Innovent and Lilly Announce Expansion of TYVYT® (Sintilimab Injection) Licensing Agreement

SUZHOU, China and INDIANAPOLIS, Aug. 18, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly", NYSE:LLY) today announced an expansion of their strategic alliance for TYVYT® (sintilimab injection), an anti-PD-1 monoclonal antibody immuno-oncology medicine that was co-developed by Innovent and Lilly in China.

In 2019, Innovent and Lilly began commercializing TYVYT in China after being granted marketing approval for relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy. TYVYT is the only PD-1 inhibitor to be included in China's National Reimbursement Drug List (NRDL) and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies.

Innovent and Lilly currently co-commercialize TYVYT in China. Under the terms of the expanded license agreement, Lilly will obtain an exclusive license for TYVYT for geographies outside of China and plans to pursue registration of TYVYT in the U.S. and other markets. In return, Innovent will receive an upfront payment of $200 million and will be eligible for up to $825 million in potential development and commercial milestones, as well as tiered double-digit royalties on net sales. Both companies will also retain the right to study TYVYT in combination with other medicines as part of their own clinical programs.

Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including in combination with Lilly's ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer, and is actively pursuing the development of TYVYT outside of China. Earlier this month, the two companies released encouraging interim analysis data from ORIENT-11 at the IASLC World Conference on Lung Cancer 2020 Virtual Presidential Symposium. ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating TYVYT or placebo in combination with Alimta® and platinum chemotherapy as a first-line treatment for advanced or recurrent non-squamous NSCLC without sensitizing EGFR mutations or ALK rearrangements. Based on the interim analysis conducted by the Independent Data Monitoring Committee, TYVYT in combination with Alimta and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival compared with placebo in combination with Alimta and platinum chemotherapy, which met the pre-defined efficacy criteria. A supplemental New Drug Application (sNDA) for this indication is under regulatory review in China. The companies look forward to future submissions with the U.S. Food and Drug Administration and other regulatory agencies for this and other indications.

"We are thrilled to expand on our successful China TYVYT collaboration with Lilly to now include markets outside of China. This agreement also marked the first solid step toward getting Innovent's innovative portfolio into the global market," said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. "We are confident that pairing Lilly's global commercial expertise with TYVYT's clinical profile will further accelerate our mission, benefitting patients globally."

"Lilly Oncology is dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them," said Anne White, president of Lilly Oncology. "Our alliance with Innovent successfully brought TYVYT to market in China. Through this expansion of our collaboration, we hope to make TYVYT accessible to patients globally. We believe TYVYT could deliver significant value to people living with cancer around the world and we intend to continue to study its potential across tumor types."

This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection) is an innovative drug with global quality standards jointly developed by Innovent and Lilly in China. TYVYT has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy and was included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the NRDL in November 2019.

In April 2020, the NMPA accepted the supplemental new drug application for TYVYT® in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar® (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with Gemzar® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.

TYVYT 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-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications globally, including more than 10 registrational or pivotal clinical trials.

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 cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 19 in clinical development, 5 in Phase 3 or pivotal clinical trials, 2 under NDA reviews with priority review status by the NMPA, while 2 products, TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection), officially approved for marketing in China. TYVYT® has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team experienced in cutting-edge biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi and other international partners. 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 create medicines that 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.

About Innovent Biologics' strategic cooperation with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focusing on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly are co-developing and commercializing oncology medicines, including TYVYT® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional antibodies targeting oncology indications. In August 2019, Innovent entered into an additional licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. In August 2020, Innovent and Lilly announced an expansion of their strategic alliance for TYVYT. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in areas such as R&D, CMC, clinical development and commercialization.

SOURCE Innovent Biologics, Inc.

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