Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 84 |
| INN | Narlumosbart |
| Status | Approved |
| Drug code(s) | JMT103 |
| Brand name | Jinlitai, 津立泰 |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | RANK-L |
| Indications of clinical studies | Giant Cell Tumor of Bone, Refractory Hypercalcemia of Malignancy, Bone metastases, osteoporosis |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2017 |
| Start of Phase 2 | March 30, 2022 |
| Start of Phase 3 | April 15, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Narlumosbart |
| US or EU approved indications | None |
| Company | Shanghai JMT-Bio Inc. |
| Licensee/Partner | CSPC Pharmaceutical Group Ltd |
| Comments about company or candidate | Sep 6, 2023: The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the biologic license application (“BLA”) for class 1 new drug Narlumosbart for Injection (brand name: Jinlitai (津立泰)) (JMT103) (the “Product”) developed by Shanghai JMT-Bio Technology Co., Ltd.* (上海津曼特生物 科技有限公司), a subsidiary of the Company, for the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China. https://doc.irasia.com/listco/hk/cspc/announcement/a230906a.pdf Aug 2023: Still listed in company pipeline as BLA accepted (https://www.cspc.com.hk/en/ir/presentations/20231H.pdf) NCT05813665 Phase 3 due to start in April 2023. CSPC Pharmaceutical (acquired Yong Shun Technology Development) June 22, 2022: CSPC Pharmaceutical Group Limited announced that the biologic license application (“BLA”) for the class 1 new drug JMT103 (Narlumosbart for Injection) (the “Product”) developed by Shanghai JMT-BioTechnology Co., Ltd.* (上海津曼特生物科技有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China, and the Center for Drug Evaluation has agreed to the submission of application for priority review. At present, the application is in progress. The indication for this application is for the treatment of unresectable or surgically difficult giant cell tumor of bone. https://doc.irasia.com/listco/hk/cspc/announcement/a220622.pdf As of the end of 2021, a pivotal trial had been completed (https://doc.irasia.com/listco/hk/cspc/annual/2021/res.pdf) NCT05278338 Phase 2 in osteoporosis due to start in March 2022. NCT04630522 Phase 1 started in Oct 2020. NCT04198480 Phase 1/2 in Refractory Hypercalcemia of Malignancy not yet recruiting as of Dec 16 2019. NCT03550508 is a Phase I, first-in-human, multi-center, open-label dose escalation clinical study of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) administered subcutaneously to patients with bone metastases from tumors; started in May 2018, study is still recruiting as of Aug 2019. JMT103 is a novel fully human anti-RANKL monoclonal antibody developed against the shortcomings of anti-RANKL monoclonal antibody drugs that are marketed abroad. The product received the IND approval from NMPA for prevention of skeletal-related events in patients with bone metastases from solid tumors in March 2017 without supplementary filing demanded. At present, the phase I clinical study of JMT103 in PRC of this indication is almost completed. Further, the IND for treatment of osteoporosis was approved in June 2017 and the phase I clinical trial of JMT103 in PRC relating to treatment of osteoporosis is currently on going. |
| Full address of company | Shanghai Asia China https://synapse.patsnap.com/organization/90dde2cce6d4a0eb17abb8eb7b47be9d |
JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |