LEBANON, N.H.--(BUSINESS WIRE)--Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, today announced that its partner Innovent Biologics has received BLA approval in China for an antibody against PD-1 to treat Hodgkin’s Lymphoma.
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.
Adimab is the leading technology provider for antibody-based drug discovery. Adimab focuses solely on its partners and does not pursue an internal product pipeline. Since 2009, Adimab has partnered with over 60 pharmaceutical and biotechnology companies. The Adimab technology has been transferred and implemented at Biogen, GSK, Lilly, Merck, and Novo Nordisk. Funded discovery partners include leading pharmaceutical companies, such as Boehringer Ingelheim, Celgene, Genentech, Gilead, Kyowa Hakko Kirin, Novartis, Roche, Sanofi, Takeda and others. Adimab has also partnered with many early-stage venture-backed companies, including Alector, Cullinan Oncology, Dragonfly, Pliant, Potenza, Tizona, iTeos and others, as well as mid-size public biopharmaceutical companies such as Acceleron, Five Prime, Innovent, Jounce, Mersana, Scholar Rock, Seattle Genetics, Surface Oncology, and others.
Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most aggressive standards for affinity, epitope coverage, species cross-reactivity and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com.
Innovent was established in 2011. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. These capabilities have enabled the company to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging the platform, the company has built up a pipeline of 20 innovative medicines in the last seven years, led by four core products that are in late-stage clinical development in China. Out of the pipeline of 20 innovative medicines, thirteen have entered into clinical development, four have entered Phase III clinical trials, one (biosimilar to Humira) has its New Drug Application (NDA) under review and Tyvyt® (sintilimab injection) has been approved for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL).
Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of the clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, Incyte, Hanmi and other biopharmaceutical companies.
Inspired by the spirit of "Start with Integrity, Succeed through Action”, Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Innovent wishes to work with all relevant parties helping the advancement of China’s biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients’ life.
Innovent is listed on the main board of the Hong Kong Stock Exchange with the stock code of HK 01801.
For more information, please visit：www.innoventbio.com.