Harbour BioMed, HanAll Biopharma’s Chinese partner, announced the first dosing of Phase 3 trial of HL036 in dry eye disease, a novel, topical anti-TNF alpha biologic, in China on the 12th.
The purpose of this Phase III clinical trial is to evaluate the effectiveness and safety of Tanfanercept (HBM9036) eye drops (0.25%) compared with placebo in the treatment of moderate-to-severe DED patients in China. This clinical trial is led by Professor Zuguo Liu, Chairman of Asia Dry Eye Society (ADES) and Director of Eye Institute of Xiamen University.
Dry eye disease is a chronic eye disease with various causes. It can cause visual impairment and damage on the surface of the eye and is a disease that lowers the patient’s quality of life. According to Harbour BioMed data, 21-30% of the Chinese population suffers from dry eye disease, and the number of patients is expected to increase considerably due to aging, excessive use of smartphones, changes in the atmospheric environment, and other factors.
Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed said: “Owing to the changing lifestyle and aging population, the number of DED patients in China has been increasing significantly in recent years crossing 300 million in 2020. Following the initiation of Phase III clinical trial, we aim to further accelerate the commercialization of this novel therapeutic solution for DED to Chinese patients very soon.”
In 2017, Harbour BioMed obtained the rights to the development and commercialization of HL036, a medicine for dry eye disease, and HL161, a therapeutic antibody for autoimmune diseases, for the China region including Taiwan, Hong Kong, and Macao through a licensing agreement with HanAll Biopharma. Under the terms of the agreement, HanAll Biopharma will be eligible to receive potentially up to $81 million in development, regulatory and sales milestones as well as tiered royalties on net sales of both products.
Meanwhile, for the HL036 eye drop, HanAll Biopharma and Daewoong Pharmaceutical completed the first Phase 3 clinical trial (VELOS-2) in the U.S. last year and are planning to start a second Phase 3 clinical trial in the third quarter of this year.