Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

SAN FRANCISCO and SUZHOU,China,Nov. 4,2021 --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,today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for sintilimab in combination with chemotherapy (oxaliplatin and capecitabine) for the first-line treatment of patients with unresectable,locally advanced,recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

The sNDA application is based on the interim analysis of the randomized,double-blind,multi-center Phase 3 ORIENT-16 clinical trial – which evaluated sintilimab in combination with chemotherapy (oxaliplatin and capecitabine),compared to placebo in combination with chemotherapy,for the first-line treatment of unresectable,recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC),sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy,in both the intention-to-treat (ITT) group and PD-L1 positive group. The results of ORIENT-16 study were released in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

The principal investigator of the ORIENT-16 study,Prof. Jianming Xu from the Fifth Medical Center of People's Liberation Army General Hospital,stated," We are very pleased to see that sintilimab in combination with chemotherapy can significantly improve the overall survival compared to chemotherapy alone,which met the predefined statistical superiority criteria. ORIENT-16 study was released in a late-breaking proffered oral presentation at the ESMO Congress 2021. This is the first double-blind,randomized controlled trial demonstrating that a PD-1 inhibitor plus chemotherapy significantly improved overall survival in the first-line treatment of advanced gastric cancer in China. In the past few decades,chemotherapy is the main treatment of advanced gastric cancer,and the overall survival continued to be less than 1 year. The data from the ORIENT-16 study highlights the potential for a new treatment option for patients with advanced gastric cancer.

Dr. Hui Zhou,Senior Vice President of Innovent,"The treatment options for advanced gastric cancer are still very limited today. The ORIENT-16 study aims to address this unmet medical need. The acceptance of this sNDA by the NMPA represents an important milestone in demonstrating the potential value of sintilimab in the first-line treatment of advanced gastric cancer. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring the new regimen of sintilimab plus chemotherapy to Chinese patients with advanced gastric cancer."

About the ORIENT-16 Study

ORIENT-16 is a randomized,multi-center Phase 3 clinical study evaluating sintilimab or placebo,in combination with chemotherapy (oxaliplatin and capecitabine),recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ClinicalTrials.gov,NCT03745170). The primary endpoint was overall survival,in PD-L1 positive (CPS>5) and all randomized patients.

As of the cutoff date for the interim analysis,a total of 650 patients were enrolled and randomly assigned with a 1:1 ratio to receive sintilimab or placebo in combination with chemotherapy until disease progression,unacceptable toxicity,withdrawal of consent,or death,whichever occurs first. The study met both primary endpoints and the safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab,and no additional safety signals were identified for the combination of sintilimab and chemotherapy. The results were published at the ESMO Congress 2021.

About Gastric Cancer

Gastric cancer is one of the most common malignant tumor types worldwide. According to GLOBOCAN estimates,there were approximately one million new cases and 769,000 new deaths of gastric cancer in 2020,making it the fifth most common cancer and third leading cause of cancer death globally. About half of all gastric cancer cases occurred in East Asia,mainly in China. Currently,the 5-year survival rate of advanced or metastatic gastric cancer ranges from 5 to 20 percent,and the median overall survival is approximately one year.

About Sintilimab

Sintilimab,marketed as TYVYT® (sintilimab injection) in China,is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an 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 of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications,including more than 10 registrational or pivotal clinical trials.

In China,Sintilimab has been approved for four indications,including:

The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy

In combination with pemetrexed and platinum chemotherapy,for the first-line treatment of nonsquamous non-small cell lung cancer

In combination with gemcitabine and platinum chemotherapy,for the first-line treatment of squamous non-small cell lung cancer

In combination with BYVASDA® (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma

Additionally,Innovent currently has two regulatory submissions under reviewin China's NMPA for sintilimab,for the first line treatment of esophageal squamous cell carcinoma,and the first line treatment of unresectable,recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally,three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma

Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy

Phase 3 study in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment.

In May 2021,the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

Sintilimab was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

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 cancer,autoimmune,metabolic diseases,and other major therapeutic areas. 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. By leveraging this platform,the company has built a robust pipeline of 26 valuable assets in major therapeutic areas,with 5 products - TYVYT® (sintilimab injection),BYVASDA® (bevacizumab biosimilar injection),SULINNO® (adalimumab biosimilar injection),HALPRYZA® (rituximab biosimilar injection),and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing,1 asset's NDA under NMPA review,sintilimab's Biologics License Application (BLA) acceptance in the U.S.,5 assets in Phase 3 or pivotal clinical trials,and an additional 15molecules in clinical studies.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization,including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company,Adimab,Incyte,MD Anderson Cancer Center,Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry,improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information,please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

Sintilimab is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection),and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection,Innovent)

BYVASDA® (bevacizumab biosimilar injection,Innovent)

HALPRYZA® (rituximab biosimilar injection,Innovent)

SULINNO® (adalimumab biosimilar injection,Innovent)

Pemazyre® (pemigatinib oral inhibitor,Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China,Hong Kong,Macau and Taiwan.

Disclaimer:

1. This indication hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

3. For medical and healthcare professionals only.

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