Innovent and Lilly Announce Inclusion of Three New First-Line Indications for Tyvyt® (Sintilimab Injection) in China's National Reimbursement Drug List

SAN FRANCISCO, Indianapolis, and SUZHOU, China, December 3, 2021 /PRNewswire/ -- Innovent Bio (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, announced today alongside Eli Lilly and Company (NYSE: LLY) that their jointly developed innovative PD-1 inhibitor, Tyvyt^®(Tyvyt, sintilimab injection) All approved indications have been successfully included in the Class B range of the new version of the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2021 Edition)" ("National Medical Insurance Catalog") through medical insurance negotiations. The new medical insurance catalog will be officially implemented starting from January 1, 2022.

This time, Tyvyt^®All four approved indications have been successfully included in the National Medical Insurance Catalog, among which: Tyvyt^®In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of advanced or recurrent non-squamous non-small cell lung cancer that is negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), in patients who have not received systemic treatment – Tyvyt^®In combination with gemcitabine and platinum-based chemotherapy for the first-line treatment of advanced or recurrent squamous non-small cell lung cancer that is not amenable to surgical resection, Tyvyt^®INNOVENT BIO + Eli Lilly and Company^®(Bevacizumab Injection) is included in the national medical insurance directory for the first time as a first-line treatment for unresectable or metastatic hepatocellular carcinoma in patients who have not received systemic therapy previously. In addition, Tyvyt^®The indication for relapsed or refractory classical Hodgkin lymphoma that has undergone at least two lines of systemic chemotherapy was first included in the National Reimbursement Drug List (NRDL) in 2019 and has now been successfully renewed.

Dr. Dechao Yu, Founder, Chairman and CEO of Innovent Bio, said: "Two years ago, Tyvyt..."^®Becoming the first PD-1 inhibitor in China to be included in the national medical insurance directory, Innovent Bio’s ideal of ‘developing high-quality biologics that ordinary people can afford’ has become a reality. Today, Tyvyt...^®Three New Indications Added to the Updated National Medical Insurance Catalog, Further Enhancing the Accessibility of this High-Quality Immuno-Oncology Therapy and Reducing the Economic Burden on Cancer Patients and Their Families. In the decade since Innovent Bio was founded, we have witnessed the transformation and development of China's biopharmaceutical industry and felt the nation's support for technological innovation and its emphasis on people's wellbeing. We are deeply grateful for the recognition from government departments this time. Innovent Bio will continue to support China’s efforts to deepen healthcare reform, working hand in hand to improve the affordability and accessibility of medicines, and striving tirelessly towards the goal of ‘Healthy China 2030’.”

Eli Lilly China President and General Manager Jiri Wen stated: "In recent years, China has continuously intensified its healthcare reform efforts, placing the protection of people's health as a top strategic priority. As a multinational pharmaceutical company with over a hundred years of ties to China, Eli Lilly has always adhered to the concept of 'Rooted in China, benefiting China,' actively participating in China’s medical and health system reform, especially sparing no effort in the area of drug supply security systems. Tyvyt^®(The inclusion of this new indication for Sintilimab Injection in the National Medical Insurance Catalogue will further reduce the medication burden on patients, allowing them to afford high-quality and innovative drugs. By adhering to treatment, patients can achieve a higher quality of life. Going forward, Eli Lilly will continue to focus on the major challenges in China's health sector, playing an important role in China’s ‘comprehensive and full-cycle health services’ ecosystem, and supporting the accelerated implementation of the ‘Healthy China 2030’ initiative.)

Mr. Liu Min, Chief Commercial Officer of Innovent Bio, stated: "Currently, Tyvyt^®Becoming the only PD-1 inhibitor with four approved indications—including first-line non-squamous non-small cell lung cancer, first-line squamous non-small cell lung cancer, first-line liver cancer, and Hodgkin's lymphoma—all of which have been included in the National Medical Insurance reimbursement list. Particularly, lung cancer and liver cancer are highly prevalent tumor types in China, ranking first and third respectively in the annual number of new cancer cases in the country, reflecting a significant unmet need for patient treatment. We will actively respond to relevant initiatives by government departments at all levels, support the implementation of medical insurance policies across various regions, further reduce the financial burden on patients, and ensure that this high-quality immunotherapy product benefits more patients and their families in China as soon as possible.”

About Sintilimab

Sintilimab, Chinese trade name: Tyvyt^®(Sintilimab Injection) is an innovative PD-1 inhibitor with international quality jointly developed by Innovent Bio and Eli Lilly and Company. Sintilimab 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 responsible for tumor immune tolerance, reactivating the anti-tumor activity of lymphocytes, and achieving the purpose of treating tumors. Currently, more than twenty clinical studies (including over ten registrational clinical trials) are underway to evaluate the anti-tumor effects of sintilimab in various solid and hematological malignancies.

Sintilimab has been approved for four indications in China and successfully included in the National Reimbursement Drug List (NRDL) of China, including:

In addition, the marketing applications of Sintilimab for first-line treatment of esophageal squamous cell carcinoma and for first-line treatment of gastric cancer have been accepted for review by the National Medical Products Administration (NMPA) in China.

Sintilimab has reached the study endpoints in three other clinical trials, including:

In May 2021, the FDA officially accepted for review the marketing application of sintilimab in combination with pemetrexed and platinum chemotherapy as first-line treatment for non-squamous NSCLC.

About Innovent Bio

"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is the ideal and goal of Innovent Bio. Founded in 2011, Innovent Bio is committed to the research, production, and commercialization of innovative drugs for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic conditions. On October 31, 2018, INNOVENT BIOLOGICS(SUZHOU)CO LTD was listed on the Main Board of the Hong Kong Stock Exchange (Stock Code: 01801).

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and internationalized operating model. It has built a product chain including 26 new drug varieties, covering multiple disease areas such as oncology, metabolic diseases, and autoimmune diseases, of which seven varieties have been selected for the national "Major New Drug Creation" project. The company already has six products (Sintilimab Injection, trade name: Tyvyt).^®, English trademark: TYVYT^®; Bevacizumab biosimilar, trade name: Da You Tong^®, English trademark: BYVASDA^®; Adalimumab biosimilar, brand name: SULIXIN^®, English trademark: SULINNO^®; Rituximab biosimilar, trade name: Dabohua^®，English trademark: HALPRYZA^®; pemigatinib oral inhibitor, trade name: Pemazyre^®, English trademark: PEMAZYRE^®; Orelabrutinib, Trade Name: Nulric^®) has been approved for marketing, the U.S. FDA has accepted the marketing application of sintilimab, five varieties have entered Phase III or pivotal clinical trials, and another 15 products have entered clinical trials.

Innovent Bio has assembled a team of top-tier biopharmaceutical development and industrialization professionals with international advanced standards, including numerous returned overseas experts. It has also established strategic collaborations with international partners such as Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceuticals of South Korea. Innovent Bio hopes to work together with everyone to enhance the development level of China's biopharmaceutical industry, fulfilling the public's access to medicines and their aspirations for better life and health. For more details, please visit the company’s website:www.innoventbio.comOr company LinkedIn accountwww.linkedin.com/company/innovent-biologics/。

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Eli Lilly and Company was born more than a century ago, with its founder committed to producing high-quality medicines to meet real medical needs. Today, we remain steadfast in this mission and continue our work based on it. Globally, our employees constantly strive to develop drugs that can make a difference in people’s lives and make them available to patients in genuine need. Moreover, we are also committed to enhancing public understanding of diseases and improving disease management. At the same time, we give back to society by engaging in charitable activities and volunteer work. For more information about Eli Lilly and Company, please visit:www.lilly.com。

About the Strategic Cooperation between Innovent Bio and Eli Lilly and Company

Innovent Bio and Eli Lilly and Company reached a biotechnology drug development collaboration in March 2015, which is also one of the largest collaborations between a Chinese biopharmaceutical company and a multinational pharmaceutical company to date. According to the collaboration terms, Innovent Bio and Eli Lilly will jointly develop and commercialize oncology drugs including Tyvyt® (Sintilimab Injection) in China. In October 2015, the two parties announced a further expansion of their established drug development collaboration, adding three novel antibody therapies for cancer treatment. In August 2019, the collaboration expanded into the diabetes field, with Innovent Bio being granted the rights to develop and commercialize a potentially world-class novel clinical-stage diabetes drug from Eli Lilly in China. These three collaborations with Eli Lilly and Company signify that Innovent Bio has established a comprehensive strategic partnership between a Chinese innovative pharmaceutical company and a global pharmaceutical giant, covering new drug research and development, clinical studies, production quality, and market sales. In August 2020, Innovent Bio and Eli Lilly announced an expansion of their strategic collaboration on Sintilimab, with Innovent Bio granting Eli Lilly exclusive rights to Sintilimab outside of China, and Eli Lilly committing to promote Sintilimab in North America, Europe, and other regions.

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