Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-LAG-3 Monoclonal Antibody in China

SUZHOU,China,Dec. 6,2019 -- Innovent Biologics,Inc. ("Innovent" or "the Company") (HKEX: 01801),a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology,autoimmune,metabolic and other major diseases,today announced that the first patient has been successfully dosed in a Phase I clinical trial (CIBI110A101) of anti-lymphocyte activation gene 3 (LAG-3)recombinant fully human monoclonal antibody drug candidate (IBI110) in China.

CIBI110A101 is a phase I clinical study conducted in China to evaluate IBI110 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety,tolerability,and initial anti-tumor efficacy of IBI110,either as monotherapy or in combination with Tyvyt® (sintilimab injection),an anti-programmed cell death protein 1 (PD-1) antibody drug. The Phase Ia study will explore the safety,tolerability and efficacy of IBI110 as monotherapy.

IBI110 is a recombinant fully human anti-LAG-3 monoclonal antibody and will provide a brand new clinical solution to cancer patients. IBI110 can directly bind to LAG-3 on the surface of T cells,disturb the interaction between LAG-3 and MHCII,relieve the inhibiting effect of LAG-3 on T cells activation and enhance the anti-tumor immune response of T cells. Furthermore,the combination of anti-LAG-3 and anti-PD-1/PD-L1 may provide synergistic enhancement and improve the anti-tumor efficacy.

Professor Caicun Zhou,director of Oncology Department of Shanghai Pulmonary Hospital,said: "Although immune checkpoint inhibitors have shown gratifying progress in oncology therapy,we still confront many new challenges. With the increasing popularity of anti-PD-1/PD-L1 antibody,some patients have shown resistance to anti-PD-1/PD-L1 therapy. Meanwhile,the efficacy of anti-PD-1/PD-L1 therapy in its initial treatment of patients also needs to be further improved. Therefore,it has great significance to develop the next generation of tumor immune drugs,while LAG-3 is one of the most promising and prospective targets in tumor immunotherapy. We are looking forward to the clinical results of IBI110."

Dr. Hui Zhou,Vice President and Head of Oncology Strategy and Medical Sciences of Innovent,said: "LAG-3 is an important immuno-inhibitory receptor,but there is no approved antibody drug targeting LAG-3 so far. Currently,a series of relevant clinical trials is ongoing abroad,and the preliminary results have shown certain safety and anti-tumor effectiveness of anti-LAG-3 antibody either as monotherapy or combination with anti-PD-1/PD-L1 antibody. Notably,the combination therapies hopefully exhibited synergistic enhancement effect. Therefore,developing drugs targeting LAG-3 may provide more novel,comprehensive and effective treatments for patients. We will evaluate the potential clinical value of IBI110 and its combination therapy,and hope to ultimately benefit more patients."

About IBI110

IBI110 is an innovative IgG4κ recombinant fully human anti-LAG-3 monoclonal antibody developed by Innovent. As class 1 innovative drug,IBI110 can directly bind to LAG-3 and block its interaction with MHCII,thus activate and enhance the anti-tumor immune response of T cells. Furthermore,IBI110 may synergize with anti-PD-1/PD-L1 antibody to improve the anti-tumor efficacy. IBI110 may hopefully exert antitumor activity and delay the drug resistance in the form of monotherapy or combination with Tyvyt® (sintilimab injection),which will provide more effective treatments for cancer patients.

About CIBI110A101

CIBI110A101 is a Phase I clinical study conducted in China to evaluate IBI110 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety,an anti-programmed cell death protein 1 (PD-1) antibody drug.

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 oncology,metabolic and other major diseases. 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 a robust pipeline of 21 innovative assets in the fields of oncology,metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development,five have entered Phase III clinical trials,three monoclonal antibodies have their New Drug Application (NDA) under review and three of them have been granted with priority review status,and one,Tyvyt® (sintilimab injection),has been approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and is the only PD-1 inhibitor that has been included in the NRDL in November 2019.

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: www.innoventbio.com.