Domestic single anti-bio-similar drugs to seize the original research 20 billion market opened

September 2, 2020, the State Drug Administration recently approved Xinda Biopharmaceuticals (Suzhou) Adamo single anti-injection, the commodity name Su Lixin, became the third domestic Adamu single anti-bio-similar drugs, will be with Baiotai's Gree Li, Haizheng's AnJianning to compete with Abevie's original research brand drug repair meth.Adamo monoantigen is an anti-immune, anti-inflammatory prescription drug, in 2019 AbbVie's Adamo single anti-global market of 19.169 billion U.S. dollars, while in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal, AbbVie's Adamo single anti-drug sales of only about 80 million yuan. With the launch of domestic Adamo single anti-biosynthic drugs, it will gradually change the situation of Adamo monoantigen in the bioengineering drug market sleeping situation.

2020 antibody drug market accelerated the pace ofSo far, the National Drug Administration (NMPA) has registered 14 new drugs for import and approval of domestic antibodies in 2020, up more than 75% from eight in the same period in 2019. On September 2, 2020, after the latest approval of Ida Biopharmaceuticals (Suzhou) Adamo single anti-injection, China has independently developed and marketed 22 antibody drugs for clinical use, and in the last 3 years approved for the market varieties accounted for more than 60%.Data show that a total of 39 imported antibody drugs registered for clinical use in China. From 2018 to the end of August 2020, 26 imported antibody drugs were approved, more than double the previous 18 years. So far in 2020, nine imported monoclonal antibody drugs have been approved for registration, reaching the full 2019 registration volume.According to data from the State Drug Administration, up to now, in 2020 the NMPA has approved five domestic monoclonal antibody drugs, namely Sansheng Guojian Pharmaceuticals (Shanghai) anti-HER2 breast cancer targeted innovative drug injection with intransictoral monoanti, domestic The antibody bio analogues are the lyxi monoantigen injection of Shanghai Fuhong Hanyu biology, the injection of trichomo-bead monoantigen, the beva bead monoantigen injection of Cyntaf Biopharmaceutical (Suzhou) and the adamu monoantigen injection.In the global pharmaceutical research and development pipeline, monoclonal antibody drugs have attracted much attention, and their characteristics of high specificity, strong targeting and low toxic side effects have been sought after by many pharmaceutical companies and belong to one of the most popular research and development fields. From January to the end of August 2020, the FDA has approved the listing of seven monoantigens, more than 90 monoantigens worldwide, and is expected to move towards 100 monoclonal antibodies.According to incomplete statistics, China's listed clinical bioengineering antibody drugs and antibody diagnostic reagents reached 50, domestic bioengineered antibody drugs have a breakthrough development, and many bioengineering polymer drugs in the development and approval.

rapid development of the domestic antibodyAccording to Minenet data, in 2019 there were 38 varieties of antibody drugs used in public hospitals in key provinces and cities, with the amount of drugs used exceeding 7.2 billion yuan, an increase of 36.25 percent over the previous year. The overall domestic market has exceeded 20 billion yuan.Key provincial and municipal public hospitals terminal anti-tumor monoantigen accounted for half of antibody drug use, the use of TOP10 antibody drugs accounted for 94.23% of the overall market. Among the top 3 varieties were quto bead monoanti, beva bead monoanti and lytoxi single resistance, with market share of 25.32%, 20.26% and 18.51%, respectively.

beads single anti-resistance leading the domestic antibody marketCurtoju monoantigen is the first monoclonal antibody approved for the treatment of human skin growth factor 2 (HER2) for metastasis breast cancer and early breast cancer, and is widely used in all stages of HER2-positive breast cancer treatment. In 2019, Roche's global quarry bead monoanti and Enmetro-pearl mono-resistance market was 7.432 billion Swiss francs, becoming Roche's leading variety, and in 2019 Roche's three targeted HER2 antibody original research drugs, curto-bead mono-resistance, Parto-pearl mono-resistance, and enmetro-bead mono-resistance, reached 11 billion Swiss francs.On August 12, 2020, Fuhong Hanxuan's Quto Zhudan Resistance (HLX02) was officially approved for listing, and the commodity name Hanquyu. Global impact of antibody drugs biosynthic drugs, resulting in a decline in sales of hercetin abroad, but the domestic market growth is still strong, showing a year-on-year growth trend.According to Minenet data, in 2019 the amount of anti-drug terminal qutozhu single drug in key provinces and cities was 1,832 million yuan, an increase of 41.96 percent year-on-year, from 2017 antibody drugs ranked 2nd on the list.Data show that in 2019, China's public medical institutions terminal qutoju single resistance has exceeded 5.5 billion yuan scale, with the domestic qutoju single anti-bio-similar drugs on the market, the price will be further popularized, so as to meet the needs of domestic patients. Public data show that as of the first half of 2020, there are seven local pharmaceutical companies qutozhu single resistance has entered Phase III clinical, respectively, Jiahe Biology, Haizheng Pharmaceuticals, Zhengda Tianqing, Shanghai Institute of Biological Products, Anke Biology, Hualan Gene, Amai Medical, the future competitive situation will remain to be seen.

the second-largest of the beva bead monoantigen antibodies   Beval bead monoantigen is a variety developed by Genentek in the United States and is now one of the most popular varieties owned by Roche in Switzerland. Beva bead monoantin is the world's first anti-tumor angiogenesis drug anti-tumor targeting preparation, in February 2004, the United States FDA first approved beva beads as a metastatic colorectal cancer treatment drug, the commercial name Avastin. With the expansion of its clinical adaptive disorders, the FDA has approved the use of beva beads for non-small cell lung cancer (NSCLC), as well as renal cell carcinoma, colorectal cancer and glioblastoma. At the end of 2012, the European Union was approved for relapsed ovarian cancer, and beval bead monoantin has been approved in more than 120 countries and regions around the world. Global Sales of Roche's Beval Beval Beads in 2019 amounted to CHF 7,073 million, an increase of 3.27% over the previous year.   On December 6, 2019, Qilu Pharmaceuticals' Beval pearl mono-resistant biosimilars were approved by NMPA under the trade name Anda. Subsequently, on June 17, 2020, Xinda Biopharmaceuticals (Suzhou) listed the same products, the commodity name is the same, the current formation of three into the market situation.   According to Minenet data, in 2019, the amount of anti-drug use in key provincial and municipal public hospital terminals was 1,466 million yuan, up 48.50 percent year-on-year, and the end-use beval pearl single resistance in China's public medical institutions was about 3.5 billion yuan market size.

is the third black Malitoxi monolith   Rituxan, a drug developed by Genentek in the United States, was approved by the FDA in November 1997 and is now the backbone of Roche. Lytoxi monoantigen is a monoclonal antibody acting on human CD20, which is mainly manifested on the surface of B lymphocytes and can be used to treat diseases caused by excessive B lymphocytes, including lymphoma, leukemia, migration rejection and certain autoimmune diseases. Lytoxident is a gold standard drug for the treatment of non-Hodgkin's lymphoma and has been approved as a first-line drug for advanced colon cancer. Roche's Lytoxi monoantigen sales for 2019 amounted to CHF 6,477 million, down 4% from the previous year. In 2000, China approved the listing of the Lytoxi single anti-anti-listing, the commodity named "Merohua".   On February 22, 2019, the State Drug Administration approved the listing application for the lyxi single anti-injection (100mg/10ml) of Shanghai Fuhong Hanxuan Biopharmaceuticals, which is the first biosimilar drug approved in China and is mainly used for the treatment of non-Hodgkin's lymphoma. Subsequently, on April 15, 2020, the application for the listing of Lytoxi monoantigen injection (500mg/50ml) from Shanghai Fuhong Hanyu Biopharmaceuticals was approved. According to the relevant data, Zhengda Tianqing, Xinda Bio, Hualan gene and other enterprises have layout.   According to Minenet data, in 2019, the amount of lysoxi single anti-drug use in key provincial and municipal public hospitals amounted to 1,339 million yuan, an increase of 11.35 percent over the previous year, and the terminals of public medical institutions in China reached a market size of 4.129 billion yuan.   Domestic research and development of single resistance is concentrated in curto pearl single resistance, Beval bead single resistance, lysioxi single resistance, Adamu single resistance and other popular varieties, with the development of the depth of research and development, Fosun subsidiary Shanghai Fuhong Hanxuan, Xinda Bio, Sansheng Guojian, Baiotai, Qilu Pharmaceuticals, Jiangsu Osaikang, Guilin Sanjin and other enterprises have related varieties of research and development layout. A new round of domestic high-quality antibody drugs on the market, will change the traditional drug main pattern. (Minenet)