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HanAll’s HL036 eye drops for dry eye syndrome treatment was approved of phase 2 clinical trial IND in China


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HL036 (Chinese code: HBM9036), which HanAll BioPharma licensed out to a Chinese company, Harbour Biomed, was approved of phase 2 clinical trial IND in China by the National Medical Products Administration (NMPA) of China. Harbour Biomed plans to measure the evaluation indices such as the degree of inhibition of corneal damage and reduction of eye irritation by administering the eye drops in 180 patients with dry eye syndrome twice a day for eight weeks.

HanAll is directly involved in global clinical development separately from clinical trials in China. In the U.S., the company has already completed phase 2 clinical trials and will begin Phase 3 trials in the U.S. early next year. The results of phase 2 clinical trials in the U.S. will be presented orally at the Ophthalmology Innovation Summit (OIS) at the American Academy of Ophthalmology’s event this month in Chicago, USA.

Shin Minjae, Executive Director at HanAll BioPharma, said, “HL036 is a new bio drug that inhibits TNF (tumor necrosis factor), an inflammatory cytokine that exacerbates dry eye syndrome, and we confirmed a significant improvement of inhibition of corneal damage and alleviation of dry eye syndrome in the topline results of phase 2 clinical trials conducted in the U.S.”

Dr. Xiaoxiang Chen, Head of Clinical Development and Regulatory Science at Harbour Biomed, said, “The medical demand for dry eye syndrome treatment in China is very high.” “HBM9036, an IND-approved eye drops, is expected to establish itself as an innovative biopharmaceutical in the field of ophthalmology.”

Harbour Biomed is a biopharmaceutical company established in Shanghai in 2016 by Dr. Jingsong Wang, who was the Head of China Research and Development Center of Sanofi, a global pharmaceutical company, and it focuses on the development of anticancer drugs and treatments for immune diseases. It acquired Harbor Antibodies, a Netherland-based company which owns a platform technology for antibody, as its subsidiary