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Photodynamic technology drugs
Aminolevulinic Acid Hydrochloride Topical Powder(艾拉®

        5-Aminolevulinic Acid Hydrochloride (ALA) is the second generation photosensitizer developed in recent years. It is a precursor substance in the process of hemoglobin synthesis. In general, the content of ALA is few in normal cells and can’t produce photosensitization. After entering into the body, exogenous ALA can be selectively absorbed and accumulated by proliferative active cells, and the metabolic conversion of ALA to PpIX or other porphyrins in the cells occurs. The photodynamic sensitization reaction will take place when PpIX as a strong photosensitizer is irradiated under a specific wavelength light and the reactive oxygen species such as singlet oxygen (1O2) will be generated, which leads to death of proliferative active cells and does not result in adverse effects on normal tissues.
        On the basis of a large number of scientific data about ALA, according to the disease spectrum and market characteristics of China, FDZJ selected infectious disease caused by the human papillomavirus (HPV) -- condyloma acuminatum as the development direction, and firstly initiated clinical research for ALA treatment of condyloma acuminatum as an new indication in the worldwide. The study showed that the clear rate was up to 98.42%, and the recurrence rates was only 10.77%. Meanwhile, the ALA-PDT treatment is featured by good patient’s tolerance, high safety, no scar, and the incidence of adverse reactions was only 7.67%. The experts draw a conclusion that ALA-PDT is the preferred choice for urethral orifice CA cure and a first-line treatment for CA traditional areas.
        Approved by State Food and Drug Administration (SFDA), in February 14 2007, the drug艾拉® (Guo Yao Zhun Zi H20070027) gains the new drug certification and manufacturing approval and in May 2007, ALA was gone to sale.                                            
        Indication of ALA: CA. CA cells are similarly proliferative active with cancer cells. Photosensitization following application of ALA Topical Solution occurs through the metabolic conversion of ALA to PpIX, which accumulates in the skin to which ALA Topical Solution has been applied. When exposed to light of appropriate wavelength and energy, the accumulated PpIX produce a photodynamic reaction, a cytotoxic process dependent upon the simultaneous presence of light and oxygen. The phototoxic effect of PDT is confined to the immediate vicinity of drug localization and does not result in adverse effects on normal tissues. In particular, subclinical and latent infections can also be cleared, thus reducing the recurrence rate.
        The successful development of ALA-PDT gives the new treatment for CA traditional areas, become the best treatment for CA in preferred therapy.

Hemoporfin for Injection (复美达®)

        Hemoporfin and its formulation Hemoporfin for Injection, an innovative porphyrin monomer Photodynamic Therapy (PDT) drug approved as class 1.1 by CFDA, is developed by Shanghai Fudan -Zhangjiang Bio-Pharmaceutical Co., Ltd. Hemoporfin has several significant technical advantages as the second generation photosensitizer. Firstly, hemoporfin is a monomeric compound with clear chemical structure and stable quality. Secondly, the phototoxic effect of hemoporfin on normal tissue is extremely low. Therefore, hemoporfin is safe in clinical usage with less adverse reactions. Thirdly, hemoporfin has features such as rapid metabolism and clearance, which makes it possess superiorities of a short light-avoidance period and the possibility of repeated treatments in a short time.
        The mechanism of the treatment of port-wine stain by Hemoporfin-PDT can be described as follows. Hemoporfin reaches peak concentration in the blood immediately after intravenous injection and spreads quickly to the surrounding tissues. Hemoporfin tends to distribute specifically in vascular endothelial cells but less in epidermal cells. When irradiated by laser or LED with certain wavelength at this point, the photodynamic reaction of hemoporfin will be triggered and the photosensitizer-rich vascular endothelium can be selectively damaged. The dilated and abnormal capillaries in the lesions of patients will be cleared by photodynamic reaction and further effects of coagulation system. Because of the selective distribution of hemoporfin, the normal epidermis in the PWS lesions will not be damaged by PDT, and the deep dermal tissue beneath it will not be injured as well since the penetration depth of the laser or LED light with certain wavelength is not enough.
        Through clinical trials, it was shown that Hemoporfin-PDT for port-wine stain, after two courses of treatment, revealed a total effective rate of 97.4% and a basic recovery rate up to 28.10%. Hemoporfin for injection as Chemical Drug Class 1.1 was approved by China Food and Drug Administration (CFDA) and obtained the new drug certification which number is “Guo Yao Zheng Zi H20120076” in December 2012. In October 2016, the Company has obtained drug approval issued by CFDA for Hemoporfin for injection, which number is “Guo Yao Zhun Zi H20163349”, officially launch on the market.

This page outlines FDZJ drug development portfolio. The content of the portfolio will change over time as new compounds progress from discovery to development. Due to the nature of the drug development process, it is not unusual for some compounds, especially those in early stages of investigation, to be terminated as they progress through development. For competitive reasons, some projects have not been disclosed and some project types may not have been identified.

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