Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1726 |
| INN | Batoclimab |
| Status | Regulatory review |
| Drug code(s) | IMVT-1401, RVT-1401, HL161BKN, HBM9161(HL161BKN), HL161 |
| Brand name | 巴托利单抗 |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic rat (OmniRat) |
| Target(s) | FcRn |
| Indications of clinical studies | Chronic Inflammatory Demyelinating Polyneuropathy, generalized Myasthenia Gravis, Thyroid Eye Disease, Graves' ophthalmopathy, Adult immune thrombocytopenia, myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2017 |
| Start of Phase 2 | April 22, 2019 |
| Start of Phase 3 | July 21, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Hanall Biopharma subsidiary of Daewoong Pharmaceutical Co. Ltd |
| Licensee/Partner | Harbour BioMed, Roivant Sciences, Immunovant Inc. |
| Comments about company or candidate | June 26, 2024 - Harbour BioMed announces that it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis. https://www.prnewswire.com/news-releases/harbour-biomed-announces-resubmission-of-biologics-license-application-for-batoclimab-to-nmpa-for-treatment-of-generalized-myasthenia-gravis-302183828.html June 29, 2023 I Harbour BioMed announces that the National Medical Products Administration (NMPA) of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis Mar 6 2023: Harbour BioMed announces the positive topline results of its phase III clinical trial of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG), which is also the first positive pivotal trial outcome for batoclimab worldwide. This marks a major milestone for Harbour BioMed as it is the Company's first product to complete phase III clinical trial and be poised for commercialization to benefit the gMG patients. NCT05039190 Phase 3 in Generalized Myasthenia Gravis started in Sep 2021 has primary completion date in March 2023; Sep 28: Harbour BioMed announced that, the clinical trial of its anti-FcRn antibody, batoclimab (HBM9161), has completed the first dosing of first patient in registrational phase III trial for the treatment of generalized myasthenia gravis (gMG). NCT05403541 Phase 3 in MG sponsored by Immunovant Sciences GmbH started in June 2022 has primary completion date in April 2024. Jan 2021: Harbour BioMed’s Batoclimab (HBM9161) receives China CDE Breakthrough Therapy Designation for treatment of adult patients with Myasthenia Gravis Sep 2020: Harbour BioMed, a global, clinical-stage, bio-pharmaceutical company announced the dosing of the first patient in two separate Phase II clinical trials of Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), in mainland China. These studies are designed to evaluate the efficacy and safety of Batoclimab for the treatment of Myasthenia Gravis (MG) and adult Immune thrombocytopenia (ITP) patients. April 15, 2020: Harbour BioMed (HBM) announced that it has received IND approval from the National Medical Products Administration (NMPA) in China to begin a Phase II/III clinical trial to evaluate the safety and efficacy of its therapeutic antibody HBM9161 to treat adult immune thrombocytopenia. NCT04346888 Phase 2 study in myasthenia gravis due to start in June 2020 not yet recruiting in April 2020. NCT04227470 is a Phase 1 Safety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in China. October 2, 2019: Health Sciences Acquisitions Corporation (“HSAC,” NASDAQ: HSAC), a special purpose acquisition company sponsored by RTW Investments, and Immunovant Sciences Ltd. (“Immunovant”), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced that they have entered into a definitive share exchange agreement (“SEA”). HSAC will acquire 100% of the issued and outstanding shares in Immunovant. Upon closing, the combined company will be called Immunovant, Inc. Top shareholders of Immunovant include Roivant Sciences and blue-chip biotech investors, including RTW Investments, BVF Partners, Adage Capital Management, Cormorant Asset Management, Eventide Asset Management, and Perceptive Advisors. Poster presentation at 2019 American Academy of Neurology (AAN) Annual Meeting, being held May 4-10, 2019, in Philadelphia, PA. (http://indexsmart.mirasmart.com/AAN2019/PDFfiles/AAN2019-000997.pdf) NCT03922321 Phase 2 study in Graves' Ophthalmopathy started recruiting in April 2019. NCT03863080, a Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RVT-1401 in Myasthenia Gravis Patients, due to start in March 2019 not yet recruiting as of April 19. Phase 1 study ACTRN12618001502224 started in Dec 2017. IMVT-1401 is a novel, fully human monoclonal antibody being investigated for the treatment of IgG-mediated autoimmune diseases. IMVT-1401 is the product of a multi-step, multi-year research program, conducted by Immunovant’s collaboration partner, HanAll BioPharma, to design a highly specific anti-FcRn antibody optimized for delivery as a subcutaneous injection. These efforts have resulted in a product candidate that has been dosed at small volumes and with a small gauge needle. Immunovant intends to develop IMVT-1401 for debilitating autoimmune diseases in which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and in which reduction of IgG antibodies should lead to clinical benefit. Immunovant has in-licensed the rights to develop, manufacture and commercialize IMVT-1401 in the United States, Canada, Mexico, the EU, the United Kingdom, Switzerland, the Middle East, North Africa and Latin America. IMVT-1401 presently is in Phase 2a clinical development for the treatment of myasthenia gravis (ClinicalTrials.gov Identifier: NCT03863080). NCT03971916 Phase 1 study in healthy volunteers started June 3, 2019. In September 2017, HanAll Biopharma inked a US$81 million agreement with Shanghai-based Harbour BioMed to grant rights to HL161 in Greater China. It also licensed the autoimmune disease treatment to Switzerland-based biotech startup Roivant Sciences in a deal that has a potential value of US$502.5 million in December. The contract gives Roivant Sciences rights for North America, Latin America, EU, Middle East and North Africa. HL161 is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). Blockade of FcRn-Immunoglobulin G (IgG) interactions has been shown to lead to the rapid depletion of IgG. HL161 has potential as a treatment for IgG-mediated autoimmune diseases. The company is planning a Phase I clinical study of HL161 in late 2017 as a subcutaneous injectable formulation that differentiates it from the competitors' intravenous formulations. |
| Full address of company | 1 Church Street, Suite #103, Rockville, MD 20850, USA North America United States of America http://en.hanall.co.kr/contacts.php |
Recombinant fully human monoclonal antibody with IgG1 (F allotype) heavy chain and λ light chain
| Anticipated events | Regulatory review China - anticipate approval |
| Factor(s) contributing to discontinuation | None |