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March 29, 2021/bioon.
com" target="_blank">/--Kazia Therapeutics, headquartered in Sydney, Australia, is a biotechnology company focused on bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology , dedicated to the development of innovative anti-cancer drugs.
Recently, the company announced that it has signed a license agreement with Simcere Pharmaceutical Group Ltd.
: For Kazia's new anti-cancer drug paxalisib, Simcere Pharmaceuticals has obtained the development and Commercialization rights.
bioon.com" target="_blank">/--Kazia Therapeutics, headquartered in Sydney, Australia, is a biotechnology company focused on bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology , dedicated to the development of innovative anti-cancer drugs.
Recently, the company announced that it has signed a license agreement with Simcere Pharmaceutical Group Ltd.
: For Kazia's new anti-cancer drug paxalisib, Simcere Pharmaceuticals has obtained the development and Commercialization rights.
com" target="_blank">bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
Paxalisib is a pilot project of Kazia, which is a small molecule inhibitor of the brain-permeable PI3K/Akt/mTOR pathway.
It is currently being developed for the treatment of glioblastoma (GBM), which is the most common and most aggressive in adults Sexual primary brain cancer.
Paxalisib was authorized by Roche's Genentech at the end of 2016, and the key study for the treatment of GBM will be initiated in January 2021.
Patient recruitment for GBM AGILE will be initiated.
Currently, another 7 studies are evaluating paxalisib in the treatment of other forms of brain bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors .
Previously, the US bioon.
com/fda/" target="_blank">FDA has granted paxalisib the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for the treatment of GBM, and the Rare Pediatric Disease Designation (RPDD) for the treatment of diffuse endogenous pontine glioma (DIPG).
bioon. It is currently being developed for the treatment of glioblastoma (GBM), which is the most common and most aggressive in adults Sexual primary brain cancer.
Paxalisib was authorized by Roche's Genentech at the end of 2016, and the key study for the treatment of GBM will be initiated in January 2021.
Patient recruitment for GBM AGILE will be initiated.
Currently, another 7 studies are evaluating paxalisib in the treatment of other forms of brain bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors .
Previously, the US bioon.
com/fda/" target="_blank">FDA has granted paxalisib the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for the treatment of GBM, and the Rare Pediatric Disease Designation (RPDD) for the treatment of diffuse endogenous pontine glioma (DIPG).
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Oncology bioon.
com/fda/" target="_blank">FDA
In the vast majority of GBM patients, the PI3K/Akt/mTOR pathway is disordered.
In a phase II study of newly bioon.
com/vitroDiagnostics/" target="_blank">diagnosed GBM patients with unmethylated MGMT promoter status, paxalisib showed very encouraging clinical efficacy signals.
In January 2021, the GBM AGILE platform study began to recruit patients, and the study is expected to serve as the basis for registration of key geographic areas.
bioon. In a phase II study of newly bioon.
com/vitroDiagnostics/" target="_blank">diagnosed GBM patients with unmethylated MGMT promoter status, paxalisib showed very encouraging clinical efficacy signals.
In January 2021, the GBM AGILE platform study began to recruit patients, and the study is expected to serve as the basis for registration of key geographic areas.
com/vitroDiagnostics/" target="_blank">diagnosis
Glioma (Image source: hmcisrael.
com)
com)
According to the terms of the agreement, Simcere Pharmaceuticals will be responsible for the development, registration and commercialization of paxalisib in Greater China (Mainland, Hong Kong, Macau, Taiwan).
Kazia reserves the right to develop and commercialize paxalisib in all other regions, and will continue to advance the key research of glioblastoma (GBM) AGILE as planned, including in China.
Kazia reserves the right to develop and commercialize paxalisib in all other regions, and will continue to advance the key research of glioblastoma (GBM) AGILE as planned, including in China. Kazia reserves the right to develop and commercialize paxalisib in all other regions, and will continue to advance the key research of glioblastoma (GBM) AGILE as planned, including in China.
Kazia will receive an upfront payment of US$11 million, including US$7 million in cash and US$4 million in equity investments, at a 20% premium to the recent stock transaction price.
For glioblastoma (GBM) indications, Kazia will also receive up to US$281 million in contingent milestone payments, and for indications other than glioblastoma (GBM), Kazia will also receive further milestone payments.
Simcere will also pay Kazia more than ten percent of royalties for commercial sales.
For glioblastoma (GBM) indications, Kazia will also receive up to US$281 million in contingent milestone payments, and for indications other than glioblastoma (GBM), Kazia will also receive further milestone payments.
Simcere will also pay Kazia more than ten percent of royalties for commercial sales.
Simcere is one of the leading pharmaceutical companies in China, with more than 40 listed products and an extensive development pipeline.
The company was established in 1995 and listed on the Hong Kong Stock Exchange (Hong Kong Stock Exchange: 2096).
Simcere's main strategic focus areas are bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology , central nervous system diseases and bioon.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">autoimmune diseases.
bioon. The company was established in 1995 and listed on the Hong Kong Stock Exchange (Hong Kong Stock Exchange: 2096).
Simcere's main strategic focus areas are bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology , central nervous system diseases and bioon.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">autoimmune diseases.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor bioon.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">autoimmunity
The chemical structure of paxalisib-GDC-0084 (picture source: selleckchem.
com)
com)
Dr.
James Garner, CEO of Kazia, said: “China is one of the largest pharmaceutical markets in the world and has special requirements and opportunities for innovative bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology products.
We are very pleased to cooperate with Simcere to ensure that paxalisib is in this key market.
Achieving commercial success.
Simcere's record of success is unparalleled.
They have brought first-class capabilities to paxalisib in clinical development, regulatory affairs and commercialization.
We look forward to working closely with new partners to help Chinese patients as soon as possible Provide paxalisib.
"
bioon. James Garner, CEO of Kazia, said: “China is one of the largest pharmaceutical markets in the world and has special requirements and opportunities for innovative bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology products.
We are very pleased to cooperate with Simcere to ensure that paxalisib is in this key market.
Achieving commercial success.
Simcere's record of success is unparalleled.
They have brought first-class capabilities to paxalisib in clinical development, regulatory affairs and commercialization.
We look forward to working closely with new partners to help Chinese patients as soon as possible Provide paxalisib.
"
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
Dr.
Renhong Tang, senior vice president of Simcere Pharmaceuticals, said: "We are very excited about the potential of paxalisib to play a role in this extremely challenging disease.
In China, there is a huge demand for new therapies for brain cancer, and we are the same as Kazia.
Committed to proposing new treatment options for patients.
"
Renhong Tang, senior vice president of Simcere Pharmaceuticals, said: "We are very excited about the potential of paxalisib to play a role in this extremely challenging disease.
In China, there is a huge demand for new therapies for brain cancer, and we are the same as Kazia.
Committed to proposing new treatment options for patients.
"
png" target="_blank">
png" target="_blank">In November 2020, Kazia announced the positive interim data of the ongoing Phase II study (NCT03522298) evaluating paxalisib in the treatment of glioblastoma (GBM).
The study is carried out in newly bioon.
com/vitroDiagnostics/" target="_blank">diagnosed GBM patients with unmethylated MGMT promoter status, and is evaluating the safety of paxalisib as an adjuvant therapy after patients undergoing maximum surgical resection and temozolomide (TMZ) combined with concurrent radiotherapy and chemotherapy Resistance, tolerability, recommended phase II dose (RP2D), pharmacokinetics (PK) and clinical activity.
TMZ is currently the standard care therapy for the treatment of GBM.
bioon. The study is carried out in newly bioon.
com/vitroDiagnostics/" target="_blank">diagnosed GBM patients with unmethylated MGMT promoter status, and is evaluating the safety of paxalisib as an adjuvant therapy after patients undergoing maximum surgical resection and temozolomide (TMZ) combined with concurrent radiotherapy and chemotherapy Resistance, tolerability, recommended phase II dose (RP2D), pharmacokinetics (PK) and clinical activity.
TMZ is currently the standard care therapy for the treatment of GBM.
com/vitroDiagnostics/" target="_blank">diagnosis
The results as of August 31, 2020 show: (1) The median overall survival (OS) of adjuvant paxalisib treatment is 17.
5 months, which is clinically significant compared with 12.
7 months related to the existing standard care TMZ Life is extended.
(2) The median progression-free survival (PFS) of adjuvant paxalisib treatment is 8.
4 months, which represents a favorable result compared with the existing standard care TMZ of 5.
3 months.
(3) One patient who received treatment remained disease-free 27 months after diagnosis.
5 months, which is clinically significant compared with 12.
7 months related to the existing standard care TMZ Life is extended.
(2) The median progression-free survival (PFS) of adjuvant paxalisib treatment is 8.
4 months, which represents a favorable result compared with the existing standard care TMZ of 5.
3 months.
(3) One patient who received treatment remained disease-free 27 months after diagnosis.
The final data of the study is expected to be released in the first half of fiscal 2021.
For any new anticancer drug, the "gold standard" is the ability to prolong life-this is a particularly challenging goal in diseases such as glioblastoma (GBM).
These new data provide the first clinical evidence that paxalisib has the potential to achieve this goal in a very challenging patient population.
For any new anticancer drug, the "gold standard" is the ability to prolong life-this is a particularly challenging goal in diseases such as glioblastoma (GBM).
These new data provide the first clinical evidence that paxalisib has the potential to achieve this goal in a very challenging patient population.
For more than two decades, patients with newly bioon.
com/vitroDiagnostics/" target="_blank">diagnosed glioblastoma have not received any new drug treatments.
Paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this extremely challenging disease.
()
For more than two decades, patients with newly bioon. com/vitroDiagnostics/" target="_blank">diagnosed glioblastoma have not received any new drug treatments.
Paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this extremely challenging disease.
()
com/vitroDiagnostics/" target="_blank">diagnosed glioblastoma have not received any new drug treatments.
Paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this extremely challenging disease.
bioon.
com/vitroDiagnostics/" target="_blank">diagnosis
Original source: Kazia Licenses Rights to Paxalisib in Greater China to Simcere, a Leading Chinese Pharmaceutical Company
