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Generon Receives Investigative New Drug (IND) Approval from China SFDA for A-319 to Treat Patients with B Cell Malignancies

SHANGHAI--(BUSINESS WIRE)--Generon Corporation, a leading biopharmaceutical company in China, today announced it received approval for the Company’s Investigational New Drug (IND) application from the State Food and Drug Administration (SFDA) of the People’s Republic of China to initiate a Phase I clinical trial for A-319 in patients with B cell malignancies. A-319 is Generon’s second bispecific antibody in clinical development.

“Obtaining the SFDA’s approval for the A-319 Phase I trial is a significant accomplishment for Generon’s ITabTM platform. The IND approval is another step in demonstrating Generon’s innovative capabilities”

A-319 is the first CD19 engaging bispecific antibody approved by the SFDA for clinical trials in China. The CD3/CD19 bispecific antibody was developed using Generon’s Immuno-Therapy Antibody (ITab)TM technology platform. The IND approval enables Generon to commence Phase I clinical trials in China enrolling patients with B cell malignancies including acute lymphoblastic leukemia (ALL) and B cell lymphoma.

Dr. Mi Jian Qing, Professor at Ruijin Hospital, Shanghai Jiaotong University expressed his enthusiasm about the biology of A-319 and the potential benefits for ALL patients. He commented: “Obtaining the SFDA’s approval for the A-319 Phase I trial is a significant accomplishment for Generon’s ITabTM platform. The IND approval is another step in demonstrating Generon’s innovative capabilities”.

Yifan Pharmaceuticals, Generon’s parent company, congratulated Generon’s team on the continued effort to develop innovative therapies. Dr. Xiao Qiang Yan, CEO and CSO of Generon, said, “Initiation of a Phase I study for A-319 in China is one of Generon’s goals this year. A-319 has a similar mechanism of action to eliminate malignant B cells to those of CAR-T and other CD19/CD3 bispecific antibodies, but it is more convenient for patient dosing and potentially with better safety. A-319 is our second T-cell activating bispecific antibody to enter clinical development. Generon is expanding its ITabTM pipeline for both liquid and solid tumors and committed to bringing innovative immune-oncology antibodies to cancer patients in China and the world”.

B cell malignancies

B cell malignancies refer to the different types of cancers that form in B cells in the immune system, including B-cell lymphomas and B-cell leukemia. B-cell lymphoma may be either indolent (slow-growing) or aggressive (fast-growing). Most B-cell lymphomas are non-Hodgkin lymphomas (NHL). There are many different types of B-cell non-Hodgkin lymphomas including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). B-cell leukemia includes B-cell chronic lymphocytic leukemia (CLL), Acute lymphoblastic leukemia (ALL), B-cell prolymphocytic leukemia (PLL), and hairy cell leukemia (HCL). The prognosis and treatment of B cell malignancies depend on the specific type of the B cell lymphoma/leukemia, as well as the stage and grade. Recent immunotherapy (T-cell activating) approaches have demonstrated significant clinical benefits for patients.

About A-319

A-319 is a T-cell activating bispecific antibody (BsAb) designed to target CD19 and CD3 (anti-CD19, anti-CD3) and is under development for the treatment of patients with B cell malignancies including B-cell leukemia and B-cell lymphoma. A-319 activates T lymphocytes in a patient to kill CD19 expressing malignant B-cells.

About Generon Corporation

Generon (Shanghai) Corporation (Generon) is a privately held and leading biotechnology company located in Shanghai, China focusing on the development of innovative biological therapies for patients worldwide. It is the therapeutic biologics division of its parent company, Yifan pharmaceuticals.

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