Innovent and Eli Lilly Announce Acceptance of a Supplemental NDA of TYVYT in Platinum as First-Line Therapy in Non-Small Cell Lung Cancer in China

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, jointly announced with Eli Lilly and Company that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum as first-line therapy in squamous non-small cell lung cancer (squamous NSCLC). Recently, the NMPA accepted sNDA for TYVYT® (sintilimab injection) as first-line therapy in non-squamous NSCLC on Apr 23, 2020.

The sNDA was based on the analysis of a randomized, double-blind, Phase 3 clinical study (ORIENT-12)—TYVYT® (sintilimab injection) or placebo in combination with Gemzar® (gemcitabine) and platinum as first-line therapy for advanced or metastatic squamous NSCLC. Based on the analysis conducted by the Independent Data Monitoring Committee (IDMC), TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with Gemzar® (gemcitabine) and platinum, which met the pre-defined efficacy criteria. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference and journal.

Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital, stated: “We are pleased to see that sintilimab in combination with chemotherapy has met predefined primary endpoint in ORIENT-12 study. There still exists large unmet medical needs in squamous NSCLC patients. Globally, ORIENT-12 has demonstrated for the first time survival benefit by treatment with PD-1 inhibitor in combination with gemcitabine and platinum in first-line squamous NSCLC. The result of this study has great clinical value.”

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: “For Innovent, this is the second double-blind, randomized Phase 3 study of NSCLC that met primary endpoint following ORIENT-11, a randomized Phase 3 study of 1L non-squamous NSCLC (NCT03607539). This is also the second sNDA of TYVYT® (sintilimab injection) for first-line NSCLC indication. The acceptance of the sNDA by NMPA represents further progress in covering first-line NSCLC disease area. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced squamous NSCLC as soon as possible.”

“Lilly and Innovent are committed to bring new anti-tumor treatments, developed with global standards, to patients in China. TYVYT® (sintilimab injection) is the first success of this partnership. After being included in the NRDL for relapsed or refractory classical Hodgkin’s lymphoma, the acceptance of the sNDA for new indication of NSCLC is another important milestone of TYVYT® (sintilimab injection) in the field of oncology therapy,” said Dr. Li WANG, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. “ORIENT-12 provides new combination option of chemotherapy for squamous NSCLC patients and we look forward to bringing this new treatment solution to lung cancer patients in China as soon as possible. In the future, we will continue to strengthen cooperation with Innovent to further explore TYVYT® (sintilimab injection)’s potential in the field of immuno-oncology therapy and the potential benefits TYVYT® (sintilimab injection) may bring to more patients.”

About Innovent

Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture 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 Limited with the stock code: 01801.HK.

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.