Drugs / Batoclimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | generalized myasthenia gravis | 2023-06-29 | “NMPA of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG).” harbourbiomed.com ↗ “BIOLOGIC LICENSE APPLICATION OF BATOCLIMAB (HBM9161) ACCEPTED BY THE NMPA” irasia.com ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04227470 | Mar 2020 → Dec 2021 | neuromyelitis optica | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03971916 | Jun → Nov 2019 | — | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07188844 | Aug 2025 → Nov 2028 expected | polyneuropathy, inflammatory demyelinating, chronic | Immunovant Sciences GmbH | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT05907668 | May 2023 → Jul 2025 | Graves disease | Immunovant Sciences GmbH | Completed | No outcome recorded |
| Phase 2 | NCT05581199 | Dec 2022 → Jan 2026 overdue | polyneuropathy, inflammatory demyelinating, chronic | Immunovant Sciences GmbH | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04253236 | Aug 2020 → Apr 2021 | autoimmune hemolytic anemia, warm type | Immunovant Sciences GmbH | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04346888 | Jul 2020 → Aug 2021 | generalized myasthenia gravis | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | Met primary |
| Phase 2 | NCT03938545 | Jul 2019 → Feb 2021 | disease of orbital part of eye adnexa | Immunovant Sciences GmbH | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT03863080 | May 2019 → Oct 2020 | myasthenia gravis | Immunovant Sciences GmbH | Completed | Met primary |
| Phase 2 | NCT03922321 | Apr 2019 → Feb 2020 | disease of orbital part of eye adnexa | Immunovant Sciences GmbH | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05015127 | Sep 2021 → Oct 2022 | disease of orbital part of eye adnexa | Harbour BioMed (Guangzhou) Co. Ltd. | Unknown | No outcome recorded |
| Phase 2/3 | NCT04428255 | Jul 2020 → Aug 2021 | autoimmune thrombocytopenic purpura | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT05524571 | Jan 2023 → Feb 2026 | endocrine exophthalmos | Immunovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT05517421 | Nov 2022 → Nov 2025 | endocrine exophthalmos | Immunovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT05517447 | Nov 2022 → Apr 2026 | endocrine exophthalmos | Immunovant Sciences GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT05332210 | Jun 2022 → Apr 2024 | myasthenia gravis | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | Met primary |
| Phase 3 | NCT05403541 | Jun 2022 → Jan 2025 overdue | generalized myasthenia gravis | Immunovant Sciences GmbH | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05039190 Comparator | Sep 2021 → Jan 2023 | myasthenia gravis | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-03-06 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease hanall.com ↗ |
| 2024-06-27 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Announces Resubmission of Biologics License Application for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis harbourbiomed.com ↗ |
| 2023-06-29 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA harbourbiomed.com ↗ |
| 2023-06-29 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION OF BATOCLIMAB (HBM9161) ACCEPTED BY THE NMPA irasia.com ↗
BIOLOGIC LICENSE APPLICATION OF BATOCLIMAB (HBM9161) ACCEPTED BY THE NMPA |
| 2023-03-06 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Announces Positive Topline Results from Phase III Trial of Batoclimab for Treatment of Generalized Myasthenia Gravis harbourbiomed.com ↗ |
| 2023-03-06 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma’s Licensed Partner in China Announces Positive Topline Phase 3 Results for Batoclimab in Myasthenia Gravis hanall.com ↗
HanAll Biopharma Co., Ltd. (KRX: 009420. KS) announced that its licensed partner Harbour BioMed in Greater China reported positive top-line results from its pivotal Phase 3 clinical trial of batoclimab in generalized myasthenia gravis (gMG) patients. |
| 2021-09-02 | HanAll BioPharma Co., Ltd. | Regulatory HanAll\'s Partner HBM Announces IND Approval for Phase 2 of Batoclimab in CIDP in China hanall.com ↗
HanAll Biopharma (KRX: 009420.KS) today announced that its partner for HL161(batoclimab) & HL036(tanfanercept) for the Chinese market, Harbour BioMed, has received IND approval for Phase 2 of batoclimab in patients with chronic inflammatory demyelinating polyneuropathy(CIDP) in China. |
| 2021-09-01 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Announces IND Approval for Phase II Trial of Anti-FcRn Batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy in China harbourbiomed.com ↗ |
| 2021-07-07 | HanAll BioPharma Co., Ltd. | Results HanAll\'s Partner HBM Announces Positive Topline Results from Phase 2 of Batoclimab in MG hanall.com ↗
HanAll Biopharma (KRX: 009420.KS) today announced that its partner for HL161 (batoclimab) & HL036 (tanfanercept) , Harbour BioMed, reported positive topline results from Phase 2 of batoclimab in MG. |
| 2021-07-06 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Reports Positive Topline Results from Phase 2 Trial of Batoclimab (HBM9161) in Generalized Myasthenia Gravis harbourbiomed.com ↗
Harbour BioMed (“HBM”, HKEX: 02142) today announced positive topline results from its Phase 2 proof-of-concept clinical trial of batoclimab (HBM9161) in Chinese generalized myasthenia gravis (gMG) patients. |
| 2021-01-28 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed’s Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis harbourbiomed.com ↗
Harbour BioMed (HBM) (HKEX: 02142.HK) announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). |
| 2020-08-26 | HanAll BioPharma Co., Ltd. | Results HL161(batoclimab) Demonstrated Positive Top-line Results in Phase 2 Clinical Trial in Myasthenia Gravis hanall.com ↗
The MG-ADL(myasthenia gravis activities of daily living) index, which assesses the effect of improvement in symptoms as experienced by a patient, increased by an average of 3.8 points, which is a statistically significant improvement in comparison to the placebo group(p=0.029). |
| 2020-08-25 | Ligand Pharmaceuticals | Results Ligand OmniAb® Partner Immunovant Announced Positive Topline Results from Multicenter, Placebo-Controlled Phase 2a Trial of IMVT-1401 in Myasthenia Gravis ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) OmniAb® partner Immunovant, Inc. (NASDAQ: IMVT) announced positive topline results from ASCEND MG, a Phase 2a study of OmniAb-derived IMVT-1401 in patients with myasthenia gravis (MG). |
| 2020-06-02 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves' Ophthalmopathy harbourbiomed.com ↗ |
| 2020-04-16 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Immune Thrombocytopenia harbourbiomed.com ↗ |
| 2020-03-31 | HanAll BioPharma Co., Ltd. | Results Immunovant, HanAll’s partner, Announces Topline data from Phase 2 for IMVT-1401 in TED hanall.com ↗
Immunovant, HanAll Biopharma’s partner, announced the Topline results of Phase 2a clinical trial (ASCEND-GO1) conducted with thyroid eye disease(TED) patients |
| 2020-02-21 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Announces Completion of Phase 1 Study in China of HBM9161, an Anti-FcRn Antibody harbourbiomed.com ↗
The results demonstrated an excellent safety profile and potent IgG reduction capability. |
All press releases naming this drug 29 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | batoclimab | “OBJECTIVE: To examine the efficacy and safety profile of batoclimab, a monoclonal IgG1 antibody, in patients with generalized MG.” PMID 38436998 ↗ Mar 20248“CONCLUSION: Batoclimab is effective and safe in Chinese patients with gMG.” PMID 35412216 ↗ Apr 2022 |
| Known as | HBM 9161 | “The study will investigate the safety, and tolerability, pharmacodynamics and efficacy of HBM 9161 in patients with attack of NMOSD in China.” NCT04227470 ↗ |
| Known as | HL161 | “Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis” NCT05332210 ↗2“HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis” NCT04346888 ↗ “HBM9161 (HL161) Subcutaneous Injection” NCT05039190 ↗ |
| Known as | HL161BKN | “HBM9161(HL161BKN) is a human monoclonal antibody.” NCT04227470 ↗1“HBM9161(HL161BKN) is a human monoclonal antibody.” NCT03971916 ↗ |
| Known as | IMVT-1401 | “following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo” NCT03863080 ↗1“IMVT-1401 (batoclimab)” NCT05907668 ↗ |
| Known as | RVT-1401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03922321 ↗ |
| Action | Inhibit | “By blocking the FcRn IgG-Fc binding site and accelerating the degradation of IgG” NCT04227470 ↗1“IgG receptor FcRn large subunit p51 inhibitor” CHEMBL4650514 ↗ |
| Modality | Monoclonal antibody | “RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.” NCT03922321 ↗ |
| Route | Subcutaneous | “Subcutaneous administration of RVT-1401” NCT03863080 ↗ |
| Target | FCGRT | “IgG receptor FcRn large subunit p51 inhibitor” CHEMBL4650514 ↗ |