On November 26, 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, reported with Beijing Hanmi Pharmaceutical Co., Ltd. (a subsidiary of Hanmi Pharmaceutical Co., Ltd.) ("Hanmi") that the first patient has been successfully dosed in a Phase I clinical trial (CIBI315A101) of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and human epidermal growth factor receptor 2 (HER2) (IBI315), an innovative antibody co-developed by both companies (Press release, Innovent Biologics, NOV 26, 2019, View Source [SID1234551729]).

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CIBI315A101 is a phase I clinical trial conducted in China to evaluate the safety, tolerability, initial efficacy and recommended Phase II dose ("RP2D") of IBI315 in the treatment of patients with HER2-expressing advanced solid malignancies, either as monotherapy or in combination with chemotherapy.

IBI315 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and HER2, which may offer a novel solution to treat HER2-expressing malignancies. IBI315 can simultaneously block the PD-1/PD-L1 signaling pathway, the HER2 signaling pathway, and bridge PD-1-expressing T cells to HER2-expressing tumor cells. IBI315 combines both the targeted therapy and the immunotherapy mechanisms of action, thereby potentially enhancing anti-tumor activity and increasing anti-tumor efficacy.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "IBI315, as one of our pivotal drug candidates in our pipeline of cancer immunotherapies, is the world’s first PD-1/HER2 bispecific antibody that has entered clinical development. The development of IBI315 is therefore highly valuable and we hope that this new therapeutic bispecific antibody will offer a novel and more effective solution to patients’ unmet medical needs and ultimately benefit more patients."

Mr. Se Chang Kwon, CEO of Hanmi Pharmaceutical, said: "The new drug candidate developed upon Hanmi’s PENTAMBODYTM bispecific platform technology has successfully entered into clinical stage. We will continue to cooperate closely with our partner Innovent to focus on our R&D to further advance clinical and commercial development."

About IBI315

IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and HER2 simultaneously. Preclinical studies have shown that the bridging effects between T cells and tumor cells introduced by IBI315 may enhance anti-tumor activity.

About CIBI315A101

CIBI315A101 is a phase I clinical trial conducted in China to evaluate IBI315 in the treatment of patients with HER2-expressing advanced solid malignancies. The primary objectives of this study are safety, tolerability, initial efficacy and recommended Phase II dose ("RP2D") of IBI315, either as monotherapy or in combination with chemotherapy.