Tyvyt (Sintilimab Injection), an Innovative PD-1 Inhibitor Jointly Developed by Innovent and Lilly, is Included in the New Catalogue of National Reimbursement Drug List (NRDL)

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today jointly announced with Eli Lilly and Company that the innovative PD-1 inhibitor Tyvyt® (sintilimab injection), co-developed by both companies, is the only PD-1 inhibitor that has been included in the new Catalogue of National Reimbursement Drug List ("NRDL") according to the latest announcement from the National Healthcare Security Administration ("NHSA"). (Details of medical insurance reimbursement and other relevant information shall be subject to the information publicized by the Chinese government.) 

The inclusion of Tyvyt® (sintilimab injection) to the NRDL demonstrates that the NHSA has recognized its clinical value, patients benefit and novelty among other factors. This will also allow more patients to be able to afford the new immunotherapy drugs to improve their lives.

Dr. Michael Yu, Founder, Chairman and Chief Executive Officer of Innovent, said: "In recent years, the country's healthcare system reform has been systematically promoting the 'Healthy China' strategy, to improve the health and well-being of ordinary people. We are glad to have such an opportunity and recognition from the government, making sintilimab the only anti-PD-1 monoclonal antibody drug to be included in the NRDL. Innovent's mission is to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people. We will continue to work together with all relevant parties to improve drug efficacy, accessibility and affordability, which contributing to making a better and healthier life for ordinary people."

Mr. Julio Gay-Ger, President and General Manager of Eli Lilly China, said: "Tyvyt® (sintilimab injection) is the first achievement of the strategic cooperation between Eli Lilly and Innovent, and its launch in the 1st half of this year has brought a new choice of immunotherapy for many patients. The negotiation to enter the NRDL is to improve the accessibility and further reduce the economic burden of patients. In the future, we will continue to deepen our cooperation with Innovent, and work together with all stakeholders to benefit Chinese patients through innovative drugs, healthcare services, flexible payment schemes and other innovative approaches."

Mr. Min Liu, Chief Commercial Officer and General Manager of Shanghai Branch of Innovent, said: "We believe that the inclusion of Tyvyt® (sintilimab injection) in the NRDL will further help more cancer patients alleviate their economic burden and receive long-term and most advanced treatment. Next, we will actively respond to the requirements of government, work together closely to implement the medical insurance policies, and accelerate the accessibility of sintilimab in the hospital channel. We will also continue to explore innovative payment schemes with relevant parties, and strive to enable more patients to benefit from the scientific progress."

Tyvyt® (Recombinant anti-human PD-1 Monoclonal Antibody, international trademark: Tyvyt®, generic name: sintilimab injection) is an innovative PD-1 inhibitor jointly developed by Lilly and Innovent. It was officially approved by National Medical Products Administration ("NMPA") on 24 December 2018 and used for the treatment of relapsed or refractory classic Hodgkin's lymphoma ("r/r cHL") after at least second-line system chemotherapy.

About Tyvyt® (Sintilimab Injection)

Tyvyt® (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for r/r cHL, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology ("CSCO") for Lymphoid Malignancies. Tyvyt® (sintilimab injection) is the only PD-1 inhibitor that has been included in the NRDL in November 2019.

Tyvyt® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials. Innovent is also conducting clinical studies of sintilimab injection in the United States.

About Innovent

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. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China Limited with the stock code: 01801.HK.

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. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, five have entered Phase III clinical trials, three monoclonal antibodies have their New Drug Application ("NDA") under review and three of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), has been approved for r/r cHL and is the only PD-1 inhibitor that has been included in the NRDL in November 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

About Innovent Biologics' strategic cooperation with Eli Lilly and Company

Eli Lilly and Company launched a program focusing on biological medicine co-development with Innovent Biologics in March 2015. It is one of the biggest examples of cooperation between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Eli Lilly and Innovent Biologics will co-develop and commercialize at least three oncology medicines in the next 10 years. In October 2015, the two companies announced the extension of their existing collaboration with the addition of three new co-developments of oncology antibodies. Its collaboration with Eli Lilly indicates that Innovent Biologics has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, pipeline quality and commercial.

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