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San Francisco, USA and Suzhou, China October 28, 2021/PRNewswire/ - Cinda Biopharmaceutical Group (Hong Kong Stock Exchange stock code: 01801) ("Cinda Bio"), a company dedicated to R&D, production and sales A biopharmaceutical company specializing in innovative drugs for the treatment of tumors, metabolic diseases, autoimmunity and other major diseases, and Shenzhen Xinhe Bio-Medical Technology Co.
, Ltd.
("Xinhe Bio"), a company dedicated to creating an internationally leading AI-enabled RNA innovation Pharmaceutical’s biotechnology company jointly announced that the two parties have reached a strategic cooperation to conduct clinical research on the combination of Sintilimab injection and Neo-Bio’s personalized neoantigen vaccine NEO_PLIN2101 in the treatment of tumors
.
According to the cooperation agreement, Cinda Biosciences will establish a clinical research partnership with Xinhe Biologics to evaluate the safety and pharmacokinetics of the combination of Cinda Bio's Sintilimab and Xinhe Biologics NEO_PLIN2101 in cancer subjects.
We will jointly advance the development of combined immunotherapy for solid tumors in terms of science, pharmacodynamics and preliminary efficacy, and plan to submit a clinical research application (IND) to the China National Medical Products Administration (NMPA) in the near future
.
Dr.
Liu Yongjun, President of Cinda Biopharmaceutical Group, said: "We are deeply impressed by Xinhe Bio's differentiated R&D pipeline and international scientific research team.
We are very pleased to reach this strategic cooperation to jointly explore Sintilimab and neoantigen vaccine therapeutic entities.
The clinical value of tumors
.
Cinda Bio is deeply involved in the field of anti-tumor.
Dr.
Wang Yi, founder and CEO of Xinhe Biologics, said: “Currently, neoantigen vaccines are emerging therapeutic fields worldwide.
Since its establishment, Xinhe Biosciences has been focusing on the research of tumor neoantigen vaccines and hopes to overcome the current situation through the application of new technologies.
There are difficulties with immunotherapy in the treatment of solid tumors
.
We are very pleased to reach this strategic cooperation with Innovent .
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 is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking PD-1/programmed death receptors that cause tumor immune tolerance.
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 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 Dyutong® (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 the drug; Phase III clinical study of single agent for second-line treatment of advanced squamous non-small cell lung cancer that failed platinum-containing chemotherapy; Combination of Dyutong® (bevacizumab injection) and chemotherapy for epidermal growth A phase III clinical study of factor receptor tyrosine kinase inhibitors (EGFR-TKI) for failed EGFR-mutant non-squamous non-small cell lung cancer
.
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 NEO_PLIN2101
NEO_PLIN2101 is a "tailor-made" personalized neoantigen vaccine developed by Xinhe Biologics.
It can be customized according to the unique tumor gene mutation points of each patient.
Through high-throughput sample sequencing and AI algorithm prediction, from tumor From the specific mutant cells, high-quality neoantigen fragments that can be efficiently presented by tumor cells and can trigger a strong immune response in the body are selected.
The corresponding encoded mRNA neoantigen vaccine is synthesized in vitro, and it is injected back into the patient to activate T cells.
And kill the tumor cells with the above antigens
.
Compared with traditional drugs, NEO_PLIN2101 has stronger tumor specificity and immunogenicity, and can induce the body's natural immune response
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
.
Founded in 2011, Cinda Bio is committed to the development, production and sales of innovative drugs for the treatment of tumors, autoimmune, metabolic diseases and other major diseases
Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.
A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.
Innovent 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
.
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
For details, please visit the company's website: or the company's LinkedIn account
.
statement:
1.
The indication is the usage of the drug under study, which has not yet been approved in China;
2.
Cinda does not recommend any unapproved drugs/indications;
3.
Only for communication and use by medical and health professionals
.
About Xinhe Bio
Founded in 2017, Xinhe Biosciences is committed to building an internationally leading RNA innovative drug platform
.
The company has built a multi-omics big data collection platform and a multi-bioomics database, using AI and bio-information technology for in-depth drug target mining and fully automated drug design for innovative RNA drug research and development, and has established a leading domestic RNA drug production The center supports pipeline R&D and clinical needs
Xinhe Biosciences brings together the world's top scientists, senior industry experts, and a world-class academic advisory team.
The core R&D team includes dozens of doctors/postdoctors from famous universities such as Harvard, Cambridge, Cornell, Tsinghua University, Peking University, Chinese Academy of Sciences, etc.
The professional fields cover omics sequencing, the AI algorithm, biological information, and drug delivery tumor immunity and other directions
.
Team members have held core R&D positions in top international research institutions or companies such as Harvard University Medical School, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Boston Children’s Hospital, Allen Institute, etc.
The research results have been published in Nature , Science, Cell and other international authoritative journals published hundreds of articles
.
The company independently developed AI bio-information target mining platform, RNA drug platform, automatic drug design platform, multi-omics big data collection and analysis platform, and drug screening verification platform, aiming to promote RNA drugs by combining artificial intelligence algorithms + real-world data verification In clinical research, its independently developed and independently developed NeoCuraTM AI ALPINE tumor neoantigen prediction system has the highest prediction accuracy in the world
.
Relying on its own R&D expertise and technological advantages, Xinhe Biology has carried out in-depth research in tumor neoantigen vaccines, tumor microenvironment immunomodulators, etc.
, combined with different individuals to develop personalized neoantigen vaccines, and established public neoantigens for high-incidence cancers in China The library significantly reduces the cost of neoantigen drug treatment and shortens the preparation cycle
.
At present, Xinhe Biotechnology has jointly carried out clinical trials with a number of hospitals, which will become a new milestone in the field of tumor treatment
.
Relying on leading AI technology, outstanding innovation capabilities and strong tumor pipelines, Xinhe Biosciences has been selected as the "2021 China's Most Potential Enterprise" and "2021 China's TOP10 AI/Computational Pharmaceutical Innovation Enterprise"
.
For details, please visit the company's website:
.
Cinda Biosciences forward-looking statement
The information published in this press release may contain certain forward-looking statements
.
These statements are inherently risky and uncertain
.
When using "expect," "believe," "forecast," "expect," "intend," and other similar expressions, all matters related to the company are intended to indicate that they are forward-looking statements
.
The company has no obligation to continuously update these forward-looking statements
.
These forward-looking statements are based on the current views, assumptions, expectations, estimates, forecasts and understandings of the company’s management on future affairs at the time the statement is made
.
These statements are not guarantees for future development and will be affected by risks, uncertainties and other factors.
Some of them are beyond the control of the company and are difficult to predict
.
Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions, actual results may differ significantly from the information contained in the forward-looking statements
.
Source: Cinda Bio