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CStone Pharmaceuticals announced on March 31 that the National Medical Products Administration (NMPA) of China has approved its new drug listing application for its gastrointestinal stromal tumor (GIST) precision targeting drug Taijihua® (avatinib tablets) It is used to treat adult patients with unresectable or metastatic GIST with PDGFRA exon 18 mutation (including PDGFRA D842V mutation).
The drug is China's first approved precision treatment drug for PDGFRA exon 18 mutant GIST.
GIST is a sarcoma that occurs in the gastrointestinal tract.
Sarcoma is a tumor that occurs in bone or originates from connective tissue.
Gastrointestinal stromal tumors originate from cells in the wall of the gastrointestinal tract and most commonly occur in the stomach or small intestine.
Most patients are diagnosed between 50 and 80 years old.
They are usually found during gastrointestinal bleeding, surgery or medical imaging examinations, and rarely after tumor rupture or gastrointestinal obstruction.
In primary GIST, about 5% to 6% of cases are caused by the PDGFRA D842V mutation, which is the most common PDGFRA exon 18 mutation.
Taijihua® is a kinase inhibitor developed by Blueprint Medicines, a partner of CStone Pharmaceuticals.
CStone Pharmaceuticals reached an exclusive cooperation and licensing agreement with Blueprint Medicines, and obtained the exclusive development and commercialization of a variety of drugs including avatinib in the Greater China region (including mainland China, Hong Kong, Macau and Taiwan) Authorization.
The approval of Taijihua® for the treatment of unresectable or metastatic GIST patients with PDGFRA exon 18 mutation is based on an open-label, multi-center phase I/II clinical study to evaluate the treatment of Taijihua® Safety, pharmacokinetic characteristics and anti-tumor efficacy in patients with unresectable or metastatic advanced GIST.
Taijihua® initially showed significant anti-tumor activity in Chinese GIST patients with PDGFRA D842V mutation.
At a dose of 300 mg once daily, of 8 patients with PDGFRA D842V mutation, all patients had target lesions Reduced, the overall response rate (ORR) was 62.
5%.
Taijihua® is generally well tolerated, and most of the treatment-related adverse events reported in the study were grade 1 or 2.
In the United States, the U.
S.
Food and Drug Administration approved Taijihua® to be marketed under the trade name AYVAKITTM for the treatment of unresectable or metastatic GIST adult patients with PDGFRA exon 18 mutations (including PDGFRA D842V mutations).
In the European Union, the European Medicines Agency approved it to be marketed under the trade name AYVAKYT® for the treatment of unresectable or metastatic gastrointestinal stromal tumors in adults with PDGFRA D842V mutation.
Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, said: “Taijihua® is the second first-of-its-kind product approved by CStone Pharmaceuticals in the same month.
This approval is a full contribution to CStone’s entire team’s efforts.
Affirmative.
We thank all the patients and researchers who participated in the clinical research of Taijihua® for their dedication and contribution.
At the same time, we are also very grateful to the State Food and Drug Administration for the priority review and approval work carried out by the State Food and Drug Administration for the approval of Taijihua®.
To jointly solve the urgent unmet medical needs of Chinese cancer patients.
With the approval of the company's two precision treatment drugs, we will continue to spare no effort to bring more first-of-its-kind and best-in-class tumors to cancer patients worldwide Therapeutic drugs.
"Professor Shen Lin, deputy dean of Peking University Cancer Hospital, said: "For a long time, PDGFRA exon 18 mutation GIST patients lack therapeutic drugs.
Taijihua® is used in Chinese advanced GIST patients with PDGFRA exon 18 mutation.
It has shown very good anti-tumor activity, and has good safety and tolerability.
Taijihua's approval in China will undoubtedly bring huge survival benefits to these patients.
"Avatinib has not been approved for other indications in China, the United States, and the European Union, or medical regulatory agencies in other regions have not yet made an approval decision for any indications of avatinib.
Globally, Ah The clinical development
of vatinib for patients with advanced and indolent systemic mastocytosis (SM) is underway.
The U.
S.
FDA has granted avatinib a breakthrough therapy designation for the treatment of advanced SM, including subtypes of aggressive SM.
SM with related hematological tumors and mast cell leukemia, as well as moderately to severely inert SM.
End's past selection of onlookers Nature: immunotherapy known as the "anti-cancer star" may be a reminder for this type of cancer patients "Reven AstraZeneca announced the Phase 3 clinical results of the new crown vaccine: no increase in the risk of thrombosis, 100% prevention of severe COVID-19 fever instead of morphine to treat pain dependence! Science sub-Journal: based on CRISPR and zinc finger protein gene therapy technology to relieve Chronic pain fever EJCN: Another effect of green tea! Speed up the recovery rate of gastric cancer patients after surgery Hot text Eat less high-sugar foods and sugar-sweetened beverages during adolescence, or significantly increase the risk of colorectal cancer in adulthood! Medical immunotherapy | Biosimilars | Vaccines | Drug Resistance | Drug Targets | Healthy Life | Pharmaceutical News | Drug Inventory | Pharmaceutical Technology | Basic Research on Drug Side Effects / Translational Medicine Leukemia | Lung Cancer | Gastric Cancer | Colorectal Cancer | Liver Cancer | Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | In Vitro Diagnosis of Intestinal Microorganism Medical Devices/Biotechnology | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision Medicine Policy Anti-cancer Drugs | 4+7 Volume Procurement | Consumables | Filing System | Registrant System | Healthy China | New Basic Drug List | AI Medical Devices | Telemedicine | Same-Share Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
The drug is China's first approved precision treatment drug for PDGFRA exon 18 mutant GIST.
GIST is a sarcoma that occurs in the gastrointestinal tract.
Sarcoma is a tumor that occurs in bone or originates from connective tissue.
Gastrointestinal stromal tumors originate from cells in the wall of the gastrointestinal tract and most commonly occur in the stomach or small intestine.
Most patients are diagnosed between 50 and 80 years old.
They are usually found during gastrointestinal bleeding, surgery or medical imaging examinations, and rarely after tumor rupture or gastrointestinal obstruction.
In primary GIST, about 5% to 6% of cases are caused by the PDGFRA D842V mutation, which is the most common PDGFRA exon 18 mutation.
Taijihua® is a kinase inhibitor developed by Blueprint Medicines, a partner of CStone Pharmaceuticals.
CStone Pharmaceuticals reached an exclusive cooperation and licensing agreement with Blueprint Medicines, and obtained the exclusive development and commercialization of a variety of drugs including avatinib in the Greater China region (including mainland China, Hong Kong, Macau and Taiwan) Authorization.
The approval of Taijihua® for the treatment of unresectable or metastatic GIST patients with PDGFRA exon 18 mutation is based on an open-label, multi-center phase I/II clinical study to evaluate the treatment of Taijihua® Safety, pharmacokinetic characteristics and anti-tumor efficacy in patients with unresectable or metastatic advanced GIST.
Taijihua® initially showed significant anti-tumor activity in Chinese GIST patients with PDGFRA D842V mutation.
At a dose of 300 mg once daily, of 8 patients with PDGFRA D842V mutation, all patients had target lesions Reduced, the overall response rate (ORR) was 62.
5%.
Taijihua® is generally well tolerated, and most of the treatment-related adverse events reported in the study were grade 1 or 2.
In the United States, the U.
S.
Food and Drug Administration approved Taijihua® to be marketed under the trade name AYVAKITTM for the treatment of unresectable or metastatic GIST adult patients with PDGFRA exon 18 mutations (including PDGFRA D842V mutations).
In the European Union, the European Medicines Agency approved it to be marketed under the trade name AYVAKYT® for the treatment of unresectable or metastatic gastrointestinal stromal tumors in adults with PDGFRA D842V mutation.
Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, said: “Taijihua® is the second first-of-its-kind product approved by CStone Pharmaceuticals in the same month.
This approval is a full contribution to CStone’s entire team’s efforts.
Affirmative.
We thank all the patients and researchers who participated in the clinical research of Taijihua® for their dedication and contribution.
At the same time, we are also very grateful to the State Food and Drug Administration for the priority review and approval work carried out by the State Food and Drug Administration for the approval of Taijihua®.
To jointly solve the urgent unmet medical needs of Chinese cancer patients.
With the approval of the company's two precision treatment drugs, we will continue to spare no effort to bring more first-of-its-kind and best-in-class tumors to cancer patients worldwide Therapeutic drugs.
"Professor Shen Lin, deputy dean of Peking University Cancer Hospital, said: "For a long time, PDGFRA exon 18 mutation GIST patients lack therapeutic drugs.
Taijihua® is used in Chinese advanced GIST patients with PDGFRA exon 18 mutation.
It has shown very good anti-tumor activity, and has good safety and tolerability.
Taijihua's approval in China will undoubtedly bring huge survival benefits to these patients.
"Avatinib has not been approved for other indications in China, the United States, and the European Union, or medical regulatory agencies in other regions have not yet made an approval decision for any indications of avatinib.
Globally, Ah The clinical development
of vatinib for patients with advanced and indolent systemic mastocytosis (SM) is underway.
The U.
S.
FDA has granted avatinib a breakthrough therapy designation for the treatment of advanced SM, including subtypes of aggressive SM.
SM with related hematological tumors and mast cell leukemia, as well as moderately to severely inert SM.
End's past selection of onlookers Nature: immunotherapy known as the "anti-cancer star" may be a reminder for this type of cancer patients "Reven AstraZeneca announced the Phase 3 clinical results of the new crown vaccine: no increase in the risk of thrombosis, 100% prevention of severe COVID-19 fever instead of morphine to treat pain dependence! Science sub-Journal: based on CRISPR and zinc finger protein gene therapy technology to relieve Chronic pain fever EJCN: Another effect of green tea! Speed up the recovery rate of gastric cancer patients after surgery Hot text Eat less high-sugar foods and sugar-sweetened beverages during adolescence, or significantly increase the risk of colorectal cancer in adulthood! Medical immunotherapy | Biosimilars | Vaccines | Drug Resistance | Drug Targets | Healthy Life | Pharmaceutical News | Drug Inventory | Pharmaceutical Technology | Basic Research on Drug Side Effects / Translational Medicine Leukemia | Lung Cancer | Gastric Cancer | Colorectal Cancer | Liver Cancer | Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | In Vitro Diagnosis of Intestinal Microorganism Medical Devices/Biotechnology | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision Medicine Policy Anti-cancer Drugs | 4+7 Volume Procurement | Consumables | Filing System | Registrant System | Healthy China | New Basic Drug List | AI Medical Devices | Telemedicine | Same-Share Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
