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重组人类甲状旁腺素的改进稳定性调配物

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摘要

本发明涉及包含全长重组人类甲状旁腺素(rhPTH(1‑84))的药学组合物及剂型。本发明进一步涉及新颖和/或经改进的PTH组合物，其具有经改进的使用中稳定性，所述PTH组合物对响应物理及化学应力的蛋白质降解具有抗性。

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公开/公告号CN112638407A

专利类型发明专利
公开/公告日2021-04-09

原文格式PDF
申请/专利权人夏尔-NPS医药品有限公司;
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申请/专利号CN201980056225.X
发明设计人 N·迪克西特;V·阮;P·苏亚克;S·巴苏;
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申请日2019-07-12
分类号A61K38/29(20060101);A61P19/10(20060101);C07K14/635(20060101);
代理机构11287 北京律盟知识产权代理有限责任公司;
代理人章蕾
地址美国马萨诸塞州
入库时间 2023-06-19 10:32:14

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法律状态公告日

法律状态信息

法律状态
2023-04-28

专利申请权的转移 IPC(主分类):A61K38/29 专利申请号:201980056225X 登记生效日:20230418 变更事项:申请人变更前权利人:夏尔-NPS医药品有限公司变更后权利人:美国武田药品工业公司变更事项:地址变更前权利人:美国马萨诸塞州变更后权利人:美国马萨诸塞州

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1. 重组人类甲状旁腺素的改进稳定性调配物 [P] . 中国专利： CN112638407A . 2021-04-09
2. 包含重组人类CD38细胞外结构域的组合物、方法和/或试剂盒 [P] . 中国专利： CN109790210A . 2019-05-21
3. Preparation of isolated protein, substantially pure or recombinant, isolated trt protein, substantially pure or recombinant isolated trt protein, substantially pure or recombinant, isolated trt protein or a variant thereof, or a fragment, polynucleotide, synthetic, substantially pure or recombinant, isolated nucleic acid, encoding a trt protein, expression vector, transfected cell, non-human animal, or its progeny, transgenic non-human animal, antibody or its binding fragment, antibody, specifically immunoreactive under immunologically reactive conditions, for a trt protein or its immunogenic fragment, processes of determining whether a compound or treatment is a modulator of a trt activity or expression, of determining whether a test compound is a modulator of a trt activity, of preparing recombinant telomerase, to detect a trt gene product in a sample, to detect the presence of d and at least one telomerase positive human cell in a biological sample comprising human cells, to diagnos [P] . BR9711844A . 2000-01-18

机译：分离的蛋白质，基本上纯的或重组的分离的trt蛋白，基本上纯的或重组的分离的trt蛋白，基本上纯的或重组的分离的trt蛋白或其变体或片段，多核苷酸，合成的，基本上纯的或重组的分离的核酸的制备编码trt蛋白的酸，表达载体，转染的细胞，非人类动物或其后代，转基因非人类动物，抗体或其结合片段，抗体，在免疫反应条件下对trt蛋白或其免疫原具有特异性片段，确定化合物或处理是否是trt活性或表达的调节剂，确定测试化合物是否是trt活性的调节剂，制备重组端粒酶以检测样品中trt基因产物的过程，检测包含人细胞的生物样品中d和至少一种端粒酶阳性人细胞的存在，以进行诊断
4. human isolated, synthetic or recombinant antibody, or a functional part or a functional equivalent thereof, isolated, synthetic or recombinant nucleic acid molecule, vector, isolated or recombinant cell or non-human animal, composition, use of an antibody or functional part or functional equivalent, and methods for producing an antibody or functional part or functional equivalent, for detecting myeloproliferative or lymphoproliferative cells, for determining whether a myeloid or lymphoid cell is a myeloproliferative or lymphoproliferative cell, for identifying myeloproliferative or lymphoproliferative cells, for To determine whether myeloproliferative or lymphoproliferative cells are present in a sample to treat and / or prevent a myeloproliferative or lymphoproliferative disorder, to determine whether an individual suffers from a myeloproliferative or lymphoproliferative disorder to typify a sample containing m cell. or a lymphoid cell-containing sample from an individual, and, to det [P] . BR112016014072A2 . 2018-01-09

机译：人类分离的，合成的或重组的抗体或其功能部分或功能等同物，分离的，合成的或重组的核酸分子，载体，分离的或重组的细胞或非人类动物，抗体的组成，用途或功能部分等同物，以及产生抗体或功能性部分或功能等同物的方法，用于检测骨髓增生性或淋巴增生性细胞，确定髓样或淋巴增生性细胞是骨髓增生性或淋巴增生性细胞，鉴定骨髓增生性或淋巴增生性细胞，以确定骨髓增生性或淋巴细胞增生性样品中存在淋巴增生细胞，以治疗和/或预防骨髓增生性或淋巴增生性疾病，以确定个体是否患有骨髓增生性或淋巴增生性疾病，以代表包含m细胞的样品。或来自个体的含有淋巴样细胞的样本，并且
5. Protein isolated and htrt preparation, htrt protein fragment, human telomerase, isolated polynucleotide, expression vector, cell, non-human organism, isolated or recombinant antibody, processes for determining whether a compound or treatment is a modulator of an activity or expression of htrt, if a test compound is a modulator of a telomerase reverse transcriptase activity, to identify a compound that modulates htrt activity, to prepare recombinant telomerase, to detect a htrt people product in a sample and the presence of at least one telomerase positive human cell in a biological sample, to diagnose a telomerase-related condition in a patient and cancer to provide a prognosis for a cancer patient, to monitor the ability of an anti-cancer treatment, to reduce the ability proliferation of cancer cells in a patient, to increase the proliferative capacity of a vertebrate cell, to treat a condition associated with a high level of telomerase activity within a cell, to isolate a selected nu [P] . BR9712254A . 2000-01-18

机译：分离的蛋白和htrt制剂，htrt蛋白片段，人类端粒酶，分离的多核苷酸，表达载体，细胞，非人类有机体，分离的或重组抗体，确定化合物或治疗是否是htrt活性或表达调节剂的过程，如果受试化合物是端粒酶逆转录酶活性的调节剂，则鉴定可调节htrt活性的化合物，制备重组端粒酶，检测样品中的htrt人产物以及是否存在至少一个端粒酶阳性人类细胞生物学样品，以诊断患者和癌症中的端粒酶相关病症，为癌症患者提供预后，以监测抗癌治疗的能力，减少患者癌细胞的增殖能力，从而增加癌症患者的预后。脊椎动物细胞的增殖能力，用于治疗与细胞内端粒酶活性高水平有关的疾病，分离选定的核酸