News | July 24, 2019

First Patient Dosed In Sintilimab And Anti-VEGF Monoclonal Antibody IBI305 With Chemotherapy In Patients With EGFR-Mutant Non-Squamous NSCLC Who Have Progressed From Prior EGFR-TKI Treatment

Suzhou, China /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 the first patient has been dosed in ORIENT-31, a trial that evaluates Tyvyt® (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody co-developed with Eli Lilly and Company, and IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, in combination with chemotherapy backbone in patients with EGFR-mutant non-squamous non-small cell lung cancer(NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

The ORIENT-31 study is a randomized, double-blind, multi-center, Phase III trial conducted in China to evaluate the safety and efficacy of Tyvyt® and IBI305 in combination with chemotherapy backbone in patients with EGFR-mutant NSCLC who have progressed from EGFR-TKI treatment. 480 patients will be enrolled in the study.

"Lung cancer has the highest incidence and mortality among all malignancies in China. In 2018, there were 2.09 million new cases of lung cancer worldwide, including more than 770,000 new cases in China. NSCLC accounts for about 80% to 85% of all lung cancer cases, and at diagnosis about 70% of NSCLC patients are locally advanced or metastatic. Patients with advanced NSCLC with EGFR mutations are recommended to use EGFR-TKI as first line therapy. However, after progression on first-line TKI therapy, and new treatment options are urgently needed in clinical practice. Immunological checkpoint inhibitors and anti-angiogenic drugs have brought new hope to patients. We hope to validate the therapeutic potential of Tyvyt® and IBI305 in combination with chemotherapy in the ORIENT-31 trial," said Professor Shun Lu, Director of the Department of Oncology, Shanghai Chest Hospital.

"China has a huge burden of lung cancer, and nearly 40% of lung cancers worldwide occur in China. The treatment options and efficacy of EGFR-positive NSCLC after EGFR-TKI failure are still very limited, so there is a huge unmet clinical need. Through ORIENT-31 study, we hope to provide effective cancer therapies for our patients," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About Tyvyt® (sintilimab injection)

Tyvyt® (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-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. Tyvyt® (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.

About ORIENT-31

The ORIENT-31 study is a randomized, double blind, multi-center, Phase III trial conducted in China to evaluate the safety and efficacy of Tyvyt® and IBI305 in combination with chemotherapy in patients with EGFR-mutant NSCLC who have progressed from prior EGFR-TKI treatment. Subjects will be 1:1:1 randomized to Group A (sintilimab+IBI305+Chemotherapy backbone), Group B (sintilimab + Chemotherapy backbone) or Group C (Chemotherapy backbone). A total of 480 patients will be enrolled in to the study. The primary endpoint is Progression Free Survival.

About Combination Therapy

The combination of anti-angiogenesis and immune checkpoint inhibitors could produce synergistic antitumor effects. Anti-VEGF blockade enhances antigen-presenting cell (APC) maturation and cytotoxic T cell (CTL) activation, down-regulates myeloid suppressor cells (MDSCs) and regulatory T cell (Treg) populations, and normalizes the tumor blood vessels; all of these effects could promote tumor elimination when combined with an immune checkpoint inhibitor.

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, autoimmunity 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 up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmunity, and cardiovascular diseases. Fourteen assets have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and two of them have been granted with priority review status, and one, Tyvyt® (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:

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

To learn more about Lilly, please visit us at and

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

In March 2015, Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic collaborations of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.

Source: Innovent Biologics, Inc.

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