Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Gastric Cancer

SUZHOU, China, Jan. 16, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt^® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ).

The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial conducted in China to evaluate the efficacy and safety of  Tyvyt^® (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. The phase III study will enroll 650 patients. The study follows a phase Ib study that evaluated Tyvyt^® (sintilimab injection) in combination with chemotherapy in patients with gastric cancer.

"Over the past decade, the treatment of various malignant tumors has progressed rapidly. From traditional chemotherapy to targeted molecular therapy and immunotherapy, the prognosis of cancer patients has been improved remarkably. However, breakthroughs in the treatment of gastric cancer have been few. With the exception of trastuzumab in first-line use for HER-2 positive patients, several phase III clinical trials have failed successively. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of sintilimab in combination with chemotherapy in ORIENT-16, a phase III trial," said Dr. Jianming Xu, a professor from the Chinese PLA General Hospital.

"Gastric cancer is the second most common malignant tumor in China. The development of new agents for the treatment of advanced gastric cancer has been stagnant, and unmet clinical need is huge. Based on the encouraging efficacy signal we have observed in our phase Ib study, we have decided to conduct ORIENT-16, a phase III study in first-line gastric cancer. Our goal is to provide more effective cancer treatment options for the benefit of these patients and for their families," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Tyvyt^® (sintilimab injection)

Tyvyt^® (sintilimab injection) is an innovative drug jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt^® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1?Programmed Cell Death-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.

About ORIENT-16 Study

The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial which evaluates the efficacy and safety of Tyvyt^® (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. Patients will receive Tyvyt^® (sintilimab injection) or placebo in combination with capecitabine and oxaliplatin, followed by Tyvyt^® (sintilimab injection) or placebo and capecitabine until disease progression. Participants will be randomly assigned in a 1:1 ratio into the experimental or control groups. The study will enroll 650 patients. The primary endpoints are overall survival in both the entire population and in PD-L1 positive population of patients.

About Advanced, Recurrent or Metastatic Gastric Cancer (GC)

Gastric cancer is one of the most common malignant tumors worldwide, ranking fifth in incidence and third in cancer-related deaths. More than half of the cases and deaths from gastric cancer occur in China. Many patients have advanced disease at the initial diagnosis and have little opportunity for therapy with curative intent. The prognosis of patients with advanced and metastatic gastric cancer is poor with an overall survival less than 12 months.

About Innovent

Innovent was established in 2011. 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. These capabilities have enabled the company to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging the platform, the company has built up a pipeline of 20 innovative medicines in the last seven years, led by four core products that are in late-stage clinical development in China. Out of the pipeline of 20 innovative medicines, thirteen have entered into clinical development, four have entered Phase III clinical trials, one (biosimilar to Humira) has its New Drug Application (NDA) under review and Tyvyt^® (sintilimab injection) is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of the clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, Incyte, Hanmi and other biopharmaceutical companies.

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. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients' life.

Innovent is listed on the main board of the Hong Kong Stock Exchange with the stock code of HK 01801.

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 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.

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SOURCE Innovent Biologics, Inc.