Innovent Biologics and Lilly to Present Seven Clinical Studies of TYVYT® (Sintilimab Injection) at ESMO Asia 2020

SAN FRANCISCO, U.S. and SUZHOU, China, Nov. 5, 2020 /PRNewswire/ -- Innovent Biologics ("Innovent Bio," HKEX 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 jointly announced with Eli Lilly and Company (NYSE: LLY) seven studies on Tyvyt^®(Latest clinical research findings on sintilimab injection will be presented at the virtual 2020 ESMO Asia Congress, held from November 20 to 22.)

In the announced schedule for the 2020 ESMO Asia Congress, Tyvyt^®(Sintilimab Injection) A total of seven studies were selected, including one preferred oral presentation (Phase III clinical study) and six e-posters. The studies covered the following tumor types: liver cancer, lung cancer, gastric cancer, and esophageal cancer.

1.

Oncology Field: Liver Cancer

Report Format: Proffered Paper Oral Presentation (Preferred)

Report Title: ORIENT-32 Study of Sintilimab Plus Bevacizumab Versus Sorafenib as First-Line Treatment for Advanced Hepatocellular Carcinoma

Report No.: 523

Reporter: Professor Zhengang Ren

Report Date: November 21, 2020

2.

Oncology: Liver Cancer

Format: Electronic Poster (E-poster)

Report Title: Anlotinib Hydrochloride Capsules Combined with Sintilimab as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC)

Report No.: 170P

Principal Investigator: Professor Chen Xiaofeng

3.

Oncology Field: Non-Small Cell Lung Cancer

Report Format: Electronic Poster (E-poster)

Report Title: Efficacy and Safety of Sintilimab Combined with Docetaxel in the Treatment of Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Report No.: 402P

Principal Investigator: Professor Zhehai Wang

4.

Oncology Field: Non-Small Cell Lung Cancer

Format: Electronic Poster (E-poster)

Report Title: Phase I Clinical Study of CIK Cells Combined with Sintilimab and Chemotherapy for the Treatment of Advanced Non-Small Cell Lung Cancer

Report No.: 386P

Principal Investigator: Professor Ren Xiubao

5.

Oncology Field: Esophageal Cancer

Format: Electronic Poster (E-poster)

Report Title: Neoadjuvant Therapy with Sintilimab Combined with Triple-Drug Chemotherapy (Liposomal Paclitaxel/Cisplatin/S-1) for Resectable Esophageal Squamous Cell Carcinoma

Report No.: 175P

Principal Investigator: Professor Gu Yanhong

6.

Oncology Field: Gastric Cancer

Report Format: Electronic Poster (E-poster)

Report Title: Phase II Clinical Study of Sintilimab Combined with the FLOT Regimen as Neoadjuvant Therapy for Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Report No.: 160P

Principal Investigators: Professor Luo Suxia, Professor Li Ning

7.

Oncology: Gastric Cancer

Report Format: Electronic Poster (E-poster)

Report Title: Perioperative Treatment with Sintilimab Combined with Concurrent Chemoradiotherapy for Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Report No.: 196TiP

Principal Investigator: Professor Liu Baorui

About Tyvyt^®(Sintilimab Injection)

Tyvyt®^®(Sintilimab Injection) is an innovative biologic of international quality, jointly developed by Innovent Bio and Eli Lilly and Company in China. Its first approved indication was for relapsed/refractory classical Hodgkin lymphoma, and it was included in the 2019 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) in Combination with Alimta^®Application for the new indication of (Pemetrexed Disodium for Injection) and platinum-based chemotherapy as first-line treatment for non-squamous non-small cell lung cancer. In May 2020, Tyvyt^®(Sintilimab Injection) in Combination with Gemzar^®(Gemcitabine for Injection) and Platinum-based Chemotherapy as First-line Treatment for Squamous Non-small Cell Lung Cancer: Phase III Study Meets Primary Endpoint, Tyvyt^®(The sintilimab injection) monotherapy as second-line treatment for advanced/metastatic esophageal squamous cell carcinoma in the ORIENT-2 study also met its primary endpoint. In August 2020, the NMPA officially accepted the application for Tyvyt.^®(Sintilimab Injection) combined with Gemzar^®(Gemcitabine for Injection) and platinum-based chemotherapy as first-line treatment for squamous non-small cell lung cancer: application for a new indication. In September 2020, Tyvyt^®(Sintilimab Injection) in Combination with Byvasda^®(Bevacizumab Injection) Phase III Clinical Study (ORIENT-32) for First-Line Treatment of Advanced Hepatocellular Carcinoma Met Primary Endpoint in Interim Analysis.

Tyvyt^®(Sintilimab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/Programmed Death-Ligand 1 (PD-L1) pathway responsible for tumor immune tolerance. This action reactivates the anti-tumor activity of lymphocytes, achieving the goal of tumor treatment. Currently, more than 20 clinical studies (including over 10 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

“Driven by Trust, Delivered 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 medicines for the treatment of major diseases, including cancer, metabolic disorders, and autoimmune diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. 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 virtue of its innovative achievements and internationalized operating model. It has built a product pipeline comprising 23 new drug candidates, covering multiple disease areas including oncology, metabolic diseases, and autoimmune disorders. Among these, six candidates were selected for the National “Major New Drug Development” Special Program, and four products (Sintilimab Injection, brand name: Tyvyt^®, English trademark: TYVYT^®; Bevacizumab biosimilar, brand name: Byvasda^®, English trademark: BYVASDA^®；Adalimumab Biosimilar, Brand Name: Sulixin^®, English Trademark: SULINNO^®; Rituximab biosimilar, brand name: Dabohua^®, English trademark: HALPRYZA^®) received NMPA approval for market launch; four candidates have entered Phase III or pivotal clinical studies, and an additional 15 products have entered 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 world-class team of experts in the development and industrialization of high-end biologics, including numerous overseas-returning specialists. The company has established strategic collaborations with international partners such as Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical (South Korea). Innovent Bio is committed to working collaboratively to advance China’s biopharmaceutical industry, thereby improving drug accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more information, please visit the company website:www.innoventbio.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Founded more than a century ago, the company was established with a commitment to producing high-quality medicines that meet real medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop life-changing medicines and deliver them to patients who truly need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through charitable initiatives and volunteer activities. For more information about Eli Lilly and Company, please visit:www.lilly.com。

Strategic Collaboration between Innovent Bio and Eli Lilly

Eli Lilly and Innovent Bio 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, Eli Lilly and Innovent Bio will jointly develop and commercialize in China products 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 partnership was extended into 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. In August 2020, Innovent Bio granted Eli Lilly an exclusive license for sintilimab in regions outside China. These four collaborations with Eli Lilly and Company mark the establishment of a comprehensive strategic partnership between Innovent Bio, an innovative Chinese pharmaceutical company, and a global pharmaceutical giant, covering new drug research and development, clinical studies, manufacturing quality, and marketing and sales.