Immunovant drives global commercialization; key indication trial results slated for 2027.
From development and regulatory milestones to sales royalties: outlining the next-gen antibody commercialization strategy.
HanAll Biopharma (009420) has presented the global commercialization of its next-generation FcRn antibody, imeropruvat (IMVT-1402), as its primary future milestone. The company stated that its global partner, Immunovant, is driving clinical development with a top-priority goal of launching the Graves' disease treatment in 2028.
In a written interview with Market Times, HanAll expressed expectations that the clinical results for Graves' disease and myasthenia gravis scheduled for 2027 will serve as a pivotal turning point to validate the competitiveness and commercial potential of imeropruvat. The company also detailed the commercialization cooperation framework for batoclimab—which recently received marketing approval in China—along with the contractual revenue structure for imeropruvat.
Below is an edited transcript of the Q&A with HanAll Biopharma.
Q. What are the plans for batoclimab's Chinese launch, reimbursement listing, and regulatory milestone receipts?
A. We expect to receive milestones tied to batoclimab's marketing approval in China in accordance with the contract, though specific amounts and timing cannot be disclosed.
Local marketing and sales will be handled by NBP Pharma, a sub-licensee of Harbour BioMed. Specific launch schedules, National Reimbursement Drug List (NRDL) inclusion plans, and market strategies will be executed in line with the local partner's business roadmap.
Q. How is commercial cooperation progressing with local partners such as Harbour BioMed?
A. The commercialization of batoclimab in the Greater China region is proceeding under the licensing agreement between Harbour BioMed and HanAll. We will closely cooperate with Harbour BioMed on necessary fronts to ensure the smooth progression of the business in the Chinese market. We ask for your understanding that specific terms of agreement and operational methods remain confidential under contractual agreements and partnership protocols.
Q. What is the outlook for batoclimab outside of China, and what is the contractual revenue structure for imeropruvat?
A. Discussions regarding the future utilization of batoclimab are ongoing, and relevant details will be disclosed as soon as consultations are finalized.
Imeropruvat is a compound included in the existing licensing agreement between HanAll Biopharma and Roivant. Under the contract, HanAll is entitled to receive developmental and regulatory milestones at key stages, as well as royalties ranging from the mid-single digits to mid-teens on total net sales generated post-commercialization.
Q. What are the differentiators of imeropruvat, and which endpoints are you focusing on in the Phase 3 myasthenia gravis trial?
A. Imeropruvat (HL161ANS) is a next-generation FcRn antibody treatment developed to maintain the high IgG reduction efficacy of batoclimab while improving safety and administration convenience.
Phase 1 trials showed that a weekly 600mg dose of imeropruvat for four weeks achieved IgG reduction levels comparable to batoclimab. Notably, despite the IgG reduction, no significant decreases in albumin or increases in LDL cholesterol were observed, confirming its potential as a safer therapeutic option for autoimmune disease patients requiring long-term, repeated administration. Furthermore, it is being developed as an auto-injector device allowing patients to self-administer at the press of a button, which is expected to bolster its competitive edge in administration convenience.
Through prior clinical trials of batoclimab, HanAll confirmed that deep IgG reductions can lead to superior and more sustained symptom improvement. In pivotal generalized myasthenia gravis (gMG) Phase 3 trials, the high-dose group demonstrated an average 74% IgG reduction alongside a 5.6-point mean improvement in MG-ADL scores, while the low-dose group showed 64% and 4.7-point improvements, respectively.
A particularly notable aspect is the durability of the therapeutic effect. Among patients in the high-dose group who reached minimal symptom expression (MSE) status by week 6, 75% maintained that status for six weeks or longer. This outcome supports the premise that high-level IgG reduction positively influences not only the magnitude of symptom relief but also the durability of the therapeutic response.
In the ongoing imeropruvat clinical trials, we are focusing on confirming clinical efficacy via changes in week 12 MG-ADL scores, the durability of symptom relief, and the safety and tolerability profile upon long-term administration. If imeropruvat can sustain high-level IgG reduction while minimizing impacts on albumin and LDL cholesterol, it is expected to secure robust competitiveness as a next-generation FcRn therapy encompassing efficacy, safety, and convenience.
※ The figures above are from Immunovant's global Phase 3 clinical trial of batoclimab, which is a separate trial from the Phase 3 study that served as the basis for marketing approval in China. (Editor)
Q. What is the significance of the early refractory rheumatoid arthritis results, and what are the follow-up validation and presentation plans?
A. The preliminary results in D2T RA (difficult-to-treat rheumatoid arthritis) are evaluated as meaningful outcomes that demonstrate potential as a new therapeutic option, as they confirmed a high level of clinical improvement in refractory patient cohorts who responded inadequately to multiple existing therapies.
Because this trial carries a strong proof-of-concept (PoC) nature to ascertain imeropruvat's therapeutic potential in refractory rheumatoid arthritis, we place great significance on the efficacy signals secured in the early phase. Although the data were obtained from an open-label cohort without a concurrent placebo control group, observing high response rates in patients refractory to conventional treatments is highly encouraging. (ACR20: 72.7%, ACR50: 54.5%, ACR70: 35.8%)
The subsequent Period 2 aims to evaluate symptom improvement effects between placebo- and imeropruvat-treated patient groups. Immunovant has previously announced plans to comprehensively disclose D2T RA trial results, FDA meeting outcomes, and future development strategies in the second half of 2026, with no changes to the schedule thus far.
Q. What are your core future milestones and the message you wish to convey to shareholders?
A. The milestone we regard as most critical going forward is the global commercialization of imeropruvat. Currently, our global partner Immunovant is driving clinical development with a top-priority objective of launching the Graves' disease (GD) treatment in 2028.
With clinical data readouts for key indications such as Graves' disease and myasthenia gravis slated for 2027, we expect this period to serve as a crucial turning point to validate imeropruvat's clinical competitiveness and commercial viability.
If launched according to schedule, imeropruvat—alongside batoclimab, which recently secured marketing approval in China—is expected to contribute to our sustained revenue generation.
Moreover, building upon the experience and know-how accumulated throughout the development of FcRn novel drugs, HanAll Biopharma will continue to pursue the development of next-generation FcRn therapeutics. Through this, we aim to further solidify our competitiveness in the FcRn market and sustain our global leadership.
