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In the past week, a number of new drugs have been approved for marketing, clinical trials, and new indications have received good news, involving domestic and foreign pharmaceutical companies such as Ono Pharma, Fosun Pharma, and Yunnan Baiyao
.
Yunnan Baiyao: "Quansanqi Tablets", a Class 1 New Chinese Medicine Drug Approved for Clinical On February 28, Yunnan Baiyao's new Class 1 Chinese Medicine Drug "Quansanqi Tablets" was approved by the State Food and Drug Administration, and is being used for the treatment of blood stasis in the heart and veins.
Clinical trials of chest tightness and heartache caused by
.
It is reported that this project is a major scientific and technological project specifically approved by the Yunnan Provincial Department of Science and Technology.
It is the first type 1 new drug of traditional Chinese medicine approved by Yunnan Baiyao after the reform of traditional Chinese medicine registration and classification.
The second approved new medicine for TCM syndromes
.
Ono Pharma: Velexbru BTK Inhibitor Approved in Taiwan Recently, Ono Pharma announced that the company's BTK inhibitor Velexbru has been approved in Taiwan, China for the treatment of adult patients with relapsed or refractory B-cell primary central nervous system lymphoma
.
Primary CNS lymphoma is a malignant lymphoma that relapses in some patients after treatment and in refractory patients who do not respond to drug therapy
.
Treatment options for patients with relapsed or refractory primary CNS lymphoma are currently not established because no standard of care has been established
.
Velexbru is the first BTK inhibitor approved in Taiwan for the treatment of adult patients with relapsed or refractory B-cell PCNSL
.
Fosun Kite: FKC889 Clinical Approval On March 2, Fosun Pharma announced that Fosun Kite, a subsidiary of the company, recently received a request from the State Food and Drug Administration to approve its CD19-targeted autologous CAR-T cell therapy product FKC889 for treatment Approval for a clinical trial in adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after prior second-line therapy or more
.
According to the announcement, FKC889 is a CAR-T cell therapy drug introduced by Fosun Kite from Kite Corporation of the United States to Tecartus for industrialization and commercialization in China
.
According to reports, mantle cell lymphoma is a rare non-Hodgkin lymphoma.
Patients with relapsed or refractory mantle cell lymphoma have a poor prognosis and lack effective treatment methods, so innovative solutions are urgently needed in clinical practice
.
With the approval of the FKC889 clinical trial, Fosun Kite stated that it will carry out relevant clinical trials as soon as possible, hoping to bring clinical benefits to more patients with relapsed/refractory mantle cell lymphoma
.
Fuxing Medicine: Rituximab has been approved for a new indication.
In the past week, Fuxing Medicine has received good news.
In addition to the clinical approval of FKC889 mentioned above, its holding subsidiary Shanghai Fuhong Henliusn and its holding subsidiary developed Rituximab injection has also been approved for new indications
.
The announcement shows that rituximab injection has been approved by the State Food and Drug Administration in combination with methotrexate for moderate to severe active rheumatoid arthritis ( RA) in adult patients
.
It is understood that rheumatoid arthritis (RA) is a common chronic disease characterized by progressive joint erosion and destruction, and is a non-specific autoimmune disease
.
The etiology is not fully understood, but the main clinical manifestations are joint stiffness, pain, inflammation, limited mobility, and joint erosion, which can lead to joint deformity and dysfunction
.
With the approval of new indications for rituximab injection, it will bring new treatment options to the majority of patients
.
Previously, the product has been approved in mainland China for non-Hodgkin's lymphoma and chronic lymphocytic leukemia indications (all indications for which the original research rituximab was approved in China)
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Yunnan Baiyao: "Quansanqi Tablets", a Class 1 New Chinese Medicine Drug Approved for Clinical On February 28, Yunnan Baiyao's new Class 1 Chinese Medicine Drug "Quansanqi Tablets" was approved by the State Food and Drug Administration, and is being used for the treatment of blood stasis in the heart and veins.
Clinical trials of chest tightness and heartache caused by
.
It is reported that this project is a major scientific and technological project specifically approved by the Yunnan Provincial Department of Science and Technology.
It is the first type 1 new drug of traditional Chinese medicine approved by Yunnan Baiyao after the reform of traditional Chinese medicine registration and classification.
The second approved new medicine for TCM syndromes
.
Ono Pharma: Velexbru BTK Inhibitor Approved in Taiwan Recently, Ono Pharma announced that the company's BTK inhibitor Velexbru has been approved in Taiwan, China for the treatment of adult patients with relapsed or refractory B-cell primary central nervous system lymphoma
.
Primary CNS lymphoma is a malignant lymphoma that relapses in some patients after treatment and in refractory patients who do not respond to drug therapy
.
Treatment options for patients with relapsed or refractory primary CNS lymphoma are currently not established because no standard of care has been established
.
Velexbru is the first BTK inhibitor approved in Taiwan for the treatment of adult patients with relapsed or refractory B-cell PCNSL
.
Fosun Kite: FKC889 Clinical Approval On March 2, Fosun Pharma announced that Fosun Kite, a subsidiary of the company, recently received a request from the State Food and Drug Administration to approve its CD19-targeted autologous CAR-T cell therapy product FKC889 for treatment Approval for a clinical trial in adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after prior second-line therapy or more
.
According to the announcement, FKC889 is a CAR-T cell therapy drug introduced by Fosun Kite from Kite Corporation of the United States to Tecartus for industrialization and commercialization in China
.
According to reports, mantle cell lymphoma is a rare non-Hodgkin lymphoma.
Patients with relapsed or refractory mantle cell lymphoma have a poor prognosis and lack effective treatment methods, so innovative solutions are urgently needed in clinical practice
.
With the approval of the FKC889 clinical trial, Fosun Kite stated that it will carry out relevant clinical trials as soon as possible, hoping to bring clinical benefits to more patients with relapsed/refractory mantle cell lymphoma
.
Fuxing Medicine: Rituximab has been approved for a new indication.
In the past week, Fuxing Medicine has received good news.
In addition to the clinical approval of FKC889 mentioned above, its holding subsidiary Shanghai Fuhong Henliusn and its holding subsidiary developed Rituximab injection has also been approved for new indications
.
The announcement shows that rituximab injection has been approved by the State Food and Drug Administration in combination with methotrexate for moderate to severe active rheumatoid arthritis ( RA) in adult patients
.
It is understood that rheumatoid arthritis (RA) is a common chronic disease characterized by progressive joint erosion and destruction, and is a non-specific autoimmune disease
.
The etiology is not fully understood, but the main clinical manifestations are joint stiffness, pain, inflammation, limited mobility, and joint erosion, which can lead to joint deformity and dysfunction
.
With the approval of new indications for rituximab injection, it will bring new treatment options to the majority of patients
.
Previously, the product has been approved in mainland China for non-Hodgkin's lymphoma and chronic lymphocytic leukemia indications (all indications for which the original research rituximab was approved in China)
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
