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On March 31, Innovent announced that its specific PI3Kδ inhibitor (Parsaclisib) has passed the publication period of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
Symptoms are relapsed/refractory follicular lymphoma (r/r FL).
Follicular lymphoma is a common type of non-Hodgkin's lymphoma (NHL) and is one of the common hematological tumors.
The standard first-line therapy is R-CHOP and similar programs.
Approximately 20% will have early progress.
For most newly-treated patients who are effective in treatment, they will inevitably enter the relapse and refractory stage after the disease is stable.
Therefore, patients with relapsed or refractory follicular lymphoma still have unmet needs.
IBI376 (Parsaclisib) is a new and potent selective inhibitor of PI3K enzyme, which is selective for the delta subtype.
PI3Kδ is a key B-cell receptor signaling mediator, which is related to the growth, survival and proliferation of malignant B-cells.
It has been proven to be effective and selective before clinical use, and has potential in the treatment of patients with malignant hematological tumors (such as lymphoma) Therapeutic effect.
In December 2018, Innovent and Incyte reached a strategic cooperation on three drug candidates in clinical trials, including Parsaclisib.
According to the terms of the agreement, Cinda Biotech owns the development and commercialization rights of Parsaclisib and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.
At the 62nd American Annual Meeting of Hematology (ASH) in 2020, Incyte reported the data of a clinical study of Parsaclisib in the treatment of relapsed/refractory follicular lymphoma.
The study showed that the objective response rate (ORR) of Parsaclisib monotherapy in r/r FL patients (N=95) reached 75%, and the median progression-free survival (PFS) reached 15.
8 months.
Currently, Parsaclisib as a monotherapy for the treatment of non-Hodgkin lymphoma (follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma) and several phase 2 trials of autoimmune hemolytic anemia are in progress.
In addition, a registered clinical trial of Parsaclisib and ruxolitinib in the treatment of patients with myelofibrosis is also ongoing.
Incyte also plans to conduct trials to evaluate parsaclisib combined with tafasitamab in the treatment of non-Hodgkin's lymphoma (NHL) and chronic myeloid leukemia (CLL).
End reference materials: [1] Cinda Biologicals selected onlookers in the past Nature: Immunotherapy known as the "anti-cancer star" may be a "crushing talisman" for this type of cancer patients.
AstraZeneca announced the new crown vaccine phase 3 Clinical results: No increase in the risk of thrombosis, 100% prevention of severe COVID-19 fever instead of morphine to treat pain dependence! Science Sub-Journal: Gene Therapy Technology Based on CRISPR and Zinc Finger Protein to Relieve Chronic Pain Hot Article EJCN: Another Effect of Green Tea! Speed up the recovery rate of gastric cancer patients after surgery.
In adolescence, high-sugar foods and sugary beverages should be eaten and drink less, or it can significantly increase the risk of colorectal cancer in adulthood! Pharmaceutical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company 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 | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | 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 version of the basic drug catalog | AI medical devices | Telemedicine | Same stock market with different rights/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
Symptoms are relapsed/refractory follicular lymphoma (r/r FL).
Follicular lymphoma is a common type of non-Hodgkin's lymphoma (NHL) and is one of the common hematological tumors.
The standard first-line therapy is R-CHOP and similar programs.
Approximately 20% will have early progress.
For most newly-treated patients who are effective in treatment, they will inevitably enter the relapse and refractory stage after the disease is stable.
Therefore, patients with relapsed or refractory follicular lymphoma still have unmet needs.
IBI376 (Parsaclisib) is a new and potent selective inhibitor of PI3K enzyme, which is selective for the delta subtype.
PI3Kδ is a key B-cell receptor signaling mediator, which is related to the growth, survival and proliferation of malignant B-cells.
It has been proven to be effective and selective before clinical use, and has potential in the treatment of patients with malignant hematological tumors (such as lymphoma) Therapeutic effect.
In December 2018, Innovent and Incyte reached a strategic cooperation on three drug candidates in clinical trials, including Parsaclisib.
According to the terms of the agreement, Cinda Biotech owns the development and commercialization rights of Parsaclisib and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.
At the 62nd American Annual Meeting of Hematology (ASH) in 2020, Incyte reported the data of a clinical study of Parsaclisib in the treatment of relapsed/refractory follicular lymphoma.
The study showed that the objective response rate (ORR) of Parsaclisib monotherapy in r/r FL patients (N=95) reached 75%, and the median progression-free survival (PFS) reached 15.
8 months.
Currently, Parsaclisib as a monotherapy for the treatment of non-Hodgkin lymphoma (follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma) and several phase 2 trials of autoimmune hemolytic anemia are in progress.
In addition, a registered clinical trial of Parsaclisib and ruxolitinib in the treatment of patients with myelofibrosis is also ongoing.
Incyte also plans to conduct trials to evaluate parsaclisib combined with tafasitamab in the treatment of non-Hodgkin's lymphoma (NHL) and chronic myeloid leukemia (CLL).
End reference materials: [1] Cinda Biologicals selected onlookers in the past Nature: Immunotherapy known as the "anti-cancer star" may be a "crushing talisman" for this type of cancer patients.
AstraZeneca announced the new crown vaccine phase 3 Clinical results: No increase in the risk of thrombosis, 100% prevention of severe COVID-19 fever instead of morphine to treat pain dependence! Science Sub-Journal: Gene Therapy Technology Based on CRISPR and Zinc Finger Protein to Relieve Chronic Pain Hot Article EJCN: Another Effect of Green Tea! Speed up the recovery rate of gastric cancer patients after surgery.
In adolescence, high-sugar foods and sugary beverages should be eaten and drink less, or it can significantly increase the risk of colorectal cancer in adulthood! Pharmaceutical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company 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 | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | 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 version of the basic drug catalog | AI medical devices | Telemedicine | Same stock market with different rights/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption