Innovent Receives IND Approval of a Bispecific Antibody (IBI318) by the NMPA

Thursday, February 7, 2019 General News
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SUZHOU, China, Feb. 7, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical

company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, today announced that its IND application for IBI318, a recombinant fully human bispecific antibody
targeting programmed cell death protein 1 (PD-1) and an undisclosed target for a tumor-associated antigen (TAA), recently has been approved by the National Medical Products Administration (NMPA) to initiate clinical trials in patients with hematological and advanced solid tumors.

PD-1 is a validated target in the field of anti-tumor immunotherapy. Anti-PD-1 monoclonal antibodies as single agents and in combination with chemotherapy have shown superior efficacy compared to the previous standard of care treatment in multiple tumor types, and have provided patients with new treatment options. However, monotherapy and combination therapy with anti-PD-1 antibodies in solid tumors only benefit a fraction of cancer patients. Development of more effective immunotherapies enables more cancer patients to benefit from this innovative therapeutic approach.

IBI318, a recombinant fully human immunoglobulin G1 (IgG1) bispecific antibody targeting PD-1 and an undisclosed target for a TAA, may offer a novel solution to patients' unmet medical needs. IBI318 simultaneously blocks both PD-1 and an undisclosed tumor associated signaling transduction pathway, and enhances the formation of immune synapses, thereby potentially enhancing  anti-tumor activities and increase anti-tumor efficacy. The IND approval of IBI318 by the NMPA highlights the significant progress Innovent has made in innovative immuno-oncology.

"IBI318 is one of the exciting, innovative anti-cancer programs that Innovent has pursued. We have a few bispecific antibody product candidates that have reached the clinical stage of development in both oncology and ophthalmology therapeutic areas. Many of these projects have the potential to be global first-in-class assets that could help large numbers of patients in need. The IND approval by NMPA of the bispecific antibody IBI318 has confirmed Innovent's ability to innovate and encouraged us to continue our pursuit of global innovation," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI318

IBI318, was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and an undisclosed target for a TAA.  IBI318 simultaneously blocks both PD-1 and another tumor associated signaling transduction pathway, and enhances the formation of immune synapses, thereby potentially enhancing anti-tumor activities and increase anti-tumor efficacy.

About Innovent

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. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of major diseases such as cancer. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

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. Leveraging the platform, the company has built up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases.  Fourteen have entered into clinical development, four have entered Phase 3 clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review and one, TyvytŪ (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit:

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SOURCE Innovent Biologics, Inc.

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