Hubble Kisen is a modern high-tech pharmaceutical company. The company has more than 90 top professional and technical personnel in the fields of chemistry, preparation, biopharmaceuticals, among which there are more than 10 doctors and more than 20 masters, and more than 90% of them have bachelor degree or above.
With senior review consultant and registration team, familiar with CFDA, FDA, EMA registration procedures and requirements.
It has perfect rules and systems for project establishment, research and development, process quality control, and incentives to ensure the steady progress of the project.
At the beginning of the company’s establishment, it took "Care for life with continuous innovation" as its own responsibility, adhered to the enterprise spirit of "Excellent, innovation, integrity, and dedication", while rapidly developing, actively assumed various social responsibilities and gave back to the society with gratitude.
Based on industry policies, Hubble Kisen has set a research and development strategy that uses innovative drugs as the "spire", improved new drugs as the "tower body" and generic drugs as the "tower base". In the field of research covers many fields, including tumor, cardio cerebral blood vessel, diabetes, skin and gynecological diseases, 3 technological platforms have been built according to the research and development strategy:1. Key technology platform of functional excipients and nanomedicine
The research includes nanocarrier excipients, controllable preparation of nanopharmaceuticals, large-scale production and quality evaluation system. The platform has hardware such as Malvern particle size analyzer, nanopharmaceutical pilot freeze-drying line, and functional auxiliary materials pilot synthesis workshop. Functional excipients and nano drugs.2. Key technology platform of biological macromolecular drugs
It has constructed Escherichia coli high-efficiency expression technology platform, glycosyl engineering Pichia pastoris technology platform, phage display technology platform, built a biotechnology drug pilot and quality research platform, developed Biosimilar ranibizumab, romistimum, certozine Monoclonal antibodies and other projects will quickly realize the transformation of high-end biological macromolecules from research and development to mass production.3. Generic drug development and consistency evaluation technology platform
It has 20 online versions of Agilent HPLC, 10 stand-alone versions of HPLC; 2 sets of gas chromatography, 10 sets of Agilent automatic sampling dissolution apparatus, 1 set of liquid chromatography, and one-millionth electronic balance, potency tester, dry and wet Laser particle size analyzer, rapid moisture analyzer, transdermal absorption analyzer, automatic polarimeter, multifunctional granulating / pelletizing / coating fluidized bed, tablet press, granulator, vacuum freeze dryer, dissolution apparatus, Aluminum-plastic blister packaging machine, three-dimensional motion mixer, constant temperature and humidity box, low temperature and high speed centrifuge and other advanced equipment.
Based on the principle of "Approval, R & D, and production for the current project", Hubble Kisen has obtained 2 clinical approvals, 1 clinical acceptance of 2.2 new drugs, 1 new excipient, and 2 reports for production; More than 30 other varieties are steadily advancing, and the Xinli project is also being followed up; its functional excipients and key technology platforms for nano-medicine and biomacromolecule platforms will gradually launch more new drugs, generic drugs and consistency evaluation technology platform in the future, 3-4 new varieties will obtain production approval documents every year, enriching our sales market.