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在内质网形成的糖蛋白具有相似的糖链，由Cis面进入高尔基体后，在各膜囊之间的转运过程中，发生了一系列有序的加工和修饰，原来糖链中的大部分甘露糖被切除，但又被多种糖基转移酶依次加上了不同类型的糖分子，形成了结构各异的寡糖链。O-连接的糖基化在高尔基体中进行，通常第一个连接上去的糖单元是N-乙酰半乳糖，连接的部位为Ser、Thr和Hyp... 阅260 转5 评0 公众公开 18-03-29 09:35 |
主要过程是将糖基在糖基转移酶作用下将糖链转移至蛋白质，和蛋白质上的氨基酸残基形成糖苷键，经过一系列转运、糖链末端的剪切，修饰和岩藻糖化或者唾液酸化等完成糖基化蛋白质的组装（以N-糖基化为例，见图1）在ER形成的糖蛋白具有相似的糖链,由Cis面进入高尔基体后,在各膜囊之间的转运过程中,原来糖链上的大部分甘露糖被切除,但又由多种糖基... 阅11303 转47 评0 公众公开 18-03-29 09:34 |
虽然更新的抗体INN命名避免了前述原则的一些问题，但亚词干A的含义包括靶向的物种（细菌、真菌、病毒）、靶向蛋白的类型（细胞因子、毒素）、适应症（肿瘤）、组织器官（心血管、骨）、药物作用机制（免疫调节）等，其涵盖范畴过于多样化和宽泛，而且新型各类抗体药物研发层出不穷，应就亚词干及INN中缀的收录原则及其详略进行规范，而非随机定... 阅541 转1 评0 公众公开 17-12-13 10:25 |
阅148 转0 评0 公众公开 16-09-26 11:34 |
After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the reference product sponsor and the subsection (k) applicant shall engage in good faith negotiations to agree on which, if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor sh... 阅128 转0 评0 公众公开 16-08-08 14:33 |
EMA recommends approval of etanercept biosimilar.Samsung Bioepsis expects that, ‘if approved, Benepali could be the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there’.Samsung Bioepis had its etanercept biosimilar approved in Korea on 8 September 2015, ... 阅33 转0 评0 公众公开 15-12-04 13:31 |
Amgen Biosimilars: First submission for Humira biosimilar in the United States.Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab).Amgen believes this submission is the first adalimumab biosimilar application subm... 阅45 转0 评0 公众公开 15-12-04 13:30 |
Biosimilars of rituximab Posted 27/02/2015.Table 1: Biosimilars and non-originator biologicals* of rituximab approved or in development.The fact that the patents on the originator product, Roche’s MabThera/Rituxan (rituximab), already expired in Europe in February 2013, is perhaps spurring development and explains th... 阅66 转0 评0 公众公开 15-11-27 14:30 |
ProBioGen Germany signed a biosimilar deal with Bio Farma Indonesia.ProBioGen AG and Bio Farma signed an agreement for the development of a biosimilar trastuzumab for cancer treatment. 阅50 转0 评0 公众公开 15-11-03 16:56 |
FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept.Sandoz, a Novartis company, announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Enbrel (etanercept) – a TNF-alpha inhibitor.This is the second BLA sub... 阅36 转0 评0 公众公开 15-11-03 16:52 |
