HanAll Biopharma's Chinese partner, Harbour BioMed, said it has resubmitted the biologics license application (BLA) for HBM9161 (ingredient: batoclimab), a myasthenia gravis treatment candidate, to the Chinese National Medical Products Administration (NMPA).

The resubmission comes after Harbour BioMed secured positive top-line data that met the primary endpoint from a phase 3 clinical trial conducted on Chinese patients with myasthenia gravis in March 2023.

Subsequently, in June of the same year, the company submitted a BLA to the NMPA for the marketing authorization of HBM9161 in China.

However, after consultation with the NMPA, Harbour BioMed voluntarily withdrew the BLA to include the extension period data from the ongoing phase 3 trial in their submission in December.

Harbour BioMed has stated that the resubmission includes long-term safety data from the phase 3 clinical trial, by clinical protocols, without additional patient recruitment.

Previously, batoclimab demonstrated statistically significant improvements over placebo in the primary endpoint of the phase 3 trial, and key secondary endpoints were also met.

Consistent safety and tolerability were reaffirmed in the earlier phase 2 trial, and no new adverse events were reported.

"Batoclimab has not only demonstrated consistent data through multiple clinical trials but also has been developed in a subcutaneous injection form, which is expected to significantly improve patient's quality of life," HanAll Biopharma CEO Jung Seung-won said. "With this resubmission of the BLA, we will continue our efforts to commercialize batoclimab in China as well as in the U.S. and Japan."

HanAll Biopharma is also set to receive royalties based on the annual sales of batoclimab in China, as part of its agreement with Harbour BioMed.