Immunovant pursues global commercialization... Clinical results for major indications scheduled for 2027, including development and approval milestones and sales royalties… Description of next-generation antibody commercialization strategy
Hanall Biopharma (009420) presented the global commercialization of the next-generation FcRn antibody Imerofruvat as a key future milestone. The company announced that its global partner, Immunovant, is pursuing clinical development with the top priority of launching a treatment for Graves' disease in 2028.
In a written interview with the Market Times, Hanol expected that the clinical results for Graves' disease and myasthenia gravis, scheduled for 2027, will be a turning point that will confirm the competitiveness and commercialization potential of Imeropruvat. The commercialization cooperation method for batoclimab, which has received product approval in China, and the contractual profit structure for Imeropruvat were also explained.
The following is a Q&A with Hanall Biopharma.
Q. What are the plans for vatoclimab's launch in China, insurance registration, and approval milestones?
A. , .
NBP , schedule and National Medical Insurance List(NRDL) Listed plan, market strategy etc. local Partner's business in plan according to to be promoted It is planned.
Q. Harbor Biomed etc. local with partner commercialization Cooperation is how Is it progressing?.
A. of batoclimab Greater China commercialization Harbor Biomed and our company interracial license in the contract according to to proceed It is planned and Our company china in the market business smoothly lead to number so that Harbor Biomed and necessary in part about closely cooperate go out It is planned. concrete discussion content and operate The method is contract and with partners In consultation about As a matter in detail tell you difficult dot understanding please.
Q. What is the direction of use of vatoclimab outside of China and the contractual profit structure of Imeropruvat?
A. Discussions on the future direction of use of vatoclimab are ongoing, and related details will be made public as soon as the discussions are concluded.
Imerofruvat is a substance included in the existing license agreement between Hanall Biopharma and Roivant. According to the agreement, Hanall Biopharma can receive royalties in the mid-single digits to mid-teens range (mid-single digits to mid-teens) of the total net sales generated after major milestones such as development and approval and commercialization.
Q. What are the differences between Aimeropruvat and the indicators to pay attention to in phase 3 myasthenia gravis?
A. Imeropruvat (HL161ANS) is a next-generation FcRn antibody treatment developed to improve safety and convenience of administration while maintaining the high IgG-lowering effect of batoclimab.
In phase 1 clinical trials, a similar IgG reduction effect as batoclimab was confirmed when 600 mg of imeropruvat was administered once a week for 4 weeks. In particular, a significant decrease in albumin and an increase in LDL cholesterol were not observed despite the decrease in IgG, confirming the possibility of it being a safer treatment option for patients with autoimmune diseases who require repeated administration over a long period of time. In addition, it is being developed as an auto-injector (self-injector) formulation that can be administered directly by the patient with one button, and is expected to be competitive in terms of administration convenience.
Hanall Biopharma confirmed the possibility that deep IgG reduction could lead to better and more sustained symptom improvement through the previously conducted batoclimab clinical trial. In fact, in the phase 3 clinical trial for generalized myasthenia gravis (gMG), the high-dose group showed an average 74% decrease in IgG and an average 5.6-point improvement in MG-ADL score, while the low-dose group also showed an improvement of 64% and 4.7 points, respectively.
Of particular note is the sustainability of the treatment effect. In the high-dose treatment group, 75% of patients who achieved minimal symptom onset (MSE) by week 6 maintained this state for more than 6 weeks. These results support the possibility that high levels of IgG reduction may have a positive effect not only on the magnitude of symptom improvement but also on the sustainability of treatment effects.
The ongoing clinical trial of Imeropruvat is focusing on the sustainability of symptom improvement effects, safety and tolerability during long-term administration, as well as confirmation of clinical effectiveness through changes in MG-ADL scores at 12 weeks. If aimerofruvat can minimize the impact on albumin and LDL cholesterol while maintaining a high level of IgG reduction effect, it is expected to be competitive as a next-generation FcRn treatment with efficacy, safety, and convenience.
※ The above figures are the results of the global phase 3 clinical trial of vatoclimab conducted by Immunovant, which is a different trial from the phase 3 clinical trial that served as the basis for product approval in China. (Editor)
Q. What is the meaning of the initial results for refractory rheumatoid arthritis and plans for follow-up verification and announcement?
A. The initial results of D2T RA are evaluated as meaningful results that demonstrate the potential as a new treatment option in that they confirmed a high level of clinical improvement in a group of refractory patients who did not respond sufficiently to various existing treatments.
As this clinical trial has a strong proof-of-concept (PoC) nature to confirm the therapeutic potential of Aimeropruvat in intractable rheumatoid arthritis, the efficacy signal secured in the early stage is of great significance. Although the results were obtained in an open-label administration phase without a placebo control group, it is encouraging to see a high response rate in patients who did not respond sufficiently to existing treatments. (ACR20: 72.7%, ACR50: 54.5%, ACR70: 35.8%)
The following period 2 aims to evaluate the effect of symptom improvement in the patient group receiving placebo and imerofruvat. Immunovant has announced that it will comprehensively announce the D2TRA clinical results, meeting results with the FDA, and future development plans in the second half of 2026, and there has been no change to the schedule as of now.
Q. What are the key milestones for the future and the message you would like to convey to shareholders?
A. The most important milestone for our company in the future is the global commercialization of Imerofruvat. Currently, our global partner, Immunovant, is pursuing clinical development with the top priority of launching a treatment for Graves' disease (GD) in 2028.
In 2027, clinical results are scheduled to be announced in major indications such as Graves' disease and myasthenia gravis, which is expected to be an important turning point in confirming the clinical competitiveness and commercialization potential of Aimeropruvat.
If launched as planned, Imeropruvat is expected to contribute to the company's continued profit generation along with batoclimab, which recently obtained product approval in China.
In addition, HanAll Biopharma continues to pursue the development of next-generation FcRn treatments based on the experience and know-how accumulated during the development of FcRn new drugs. Through this, we aim to further strengthen our competitiveness in the FcRn market and maintain our leadership in the global market.
