Mirae Asset Securities logo

Batoclimab phase 3 trial data announced

Immunovant announces positive clinical trial results

On Mar. 19, HanAll Biopharma’s US partner Immunovant announced key clinical trial results for batoclimab. In a phase 3 trial for the treatment of myasthenia gravis (MG), batoclimab met the primary endpoint (i.e., mean change in MG-ADL score from baseline at week 12). The high-dose group showed a 5.6p improvement on the MG-ADL scale (with IgG reduced by 74%), while the low-dose group saw a 4.7p improvement (with IgG reduced by 64%). Meanwhile, in a phase 2b trial for chronic inflammatory demyelinating polyneuropathy (CIDP), batoclimab showed a 1.8p average improvement in adjusted INCAT disability scores, with an 84% response rate in patients achieving a 70% or greater reduction in IgG levels.

Despite positive results, commercialization plans put on hold for now

Despite the positive results, Immunovant will not immediately seek FDA approval for batoclimab for MG or CIDP; instead, it intends to wait until the results of ongoing phase 3 trials for thyroid eye disease (TED) are available (likely in 2H25) before deciding on approval/commercialization plans. In the meantime, it plans to prioritize IMVT-1402 (leveraging data from the batoclimab trials to accelerate development/explore new indications). Immunovant’s strategy update following the release of TED trial results later this year should serve as a key inflection point.

IMVT-1402 development is progressing smoothly, with six investigational new drug (IND) applications now cleared and pivotal studies (2.25ml autoinjector) for Graves’ disease and difficult-to-treat rheumatoid arthritis (D2T RA) in the enrollment stages.

Retain Buy, but lower TP to W44,000

We retain our Buy recommendation on HanAll Biopharma but lower our target price to W44,000 (from W54,000). Our previous target price was based on the assumption that batoclimab would be commercialized in 2026. However, following Immunovant’s strategic shift, we pushed back the expected timing of commercialization (IMVT-1402) from 2026 to 2028 for the MG indication and from 2028 to 2029 for the CIDP indication. Accordingly, we revised down our valuation of HanAll Biopharma’s novel drug pipeline from W2.5tr to W2tr.

HanAll Biopharma shares could face a short-term correction due to the strategic shift away from batoclimab. However, we expect commercialization efforts to resume following the release of phase 3 results for TED (expected in 2H25). These results should be a key determinant going forward.