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When HanAll Biopharma handed over rights to its experimental antibody drug in 2017, it was banking on a global breakthrough. Batoclimab, designed to lower harmful autoantibodies in autoimmune diseases, seemed poised to compete with argenx’s Vyvgart (efgartigimod alfa), the first-in-class FcRn inhibitor.
But nearly seven years later, that bet is looking uncertain. Immunovant, the U.S. biotech spun out by Roivant Sciences to develop batoclimab, has decided to shift its focus elsewhere.
With Immunovant moving on, HanAll is doubling down on batoclimab’s potential in Asia.
With Immunovant moving on, HanAll is doubling down on batoclimab’s potential in Asia.
Immunovant confirmed on Wednesday that it has no immediate plans to seek regulatory approval for the drug in myasthenia gravis (MG) or chronic inflammatory demyelinating polyneuropathy (CIDP)—two diseases in which batoclimab recently met key clinical trial goals.
Instead, it is prioritizing a next-generation version, IMVT-1402, which it believes will deliver stronger efficacy with fewer side effects.
The decision leaves HanAll at a crossroads. The Korean drugmaker retains commercialization rights in Asia and has no intention of shelving batoclimab. The company has already started the regulatory process in Japan for MG and thyroid eye disease (TED), banking on positive phase 3 results.
“We still believe batoclimab has strong commercial potential,” a HanAll Biopharma spokesperson said Thursday. “While Immunovant’s final decision remains uncertain, we don’t see batoclimab as being inferior in terms of antibody reduction or efficacy.”
The clinical data suggests the drug is competitive. In the phase 3 MG trial, patients receiving the highest dose of batoclimab saw an average improvement of 5.6 points in symptom scores, compared to 3.6 points for those on placebo. Those on a lower dose improved by 4.7 points.
The drug also led to greater reductions in immunoglobulin G (IgG) autoantibodies—74 percent in the high-dose group, compared to 61 percent for Vyvgart and 69 percent for Johnson & Johnson’s nipocalimab.
The drug also achieved greater IgG reductions than its competitors, with a 74 percent drop in autoantibody levels in the high-dose group—outpacing argenx’s Vyvgart (61 percent) and Johnson & Johnson’s nipocalimab (69 percent). The CIDP trial showed similarly promising results, with 84 percent of patients who experienced a 70 percent IgG reduction responding to treatment.
For Immunovant, though, the numbers weren’t enough. The company is betting that IMVT-1402, still in clinical development, will outperform batoclimab, arguing that the new drug offers “deeper and more durable clinical responses” while avoiding common side effects of first-generation FcRn inhibitors, such as drops in albumin and spikes in LDL cholesterol.
Phase 3 trials for IMVT-1402 are set to begin later this year, and for now, Immunovant isn’t planning to seek FDA approval for batoclimab in MG or CIDP. The one exception could be TED, where a final decision will come after phase 3 results later this year.
The market for FcRn inhibitors is growing increasingly competitive. Argenx’s Vyvgart, the first FDA-approved FcRn inhibitor, has already expanded into a subcutaneous version, and Johnson & Johnson’s nipocalimab is advancing toward regulatory approval.
HanAll, meanwhile, is charting its own course. It intends to leverage clinical trial data from Asian patients in its regulatory filings in Japan and beyond. Even if batoclimab doesn’t make it to market in the U.S., the company sees a path forward.
“Immunovant will do what it thinks is best for its portfolio,” the HanAll spokesperson said. “We believe in batoclimab. And we’re moving forward.”
Meanwhile, as of 2:25 p.m. Thursday, HanAll Biopharma’s stock was trading at 29,400 won ($20.13), down 16.2 percent from the previous day.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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