Cinda Biotech announced that the National Medical Products Administration has accepted the application for new indications for the treatment of first-line esophageal squamous cell carcinoma patients with daboshu (sintilimab injection) combined with chemotherapy

San Francisco, USA and Suzhou, China September 23, 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, A biopharmaceutical company with innovative drugs for major diseases such as autoimmunity, today announced that the National Medical Products Administration (NMPA) has officially accepted the innovative PD-1 inhibitor Daboshu® (sintilimab injection) combined with chemotherapy (cisplatin) + Paclitaxel/Cisplatin+5-Fluorouracil) New indications for the first-line treatment of esophageal squamous cell carcinoma (sNDA)

This new indication application is based on a randomized, double-blind, international multicenter Phase III clinical study (ORIENT-15)-Sintilimab combined with chemotherapy versus placebo combined with chemotherapy for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma

The principal investigator of the ORIENT-15 study, Professor Lin Lin, deputy dean of Peking University Cancer Hospital, said: "In China, esophageal cancer is the fifth most common malignant tumor in incidence and fourth in mortality, and squamous cell carcinoma is the most

Dr.

About the ORIENT-15 study

The ORIENT-15 study is a comparison of Sintilimab combined with chemotherapy (cisplatin + paclitaxel/5-fluorouracil) and placebo combined with chemotherapy (cisplatin + paclitaxel/5-fluorouracil) for the first-line treatment of unresectable locally advanced and recurrent unresectable Or a randomized, double-blind, international multicenter, phase III study of patients with metastatic esophageal squamous cell carcinoma (ClinicalTrials.

About esophageal squamous cell carcinoma

Esophageal cancer is a malignant tumor derived from the epithelium of the esophageal mucosa and is one of the most common malignant tumors in the world

The main pathological types of esophageal cancer are squamous cell carcinoma and adenocarcinoma.

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:

Single agent 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 Gemcitabine and platinum-based chemotherapy are suitable for the first-line treatment of non-resectable locally advanced or metastatic squamous NSCLC; combined with Dayoutong® (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma

In addition, the listing application of Sintilizumab for the first-line treatment of esophageal squamous cell carcinoma and the listing application for the second-line treatment of squamous NSCLC have been accepted and reviewed by the China National Medical Products Administration (NMPA)

Sintilimab reached the study endpoints in two other clinical trials, 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; for the second-line treatment of advanced/metastatic esophageal squamous cell carcinoma Clinical

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 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

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.

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Source: Cinda Bio