China's NMPA Approves Innovent's Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) for Hodgkin's Lymphoma

SUZHOU, China, Dec. 27, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt^® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL). The approval of Tyvyt^® (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology.

According to Cancer Today from the WHO's International Agency for Research for Cancer, China will have about 4.28 million newly diagnosed cancer patients and 2.86 million deaths from cancer in 2018^[1]. Thus China faces massive challenges from its growing burden of cancer. Lymphoma is one of the common cancers in China, and cHL, a type of B-cell lymphoma affects young and middle-aged people. Although the combination therapy of chemotherapy and radiation has a good likelihood of inducing a complete response, patients have a 15- 20% chance of recurrence after the first line treatment. Therefore, patients urgently need new innovative medications and treatment solutions. Delivering effective treatment for r/r cHL is a serious challenge for the oncology and hematology community.

Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt^® (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China's efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent's R&D capabilities. I have confidence that Tyvyt^® (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China."

Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt^® (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin's lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community."

Currently, Tyvyt^® (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.

About Tyvyt^® (sintilimab injection)

Tyvyt^® (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, 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 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) is now 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.

For more information, please visit: www.innoventbio.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery 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.

To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

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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SOURCE Innovent Biologics, Inc.