Healthgen Biotech Project HY-1003 Obtained the Orphan Drug Designation from U.S. FDA

Source:Posted by Themecurve| Time:2020-03-25| Hits:699

February 19, 2020, the project HY-1003, Recombinant human Alpha-1 Antitrypsin, a new bio-pharmaceutical independently developed by Wuhan Healthgen Biotechnology Corp.( hereinafter referred to as Healthgen Biotech) by its State-of-the-Art plant expression platform, had obtained the orphan drug designation(ODD, No.:DRU-2019-7242 ) from U.S. FDA. It is another global new bio-pharmaceutical of Healthgen Biotech approved by the U.S. FDA after the plant derived recombinant human serum albumin was approved by the U.S. FDA for clinical trials, and it is also Healthgen Biotech’s first biopharmaceutical obtained the ODD. The project HY-1003 will be mainly used to treat emphysema caused by alpha-1 antitrypsin deficiency(AATD).


There are approximately 80,000-100,000 patients with emphysema caused by AATD in the U.S., and approximately 3 million people worldwide. The effective drugs for treatment is alpha-1 antitrypsin, which is completely extracted from human plasma. In the U.S., there are only about 45% of patient can use it due to the shortage supply.


The project HY-1003 is expected to solve the problem of shortage supply of emphysema therapeutic drugs. Furthermore, In the ODD approval document, FDA believes that the  alpha-1 antitrypsin derived from rice can avoid the contamination of infectious pathogens compared with the same type of drug derived from human blood, and has obvious advantages in safety. Therefore, FDA has taken the initiative to expand the scope of application of indications, which provides a larger market space for this product.


Currently, the cost of treatment for emphysema (augmentation therapy) is as high as $127,000/person per year. Based on 30% of the current market capacity, the project HY-1003 is expected to have a U.S. market of more than 3 billion U.S. dollars and a global market of approximately 100 billion U.S. dollars.

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