San Francisco, USA, and Suzhou, China, September 28, 2020 /PRNewswire/ -- Cinda Biopharmaceuticals (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmunity, announced today: Dabershu, an innovative drug jointly developed by Cinda Biotech and Lilly^®(Cindilizumab injection) in conjunction with Dayoutong^®A randomized, controlled, and open multicenter phase III clinical study (ORIENT-32) for first-line treatment of advanced liver cancer (bevacizumab injection) reached the main end of the study in midterm analysis. This is the world's first phase III study of PD-1 inhibitor combination therapy for first-line treatment of advanced liver cancer that has reached a major research end.

Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Daberschuh^®(Cindilizumab injection) in conjunction with Dayoutong^®Monotherapy with bisotrafenib (bevacizumab injection) significantly extended progression-free survival (PFS) and overall survival (OS), meeting pre-set efficacy standards, safety characteristics, and previously reported daberxil^®(Cindilizumab injection) and Dayoutong^®The results of the study (bevacizumab injection) were consistent, and there were no new safety signals. The relevant research results will be presented at an upcoming academic conference.

According to the recommendations of the Independent Data Monitoring Committee (IDMC), the Cinda Biotech Plan was submitted to Dabershu^®(Cindilizumab injection) in conjunction with Dayoutong^®The marketing application for (bevacizumab injection) for a new indication for first-line treatment of advanced liver cancer was communicated with the Drug Evaluation Center (CDE) of the China Drug Administration (CDE).

Academician Fan Jia of Zhongshan Hospital affiliated to Fudan University and the main researcher in the ORIENT-32 study said, “Liver cancer is a malignant tumor with the fourth highest incidence rate and second highest death rate in China. About half of the new cases and deaths of liver cancer worldwide occur in China every year. The first-line treatment for advanced liver cancer currently approved in China still uses sorafenib, lenvatinib, and chemotherapy as the main treatment methods. The curative effect is very limited; about 85% of liver cancer patients in China have a background of hepatitis B virus infection, which is very different from European and American countries. Therefore, it is of great significance to conduct clinical research on liver cancer patients in China. We are very happy to see that the ORIENT-32 study confirms Daberschau^®(Cindilizumab injection) in conjunction with Dayoutong^®(bevacizumab injection) significantly prolonged OS and PFS in first-line treatment for advanced liver cancer in China. This is also how all researchers have overcome many difficulties under the COVID-19 pandemic, bringing hope for new treatments to patients.”

Dr. Zhou Hui, Vice President of Cinda Biomedical Science and Strategic Oncology Department, said, “Currently, Dabershu^®(Cindilizumab injection) is the only anti-PD-1 monoclonal antibody drug included in the national medical insurance catalogue. It was approved by the National Drug Administration on December 24, 2018 for the treatment of recurrent or refractory classic Hodgkin lymphoma after at least second-line systematic chemotherapy. Da You Tong^® (bevacizumab injection) was also approved by the State Drug Administration on June 19, 2020 for the treatment of advanced non-small cell lung cancer and metastatic colorectal cancer. The results of the ORIENT-32 study prove the potential clinical value of cindilizumab combined with bevacizumab in the first-line treatment of advanced liver cancer. We anticipate Dabershaw^®(Cindilizumab injection) in conjunction with Dayoutong^®(bevacizumab injection) can benefit more patients with liver cancer. We would like to express our sincere thanks to the patients and researchers who participated in the ORIENT-32 study. Despite the significant challenges and impacts of the COVID-19 pandemic, we completed this landmark study thanks to the joint efforts of the researchers and the entire research team.”

About the ORIENT-32 study

The ORIENT-32 study is a comparison of Daberschau^®(Cindilizumab injection) in conjunction with Dayoutong^®A randomized, controlled, and open multicenter phase III clinical study on the efficacy and safety of (bevacizumab injection) and sorafenib in first-line treatment of advanced liver cancer (ClinicalTrials.gov, NCT 03794440). The main study endpoints were OS and progression-free survival PFS assessed by the Independent Imaging Review Committee (IRRC) according to RECIST v1.1 criteria.

Subjects were randomly enrolled 2:1 and received Dabershur separately^®(Cindilizumab injection) in conjunction with Dayoutong^®(bevacizumab injection) or sorafenib is treated until disease progression, intolerable toxicity, withdrawal of informed consent, death, or other circumstances requiring discontinuation of treatment as specified in the program, whichever occurred first.

About hepatocellular carcinoma

Liver cancer is a common malignant tumor of the digestive system all over the world. Liver cancer patients in China account for about half of the world, and liver cancer seriously threatens the lives and health of the Chinese people. The pathological types of liver cancer are mainly hepatocellular carcinoma (HCC), accounting for 85% to 90%; there are also a few intrahepatic cholangiocarcinoma (ICC) and mixed HCC-ICC. In our country, HCC is mainly caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections.

About Dabershu^®(cindilizumab injection)

Dabershu^®(Cindilizumab injection) is an innovative biopharmaceutical with international quality developed jointly by Cinda Biotech and Lilly Pharmaceuticals in China. The first approved indication was recurrent/refractory classic Hodgkin lymphoma, and was selected in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines. In the 2019 National Health Insurance Talks, Dabershu^®(Cindilizumab injection) is the only PD-1 inhibitor covered by national health insurance.

In April 2020, NMPA officially accepted Dabershu^®(Cindilizumab Injection) Combined with Libitai^®New indications for first-line treatment of non-squamous non-small cell lung cancer (pemetrexed disodium for injection) and platinum chemotherapy. May 2020, Dabershu^®(Cindilizumab Injection) Combined Health^®The phase III study of first-line treatment of squamous non-small cell lung cancer (gemcitabine for injection) and platinum-type chemotherapy reached a major research end, Dabershu^®The ORIENT-2 study of single-drug second-line treatment for advanced/metastatic esophageal squamous cell carcinoma (cindilizumab injection) has also reached a major research end. In August 2020, NMPA officially accepted Dabershu^®(Cindilizumab Injection) Combined Health^®New indications for first-line treatment of squamous non-small cell lung cancer (gemcitabine for injection) and platinum-type chemotherapy.

Dabershu^®(Cindilizumab injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/programmed death receptor ligand 1 (PD-L1) pathway that causes tumor immune tolerance, and reactivates the anti-tumor activity of lymphocytes to achieve the purpose of treating tumors. Currently, more than 20 clinical studies (of which more than 10 are registered clinical trials) are ongoing to evaluate the anti-tumor effects of cindilizumab on various solid tumors and hematologic tumors. At the same time, Cinda Biotech is conducting clinical research on cindilizumab injections around the world.

About Dayoutong^®(bevacizumab injection)

Da You Tong^®It is a biosimilar to bevacizumab injection, also known as recombinant anti-VEGF humanized monoclonal antibody injection. VEGF is an important factor in angiogenesis and is highly expressed in the endothelial cells of most human tumors. Anti-VEGF antibodies can selectively bind VEGF with high affinity. By blocking VEGF binding to receptors on the surface of vascular endothelial cells, they block the conduction of signal pathways such as PI3K-akt/PKB and RAS-RAF-MEK-ERK, thereby inhibiting the growth, proliferation, migration and angiogenesis of vascular endothelial cells, reducing vascular permeability, and blocking the blood supply of tumor tissue, inhibiting tumor cell proliferation and metastasis, and inducing tumor cell apoptosis, thus achieving anti-tumor therapeutic effects. Since the launch of the original research drug bevacizumab injection, it has been approved worldwide for the treatment of various solid tumors, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell cancer, cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, etc., and its remarkable efficacy and good safety have been widely recognized.

About Cinda Biotech

“Beginning with Faith, Achieving Action” to develop high-quality biopharmaceuticals that ordinary people can afford is the ideal and goal of Cinda Biotech. Established in 2011, Cinda Biotech is committed to developing, producing and selling innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmunity. On October 31, 2018, Cinda Biopharmaceuticals was listed on the main board of the Hong Kong Stock Exchange Limited, stock code: 01801.

Since its inception, the company has distinguished itself among many biopharmaceutical companies through innovative achievements and an international operating model. A product chain including 23 new drug types has been established, covering various disease fields such as tumors, metabolic diseases, and autoimmunity. Of these, 6 varieties were selected for the national “major new drug creation” project, and 3 products (cindilizumab injection, trade name: dabershu^®, English trademark: TYVYT^®; Bevacizumab injection, trade name: Dayoutong^®, English trademark: BYVASDA^®; Adalimumab Injection, Trade Name: Sulisin^®, English trademark: SULINNO^®) Approved for marketing and sale by NMPA, 1 monoclonal antibody product marketing application was accepted by the State Drug Administration and included in priority review. 4 varieties have entered phase III or critical clinical research, and 15 other products have entered or are about to enter clinical research. Cindilizumab successfully entered the national health insurance catalogue in November 2019, becoming the only PD-1 inhibitor to enter the new national health insurance catalogue.

Cinda Biotech has formed a team of high-end biopharmaceutical development and industrialization talents with advanced international standards, and reached strategic cooperation with outstanding international companies such as Eli Lilly Pharmaceuticals, Adimab, Incyte, MD Anderson Cancer Center, Alector, and South Korea's Hanmi. For more information, please visit the company website:.

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