Hanall Biopharma has begun administrating HL161 (ingredient: batoclimab) in phase 3 clinical trials conducted in China for treating myasthenia gravis.
Harbour Biomed, Hanall Biopharm’s Chinese partner, is conducting clinical trials in patients with a rare long-term condition that causes muscle weakness. The phase 3 clinical trial will be the last step needed for receiving regulatory approval.
Harbour Biomed plans to complete the study by 2022 and apply for a biologics license to the National Medical Products Administration in China.
The company saw positive results in phase 2 clinical trials of HL161 treating myasthenia gravis in July. The drug candidate showed a statistically significant improvement compared to placebo in the daily life performance of patients with myasthenia gravis, and it also had excellent safety and tolerability.
Morgan Stanley predicted that the Chinese myasthenia gravis market will grow rapidly to reach 1.27 trillion won ($1.07 billion) by 2030, expecting batoclimab to be widely used for myasthenia gravis once authorized, as the nation lacks treatment for the disorder at the moment.
“Batoclimab has proven efficacy and safety compared to placebo in Chinese patients with myasthenia gravis through previous clinical trials,” said Dr. Chongbo Zhao of the Huashan Hospital of Fudan University, China. “The study results indicate that anti-FcRn therapy, batoclimab, can rapidly and effectively improve myasthenia gravis and other autoimmune diseases.”
Harbour Biomed CEO Jingsong Wang also said, “We lacked an effective treatment for myasthenia gravis in China for decades, but we are getting closer to provide patients with batoclimab with excellent efficacy and soon achieve positive outcomes in the studies.”
Hanall Biopharma signed an agreement with Harbour Biomed in 2017 and granted the rights to develop and commercialize HL161 in China. Under the accord, the Chinese pharmaceutical partner will be providing milestone payments for each developmental stage of HL161 and give royalties corresponding to sales in China.