The Global Premiere of Clinical trial Phase I data of recombinant human lactoferrin and Lysozyme Oral Solution (Project HY1002)

September 25, 2021, the 6th “China Biomed Innovation and Investment Conference” was successfully held in Suzhou. As the star session of the conference, the Global Premiere of Clinical Data session attracted much attention from all walks of life. This year, there are nine new biopharmaceuticals in development and on the market were presented, and the key clinical data of each phase were disclosed for the first time, involving the latest progress of innovative drugs for glioblastoma, nasopharyngeal carcinoma, infant rotavirus infection, diabetes and alopecia areata. The conference was chaired by Dr. Dajun Yang, CEO of Ascentage Pharma and Chairman of the China Pharmaceutical Innovation Promotion Association.

Moderator, Dr. Dajun Yang

The nine projects in this year's clinical debut session all focus on diseases with urgent clinical needs and lack of effective treatments. Among them, the Plant-derived Recombinant Human Lactoferrin and Lysozyme Oral Solution project (hereinafter referred to as "HY1002") independently developed by Wuhan Healthgen Biotechnology Corp.(hereinafter referred to as Healthgen biotech), an innovative biopharmaceutical for the treatment of acute diarrhea caused by rotavirus infection in children, was presented at this conference.

Reporter, Zhijie Qin, Chief Medical Officer of Wuhan Healthgen Biotechnology Corp.

Rotavirus is the leading cause of acute gastroenteritis in infants and children under 5 years old worldwide. In China, rotavirus gastroenteritis accounts for about 40% and 30% of inpatient and outpatient cases of diarrhea in children under 5 years old, respectively, and about 90% of rotavirus gastroenteritis cases occur in children under 2 years old, which places a heavy burden on the health care system and patients' families. It is a widespread concern in pediatrics and public health. While, there is a lack of specific clinical treatment.

HY1002, an innovative biopharmaceutical for the treatment of acute diarrhea of rotavirus infection in children, was developed by Healthgen biotech, is a plant-derived recombinant human Lactoferrin and Lysozyme Oral Solution. In the multiple dose escalation study, 12 subjects were enrolled and the investigators administered the test drug at 60 mg/kg and 80 mg/kg respectively. The results of the trial showed "5 None", i.e. no serious adverse events in the clinical trial; no adverse events of drug withdrew; no adverse reactions leading to drug withdrew; no adverse events leading to discontinuation of the study drug; and no adverse reactions leading to discontinuation of the study drug.

Given the good safety and tolerability of the drug after single administration and multiple administration over 5 consecutive days in healthy Chinese adult subjects, a phase II clinical study has been initiated for the indication of acute diarrhea in young children due to rotavirus infection.