On November 30th, Healthgen Biotechnology Corp. announced a significant research outcome at the 9th Pharmaceutical Innovation and Investment Conference. The company’s independently developed recombinant human serum albumin injection (Aofumin®) has successfully met its clinical study endpoints, marking a notable advancement in the field of plant-based recombinant protein drugs globally.
Clinical Efficacy and Safety of OsrHSA Validated
During the conference, Professor Yang Daichang, Chairman of Healthgen Biotechnology, detailed the effectiveness and safety of the recombinant human serum albumin injection (Aofumin®) in patients with cirrhosis and hypoalbuminemia. Clinical data demonstrated that its efficacy is comparable to that of control human serum albumin, with a favorable safety profile.
Healthgen’s Innovative Technology Platform and First-in-Class Drug
Healthgen Biotechnology possesses a leading plant bioreactor technology platform. The company’s self-developed recombinant human serum albumin injection (OsrHSA, HY1001) is a first-in-class drug that utilizes an innovative rice endosperm cell bioreactor expression system. This system offers advantages such as uniformity, the elimination of potential risks of blood-borne disease transmission, and is environmentally friendly with low manufacturing costs. Compared to yeast expression systems, the rice endosperm cell system is safer, has lower immunogenicity, and is more cost-effective. In August 2024, it was included in the priority review list by the National Medical Products Administration and received acceptance for new drug application on September 12th. It is poised to become the first recombinant human serum albumin product approved in China, potentially rewriting the history of human serum albumin production and alleviating the country’s long-term dependence on imports to better meet the significant health needs of the population.
Healthgen Partners with Betta Pharmaceuticals for Commercialization
On September 29, 2024, Betta Pharmaceuticals Co., Ltd. reached a commercialization cooperation with Healthgen Biotechnology to jointly develop this globally pioneering plant-derived recombinant blood product. This collaboration is set to expedite the availability of recombinant human serum albumin to patients, offering a swift benefit to those in need.-Fineline Info & Tech
