Beijing Engineering Research Center for Targeted Lipid Formulations (the Engineering Center) was established by Beijing Tide Pharmaceutical Co., Ltd. (Tide) to research, develop and manufacture targeted preparations of chemical and biological drugs for sales in China and for exports (conditions permitting). Through systematic research and industrial production of targeted lipid preparations, the Engineering Center aims to establish a "Created-in-Beijing" brand and lead Beijing’s biopharmaceutical industry in high-end manufacturing.
Targeted formulation, also called targeting drug delivery system (TDDS), transport drugs with a suitable carrier to designated locations in the body for clinically desired duration and dose, and then release the drug in a controlled manner to realize effective treatment of diseases. The body part with the lesion is often referred to as the target site, which could be a target tissue or organ, a target cell, or an intracellular target. Application of targeted formulations enables drugs to exert their therapeutic effects with high efficiency and low toxicity, and could significantly improve overall therapeutic effect of drugs and lower adverse reactions and other side effects. The targeted lipid formulations studied by Tide are chemical drug formulations (e.g., liposomes, lipid microspheres) prepared with lipid excipients (e.g., lecithin, soy lecithin), and protein drugs with structural modifications involving phospholipids. These targeted lipid formulations can improve drug permeation through cell membranes and improve drug effectiveness. Tide has made substantial progresses and has been awarded patents in China and other countries. The patented formulations may also establish a novel preparation method for making targeted biological products.
As an international metropolis, Beijing is expected to lead the country in modernization and sustainable development under open conditions. Meanwhile, Beijing faces relative shortage of water, land, energy and other natural resources, and needs to meet strict environmental standards while serving a growing population. Therefore, Beijing should vigorously develop high value-added hi-tech industries which consume less water, land, energy and produce less pollution. The R&D of targeted drug formulations is in line with the development trend of Beijing. The pharmaceutical formulation industry uses less land, water and energy; the majority of materials can be recycled; and formulation processes complying with pharmaceutical GMP do not produce significant pollution. On the other hand, the high added value of the products, especially the targeted formulations, could provide high tax revenue for Beijing.
By the end of 2012, the Engineering Center has introduced two targeted lipid formulations into the market and both have grown to high sales volume of prescription drugs in Beijing (annual sales over RMB 500 million Yuan): Alprostadil Injection (brand name: Kaishi®) is Beijing's first locally manufactured prescription drug with annual sales over 1 billion Yuan; and Flurbiprofen Axetil Injection (brand name: Kaifen®) is the first analgesic drug with annual sales over 500 million Yuan. Tide Pharmaceutical will continue to conduct researches based upon targeted formulations with lipid microsphere carriers, and will gradually develop new pharmaceutical research and production platforms for biological products, micro-granulated solid dispersion preparations and liposomal preparations, which will help to improve the standing of Beijing’s pharmaceutical companies in China’s pharma field.
Since its inception, Tide has been paying much attention to talent acquisition and training, and has recruited highly qualified staff to participate in the establishment of the Engineering Center for targeted lipid formulations. Most of the technical staff in the Engineering Center graduated from distinguished institutions/universities, such as Tsinghua University, Peking University, and Capital Medical University, and have many years of experience in pharmacy, pharmacology and clinical fields. Nearly half of the R&D staff participated in the R&D of Alprostadil Injection and Flurbiprofen Axetil Injection and possesse experience in manufacture for lipid microsphere formulations. In 2012, the Engineering Center (as a subsidiary of Beijing Tide Pharmaceutical Co., Ltd.) applied to BDA for setting up a postdoctoral training program within the center, and by the end of year this application was approved by the China National Postdoctoral Administrative Office. In 2013, Tide will go all-out to set up the postdoctoral training program in order to attract talents to engage in research in pharmacy and pharmaceutical formulations in the Engineering Center.
In 2013, Tide allocated funding to expand the existing engineering center in order to realize the whole process of independent R&D, from experimental study, small scale development and production, pilot production, to industrial production, for multiple targeted formulations, and to undertake comprehensive research required for pre- and post-market launch of new drugs. The expanded Engineering Center covers a total of 40,000 square meters and has the capacity to produce samples under GMP conditions in pilot plant and even larger scales. The dosage forms produced will include small volume injections, large volume infusions, liposomes, emulsions, and transdermal patches, and the Engineering Center has the capacity to handle the development of biological products. This expansion will further enhance the R&D capabilities of Tide and meet its R&D needs in pre-clinical and clinical studies. Meanwhile, the expanded center will provide drugs for clinical trials and accumulate technical experiences for large-scale production; and it will carry out production with the pilot line to supply drugs for market sales during the first five years after launch of new product. In addition, with the completion of this grand center, Tide hopes to attract more pharma R&D talents to join the enterprise to undertake high-quality research together, to develop and launch more drugs to meet clinical needs, and to build a stronger and larger enterprise.