On January 7, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that its partner Innovent Biologics has received BLA approval in China for an antibody against PD-1 to treat Hodgkin’s Lymphoma (Press release, Adimab, JAN 7, 2019, View Source [SID1234532543]).
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Adimab and Innovent initiated a partnership in 2013 to discover antibodies against multiple targets selected by Innovent. The partnership has been expanded multiple times to add additional programs and to access Adimab’s bispecifics capabilities. Innovent currently has 12 programs in development derived from the Adimab Platform. The PD-1 program, which Innovent has partnered with Lilly, was initiated in the spring of 2013.
On December 27th, 2018, Innovent and its co-development partner, Eli Lilly, announced that Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).
"Innovent has been an outstanding partner. Their ability to go from inception to an approved drug in five years is impressive by any standard. Innovent has a deep pipeline of quality programs and we expect them to be a major player in the Chinese pharmaceutical industry for years to come," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab.
"Adimab’s technology helped generate one of the most competitive PD-1 programs in the industry and the quality of the antibody allowed Innovent’s PD-1 program to go from initiating discovery to approval in China in less than six years," said Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent. "Adimab has been one of our most important partners. The quality of their work and professionalism are exceptional."
About Tyvyt (sintilimab injection)
Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.