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 Esophageal Cancer

SUZHOU, China, Jan. 1, 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-15) that is to evaluate Tyvyt(®) (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with paclitaxel and cisplatin, as first-line treatment in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

The ORIENT-15 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 ESCC. The phase III study will enroll 640 patients. The study follows a phase Ib study that evaluated Tyvyt(®) (sintilimab injection) in patients with esophageal cancer and a phase II study that evaluated Tyvyt(®) (sintilimab injection) versus paclitaxel/irinotecan as second-line therapy for patients with advanced/metastatic ESCC.

"The incidence of esophageal squamous cell carcinoma in Asian countries is much higher than in western countries. Today, patients have no treatment options other than chemotherapy and radiation therapy. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of Tyvyt(®) (sintilimab injection) in combination with chemotherapy in ORIENT-15, a phase III trial," said Professor Lin Shen from the Beijing Cancer Hospital.

"Esophageal cancer is the third most common malignant tumor in China. The development of new agents for the treatment of advanced esophageal squamous cell carcinoma has been stagnant, so there is a huge unmet medical need. Based on the preliminary result or the ongoing phase II study, we have decided to conduct ORIENT-15, a phase III study as a first-line treatment for patients with esophageal squamous cell carcinoma. Our goal is to provide more effective cancer treatment options for 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-15 Study

The ORIENT-15 study is a randomized, double-blind, multi-center, phase III trial that evaluates the efficacy and safety of Tyvyt(®) (sintilimab injection) in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic ESCC in China. Patients will receive Tyvyt(®) (sintilimab injection) or placebo in combination with paclitaxel and cisplatin until disease progression. Participants will be randomly assigned in a 1:1 ratio into experimental or control groups. The study will enroll 640 patients. The primary endpoint is overall survival in both the entire population and in PD-L1 positive population of patients.

About Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is the eighth most common cancer in the world, and the sixth leading cause of cancer death. Nearly four out of five cases occur in developing countries. China has the largest population of patients with esophageal cancer in the world. The incidence and mortality in China are higher than the worldwide average, ranking 3rd and 4th respectively. The histopathological type of esophageal cancer in China is different than that in Europe and the United States. In China the major type of esophageal cancer is squamous cell carcinoma which accounts for more than 90% of cases. In the United States and Europe adenocarcinoma of the esophagus is the predominant histopathology. The prognosis of patients with advanced and metastatic esophageal cancer is poor with an overall survival of about 10 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) has been 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.

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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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