As a research hotspot in drug delivery field, nano-drug delivery system (Nanoparticulate delivery systems) is a drug delivery system with particles between 1 - 1000 nm in diameter. Featured by characteristics of improving the drug physicochemical properties, pharmacokinetic properties and pharmacological and toxicological properties, nano-drug delivery system has the advantages of sustained release, controlled release and targeting compared to ordinary preparation. A large number of nano-drug delivery systems such as liposomes, albumin nanoparticles, polymers, micelles, lipid solids nanoparticles, and nanoemulsions have been designed and developed to improve the therapeutic efficacy of original agents, reduce their side effects and improve compliance.
The Group has been committed to becoming an innovative enterprise in the pharmaceutical field, especially focusing on the development of new drug dosage forms. At present, the company's nano-drug research and development platform is mainly composed of two parts. One is the lipid-based drug delivery system; another is albumin-based nanoparticles. Phospholipids and HAS (human serum albumin) with good biocompatibility and safety were respectively selected as drug carriers to form a new drug delivery system for small-molecule chemotherapy drugs, peptides and protein drugs to improve the tissue distribution after systemic drug delivery, selectively deliver drugs to pathological sites and avoid aggregation in normal tissues.
The progresses of the projects on nano technical platform are summarized as follows:
LIBOd® (里葆多®) for the treatment of tumors, was launched to China market in August, 2009. The drug is a new doxorubicin formulation which adopts the advanced stealth liposomal encapsulation technology and has passive targeting characteristics. It is a new generation of replacement for anthracycline drugs. In oncology, it has the advantages of enhancing efficacy and remarkably reducing the side effects such as cardiac toxicity, myelosuppression and hair-loss. Original drug product of doxorubicin hydrochloride liposome injection has been approved for the treatment of AIDS-relating Kaposi’s sarcoma, Multiple Myeloma and ovarian cancer in US.
LIBOd® is in the process of registration for US FDA. After the clinical data being accepted by FDA, a pre-approval inspection on facility will be conducted before regulatory approval granted by FDA.
Vincristine sulphate liposome (LVCR) for the treatment of malignant tumors has completed Phase I clinical trial. The Group decided to transfer this project to an independent third party pharmaceutical company based on the consideration of its future prospect, production conditions and payback period, etc.
Nanoparticle Albumin-bound Paclitaxel for the treatment of tumors, has entered into pre-clinical study stage and some improvements have been made in large-scale manufacturing process. The reform of existing production line for this project has been completed, and we will initiate the bioequivalence study and then submit marketing application as soon as possible.
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