First Patient Dosed in a Clinical Trial of Tyvyt® (Sintilimab injection) in Combination with IBI305 as First Line Treatment for Patients with Advanced Hepatocellular Carcinoma

SUZHOU, China, Feb. 27, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801) today announced that the first patient has been dosed in ORIENT-32, a trial that evaluates Tyvyt^® (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody, in combination with IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, as first-line treatment for patients with advanced hepatocellular carcinoma (HCC).

The ORIENT-32 study is a randomized, open-label, multi-center, Phase II/III trial conducted in China to evaluate the safety and efficacy of Tyvyt^® in combination with IBI305, compared to sorafenib as first-line treatment in patients with advanced HCC. 566 patients will be enrolled in the study. This study follows a Phase Ib study that evaluates Tyvyt^® (sintilimab injection) in patients with advanced HCC.

"HCC is the fourth most common cancer and the second leading cause of cancer related death in China. The five-year survival rate is about 10%, and only 20-30% of patients have the opportunity for curative surgery. Current targeted therapies have only shown limited responses in HCC. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease. We hope to validate the therapeutic potential of Tyvyt^® in combination with IBI305 in the ORIENT-32 trial," said Professor Fan Jia, President of Zhongshan Hospital, and an academician of the Chinese Academy of Sciences.

"China has a huge burden of HCC. Nearly 50% of HCC cases worldwide occur in China. The development of new agents for the treatment of advanced HCC has been stagnant, so there is a huge unmet clinical need. Based on the encouraging data we have observed in our Phase Ib study, we have decided to conduct the ORIENT-32 trial, a Phase II/III study in first-line advanced HCC. We seek to discover, develop, and commercialize products that provide more effective cancer treatment to help our patients and their families," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Liver cancer is the fourth leading cause of cancer-related death worldwide. The majority of liver cancers (70%-90%) are hepatocellular carcinoma (HCC). Most patients have advanced stage at initial diagnosis and have little opportunity for curative therapies. The median overall survival is only about 12 months. Chronic hepatitis and cirrhosis caused by hepatitis B virus (HBV) infection is the main cause of HCC in China. The prognosis of these patients is even worse, with median overall survival of less than 10 months.

About Tyvyt^® (sintilimab injection)

Tyvyt^® (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the 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 approved by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL). Currently, more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on 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.

About ORIENT-32

The ORIENT-32 study is a randomized, open-label, multi-center, Phase II/III trial conducted in China to evaluate the safety and efficacy of Tyvyt^® in combination with IBI305, compared to sorafenib as first-line treatment in patients with advanced HCC until disease progression. Participants will be randomly assigned in a 2:1 ratio into experimental or control groups. A total of 566 patients will be enrolled in to the study. The primary endpoint is overall 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 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 III clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review 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: www.innoventbio.com.

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 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 to provide support to 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 partnerships 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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