Good news: Sunshine Demei efficiently helps Hausen Pharmaceutical two major products to be approved###
Recently, National Drug Administration (NMPA) has officially approved Hausen Pharmaceutical's first imitation of agomelatine and rabeprazole .
Sunshine Demei combined with rich work experience and technical capabilities to develop and verify the quantitative analysis method of high-performance liquid chromatography-mass spectrometry/mass spectrometry (HPLC-MS/MS, Nexera HPLC-TRIPLE QUAD 5500) with high sensitivity and specificity. Finally, the biological sample analysis of agomelatine and rabeprazole was efficiently completed, greatly promoting the application process of the two varieties.
Quality is the foundation of sunshine virtue and beauty, and
efficiency is the way to strengthen the body of sunshine virtue and beauty.
In the future development, Sunshine De and the United States will continue to be guided by the spirit of science, efficiency and accuracy, lead the industry and create reputations in China and abroad, cooperate sincerely with friends from all walks of life, work together to create a more brilliant tomorrow in the field of biological sample analysis.
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Beijing Sunshine Demei Pharmaceutical Technology Co., Ltd.
Beijing Sunshine Demei Pharmaceutical Technology Co., Ltd. was established in November 2016. It is a wholly-owned subsidiary of Sunshine Nohe (stock code: 688621). It is a PK/PD research platform and bioanalysis platform integrating large/small molecule drug analysis, covering the entire preclinical to clinical clinical chain. It can provide domestic and foreign customers with international standards, clinical value and patient needs-oriented innovative drug project research and development services, including: pharmacodynamic bioanalysis services, immunogenic biological analysis services, pharmacodynamic and biomarker research services and quantitative pharmacological research services. Focusing on solving the challenges encountered by customers in drug-cosity research and bioanalysis, we are committed to building a leading domestic bioanalysis and PK/PD research platform integrating preclinical and clinical research of large and small molecule innovative drugs.
Sunshine Demei mass spectrometry analysis platform
● Platform introduction: The Small Molecular Biological Analysis Laboratory is located in a laboratory of Sunshine Demei Center. It is equipped with a total of 16 liquid-mass combinatorial , and uses Watson LIMS and Analyst systems for full management and tracking. The system is highly versatile, has strong stability, and has low failure rate, which fully guarantees the rapid detection and data collection of projects. Nearly 100 projects can be completed every year, with a total of hundreds of thousands of biological samples of more than one type.
●Service capability: It can provide comprehensive services such as method development, analysis method transfer, analysis method verification, multiple matrix sample analysis and metabolite identification, and provide accurate and high-quality bioanalytical data for drug research and development.
Sunshine Demei Immune Analysis Platform
● Platform Introduction: The laboratory has a number of advanced immunoassay instruments, such as Simoa, MSD, ELISA, Luminex, ELISpot. The core technical teams have nearly 10 years of research experience in the field of pharmaceutical research and development, and have rich industry accumulation. It can not only provide high-quality, efficient and comprehensive high-quality analytical and testing services, but also provide customers with high-end customized solutions.
●Service capability: Related studies on pharmacokinetics (PK), immunogenicity, pharmacodynamics and biomarkers of drugs from preclinical to clinical stages can be carried out to support drug discovery and IND declaration.
Sunshine Demei Cell Analysis Platform
● Platform Introduction: The laboratory is equipped with flow cytometer , and has 2 P2-level cell laboratories, covering an area of about 100 square meters. The overall environment of the cell laboratory is 10,000+ local level 100, and is equipped with an efficient filtration system and disinfection equipment. At the same time, a scientific management system has been formulated to effectively ensure the good operation of the cell platform, thereby ensuring the reliability and reproducibility of experimental results.
●Service capability: It can carry out cell transfection and construction, reporter gene method, Cell-based ELISA, FCS cell phenotype, cytokine and receptor placeholding detection and other services.
Sunshine Demei Molecular Biology Platform
● Platform Introduction: Sunshine Demei has built a QPCR laboratory with independent functional partitions, with reasonable partitions to avoid cross-contamination to the greatest extent.The laboratory is equipped with advanced equipment such as Quant Studio series QPCR and GeneRotex 96 nucleic acid extractor.
●Service capability: can provide complete development and clinical research of cellular and gene therapy drugs.
Beijing Sunshine Demei Pharmaceutical Technology Co., Ltd. has accumulated rich experience in PK/PD research and GLP bioanalysis, and has established a strong market influence in this sub-field. In terms of innovative drugs, Sunshine Demei continues to strengthen and extend its service capabilities forward. The clinical pharmacological pharmacological pharmacological team actively cooperates with the company's clinical research and development department to provide support to customers in important links such as innovative drug solution design, clinical pharmacology considerations, pharmacological control, biological sample classification collection, preservation, transportation, matrix stability, quantitative pharmacology, etc., and quickly promote the progress of innovative drug projects. The company is currently running more than 30 innovative drug preclinical and phase I projects, including small molecule targeted inhibitors. , polypeptides, ADC, PDC, monoclonal antibodies, stem cell products, nucleic acid drugs, vaccine products, virus products, innovative Chinese medicine drugs, etc. Indications include: tumor, immunity, cardiovascular disease, antihypertensive, lowering glycemic, acid suppression, stroke , dry eye disease, moderate to severe enteritis, influenza, HIV, etc. Among them, two innovative drug projects are efficiently promoted to avoid the second to third, and a domestic independent intellectual property P-CAB innovative drug is to be approved for marketing. In terms of generic drugs: especially good at testing endogenous drugs, inhaled preparation drugs, chiral drugs, peptide drugs, nucleic acid drugs, ADC drugs, multi-compounds and unstable drugs. The company independently developed nearly 400 biological analysis methods. Bioanalysis of nearly hundreds of BE projects with a total of hundreds of varieties has been completed. Among them, nearly 50 projects have successfully passed the on-site inspection and exemption of verification by the National Medical Products Administration Review and Inspection Center. 17 projects and 15 varieties have obtained production approval documents, including 5 first generic agents (valsartan/amlodipine tablets, valsartan hydrochlorothiazide tablets, lemudipine benzenesulfonate tablets, agomelatine, rabeprazole) and 1 rare disease preparation (dantraline sodium for injection).
