HanAll Biopharma's 'HL161' Expands Development Indications to 6 in US and China
Chinese Partner Company Receives Approval for Phase 2 Clinical Trial of 'Chronic Inflammatory Demyelinating Polyneuropathy'
[Asia Economy Reporter Kim Ji-hee] HanAll Biopharma's Chinese partner Harbor Biomed announced on the 2nd that it has received approval from the National Medical Products Administration (NMPA) for the clinical trial plan (IND) for phase 2 clinical trials of the autoimmune disease treatment HL161 for 'chronic inflammatory demyelinating polyneuropathy.'
Harbor Biomed holds the development rights for HL161 in the China region through a license agreement with HanAll. Currently, development is underway for four diseases with high unmet needs: myasthenia gravis, thyroid eye disease, thrombocytopenia, and neuromyelitis optica spectrum disorder. With the recent approval for chronic inflammatory demyelinating polyneuropathy, the development will expand to a total of five indications.
Chronic inflammatory demyelinating polyneuropathy is a disease characterized by chronic symptoms such as muscle weakness and sensory impairment. Steroids and immunoglobulins (a treatment method that administers large amounts of antibodies collected from others' blood to alleviate symptoms) are used for patients, but the company explained that there is high demand for effective treatments with fewer side effects.
HanAll Biopharma's U.S. partner Immunovant is developing treatments for myasthenia gravis, thyroid eye disease, and warm antibody hemolytic anemia. Next year, they plan to add two more indications, aiming for clinical trials covering a total of five diseases.
As a result, HL161 will be developed for a total of six indications in North America and China, including myasthenia gravis, thyroid eye disease, warm antibody hemolytic anemia, thrombocytopenia, neuromyelitis optica spectrum disorder, and chronic inflammatory demyelinating polyneuropathy.
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Jing Songwang, CEO of Harbor Biomed, said, "Due to the side effects of steroids and the limited accessibility of immunoglobulins, there is an urgent need for effective and new treatments for autoimmune diseases," adding, "The new mechanism of action of HL161 will provide a safe and efficacious treatment."
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