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    Home > Biochemistry News > Biotechnology News > Current situation and trend of the development of bispecific antibody industry at home and abroad (below)

    Current situation and trend of the development of bispecific antibody industry at home and abroad (below)

    • Last Update: 2020-06-01
    • Source: Internet
    • Author: User
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    In "The Status and Trends of The Development of Bispecific Antibody Industry at Home and Abroad (Above), we introduce in detail the definition, development course, technical platform and molecular structure of bispecific antibodies, and in the next section we will further introduce the progress of global bi-anti-clinical research, representing targets and indications;, global clinical research progress of bispecific antibodythe number of clinical trials continued to rise, clinical trials mainly focused on Phase 1/2, the study focused on tumor indicationsAs of March 2019, there were more than 85 bispecific antibody drugs in the global commercial clinical clinical phase, with more than 85 percent of the biantibodies used in tumor and cancer indications, according to Nature's Double Anti-Anti-Review pipelineFigure 1 Clinical Study Launch of Bispecific AntibodiesPicture Source: Nature Reviews Drug DiscoveryThe number of new biantino clinical trials launched each year has grown rapidly since 2014, based on annual clinical trial sprees on bi-specific antibodies, and drug indications are dominated by tumorsMore than 95% of cancers are newly launched in clinical trials in 2017 and 2018, as shown in Figure 2Figure 2 The start of the annual bispecific antibody clinical researchpicture source: Nature Reviews Drug Discovery2, Global Biantium Clinical Research Representative Target sage and indications1Tumor-related indications: T-cell collection mechanism, immunomotherapy into the development of popular-specific biantibodies the most typical mechanism is the redirection effect of T-cell cytotoxic activity, specifically to eliminate tumor cellsIn this way, T-cells are physically connected to tumor cells through bispecific antibodies consisting of T-cell binding domains and tumor binding domains(1) In the T-cell binding domain, T-cell-involved bispecific antibodies activate T-cells mainly by binding CD3 in the TCR complexOf the 86 clinical lyse in Nature, about half of the two-resistant studies applied this mechanism (2) in the tumor binding domain, the target of most of the two-specific antibodies is known targets, such as CD19, CD20, CD33, CD38, BCMA and so on, clinical trials are mainly concentrated in Phase 1/2 Table 1 Tumor-related indications bispecific antibodies in the study (typical) data source: Nature Reviews Drug Discovery due to the clinical success of immunocheckpoint inhibitors CTLA-4, PD-1 and PD-L1 monoantigens, and there are examples of targeted immunocheckpoint monoantigens of combined therapeutic effects better than One drug alone in the same case (e.g., the combination of ipilimumab and PD-1 antibody nivolumab improves survival outcomes in melanoma patients compared to CTLA-4 antibody ipilimumab monotherapy), so bispecific antibodies for immunocheckpoints are also becoming a development hotspot , based on the support of existing research, the double resistance to the immune checkpoint as the target is designed as a target for PD-1 or PD-L1, and the other target is CTLA-4, LAG3 or TIM3 It is worth noting, however, that combination therapy has also significantly increased immune-related adverse events, so improving the safety of double resistance is particularly important in future studies 2 Non-tumor-related indications: covering a wide range of areas, clinical research focused on early In addition to tumor indications, scientists are also exploring the potential of bispecific antibodies in other disease areas, such as HIV infection, virus and bacterial infections, osteoporosis, diabetes, autoimmune deficiency diseases, etc At present, the representative double-resistance study of non-tumor indications is still mainly concentrated in clinical 1/2 phase Table 2 Non-tumor-related indications bispecific antibodies in the study (typical) data source: Nature Reviews Drug Discovery 3, domestic bispecific antibody development status and trends 1 Antibody pharmaceutical enterprises to accelerate the layout, the Yangtze River Delta region into the main gathering area domestic double anti-company, part of the listed companies and its focus on new drug research and development subsidiaries, such as Hengrui Pharmaceuticals, Lizhu Pharmaceutical's subsidiary Lizhu single resistance, Double-Scan Pharmaceuticals shares company Kangming Baio, Fosun Pharmaceutical son subsidiary Fou-hung Pharmaceutical, Anke Bio-Holding Company Boshengji and so on The other part of is the innovation of antibody drugs, such as Tianxing Pharmaceuticals, Youzhiyou, Corning Jerry, Kennlong and so on According to statistics, relying on the vigorous development of antibody drug industry, the domestic currently engaged in bi-specific antibody drug research and development of nearly 40 enterprises, mainly distributed in the Yangtze River Delta region, including Zhangjiang Biopharmaceutical Base, Suzhou Industrial Park as the main gathering place 2 Domestic research is in its early stages, clinical trials mainly focus on Phase 1 domestic Cinda Bio, Youjiyou, Corning Jerry is a company with a large rheumatoid product layout, its core dual resistance products have entered the clinical research stage As of August 2019, 14 bispecific antibodies have entered the clinical trial stage through CDE approval, but the current research is mainly focused on the clinical phase 1, it is still time before the commercialization of the drug notably, the world's first approved dual-resistant Catumaxomab could be re-listed in the next two years after it was delisted in 2017 due to poor sales At present, Ling Teng Pharmaceuticals has submitted a clinical Phase III application to the FDA in September 2019 for the disease to be a peritoneal metastatic stomach cancer that is not suitable for systemic chemotherapy Later with the development of clinical trials, Ling Teng Pharma will be in Europe, China, Taiwan and South Korea and other countries and regions to carry out international multi-center Phase III clinical trials, in order to promote catumaxomab re-listing at an early date Table 3 The list of bispecific antibodies entering the clinical trial stage data source: Firestone Creation Database 3 The ongoing investment and cooperative development boom has led to a new model of dual-resistance field entry
    since the second half of 2018, domestic and foreign "bispecific antibody" field of investment events and cooperative development has become more active By licensing WuXiBody, a technology platform for new drug development for a number of companies, The Pharmaceutical Bio ™ at the same time, there are enterprises in China to carry out research on combination therapy Earlier this year, Corning and East Sunshine Research partnered to develop PD-L1-CTLA-4 (KN046) combination therapy for the treatment of hepatocellular carcinoma to advance the clinical development and commercialization of the drug in Chinese mainland On April 11, Skyfall And Roche announced a clinical study of a combination of bispecific antibodies TJD5 and Tecentriq with the continuous maturation of dual-specific antibody development technology, product line comprehensive promotion, more large domestic pharmaceutical companies will be investment or cooperation in the way into the field of double resistance Table 4 2018-2019 typical case of investment cooperation in the field of bispecific antibody data sources: according to public data finishing four, small although compared with single resistance, the concept of bispecificity is more complex, in the different stages of bi-anti-development are full of unknown challenges, but it as a new drug still excited scientists With domestic and foreign pharmaceutical giants gradually layout of dual-resistance research and development pipeline, the number of clinical studies of bispecific antibodies, investment and cooperative development projects continue to increase in addition to the three dual-resistance drugs that have been on the market, the remaining double-resistance research is still more concentrated in the clinical phase 1/2, to achieve large-scale commercialization still needs a long way to go Despite the difficulties, we have reason to believe that as antibody technology continues to change, there will be more efficacy in the future than ordinary antibodies of the double resistance into the market references/information: , Aran F, Maarten L, Janice M, et al Bispecific antibodies: a mechanistic review of the pipeline Nature Reviews Drug Discovery, 2019, 18 (6): 585-608 Nisonoff A , Wissler F C , Lipman L N Properties of The Major Component of a Peptic Digest of Rabbit Antibody Science, 1960, 132 (3441):1770-1771 Roland E, Ulrich B Bispecific antibodies (J) Drug Discovery Today, 2015, 20 (7): 838-847 The latest review of Nature's bispecific antibodies: Global Pipelines, Targets, Mechanisms of Action ( EB/OL https://mp.weixin.qq.com/s/Hst4fVVIwWbjLkXph0b3cQ)
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