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HanAll Biopharma’s New Antibody Drug, “HL161,” Accelerates its Global Development Through the Launch of Immunovant


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HanAll Biopharma announced on the 11th that its partner, Roivant Sciences, will establish a separate drug development company specialized in autoimmune diseases to accelerate the global clinical development of “HL161,” the new antibody drug for treatment of autoimmune diseases.

Roivant's new drug development company, “Immunovant,” plans to accelerate the global clinical development of HL161 (RVT-1401), a core asset, by focusing its development capabilities on immune diseases. Dr Eric Venker, a physician from the Yale School of Medicine and pharmacist, was appointed as a person in charge of development.

On the 10th, Roivant held an event called “Roivant’s Annual Pipeline Day” in New York City, the U.S. to introduce its new drug pipelines, and announced the establishment of Immunovant and the interim results of the phase 1 clinical trial of HL161(RVT-1401) at the event.

HL161 is a biopharmaceutical that treats autoimmune diseases by reducing pathogenic autoantibodies in the body and has been undergoing phase 1 clinical trials in Australia and Canada since late last year. In the interim results of the phase 1 clinical trial, it was confirmed that the serum IgG (Immunoglobulin G), which is a biomarker that can directly measure the drug efficacy, was rapidly decreased even at the low dose of HL161. A total of 31 healthy persons who have been treated so far have demonstrated excellent tolerability and safety.

“Since Roivant established Immonovant to develop HL161 intensively, we expect that global clinical development will accelerate,” said an official of HanAll Biopharma. “HL161 clinical trials are underway and are being developed as subcutaneous injectable formulations that can be self-administered. Its demonstrate superior product profiles compared to competing products and will continue to increase the value of the new drug as the best-in-class product,” he added.
"HL161 is being developed as a subcutaneous injectable formulation that can be self-administered "The new drug value will continue to rise as a best-in-class product."

An autoimmune disease is a disease caused by an antibody or an immune cell, which protects the body from external intruders such as bacteria and viruses, attacks the patient’s body. The symptoms vary depending on which part of the body the antibody attacks, and they are divided into more than 100 diseases. The new antibody drug, HL161, is increasing its potential as a therapeutic agent for rare intractable autoimmune diseases such as myasthenia gravis, pemphigus, and optic neuritis, which are caused by pathogenic autoantibodies.

Roivant has a business vision to make patients use drugs faster by reducing the time and cost of new drug development. So far, 30 drug candidates have been licensed and developed in 11 disease areas. Roivant has been licensed for the exclusive commercialization of HL161 in the United States, Europe, Central and South America, the Middle East and North Africa, subject to upfront and milestone payments of USD 502.5 million and separate royalties to HanAll Biopharma in December last year.