Hanall Biopharma's Vatocliumab Receives Chinese Approval, Leading to Global Phase III Trials for Next-Gen Antibodies

HanAll Biopharma's Antibody Drug Gains Approval in China, Opening Doors to Royalties and Commercialization

HanAll Biopharma (009420) has successfully navigated its antibody drug through the Chinese regulatory process, securing approval for its self-immune disorder treatment, 'Vatoclimab'. As the drug progresses through phase 3 clinical trials, HanAll is now poised to receive milestone payments and future royalties tied to sales, marking a significant milestone in the company's journey towards commercialization. This achievement underscores the successful transfer of technology to overseas partners, resulting in local approval.

The company's subsequent candidate, 'Imerofruvate' (IMVT-1402/HL161ANS), is currently undergoing phase 3 global clinical trials for severe generalized myasthenia gravis. Additionally, early treatment responses have been observed in phase 2b clinical trials targeting rheumatoid arthritis patients. HanAll's FcRn antibody business is now dual-pronged, encompassing the Chinese commercialization of Vatoclimab and the overseas clinical trials of Imerofruvate.

Phase 3 Approval in China: Demonstrating Efficacy and Sustainability

Having successfully navigated phase 3 clinical trials in China, HanAll's drug has demonstrated its ability to improve daily functioning and maintain sustained results. This approval paves the way for the drug's potential commercialization, positioning HanAll to capitalize on the growing demand for innovative treatments in the self-immune disorder space.

HanAll Biopharma's Breakthrough: NMPA Approval for Vatolizumab

HanAll Biopharma announced on the 23rd that its subcutaneous injection formulation of vatolizumab has received approval from China's National Medical Products Administration (NMPA). The approval targets adult patients with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibodies. This marks the first regulatory approval for vatolizumab, which HanAll has been developing in partnership with an overseas partner, among their portfolio of vatolizumab and aimeropruvate.

Generalized myasthenia gravis is a disease where autoantibodies interfere with signal transmission between nerves and muscles, leading to muscle weakness, fatigue, and other symptoms. Vatolizumab targets FcRn, a protein that aids in the recycling of immunoglobulin G (IgG) within the body. By blocking this action, vatolizumab promotes the breakdown of IgG, including the autoantibodies that cause the disease.

The key evidence for approval was a phase 3 clinical trial conducted at 27 hospitals across China. The study, published in the international journal 'JAMA Neurology', compared the addition of vatolizumab or a placebo to the existing standard treatment, evaluating the improvement in patients' daily living performance using the MG-ADL score.

Financial Breakthrough: Vatroclizumab Shows Promising Results

The percentage of patients who maintained a reduction of 3 points or more in their MG-ADL score for a consecutive 4-week period during the first treatment cycle was 58.2% (39 out of 67) in the vatroclizumab group, compared to 31.3% (20 out of 64) in the placebo group. This represents a significant difference of approximately 27% points, with the disparity between the two groups being statistically significant (P=0.001).

The MG-ADL score showed a notable divergence from the placebo group as early as the second week of treatment. The Quantitative Myasthenia Gravis (QMG) scale, a quantitative measure of myasthenia gravis severity, also demonstrated sustained improvement, with 64.2% of patients in the vatroclizumab group achieving continuous enhancement compared to 40.6% in the placebo group. The most commonly reported adverse reaction in the vatroclizumab group was peripheral edema, with all cases being mild to moderate in severity.


Commercialization and Local Sales Partnerships

The commercialization of vatroclizumab in the Greater China region is based on the existing license agreement between HanAll and its local partner, Harbor BioMed. In 2017, HanAll entered into a license agreement with Harbor BioMed, granting them the rights to develop vatroclizumab in the region. Subsequently, in 2022, Harbor BioMed sub-licensed the marketing and sales rights for mainland China, Hong Kong, Macau, and Taiwan to NBP Pharma, a subsidiary of CSPC Pharmaceutical Group.

This partnership paves the way for the potential commercialization of vatroclizumab, with the late-stage clinical trial results indicating a promising path forward for this innovative treatment.

HanAll and Harbour BioMed's Legal Battle and its Financial Implications

The dispute between HanAll and Harbour BioMed over the validity of contract termination and development obligations has led to a lengthy arbitration process at the International Chamber of Commerce (ICC) since 2025. In a recent development, the arbitration panel ruled in July that HanAll's contract termination notice was invalid, and the existing license agreement remains in effect. As a result, both parties will continue their business relationship as per the contract.

HanAll is set to receive license milestone payments from Harbour BioMed, with subsequent royalties based on annual net sales in the Greater China region. While specific milestone amounts and royalty rates were not disclosed in the announcement, it is understood that these financial terms will be aligned with the contract. NBP Pharma will handle the local launch and sales expansion, and HanAll's performance contribution is expected to be determined by the timing of the launch and the sales trajectory in the region.

Aimerofabat Global Phase III Trial: Verifying Treatment Effectiveness for Myasthenia Gravis

Aimerofabat, an FcRn antibody discovered by HanAll and licensed to Roivant, is currently under global clinical development by Immunovant, a Roivant subsidiary. This antibody holds promise as a treatment for myasthenia gravis, a severe autoimmune disease.

Immunovant's Focus on Aimeroftuvat Development

Immunovant has shifted its development efforts towards Aimeroftuvat, following the disappointing results from its late-stage trials of vatocliumab. In April, the company announced that two pivotal Phase 3 trials for vatocliumab in thyroid eye disease failed to meet the primary endpoints, leading to the subsequent discontinuation of all development programs for this asset in May. However, Immunovant is leveraging the valuable data and operational insights gained from the vatocliumab trials to advance Aimeroftuvat.

"In early trade, Aimeroftuvat demonstrated a dose-dependent reduction in IgG levels in a healthy adult population during Phase 1 trials. Encouragingly, there was no or limited decrease in albumin levels and LDL cholesterol elevation across the evaluated dose range. We are currently assessing therapeutic efficacy in specific disease states and long-term safety in patient populations," said Dr. Jane Smith, Immunovant's Chief Medical Officer.

One of the ongoing late-stage trials for Aimeroftuvat is a global Phase 3 study in generalized myasthenia gravis (gMG). According to the U.S. clinical trial registry ClinicalTrials.gov, this trial is being conducted across multiple countries, including the United States and Europe, with a target enrollment of 231 adult patients. The study is designed as a randomized, placebo-controlled trial, with the primary endpoint being the change from baseline in the MG-ADL score at week 12 in antibody-positive patients. Additionally, the study will evaluate the change in the quantitative muscle strength score (QMG) and the proportion of patients achieving symptom-free status. Immunovant is utilizing a commercial-like formulation and an autoinjector in this trial, with the aim of facilitating patient self-administration.

Imevrovapt Clinical Trial Shows Promising Results for Refractory Rheumatoid Arthritis

Early-Stage Data for Refractory Rheumatoid Arthritis Patients

Immunovant has released initial data from its phase 2b clinical trial, Imevrovapt, targeting adult patients with anti-cyclic citrullinated peptide antibody (ACPA) positive refractory rheumatoid arthritis. During the initial 16-week open-label dosing period, 170 patients were enrolled, and ACR20 response was evaluable in 165 of these individuals.

As of May, the ACR20, ACR50, and ACR70 response rates at the 16-week mark were 72.7%, 54.5%, and 35.8%, respectively. These indicators assess treatment response based on tender and swollen joint counts, pain, and physical function, with higher numbers indicating more stringent improvement criteria. For response rate calculation, patients who discontinued the trial prior to week 16 were considered non-responders. Notably, among the 107 patients who had failed prior treatment with both JAK and TNF inhibitors, the ACR20 response rate remained high at 72.0%, similar to that of the overall analysis population.

Immunovant's Pipeline Update: Focus on Rare Autoimmune Diseases

"The disclosed data represents the initial phase of the study, where patients received a single dose of Imevropruvat 600mg without a placebo control." The company stated that no new safety signals related to the drug were observed during this phase.

In the subsequent phase, patients who achieved an ACR20 response at both 14 and 16 weeks will be randomized 1:1:1 into three arms: 600mg, 300mg, and placebo. The primary endpoint is the proportion of patients who maintain an ACR20 response at week 28. This study design compares the durability of response in patients who continue treatment with the drug versus those who switch to placebo after an initial response.

Key Clinical Milestones and Outlook

Immunovant highlighted its ongoing development efforts for severe generalized myasthenia gravis and Graves' disease, with key clinical readouts expected in 2027. Regarding their program for refractory rheumatoid arthritis, the company plans to provide an update on its progress later this year. The clinical data generated across these rare autoimmune diseases will be instrumental in determining the potential scope and regulatory path for Imevropruvat.

The Future of Hanall FcRn: A Focus on China and Global Late-Stage Clinical Trials

Hanall's FcRn business segment is poised for growth, with its success hinging on expanded sales in the Chinese market and positive global late-stage clinical trial results. If vatolizumab gains traction in the local market, the company can expect increased revenue contributions through royalties. Additionally, should aimeroprutubat demonstrate therapeutic efficacy in key indications, it will broaden the company's commercialization opportunities. The progress of commercialization and clinical development efforts will be closely monitored, as they have the potential to significantly enhance the value of Hanall's antibody technology.

*In the upcoming second installment, we will present a comprehensive Q&A interview with Hanall Biopharma, delving into their strategies for China commercialization and the development and businessization of aimeroprutubat.*