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Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-PD-1/HER2 Bispecific Antibody in China

SUZHOU, China, Nov. 26, 2019 /PRNewswire/ -- 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 jointly announced 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.

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.

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, autoimmune, 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, autoimmune, 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).

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.

About Hanmi Pharmaceutical

Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of innovative medicines, fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 20 percent of its sales in R&D and currently has over 30 programs in its clinical pipeline covering 3 major fields: 1) novel long-acting biologics based on the Company's LAPSCOVERY™ platform applied in the key target areas of diabetes, obesity and rare diseases; 2) novel targeted agents against oncology and auto-immune diseases; and 3) Fixed-dose combination programs. The company has worked closely with global partners (including Sanofi, Genentech, Spectrum, Teva, Athenex) in various co-development collaborations. More information on Hanmi is available at www.hanmipharm.com.

About Innovent Biologics' strategic collaboration with Hanmi

Hanmi pharmaceutical and Innovent Biologics on March 30, 2017 announced a strategic collaboration on a global basis. IBI315 was constructed using the PENTAMBODYTM platform technology that was developed by Hanmi's subsidiary, Beijing Hanmi Pharmaceutical Co., Ltd. PENTAMBODYTM is a next generation bispecific platform technology that allows binding pairs of various targets for both immunotherapy and targeted therapy. It follows a naturally occurring IgG-like antibody format while demonstrating good stability and other important biophysical properties. Multiple bispecific antibodies directed towards various targets using PENTAMBODYTM are being developed by Hanmi.

Cision

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SOURCE Innovent Biologics, Inc.