With the rapid development of the global pharmaceutical market and the division of labor in the pharmaceutical industry, the chain is becoming more and more refined, making specialized outsourcing in the pharmaceutical industry an important strategic choice for pharmaceutical companies. In the early stages of new drug development, FTE (Full-time equivalent) is often used by drug discovery companies to synthesize the required structural fragments and/or potential candidate compounds to accelerate the drug screening process.
Medicilon provides comprehensive chemistry research services covering all stages of your project requirements, and customers can cooperate with us through the FFS (Fee for Service) or FTE (Full-time Equivalent Service) models.
Medicilon has a dedicated R&D and project management team. According to customer requirements, it can configure different proportions of R&D staff with different levels of Ph.D., M.S., or B.S. degrees to form a joint R&D team with customers to quickly and efficiently solve the technical problems of their R&D projects, and to provide regular project progress reports and project communication meetings. Moreover, Medicilon can quickly adapt to the client's needs and provide efficient output to ensure the smooth progress of the project. This partnership model is ideal for innovative drug development projects.
The Medicilon Chemical FTE team can serve clients at different stages of drug development, including generation and optimization of lead compounds, identification, and optimization of lead compounds, synthesis scale-up, and chemical process studies. This collaboration model allows for flexible adjustment of R&D staffing, experimental protocols, and project priorities based on client and project needs.
The research department will communicate with the customer when problems are encountered in the R&D process and propose solutions to solve them. In addition, the FTE team can not only synthesize according to the synthesis line designed by the customer but also design the synthesis line according to the customer's concept. Flexible adjustment based on project requirements makes project progress clear and controllable, and provides exclusive synthesis circuit design and problem solving, all of which reflect the service advantages of the Medicilon FTE team.
FFS custom synthesis is one of Medicilon's services. Medicilon has an experienced R&D team of Ph.D., M.S., and B.S. degree researchers who constitute a golden mix and will utilize their extensive biopharmaceutical and medicinal chemistry experience to complete a variety of different custom synthesis projects including the synthesis of biologically active molecular target compounds, and other drug-like intermediates regularly.
The custom synthesis will be developed exactly to the customer's requirements for the compound, either in small (typic milligrams to 100 grams) or medium to large (typically 100 grams to kilograms) quantities. These drug-like substances include drug reference compounds, lead compounds and their derivatives, combinatorial chemical templates, and other drug-like compounds with or without references. We can deliver custom synthesis products in a timely and efficient manner. The fees charged for the FFS model depend on the type of specific experiment, the method and the number of compounds to be tested, etc.
Medicilon can undertake the synthesis of special reagents, intermediates and molecular fragments, preparation of standard products, synthesis design and preparation of impurities or metabolites, synthesis of stable isotope internal standards and synthesis of tritiated compounds.
Ringene Biopharma's pan-FGFR1-4 irreversible inhibitor RG002 tablets was approved for clinical use with the help of Medicilon
Recently, Ringene Biopharma, an innovative drug R&D company focusing on the development of drugs targeting RTK-RAS-MAPK signaling pathway, independently developed a new class of anti-tumor drugs, the irreversible pan-FGFR inhibitor RG002, which was approved clinical. The indications are advanced malignant tumors.
In the R&D of RG002, Shanghai Medicilon Inc. provides drug discovery sevices in the form of FTE collaboration to clinical application, including preclinical research, drug discovery, pharmaceutical research and preclinical research (pharmacy, safety assessment), which accelerated the research process of RG002.
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Medicilon assists Ringene Biopharma 's SHP2 allosteric inhibitor RG001 tablet to be approved for clinical use
Recently, Shanghai Ringene Biopharma (Ringene) announced that the company’s self-developed anti-tumor class I new drug SHP2 allosteric inhibitor RG001 tablet has been approved for clinical use.
Shanghai Medicilon Inc. (Medicilon) provides a range of preclinical services from drug targets to IND filing in the development of RG001 tablets to enter the clinical trial phase, including drug discovery, pharmaceutical research, and pre-clinical research (drug efficacy and safety evaluations).
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ABM Therapeutics presented Medicilon with a commemorative trophy of "our first candidate compound"
On October 31, 2020, ABM Therapeutics awarded the "Our First Candidate Compound" commemorative trophy to Dr. Li Zhigang, Vice President of Research and Development of Medicilon Chemistry Department, to thank Medicilon for its FTE form of cooperation, the pharmaceutical and chemical team helped it discover and advance the first drug candidate ABM-1310 to enter the clinical phase I in the United States.
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Medicilon Won Praise and Awards From Many Partners
Leading Tac Pharma's PROTAC drug project is a first-in-class research and development project that challenges anti-tumor and autoimmune diseases. In the cooperation with Medicilon, the Medicilon's DMPK team actively communicated with Leading Tac which helped customers solve a series of research and development problems such as large molecular weight, ensuring the completion of the project. Leading Tac awarded Medicilon the "Best Medicinal Chemistry Partner Team Award", "Best Biological DMPK Partner Team Award", "Best Biological DMPK Partner Individual Award", etc., affirming the cooperation with Medicilon.
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Feasibility assessment of new drug targets
High-throughput screening and discovery of active compounds based on structural design
Establishment of specific compound libraries (establishment of macromolecule compound library)
Rapid synthesis of PROTAC molecules and ADC payloads, as well as lipids, glycolipids, and phospholipids
Screening of new hit compounds from DEL (from active compounds to discovery of lead compounds)
Synthesis, discovery, and optimization of lead compounds
Research on SAR
Computer-aided drug design (CADD)
Processes from optimization of lead compounds to determination of preclinical drug candidates
Synthesis of reagents, intermediates, building blocks, reference compounds, metabolites, and impurities
Synthesis of Reference Compounds
Synthesis of customer-specific structure compounds
Preparation of APIs or related substances
Synthesis of standard substances
Synthesis design and preparation of impurities or metabolites
Synthesis of stable isotope internal standards
Synthesis of tritiated compounds
Synthesis and disassembly of chiral compounds
Scale-up synthesis and process optimization of preclinical candidate compounds
Synthesis of high-quality kilogram-level samples
Research on target compound synthesis technology
Separation of impurities in regulated starting materials, intermediates, APIs, and drug products using various techniques such as HPLC complete data – including 1D/2D NMR, LCMS, EA, HRMS, IR, and UV – to identify the structure of the separated impurities Collecting
Isolating and identifying the structures of API degradation products by forced oxidation
Employment of QNMR to quickly determine the contents of crude materials, intermediates, API, and synthetic impurities
NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, HSQC, HMBC, COSY, and NOESY)
LC-MS analysis
HPLC analysis (including ELSD detection)
Chiral purity testing
Preparation and separation in Pre-HPLC
Routine physical and chemical tests (ROI, LOD, Cl-, SO42-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)
Efficient team performance parameters.
Free for service (FFS) on-time delivery rate > 80%;
Chemical reaction success rate > 85%.
Compound delivered per full-time employee (FTE) each week;
The number of reactions completed by each scientific researcher > 12.
Our 10,000 m2 laboratory in Shanghai Nanhui Industrial Park is equipped with a comprehensive library of instruments and is managed under a modern business model and philosophy. We guarantee the quality and efficiency of any project we undertake. Supported by high-throughput chromatography and mass spectrometry and advanced processing software, Medicilon sets high standards for our compound screening and analysis, optimization of lead compounds, analysis of chemical and physical properties of compounds, and other drug R&D processes.
Medicilon's Chemistry Department is fully equipped with a wide range of instruments including UPLC, HPLC, LC-MS, GC-MS, GC, IC, SFC, prep-HPLC, MS directed Prep-HPLC, LC-MS-MS, and other chromatography analyzers, Biotag microwave reactors, high configuration semi-auto- chromatography system, Lyophilizer, DSC, TGA, XRPD, PSD, Polarized light microscopy, NMR, FT-IR, infrared spectroscopy (FT-IR), hydrometer (KF), ultraviolet and visible spectroscopy (UV-Vis), polarimeter, ICP-MS, NMR, HPLC, SFC, MS directed preparative HPLC, microwave reactor, DSC, TGA, thermogravimetric analyzer. ICP-MS inductively coupled plasma-mass spectrometry, etc.
Medicinal Chemistry has established the PROTAC drug discovery technology platform, which summarizes the current popular target protein ligands, establishes an extensive library of high-affinity small molecules and small molecule fragments of popular target proteins (TPSM), an extensive library of high-affinity small molecules and small molecule fragments of E3 ligases (E3SM), and a Linker system, including a large collection of Bifunctional linker (BF-Linker) with a wide diversity. Those compound libraries help to quickly and efficiently synthesize a large number of high-activity PROTAC bi-specific small molecules, thus greatly accelerating the process of drug R&D.
Medicilon will make every effort to establish and complete its PROTAC biological screening and testing platform, and the follow-up development of preclinical stages.
The molecular mechanism of PROTAC is to eliminate the target protein through the ubiquitin-proteasome system. This mechanism does not need a specific region on targets for drugs to bind like the traditional inhibitors do which functions through competitive binding. This makes some “non-druggable” target proteins “druggable”.
PROTAC molecules eliminate the target protein to amino acids through the ubiquitin-proteasome system and then can be released to react with other targets. Therefore PROTAC has the characteristics of recyclability, low dosage, and high efficiency.
Compared with biotechnology drugs, PROTAC does not trigger the production of anti-drug antibodies.
In conclusion, PROTAC has become a hotspot in the field of drug research and development which has been paid great attention by scientific research institutions and pharmaceutical companies worldwide.
Design and Synthesis of Target Protein PROTAC-POI
In vitro screening of PROTAC-POI
In Vivo Efficacy Tests of PROTAC-POI
PK/PD studies, pharmacological analysis, pharmacokinetic studies, and safety evaluation
Ringene Biopharma's pan-FGFR1-4 irreversible inhibitor RG002 tablets was approved for clinical use with the help of Medicilon one-stop preclinical biopharmaceutical R&D service platform
Medicilon assists Ringene Biopharma 's SHP2 allosteric inhibitor RG001 tablet to be approved for clinical use
ABM Therapeutics presented Medicilon with a commemorative trophy of "our first candidate compound"
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