroxyglutarate (D-2-HG) levels, block normal hematopoietic stem cell differentiation, and promote the incidence of acute leukemia
.
This is one of the mechanisms by which AML occurs and develops
.
Therefore, by blocking the activity of the IDH1 mutant enzyme, the differentiation of AML cells can be promoted, thereby exerting an anti-tumor effect
.
Tosuvo® is a first-in-class potent oral target inhibitor for IDH1 gene mutation
.
This approval is based on a Chinese registry bridging study CS3010-101
.
Tosuvo® showed excellent clinical efficacy and good tolerability in the treatment of adult R/R AML Chinese patients with IDH1 susceptibility mutations
.
Among 30 evaluable patients, the primary efficacy endpoint of complete remission and complete remission with partial hematologic recovery (CR+CRh) was 36.
7% (11/30), of which 11 patients achieved CR
.
The median duration of response for CR+CRh has not yet been reached, with an estimated 12-month sustained response rate for CR+CRh of 90.
9%
.
In addition, ivonib was well tolerated and had a manageable safety profile
.
The findings will be presented as a preferred oral presentation at the 2021 European Society for Medical Oncology (ESMO) annual meeting
.
● In July 2018, ivonib was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of adult patients with acute myeloid leukemia (AML) with a susceptibility to IDH1 gene mutation detected by an FDA-approved companion diagnostic test
.
Due to its favorable effect in the treatment of AML, ivonib was previously granted FDA Fast Track and Orphan Drug designation
.
● In September 2018, the China National Medical Products Administration approved the ivonib global phase III trial (AGILE) to evaluate ivonib combined with azacitidine in the treatment of newly diagnosed IDH1-mutant, unsuitable Efficacy of intensive chemotherapy in patients with acute myeloid leukemia
.
● In May 2019, the FDA approved a supplemental New Drug Application for ivonib for the treatment of newly diagnosed IDH1-mutated AML patients 75 years of age and older who are ineligible for intensive chemotherapy due to other comorbidities
.
● On July 19, 2019, the first patient of AGILE, a global registration phase III trial of ivonib, was dosed in China
.
● In July 2019, China's National Medical Products Administration approved CStone's bridging registration Phase I trial of ivonib for the treatment of patients with relapsed or refractory acute myeloid leukemia with IDH1 mutations
.
Since then, the first patient has been dosed in China quickly
.
● In 2020, Avnib was successfully included in the 2020 edition of the "CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies"
.
● In October 2020, ivonib was included in the "List of Overseas New Drugs Urgently Needed for Clinical Practice (the third batch)" by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China
.
● In July 2021, according to the CDE official website, ivonib was proposed to be included in priority review for the treatment of adults with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations
.
● In August 2021, the new drug application for ivonib was accepted for the treatment of adults with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations
.
Six months later, Topsuvo® was successfully approved for marketing in China, which once again showed us the strength and ability of CStone to bring innovative drugs to the market quickly
.
Based on the successful market experience of the first two precision medicines, it is believed that Topsuvo® will also reach patients quickly
.
Multi-drug and multi-indication expansion to meet clinical needs With the advancement of technology, tumor treatment has tended to be precise treatment, and various companion diagnostics have been gradually improved
.
From the very beginning, patients carry out genetic testing to find mutation targets and corresponding optimal treatment plans, and ultimately enable cancer patients to achieve long-term survival like chronic diseases
.
With the approval of the three precision therapy products, CStone's research in the field of precision therapy has gradually been carried out, and the concept of "same disease with different treatment and same disease with different treatment" can be better understood
.
In the field of AML, in addition to being approved for relapsed and refractory patients, Topsuvo® has also made significant progress as a first-line therapy
.
In August 2021, the AGILE study successfully met the primary endpoint of event-free survival (EFS), significantly improving event-free survival in treatment-naïve IDH1-mutant acute myeloid leukemia (AML) patients compared with azacitidine plus placebo Survival and overall survival, patients' median decreased
.
The trial met all of its key secondary endpoints, including complete remission (CR) rate, overall survival (OS), CR and complete remission with partial hematologic recovery (CRh) rate, and objective response rate (ORR)
.
Tosuvo® combined with azacitidine therapy is expected to bring new treatment options to this subset of previously untreated IDH1-mutant AML patients
.
The data of ivonib in IDH1-mutant cholangiocarcinoma patients also achieved excellent efficacy and safety
.
The latest results from the global phase III study ClarIDHy showed a significant improvement in the primary endpoint of progression-free survival (PFS) in previously treated patients with advanced IDH1-mutant cholangiocarcinoma
.
Median PFS was 2.
7 months and 1.
4 months in the ivonib group and placebo group, respectively
.
The PFS rate was 32% at 6 months and 22% at 12 months in the ivonib group, with a 63% reduction in the risk of disease progression or death compared to the placebo group
.
Ivornib is the first and only FDA-approved drug for targeted therapy in patients with IDH1-mutant cholangiocarcinoma
.
IDH1 gene mutations are not only seen in AML and cholangiocarcinoma, but also in a variety of tumors, including gliomas
.
In a basket trial in patients with advanced solid tumors, ivonib performed well in patients with IDH1-mutant advanced glioma, showing a favorable safety profile, long-term disease control, and significantly reduced tumor growth
.
The results were published in the Journal of Clinical Oncology in June 2020
.
In terms of lung cancer treatment, CStone's dominant field, based on the potential best-in-class PD-(L)1 inhibitor Zejiemei®, combined with the first selective RET inhibitor Pujihua® in China and the third-generation ALK/ALK/ The ROS1 tyrosine kinase inhibitor lorlatinib, with immunotherapy and precision treatment, will reflect a strong market value
.
At the same time, Pujihua® is in the first-line treatment of non-small cell lung cancer indications, as well as the indications of medullary thyroid cancer and thyroid cancer
.
Zejimet® is also expected to cover stage III and IV NSCLC patients, and clinical studies on gastric cancer, esophageal cancer and lymphoma have also achieved positive results
.
Clinical transformation and commercialization capabilities have achieved "cornerstone speed".
Four products have been launched in one year.
CStone has demonstrated a consistent "cornerstone speed", and behind this speed is CStone's strong translational medicine and clinical development capabilities
.
CStone separated the proof-of-concept (PoC) from the IND as early as 2018, and set up a translational medicine team among the first Chinese pharmaceutical companies
.
In terms of clinical research and development, CStone can uniquely design the key clinical trial protocols of each product, thereby greatly shortening the number of patients and the clinical trial period
.
This has been fully verified in the clinical trials GEMSTONE-301 and GEMSTONE-302 of Zejimet®.
It is worth mentioning that the current GEMSTONE-302 study has reached the study endpoint of overall survival (OS)
.
The data of these two clinical trials were also published simultaneously in the top international journal "The Lancet-Oncology"
.
In addition, CStone's commercialization process is very active, and it has launched three precision medicines to the market at an extraordinary speed, two of which have achieved rapid sales growth
.
Through extensive and in-depth cooperation with stakeholders in the medical field, CStone has now covered more than 400 hospitals in more than 130 cities, accounting for about 70-80% of the precision medicine-related market
.
In addition, pharmaceuticals are covered by more than 60 major commercial and government insurance plans
.
In terms of the commercialization of Zejimay®, CStone has cooperated closely with partners such as Pfizer and EQRx to promote the PD-(L)1 inhibitor Zejimay® more widely for therapeutic use.
NSCLC, gastric and esophageal cancer patients
.
From these aspects, CStone Pharmaceuticals has achieved "breaking the circle" and is on the road from Biotech to Biopharma
.
And this also reminds us that we need to feel this company from a larger scope and a higher dimension
.
2021 is the first year of CStone's commercialization, and the successful launch of Topsuvo® also makes a good start for 2022
.
In the new year, we will also continue to look forward to how CStone can further expand the commercial potential of its products, the clinical progress of various pipeline products under development and the expansion of indications for products already on the market
.
It is believed that at CStone, we can see more products with the first-in-class/best-in-class/first-tier potential and global rights and interests to be launched quickly, bringing breakthrough therapies to cancer patients and benefiting more patients
.
HK) announced that the China National Medical Products Administration (NMPA) has approved its first-in-class precision therapy drug Tuoshu New Drug Application (NDA) for Wo® (evonib tablets) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML) harboring a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
.
This is CStone's first selective RET inhibitor Pujihua® on March 24, 2021, the first-in-class product Taijihua® on March 31, 2021, and potential best-in-class PD on December 21, 2021 -The fourth product approved for marketing after the (L)1 inhibitor Zejimet®
.
As the only IDH1 inhibitor approved in China, Tosuvo® has brought innovative precision treatment solutions to the IDH1-mutated AML patient population.
more patients worldwide
.
First-in-class IDH1 inhibitor, Tosuvo® brings good news to AML patients Acute myeloid leukemia (AML) is the most common type of leukemia in adults, with about 20,000 new cases in the United States each year, and China is expected to have new cases each year There are more than 40,000 cases, and the median age of the patients is over 60 years old
.
At present, for relatively young adult patients at home and abroad, comprehensive treatment with intensive chemotherapy and high-dose chemotherapy combined with hematopoietic stem cell transplantation can achieve better curative effects
.
But AML typically progresses rapidly, and most patients eventually become resistant to treatment or relapse, developing relapsed or refractory acute myeloid leukemia
.
IDH1 mutations can be detected in about 6%-10% of AML patients, and the mutated IDH1 enzyme can lead to up-regulation of D-2-hydroxyglutarate (D-2-HG) levels, block normal hematopoietic stem cell differentiation, and promote the incidence of acute leukemia
.
This is one of the mechanisms by which AML occurs and develops
.
Therefore, by blocking the activity of the IDH1 mutant enzyme, the differentiation of AML cells can be promoted, thereby exerting an anti-tumor effect
.
Tosuvo® is a first-in-class potent oral target inhibitor for IDH1 gene mutation
.
This approval is based on a Chinese registry bridging study CS3010-101
.
Tosuvo® showed excellent clinical efficacy and good tolerability in the treatment of adult R/R AML Chinese patients with IDH1 susceptibility mutations
.
Among 30 evaluable patients, the primary efficacy endpoint of complete remission and complete remission with partial hematologic recovery (CR+CRh) was 36.
7% (11/30), of which 11 patients achieved CR
.
The median duration of response for CR+CRh has not yet been reached, with an estimated 12-month sustained response rate for CR+CRh of 90.
9%
.
In addition, ivonib was well tolerated and had a manageable safety profile
.
The findings will be presented as a preferred oral presentation at the 2021 European Society for Medical Oncology (ESMO) annual meeting
.
● In July 2018, ivonib was approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of adult patients with acute myeloid leukemia (AML) with a susceptibility to IDH1 gene mutation detected by an FDA-approved companion diagnostic test
.
Due to its favorable effect in the treatment of AML, ivonib was previously granted FDA Fast Track and Orphan Drug designation
.
● In September 2018, the China National Medical Products Administration approved the ivonib global phase III trial (AGILE) to evaluate ivonib combined with azacitidine in the treatment of newly diagnosed IDH1-mutant, unsuitable Efficacy of intensive chemotherapy in patients with acute myeloid leukemia
.
● In May 2019, the FDA approved a supplemental New Drug Application for ivonib for the treatment of newly diagnosed IDH1-mutated AML patients 75 years of age and older who are ineligible for intensive chemotherapy due to other comorbidities
.
● On July 19, 2019, the first patient of AGILE, a global registration phase III trial of ivonib, was dosed in China
.
● In July 2019, China's National Medical Products Administration approved CStone's bridging registration Phase I trial of ivonib for the treatment of patients with relapsed or refractory acute myeloid leukemia with IDH1 mutations
.
Since then, the first patient has been dosed in China quickly
.
● In 2020, Avnib was successfully included in the 2020 edition of the "CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies"
.
● In October 2020, ivonib was included in the "List of Overseas New Drugs Urgently Needed for Clinical Practice (the third batch)" by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China
.
● In July 2021, according to the CDE official website, ivonib was proposed to be included in priority review for the treatment of adults with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations
.
● In August 2021, the new drug application for ivonib was accepted for the treatment of adults with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations
.
Six months later, Topsuvo® was successfully approved for marketing in China, which once again showed us the strength and ability of CStone to bring innovative drugs to the market quickly
.
Based on the successful market experience of the first two precision medicines, it is believed that Topsuvo® will also reach patients quickly
.
Multi-drug and multi-indication expansion to meet clinical needs With the advancement of technology, tumor treatment has tended to be precise treatment, and various companion diagnostics have been gradually improved
.
From the very beginning, patients carry out genetic testing to find mutation targets and corresponding optimal treatment plans, and ultimately enable cancer patients to achieve long-term survival like chronic diseases
.
With the approval of the three precision therapy products, CStone's research in the field of precision therapy has gradually been carried out, and the concept of "same disease with different treatment and same disease with different treatment" can be better understood
.
In the field of AML, in addition to being approved for relapsed and refractory patients, Topsuvo® has also made significant progress as a first-line therapy
.
In August 2021, the AGILE study successfully met the primary endpoint of event-free survival (EFS), significantly improving event-free survival in treatment-naïve IDH1-mutant acute myeloid leukemia (AML) patients compared with azacitidine plus placebo Survival and overall survival, patients' median decreased
.
The trial met all of its key secondary endpoints, including complete remission (CR) rate, overall survival (OS), CR and complete remission with partial hematologic recovery (CRh) rate, and objective response rate (ORR)
.
Tosuvo® combined with azacitidine therapy is expected to bring new treatment options to this subset of previously untreated IDH1-mutant AML patients
.
The data of ivonib in IDH1-mutant cholangiocarcinoma patients also achieved excellent efficacy and safety
.
The latest results from the global phase III study ClarIDHy showed a significant improvement in the primary endpoint of progression-free survival (PFS) in previously treated patients with advanced IDH1-mutant cholangiocarcinoma
.
Median PFS was 2.
7 months and 1.
4 months in the ivonib group and placebo group, respectively
.
The PFS rate was 32% at 6 months and 22% at 12 months in the ivonib group, with a 63% reduction in the risk of disease progression or death compared to the placebo group
.
Ivornib is the first and only FDA-approved drug for targeted therapy in patients with IDH1-mutant cholangiocarcinoma
.
IDH1 gene mutations are not only seen in AML and cholangiocarcinoma, but also in a variety of tumors, including gliomas
.
In a basket trial in patients with advanced solid tumors, ivonib performed well in patients with IDH1-mutant advanced glioma, showing a favorable safety profile, long-term disease control, and significantly reduced tumor growth
.
The results were published in the Journal of Clinical Oncology in June 2020
.
In terms of lung cancer treatment, CStone's dominant field, based on the potential best-in-class PD-(L)1 inhibitor Zejiemei®, combined with the first selective RET inhibitor Pujihua® in China and the third-generation ALK/ALK/ The ROS1 tyrosine kinase inhibitor lorlatinib, with immunotherapy and precision treatment, will reflect a strong market value
.
At the same time, Pujihua® is in the first-line treatment of non-small cell lung cancer indications, as well as the indications of medullary thyroid cancer and thyroid cancer
.
Zejimet® is also expected to cover stage III and IV NSCLC patients, and clinical studies on gastric cancer, esophageal cancer and lymphoma have also achieved positive results
.
Clinical transformation and commercialization capabilities have achieved "cornerstone speed".
Four products have been launched in one year.
CStone has demonstrated a consistent "cornerstone speed", and behind this speed is CStone's strong translational medicine and clinical development capabilities
.
CStone separated the proof-of-concept (PoC) from the IND as early as 2018, and set up a translational medicine team among the first Chinese pharmaceutical companies
.
In terms of clinical research and development, CStone can uniquely design the key clinical trial protocols of each product, thereby greatly shortening the number of patients and the clinical trial period
.
This has been fully verified in the clinical trials GEMSTONE-301 and GEMSTONE-302 of Zejimet®.
It is worth mentioning that the current GEMSTONE-302 study has reached the study endpoint of overall survival (OS)
.
The data of these two clinical trials were also published simultaneously in the top international journal "The Lancet-Oncology"
.
In addition, CStone's commercialization process is very active, and it has launched three precision medicines to the market at an extraordinary speed, two of which have achieved rapid sales growth
.
Through extensive and in-depth cooperation with stakeholders in the medical field, CStone has now covered more than 400 hospitals in more than 130 cities, accounting for about 70-80% of the precision medicine-related market
.
In addition, pharmaceuticals are covered by more than 60 major commercial and government insurance plans
.
In terms of the commercialization of Zejimay®, CStone has cooperated closely with partners such as Pfizer and EQRx to promote the PD-(L)1 inhibitor Zejimay® more widely for therapeutic use.
NSCLC, gastric and esophageal cancer patients
.
From these aspects, CStone Pharmaceuticals has achieved "breaking the circle" and is on the road from Biotech to Biopharma
.
And this also reminds us that we need to feel this company from a larger scope and a higher dimension
.
2021 is the first year of CStone's commercialization, and the successful launch of Topsuvo® also makes a good start for 2022
.
In the new year, we will also continue to look forward to how CStone can further expand the commercial potential of its products, the clinical progress of various pipeline products under development and the expansion of indications for products already on the market
.
It is believed that at CStone, we can see more products with the first-in-class/best-in-class/first-tier potential and global rights and interests to be launched quickly, bringing breakthrough therapies to cancer patients and benefiting more patients
.
