Shandong Hubble Kisen Biological Technology Co., Ltd., a wholly owned subsidiary of Taienkang, is an innovative high-tech drug research and development enterprise co-founded by Taienkang in October 2015 with well-known experts in the field of pharmaceutical chemistry, pharmaceutical preparation and biopharmaceutical domestic and overseas. The company can complete the prescription process research, clinical research and commercial amplification research of drugs with high quality and high efficiency, also realize the full transformation of drugs from laboratory to market.
The R&D team has more than 90 employees, including two doctors, more than 20 masters, more than 90% of the staff with a bachelor’s degree or above. The team has many “5150” innovative talents and talents in short supply in key industries of Jinan city, Shandong Province. The company has 6,500 square meters of new high-end RESEARCH and development laboratory and pilot workshop. It is equipped with all the advanced instruments and equipment needed for the research of drug synthesis, drug preparation, drug analysis and biotechnology.
The company’s research direction interests include chemical innovative drugs, improved new drugs, generic drugs, and biomacromolecule drugs. Since its establishment in 6 years ago, the company has formed a ’’pyramid’’ of benign R&D structure: innovative drug as ’’the Top’’, improved new drugs and biotechnology platform as ’’the Body’’, and generic drugs as ’’the Base’’. The key technology platforms of functional excipients and nano drug delivery, biomacromolecule drugs, high-end generic drugs and consistency evaluation technology platforms have been established. Currently, a series of targeted anti-tumor innovative drugs, nano-micelle drugs, biotechnology drugs and characteristics generic drugs are under development. More than 30 varieties are being developed or declared.
Shandong Hubble Kisen was recognized as a ’’High-tech Enterprise’’ in 2019, and was one of the first batch of national pharmaceutical production license (Category B) in the form of pharmaceutical Marketing Authorization Holder (MAH) in 2020. The company’s first product ’’Dapoxetine Hydrochloride Tablets’’ have been successfully marketed, which is the first imitation variety in China and the first pharmaceutical production approval obtained by MAH in Shandong Province. ’’Dapoxetine Hydrochloride Tablets’’ (Aitingjiu) has achieved commercial production, its accumulated production and sales of more than 12 million tablets, and with good curative effect and excellent quality has been recognized by users.
Taienkang always treats the research and development as the primary area and continues to increase efforts. It’s Hubble Kisen R&D center is equipped with analysis, preparation, synthesis, fermentation and other research needs of a variety of instruments and equipment to world-class scientific research level for helping the career of medical and health to take-off.
There is a complete series of drug analysis instrument such as Agilent’s ’’online version’’ high performance liquid chromatography, totally 20 sets; Waters, Agilent, Shimadzu and other stand-alone high performance liquid chromatography totally 24 sets, and with 3 sets of Agilent GC, 10 sets of Agilent automatic dissolution instrument, as well as Agilent triple quadrupole LC / MS, ICP-MS, organic carbon analyzer, Malvin particle size analyzer, Mettler automatic moisture analyzer, high-precision one million balances, nano particle Zeta potential analyzer, etc., for the relevant equipment matching with a series of detectors, such as fluorescence detectors, evaporative light detector, differential refractive index detector.
It is equipped with more than 40 sets of equipment such as MALDI-TOF-MS liquid mass spectrometer, capillary electrophoresis apparatus, automatic constant temperature shaker, 10-100L full-automatic fermentation tank, atmospheric pressure and high pressure protein purification system for the development of biotechnology drugs; it has advanced solid preparation development equipment, including wet mixing granulator, multifunctional pelletizing and pelletizing machine, tablet press, coating machine, etc. in a total of 20 sets; it is also equipped with full-automatic bottle washing machine, dry heat and moist heat sterilizer, 2/5/10/25 ml full-automatic canning line, freeze dryer and other small volume injection pilot production lines.
The company has established three pharmaceutical R&D technology platforms: Key technology platform for functional accessories and nano-particle delivery, key technology platform for biopharmaceutical macromolecule drugs and technical platform for generic drug development and consistency evaluation.