Innovent announces the use of Daboshu (Xindi Lizumab injection) combined with Dayoutong (bevacizumab injection) and chemotherapy for the treatment of EGFR-mutant non-squamous non-small cell lung cancer that has failed EGFR-TKI treatment Phase III clinical study reached

San Francisco and Suzhou, China October 18, 2021/PRNewswire/ - Cinda Biopharmaceutical Group (Hong Kong Stock Exchange stock code: 01801), a company dedicated to R&D, production and sales for the treatment of tumors, metabolic diseases, and its own A biopharmaceutical company with innovative drugs for major diseases such as immunity, today announced: Innovative drug PD-1 inhibitor Daboshu® (Sintilimab Injection) jointly developed by Cinda Biotech and Eli Lilly and Dalton® (Bevacizumab injection) and chemotherapy for epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment failure of EGFR-mutant non-squamous non-small cell lung cancer is a randomized, double-blind, multiple The center's Phase III clinical study (research code: ORIENT-31) reached the primary endpoint in the first interim analysis

This is the world's first prospective, double-blind, multi-center Phase III study to demonstrate that PD-1 inhibitors combined with anti-vascular drugs and chemotherapy can significantly improve PFS in EGFR-TKI-treated non-squamous NSCLC populations

The first interim analysis conducted by the Independent Data Monitoring Committee (iDMC) showed that in the intention-to-treat (ITT) population, based on the blinded Independent Imaging Evaluation Committee (BIRRC) evaluation, Daboshu® combined with Dauroto® and chemotherapy, Comparative chemotherapy achieved a significant and clinically significant progression-free survival (PFS) extension, reaching the preset superiority standard

The main investigator of the ORIENT-31 study, Professor Lu Shun, Department of Oncology, Shanghai Chest Hospital, said: “For patients with advanced non-squamous NSCLC with EGFR mutations who have progressed in EGFR-TKI treatment, platinum-containing dual-drug chemotherapy is the standard recommended by the current guidelines.

Dr.

About EGFR mutant non-squamous NSCLC

Lung cancer is the malignant tumor with the highest mortality rate in the world, and its incidence ranks second in the global incidence of malignant tumors

About the ORIENT-31 study

The ORIENT-31 study is a comparison of Daboshu® (sintilizumab injection) with or without Dayoutong® (bevacizumab biosimilar) and chemotherapy for the progress of EGFR-TKI treatment A randomized, double-blind, multi-center phase three clinical trial of efficacy and safety in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations (ClinicalTrials.

Subjects allowed to enter the study include: first- and second-generation EGFR TKI treatment progression and T790M-negative subjects, first- and second-generation EGFR TKI treatment progression and T790M-positive subjects who have received third-generation EGFR TKI treatment progression, and first-line recipients Three-generation TKI treatment progressed subjects

About Sintilimab

Sintilimab, the Chinese trade name of Daboshu® (sintilimab injection), is an innovative PD-1 inhibitor drug with international quality jointly developed by Xinda Biopharmaceuticals and Eli Lilly

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

For the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least second-line systemic chemotherapy; combined with pemetrexed and platinum-based chemotherapy for the first-line treatment of EGFR or ALK-negative advanced non-squamous NSCLC; combined with gemcitabine and Platinum-based chemotherapy is suitable for the first-line treatment of locally advanced or metastatic squamous NSCLC that is not resectable; it is combined with Dayton® (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma

In addition, the listing application of Sintilimab as a single agent for the first-line treatment of esophageal squamous cell carcinoma has been accepted and reviewed by the China National Medical Products Administration (NMPA)

Four other clinical trials of Sintilimab reached the study endpoints, including:

Combination of oxaliplatin and capecitabine in the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma phase III clinical study single agent for the second-line treatment of advanced/metastatic esophageal squamous cell carcinoma Phase II clinical study of single agent for second-line treatment of advanced squamous non-small cell lung cancer that failed platinum-containing chemotherapy.

In May 2021, the listing application of sintilimab combined with pemetrexed and platinum for the first-line treatment of non-squamous NSCLC has been formally accepted and reviewed by the US FDA

Sintilimab has successfully entered China's National Medical Insurance List in November 2019, becoming the first and only PD-1 inhibitor to enter the National Medical Insurance List that year

About Dayoutong® (bevacizumab biosimilar)

Dayoutong® is a biosimilar drug of bevacizumab injection, also known as recombinant anti-VEGF humanized monoclonal antibody injection

About Cinda Bio

"Starting from the letter, reaching the line", to develop high-quality biological drugs that the common people can afford is the ideal and goal of Cinda Bio

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
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A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.
Among them, 6 varieties have been selected for the national "Major New Drug Creation" project
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The company has 5 products (sintilimab injection, trade name: Daboshu®, English trademark: TYVYT®; bevacizumab biosimilar drug, trade name: Dayotong®, English trademark: BYVASDA ®; Adalimumab biosimilar, trade name: Su Lixin®, English trademark: SULINNO®; Rituximab biosimilar, trade name: Dabohua®, English trademark: HALPRYZA®; pemigatinib oral inhibitor , Trade name: Daburtan®, English trademark: PEMAZYRE®) was approved for marketing, 1 product marketing application was accepted by NMPA, Sintilimab's marketing application in the United States was accepted by FDA, and 5 varieties entered phase III or critical Sexual clinical research, and another 15 products have entered clinical research
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Sintilimab successfully entered the National Medical Insurance List in November 2019, becoming the country's first and the only PD-1 inhibitor to enter the National Medical Insurance List that year
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Cinda Bio has established an internationally advanced high-end biopharmaceutical development and industrialization talent team, including many returned experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi of South Korea.
Reach strategic cooperation
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Cinda Bio hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to medicines and the people's pursuit of life and health
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For details, please visit the company's website:or the company's LinkedIn account.

statement:

This indication is the use of drugs under research and has not yet been approved in China; Cinda does not recommend any unapproved drugs/indications; it is only for medical and health professionals to communicate and use
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Source: Cinda Bio