Innovent Biologics and Lilly's Expanded Strategic Collaboration for TYVYT® (Sintilimab Injection) Cleared U.S. HSR Waiting Period and Officially Takes Effect

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2020 /PRNewswire/ -- Innovent Biologics (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, today announced the previously disclosed expansion on August 18, 2020, of its agreement with Eli Lilly and Company regarding Tyvyt^®(Sintilimab Injection) The global strategic partnership has passed the waiting period under the U.S. Hart-Scott-Rodino (“HSR”) Act. With all conditions to the cooperation agreement now fulfilled, the transaction has officially taken effect. Innovent Bio and Eli Lilly will proceed with the necessary handover of authorization documents in accordance with the terms of the collaboration, and Eli Lilly will pay Innovent Bio a $200 million upfront payment for this partnership.

About Tyvyt^®(Sintilimab Injection)

Tyvyt^®(Sintilimab Injection) is an innovative biologic of international quality, jointly developed by Innovent Biologics and Eli Lilly and Company in China. Its first approved indication is for relapsed/refractory classical Hodgkin lymphoma, and it was included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma. During the 2019 National Reimbursement Drug List negotiations, Tyvyt^®(Sintilimab Injection) is the only PD-1 inhibitor included in the National Reimbursement Drug List. In April 2020, the NMPA officially accepted the application for Tyvyt.^®(Sintilimab Injection) Combined with Alimta^®(Pemetrexed Disodium for Injection) and platinum-based chemotherapy as first-line treatment for non-squamous non-small cell lung cancer: application for new indication; May 2020, Tyvyt^®(Study ORIENT-2, evaluating sintilimab injection as monotherapy in the second-line treatment of advanced/metastatic esophageal squamous cell carcinoma, met its primary endpoint; in August 2020, the NMPA formally accepted the application for Tyvyt)^®(Sintilimab Injection) in Combination with Gemzar^®Application for a New Indication of Gemcitabine for Injection and Platinum-Based Chemotherapy as First-Line Treatment for Squamous Non-Small Cell Lung Cancer.September 2020, Tyvyt^®(Sintilimab Injection) Combined with Dazuo^®(Bevacizumab Injection) Multicenter Phase III Clinical Study (ORIENT-32) for First-Line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint in Interim Analysis.

Tyvyt®^®(Sintilimab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/Programmed Death-Ligand 1 (PD-L1) pathway that leads to tumor immune tolerance. This reactivates the anti-tumor activity of lymphocytes, achieving the goal of cancer treatment. Currently, more than twenty clinical studies (including over ten registrational clinical trials) are underway to evaluate the anti-tumor efficacy of sintilimab in various solid tumors and hematologic malignancies. Innovent Bio is also conducting global clinical research on Sintilimab Injection.

About Innovent Bio

“Rooted in Trust, Realized through Action.” It is the vision and goal of Innovent Bio to develop high-quality biologics that are affordable to the general public. Founded in 2011, Innovent Bio is dedicated to the development, manufacturing, and sales of innovative drugs for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases. On October 31, 2018, Innovent Biologics was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with the stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies by leveraging innovative achievements and an internationalized operational model. It has built a product pipeline comprising 23 new drug candidates, covering multiple therapeutic areas including oncology, metabolic diseases, and autoimmune disorders. Among these, six candidates have been selected for the National “Major New Drug Development” Special Project, and three products (Sintilimab Injection, brand name: Tyvyt^®, English Trademark: TYVYT^®; Bevacizumab Injection, Brand Name: Byvasda^®, English trademark: BYVASDA^®; Adalimumab Injection, Brand Name: Sulixin^®, English trademark: SULINNO^®) received NMPA approval for marketing and sales; one monoclonal antibody product’s marketing application was accepted by the National Medical Products Administration (NMPA) and included in the priority review program; four candidates entered Phase III or pivotal clinical studies; and an additional 15 products have entered or are about to enter clinical development. Sintilimab was successfully included in the National Reimbursement Drug List (NRDL) in November 2019, becoming the only PD-1 inhibitor included in the updated NRDL.

Innovent Bio has assembled a high-caliber team of professionals in the development and industrialization of biologics, operating at an internationally advanced level. The company has established strategic collaborations with leading global organizations, including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Alector, and Hanmi Pharmaceutical (South Korea). For more details, please visit the company’s website:www.innoventbio.com。

Strategic Cooperation Between Innovent Bio and Eli Lilly

Innovent Bio and Eli Lilly and Company entered into a biopharmaceutical development collaboration in March 2015, which remains one of the largest partnerships to date between a Chinese biopharmaceutical company and a multinational pharmaceutical corporation. Under the terms of the agreement, Innovent Bio and Eli Lilly and Company will jointly develop and commercialize in China, including Tyvyt^®Oncology drugs, including sintilimab injection. In October 2015, the two parties announced a further expansion of their established drug development collaboration by adding three novel oncology therapeutic antibodies. In August 2019, the collaboration was extended to the field of diabetes, with Innovent Bio obtaining authorization to develop and commercialize in China a potential global best-in-class novel clinical-stage diabetes drug from Eli Lilly. These three collaborations with Eli Lilly and Company mark that Innovent Bio has established a comprehensive strategic partnership between an innovative Chinese pharmaceutical enterprise and a global pharmaceutical giant, covering new drug research and development, clinical studies, manufacturing quality, and marketing and sales. In August 2020, Innovent Bio and Eli Lilly and Company announced the expansion of Tyvyt^®(Strategic Cooperation on Sintilimab Injection) Innovent Bio will grant Eli Lilly an exclusive license for sintilimab in regions outside China, and Eli Lilly will be committed to promoting sintilimab in North America, Europe, and other regions.