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Photodynamic technical platform

        Photodynamic therapy (PDT), developed in the late 1970s, is a new technique for the selective treatment of malignant diseases, e.g. cancers. Following with operation, radiotherapy, chemotherapy and immunotherapy, PDT is a new way to treat cancers under the development of R&D, and has become one of the most active research fields studied by scientists relating to cancer in the world.
        The action mechanism of PDT: Photosensitizer specifically accumulates in the abnormal growth tissue (such as tumors and vascular proliferation) after administration, the photodynamic sensitization reaction will take place when irradiated under a specific wavelength light and the reactive oxygen species such as singlet oxygen (1O2) will be generated, which leads to biomacromolecule photooxidation inactivation, then trigger a cascade of biochemical responses which inactivate target cells either directly or through the induction of vascular stasis, 
        As the first photosensitizer, Porfimer Sodium, was successively approved in United States, Canada, Europe Union, Japan and Korea from 1993 to 1997, it greatly promoted research, development and application of PDT.  In recent years, with the development of new PDT drugs and improvement of laser equipment technology, PDT has ushered in the unprecedented peak of development. There are more than a dozen of new photodynamic drugs launched or under clinical studies in the world, the indications of which include lung cancer, esophageal cancer, bladder cancer, head and neck neoplasm, skin cancer, prostatic cancer, etc. Meanwhile, it is also widely used to treat non-tumor diseases such as condyloma acuminatum, port-wine stains (PWS), age-related macular degeneration (AMD), actinic keratosis, and so on. It is believed that PDT will become a routine clinical treatment.
        Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (FDZJ) closely pays attention and keeps pace with the international development of PDT, especially for the treatment of some precancerous lesions and non-tumor disease that cannot be treated or intervened at present. Early in 1999, FDZJ started to engage in the study of PDT drugs and gradually set up the PDT R&D platform. During this period, a complete R&D system including synthesis and screening of photosensitizers, research on indications and mechanism of action, process development, clinical studies, and development of supporting laser equipment and medical devices has been established.
        FDZJ has been expanding development of drugs based on photodynamic technical platform, and photodynamic medicine will become the most important product group of the company.

The progresses of the projects on photodynamic technical platform are summarized as follows:
        The photodynamic therapy with Aminolevulinic Acid Hydrochloride is one of the key R&D projects of the Group, and researches based on this therapy include photodynamic treatment of condyloma acuminatum (ALA,艾拉®), cervical intraepithelial neoplasia (CIN) infected by HPV, moderate to severe acne and adjunctive treatment of brain glioma. 
        ALA (艾拉®), the first photodynamic medicine for the treatment of condyloma acuminate in the world, several years after it was launched in China market from 2007, has achieved great responses and become the clinical preferred choice because of its safety, effectiveness and low recurrence rate. The treatment with ALA-mediated PDT developed by FDZJ was incorporated in the official clinical guidelines and < Dermatovenercology > from 2013. The latest ninth edition of <Dermatovenercology> adds the new application of the ALA-mediated photodynamic therapy on the acne treatment, and also includes Hemoporfin developed by the Group as new photosensitizer for the treatment of PW.
        The clinical research of ALA-mediated PDT on the treatment of CIN infected by HPV is still on progress. Previous literature shows that this therapy has a good therapeutic effect on CIN, and we will continue to optimize the clinical trial plan, adhere to the research of this project and strive for early approval of this new indication.
        Aminolevulinic Acid Hydrochloride used for the treatment of moderate to severe acne has obtained the clinical trial approval letter and phase I clinical study is under way.
        Aminolevulinic Acid Hydrochloride used for the adjunctive therapy of brain glioma has completed pre-clinical study. Considering market prospects and future capital investment, we decided to postpone this project.
        In addition to series products of Aminolevulinic Acid Hydrochloride, we also launched another important PDT drug-FuMeiDa® (the brand name of Hemoporfin in China), which is a new chemical entity(NCE). The product was launched in Chinese market in 2017, with the indication of PWS.
        PWS is the most common congenital vascular malformation characterized by ectatic capillaries in the papillary layer of the dermis. The visible manifestation of this disorder is often considered a disfigurement. The lesions tend to become darker and thicker with time and rarely fade away for life. PWS occurs in anywhere on the body and particularly in face and neck and is reported about 0.3~0.4% incidence of infants worldwide. Before age 40, over 65% of patients without treatment will face the situation of thicken and modular lesions cause great emotional depression.
        After injection into the blood, Hemoporfin spreads quickly to the surrounding tissues and tends to distribute specifically in vascular endothelial cells. It would selectively damage the photosensitizer-rich vascular endothelium by the use of laser or LEDs with certain wavelength. The dilated and abnormal capillaries in the lesions of patients will be cleared by photodynamic reaction and further effects of coagulation system. As a second generation photosensitizer, compared with traditional therapies, Hemoporfin is featured by stable chemical structure, lower photosensitization, rapider metabolism, shorter light-avoidance period requirement, more uniform to treat, higher cure rate, lower incidence of scar formation and lower recurrence rate. The excellent efficacy of the drug in the market and the high cure rate compared to the traditional laser treatment rejoice the clinicians and researchers. FuMeiDa® was launched to market in 2017 and the post-marketing Phase IV clinical trial is under way. Meanwhile, the international registration of this drug was officially initiated in 2017. The Group has already made a preliminary communication with the Food and Drug Administration of the United States (“FDA”). We will submit the IND application as soon as we optimize the corresponding registration scheme.
        Deuteporfin, as a photosensitizer for treatment of tumors, has entered into the Phase II clinical trial. The progress of its clinical trial was slow due to various reasons. Considering the safety and efficacy of the drug, we decided to terminate the clinical research.

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