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10% IVIG of Hualan Bio Obtaining Clinical Trial Notification

10% IVIG of Hualan Bio Obtaining Clinical Trial Notification

Recently, Hualan Biological Engineering Inc. has obtained Clinical Trial Notification for Human Immunoglobulin (pH4) for Intravenous Injection (IVIG) of three specifications issued by the NMPA. The product is a new generation of Human Immunoglobulin (pH4) for Intravenous Injection prepared by double virus removal technology, chromatography purification process and nano-membrane filtration + low pH incubation. The specifications, product yield, virus safety and other aspects have been improved. At present, there are no similar technologies and high concentration products on the market in China. According to registration procedure, Hualan Bio shall implement clinical trials as soon as possible after obtaining Clinical Trial Notification. Hualan Bio will apply the production approval documents after the successful clinical trial.

Details of the above IVIG are as follows:

Product name

Indication

Strength

Dosage

Human Immunoglobulin (pH4) for Intravenous Injection

1. Primary immunoglobulin deficiency diseases, such as X-linked hypoimmunoglobulinemia, common variable immunodeficiency disease (CVID), IgG subclass deficiency, etc.

2. Secondary immunoglobulin deficiency diseases, such as severe infections, neonatal sepsis, etc.

3. Autoimmune diseases (AID), such as primary thrombocytopenic purpura, Kawasaki disease (KD), etc.

2.5g/Vial (10% 25ml)

Injection

2.5g/Vial 5% 50ml

5g/Vial    (10% 50ml)

Hualan | Hualan Biological


TAG:  Human Immunoglobulin (pH4), NMPA, Hualan Bio, Clinical Trial Notification