NMPA Accepts sNDA for Tyvyt® (Sintilimab Injection) in Combination with Gemcitabine for First-Line Treatment of Squamous Non-Small Cell Lung Cancer

Suzhou, August 12, 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, metabolic disorders, and autoimmune 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 Tyvyt, an innovative PD-1 inhibitor co-developed by the two companies.^®(sintilimab injection) supplemental new drug application (sNDA) for the first-line treatment of squamous non-small cell lung cancer (NSCLC). Prior to this, the NMPA had officially accepted the application for Tyvyt on April 23, 2020.^®(Sintilimab Injection) New Indication Application for First-Line Treatment of Non-Squamous NSCLC.

This indication application is based on a randomized, double-blind, Phase III controlled clinical study (ORIENT-12) — Tyvyt^®(Sintilimab Injection) or Placebo Combined with Gemzar^®(Gemcitabine) and platinum-based agents are used as first-line treatment for advanced or metastatic squamous NSCLC. Based on the analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt^®(Sintilimab Injection) in combination with gemcitabine and platinum significantly prolonged progression-free survival (PFS) compared with placebo plus gemcitabine and platinum, meeting the prespecified superiority criteria. The safety profile was consistent with previously reported data for Tyvyt^®(Sintilimab Injection) The study results were consistent, with no new safety signals identified. Detailed study data will be presented at upcoming international academic conferences and published in academic journals.

Professor Zhou Caicun, Director of the Department of Oncology at Shanghai Pulmonary Hospital and Principal Investigator of the ORIENT-12 study, stated, “We are delighted to see that Tyvyt^®(Sintilimab Injection) This study met its prespecified primary endpoint. There remains a significant unmet medical need in patients with squamous non-small cell lung cancer (NSCLC). The ORIENT-12 study is the globalFirst"The randomized, double-blind, controlled study confirming that the regimen of PD-1 antibody combined with gemcitabine and platinum significantly improves progression-free survival benefits in first-line squamous NSCLC patients holds significant clinical importance."

Dr. Hui Zhou, Vice President of the Medical Science and Strategic Oncology Department at Innovent Bio, stated, “This is the second randomized, double-blind, Phase 3 study in NSCLC conducted by Innovent Bio to meet its primary endpoint, following the ORIENT-11 study (a randomized, double-blind, Phase 3 study of first-line non-squamous NSCLC, NCT03607539), and also represents Innovent Bio’s second new indication application for first-line NSCLC. The acceptance of this application by the NMPA signifies that Tyvyt^®(Sintilimab Injection) has achieved significant progress in its layout for first-line NSCLC. 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 squamous NSCLC as soon as possible.”

Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated, “Eli Lilly and Innovent Bio are committed through their collaboration to bringing anti-tumor drugs of international quality to cancer patients in China. Tyvyt^®(Sintilimab Injection) As the first fruit of the collaboration between both parties, following its inclusion in the National Reimbursement Drug List for the treatment of relapsed or refractory classical Hodgkin lymphoma, the acceptance of the registration application for the new indication of non-small cell lung cancer marks another milestone for Tyvyt.^®(Sintilimab Injection) marks another important milestone in the field of oncology treatment. The ORIENT-12 study provides a new combination chemotherapy option for patients with squamous non-small cell lung cancer (NSCLC), and we look forward to bringing this novel treatment regimen to lung cancer patients in China as soon as possible. In the future, we will continue our in-depth collaboration with Innovent Bio to further explore the potential of tumor immunotherapy and bring benefit to more patients.”

Regarding SquamousNSCLC

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, and about 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not amenable to curative surgery. Meanwhile, a considerable proportion of early-stage NSCLC patients who undergo surgical treatment experience recurrence or distant metastasis, ultimately leading to death due to disease progression. Approximately 35% of NSCLC patients in China have squamous NSCLC lacking driver genes. For this population, therapeutic options remain limited, indicating a significant unmet medical need.

AboutORIENT-12 Study

The ORIENT-12 study is an evaluation of Tyvyt^®A randomized, double-blind, Phase III controlled clinical study evaluating the efficacy and safety of sintilimab injection or placebo in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer (NSCLC) (ClinicalTrials.gov, NCT03629925). The primary endpoint was progression-free survival (PFS) assessed by an independent radiology review committee according to RECIST v1.1 criteria. Secondary endpoints included overall survival (OS), safety, and others.

A total of 357 subjects were enrolled in this study and randomized in a 1:1 ratio to receive Tyvyt, respectively.^®(Sintilimab Injection) 200 mg or placebo in combination with Gemzar^®(Gemcitabine) and platinum-based therapy, administered once every 3 weeks; after completing 4 or 6 cycles of combination therapy, proceed to Tyvyt.^®(Sintilimab Injection) or placebo maintenance therapy until disease progression, intolerable toxicity, or other circumstances requiring treatment discontinuation. Patients in the control group may conditionally cross over to Tyvyt upon disease progression.^®(Sintilimab Injection) Monotherapy.

AboutORIENT-11 Study

The ORIENT-11 study is an evaluation of Tyvyt^®(Sintilimab Injection) or Placebo Combined 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 progression-free survival (PFS) assessed by an independent radiology review committee according to RECIST v1.1 criteria. Secondary endpoints included overall survival (OS), safety, and others.

A total of patients were enrolled in this study397 subjects were randomized in a 2:1 ratio to receive Tyvyt, respectively.^®(Sintilimab Injection) 200 mg or placebo in combination with Alimta^®(Pemetrexed disodium for injection and platinum-based therapy, administered once every 3 weeks; after completing 4 cycles of treatment, patients enter the phase of Tyvyt® (sintilimab injection) or placebo in combination with Alimta^®(Pemetrexed Disodium for Injection) Maintenance phase: treatment continues until disease progression, intolerable toxicity, or other conditions requiring discontinuation of treatment. Patients in the control group may conditionally cross over to Tyvyt upon disease progression.^®(Sintilimab Injection) Monotherapy.

The study has met its primary endpoint, and the NMPA officially accepted the application for Tyvyt on April 23, 2020.^®(Sintilimab Injection) New Indication Application.

About Tyvyt^®(Sintilimab Injection)

Tyvyt®^®(Sintilimab Injection) is an innovative, internationally-quality biopharmaceutical jointly developed by Innovent Biologics and Eli Lilly in China. Its first approved indication is 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.

In April 2020, the NMPA officially accepted the application for Tyvyt.^®(Sintilimab Injection) in Combination with Alimta^®Application for a new indication of (pemetrexed disodium for injection) in combination with platinum-based chemotherapy as first-line treatment for non-squamous non-small cell lung cancer; May 2020, Tyvyt^®(Sintilimab Injection) Combined with Gemzar^®(Gemcitabine for Injection) and Platinum-Based Chemotherapy as First-Line Treatment for Squamous Non-Small Cell Lung Cancer: Phase III Study Meets Primary Endpoint, Tyvyt^®(The Sintilimab Injection) Monotherapy as Second-Line Treatment for Advanced/Metastatic Esophageal Squamous Cell Carcinoma: The ORIENT-2 Study Met Its Primary Endpoint; In August 2020, the NMPA Officially Accepted the Application for Tyvyt^®(Sintilimab Injection) in Combination with Gemzar^®Application for a new indication of (gemcitabine for injection) and platinum-based chemotherapy as first-line treatment for squamous non-small cell lung cancer.

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 responsible for tumor immune tolerance. This action reactivates the anti-tumor activity of lymphocytes, achieving the goal of cancer treatment. Currently, more than twenty clinical studies (including over ten registration-enabling trials) are underway to evaluate the anti-tumor efficacy of sintilimab in various solid tumors and hematologic malignancies. Innovent Bio is also conducting global clinical research on Sintilimab Injection.

About Innovent Bio

“Rooted in Trust, Delivered through Action.” It is Innovent Bio’s vision and goal to develop high-quality biologics that are affordable to the general public. Established in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines 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 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 have been selected for the National “Major New Drug Creation” Special Project, 19 have entered clinical studies, five have reached Phase III or pivotal clinical trials, and marketing applications for two monoclonal antibody products have been accepted by the National Medical Products Administration (NMPA), both of which have been granted priority review. Two products have already been launched (Sintilimab Injection, brand name: Tyvyt^®, English trademark: TYVYT^®; Bevacizumab Injection, Brand Name: Dayoutong^®, English trademark: BYVASDA^®) received NMPA approval for marketing and sales. Sintilimab was successfully included in the National Reimbursement Drug List in November 2019, becoming the only PD-1 inhibitor included in the new version of the National Reimbursement Drug List.

Innovent Bio has assembled a high-caliber team of professionals in the development and industrialization of biologics, boasting international advanced standards. This team includes numerous overseas-returning experts. The company has established strategic collaborations with leading international organizations, including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Alector, and Hanmi Pharmaceutical (South Korea). Innovent Bio is committed to working collaboratively to elevate the development level 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’s 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’s founder was committed to producing high-quality medicines to meet pressing medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop transformative medicines that improve people’s lives and ensure they reach the patients who need them most. 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

In March 2015, Innovent Bio and Eli Lilly and Company entered into a biopharmaceutical development collaboration, which remains one of the largest partnerships to date between a Chinese biopharmaceutical company and a multinational pharmaceutical corporation. Under the terms of the agreement, Innovent Bio and Eli Lilly and Company will jointly develop and commercialize in China, including Tyvyt^®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 partnership was extended into the field of diabetes, with Innovent Bio obtaining authorization to develop and commercialize in China one of Eli Lilly’s potential global best-in-class novel clinical-stage diabetes medications. These three collaborations with Eli Lilly and Company mark that Innovent Bio has established a comprehensive strategic partnership between an innovative Chinese pharmaceutical enterprise and a global pharmaceutical giant, covering new drug research and development, clinical trials, 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;

3. For healthcare professionals only