NMPA Accepts sNDA for Tyvyt® (Sintilimab Injection) as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer

SUZHOU, China, April 24, 2020 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic diseases, today jointly announced with Eli Lilly and Company (NYSE ticker symbol: LLY) that the National Medical Products Administration (NMPA) has formally accepted the application for their co-developed innovative PD-1 inhibitor, Tyvyt^®(Sintilimab Injection) Supplemental New Drug Application (sNDA) for the first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). In December 2018, Tyvyt^®(Sintilimab Injection) has been approved by the National Medical Products Administration for the treatment of relapsed or refractory classical Hodgkin lymphoma in patients who have received at least two prior lines of systemic chemotherapy.Tyvyt^® (Sintilimab Injection)It is currently the only PD-1 monoclonal antibody product included in the National Reimbursement Drug List.

This indication application is based on a randomized, double-blind, Phase III controlled clinical study (ORIENT-11)—Tyvyt^®(Sintilimab Injection) or Placebo in Combination with Alimta^®(Pemetrexed Disodium for Injection) and platinum-based agents are used as first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer without EGFR sensitizing mutations or ALK gene rearrangements. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt^®(Sintilimab Injection) Combined with Alimta^®(Pemetrexed Disodium for Injection) and Platinum Compounds versus Placebo Combined with Alimta^®(Pemetrexed Disodium for Injection) and platinum-based agents significantly prolonged progression-free survival (PFS), meeting the pre-specified superiority criteria. As of the data cutoff date for the interim analysis, the median follow-up time was 8.9 months. The median PFS assessed by the Independent Review Committee (IRC) was 8.9 months in the experimental group and 5.0 months in the control group, with a hazard ratio (HR) of 0.482 (95% CI: 0.362, 0.643; P < 0.00001). The safety profile was consistent with previously reported findings for Tyvyt^®(Sintilimab Injection) The study results were consistent, with no new safety signals identified. Detailed study data will be presented at future international academic conferences and published in academic journals.

Professor Zhang Li from the Sun Yat-sen University Cancer Center, the principal investigator of the ORIENT-11 study, stated: "Nearly half of Chinese patients with non-squamous non-small cell lung cancer are negative for driver genes, rendering them unresponsive to targeted therapies and leaving limited treatment options. The ORIENT-11 study confirmed that Tyvyt^®(Sintilimab Injection) in combination with chemotherapy can significantly delay disease progression in this patient population.”

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology at Innovent Bio, stated, “In China, lung cancer ranks first among all cancers in both incidence and mortality. Despite advances in treatment technologies, there remains a substantial unmet clinical need for effective lung cancer therapies. The acceptance of this application by the NMPA signifies that Tyvyt”^®(Sintilimab Injection) has made significant progress in the exploration of lung cancer indications. We will actively cooperate with regulatory authorities, hoping to promote the early approval of this indication and provide more treatment options for patients with first-line non-squamous non-small cell lung cancer as soon as possible.”

“The original intention of the strategic cooperation between Eli Lilly and Innovent Bio is to bring anti-tumor drugs of international quality to cancer patients in China. Tyvyt”^®“(Sintilimab Injection) is the first fruit of our collaboration and currently the only PD-1 monoclonal antibody included in the National Reimbursement Drug List for the treatment of relapsed or refractory classical Hodgkin lymphoma,” said Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center. “The exciting results from the ORIENT-11 study have propelled Tyvyt”^®(Sintilimab Injection) Progress in Expanding Lung Cancer Indications. This submission of indications is for Tyvyt^®Another new milestone. In the future, we will deepen our collaboration with Innovent Bio to further explore its potential in the field of tumor immunotherapy, looking forward to bringing more benefits to patients.”

AboutORIENT-11 Study

The ORIENT-11 study is an evaluation of Tyvyt^®(Sintilimab Injection) or placebo in combination with Alimta^®A Randomized, Double-Blind, Phase III Controlled Clinical Study on the Efficacy and Safety of Pemetrexed Disodium for Injection Combined with Platinum-Based Chemotherapy as First-Line Treatment for Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer (ClinicalTrials.gov, NCT03607539). The primary endpoint was assessed by an Independent Review Committee according to RECIST v1.1 criteria.Progression-Free Survival(PFS). Secondary endpoints included overall survival (OS), safety, etc.

A total of 397 subjects were enrolled in this study and randomized in a 2:1 ratio to receive Tyvyt, respectively.^®(Sintilimab Injection) 200 mg or placebo combined with Alimta^®(Pemetrexed Disodium for Injection) and platinum-based therapy, administered once every 3 weeks; after completing 4 cycles of treatment, proceed to Tyvyt^®(Sintilimab Injection) or Placebo Combined with Alimta^®(Pemetrexed Disodium for Injection) Maintenance phase: treatment continues until disease progression, intolerable toxicity, or other conditions requiring discontinuation of therapy. In the control group, patients may conditionally cross over to Tyvyt upon disease progression.^®(Sintilimab Injection) monotherapy.

On Non-Squamous Non-Small Cell Lung Cancer

Lung cancer is currently the most prevalent malignant tumor in China, ranking first in both incidence and mortality. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases. About 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not amenable to curative surgery. Furthermore, a significant proportion of early-stage NSCLC patients who undergo surgical treatment experience recurrence or distant metastasis, ultimately leading to death due to disease progression. Approximately 70% of NSCLC patients in China have non-squamous NSCLC. Among these, nearly 50% lack EGFR sensitizing mutations or ALK gene rearrangements. These patients with advanced lung cancer are not eligible for targeted therapy, have limited treatment options, and represent a substantial unmet medical need.

About Tyvyt^®(Sintilimab Injection)

Tyvyt®^®(Sintilimab Injection) is an innovative, international-quality biologic jointly developed by Innovent Biologics and Eli Lilly and Company in China. Its first approved indication was for relapsed/refractory classical Hodgkin lymphoma, and it was included in the 2019 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma. During the 2019 National Reimbursement Drug List negotiations, Tyvyt^®(Sintilimab Injection) is the only PD-1 inhibitor included in the National Reimbursement Drug List.

Tyvyt®^®(Sintilimab Injection) 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 that leads to tumor immune tolerance, reactivating the anti-tumor activity of lymphocytes, and thus achieving the purpose of treating tumors. Currently, more than twenty clinical studies (including over 10 registration clinical trials) are ongoing to evaluate the anti-tumor effects of sintilimab in various solid tumors and hematologic malignancies. Innovent Bio is also currentlyGlobalConduct clinical research on Sintilimab Injection.

About Innovent Bio

“Rooted in Trust, Realized through Action.” It is Innovent Bio’s vision and goal to develop high-quality biologics that are affordable for the general public. Established in 2011, Innovent Bio is dedicated to the development, manufacturing, and sales of innovative drugs for the treatment of major diseases, including cancer, autoimmune disorders, and metabolic diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with the stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies by leveraging innovative achievements and an internationalized operational model. It has built a product pipeline comprising 23 new drug candidates, covering multiple therapeutic areas including oncology, autoimmune diseases, and metabolic disorders. Among these, six candidates were selected for the National “Major New Drug Development” Special Project, 16 have entered clinical studies, five have reached Phase III or pivotal clinical trials, and marketing applications for three monoclonal antibody products have been accepted by the National Medical Products Administration (NMPA), all of which have been included in the priority review program. One product (Sintilimab Injection, brand name: Tyvyt^®, English trademark: Tyvyt^®) received marketing approval from the National Medical Products Administration, with its first approved indication being relapsed/refractory classical Hodgkin lymphoma, and in November 2019, it became the only PD-1 inhibitor included in the updated National Reimbursement Drug List.

Innovent Bio has assembled a world-class team of experts in the development and industrialization of high-end biologics, including numerous overseas-returning specialists, and has established strategic collaborations with international pharmaceutical companies such as Eli Lilly and Company, Adimab, Incyte, and Hanmi Pharmaceutical. Innovent Bio is committed to working together with all stakeholders to elevate the development of China’s biopharmaceutical industry, thereby improving drug accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company website:www.innoventbio.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Founded more than a century ago, the company was established with a commitment to producing high-quality medicines that meet real medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop medicines that transform lives and deliver them to patients who truly need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through philanthropy and volunteerism. For more information about Eli Lilly and Company, please visit:www.lilly.com。

On the Strategic Cooperation Between Innovent Bio and Eli Lilly and Company

Innovent Bio and Eli Lilly reached a biopharmaceutical drug development collaboration in March 2015, which is one of the largest collaborations to date between a Chinese biopharmaceutical company and a multinational pharmaceutical company. According to the terms of the collaboration, Innovent Bio and Eli Lilly will jointly develop and commercialize Tyvyt in China.^®Oncology drugs, including sintilimab injection. In October 2015, the two parties announced a further expansion of their established drug development collaboration by adding three novel oncology therapeutic antibodies. In August 2019, the collaboration was extended to the field of diabetes, with Innovent Bio licensed to develop and commercialize in China a potential global best-in-class novel clinical-stage diabetes drug from Eli Lilly. These three collaborations with Eli Lilly and Company mark that Innovent Bio has established a comprehensive strategic partnership between a Chinese innovative pharmaceutical enterprise and a global pharmaceutical giant, covering new drug research and development, clinical studies, manufacturing quality, and marketing and sales.

Declaration:

1. This indication is an investigational use of the drug and has not yet been approved in China;
2. Innovent Bio does not recommend the use of any unapproved drugs/indications