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Photodynamic therapy drugs
ALA(Aminolevulinic acid Hydrochloride)

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 and the metabolism of ALA is the first step in the biochemical pathway resulting in heme synthesis. ALA is not a photosensitizer, but rather a metabolic precursor substance of protoporphyrin IX (PpIX), which is a photosensitizer.

In general, the content of ALA is few in normal cells and can’t produce photosensitization. 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.

A randomized, parallel CO2 laser-controlled, multi-center clinical study was conducted by Fudan-Zhangjiang Bio-Pharmaceutical Co,. Ltd (FDZJ). Patients with condyloma acuminatum (CA) were enrolled the group of ALA-PDT or the controlled randomly. 442 patients, including 331 patients in ALA-PDT, and 111 patients in control group, were completed in this trial. The clear rate were 98.42% in ALA-PDT group and 100% in control group respectively(P=0.0753). The recurrence rates were 10.77% and 33.33% in ALA-PDT and control group respectively(P<0.0001). The study shows that ALA–PDT has much higher efficacy and safety, and lower recurrence rate in CA cure. And we can draw a conclusion that ALA-PDT is a safe and effective treatment in CA therapy. .

Approved by State Food and Drug Administration (SFDA), in February 14 2007, the drug ALA (H20070027) gains the new drug certification and manufacturing approval and in May 2007, ALA was gone to sale. The successful development of ALA-PDT gives the new treatment for CA traditional areas, fill a gap in urethral orifice CA cure, become the best treatment for CA in preferred therapy.

FuMeiDa(Hemoporfin for Injection)

Hemoporfin and its formulation Hemoporfin for injection, an innovative porphyrin monomer Photodynamic Therapy (PDT) drug approved as class 1.1 by CFDA, is the second generation photosensitizer developed by Shanghai Fudan -Zhangjiang Bio-Pharmaceutical Co., Ltd. Hemoporfin has several significant technical advantages compared to the first generation photosensitizer HpD (hematoporphyrin derivatives). First, Hemoporfin is a monomeric compound with clear chemical structure and stable quality, while HpD is actually a complex mixture of porphyrins. Second, the phototoxic effect of Hemoporfin on normal tissue is extremely low. Moreover, both the acute and chronic toxicity of Hemoporfin are lower than hematoporphyrin derivatives. Therefore, Hemoporfin is safe in clinical usage with less adverse reactions. Third, 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. As a result, Hemoporfin is the most ideal photosensitizer for the treatment of port-wine stain at present stage.

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. Due to 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 of 28.10%. Clinical experts agree that Hemoporfin-PDT has brought an epoch-making progress to treat this difficult disease.

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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