The 7th domestic beval bead single anti-report listing set harvest is coming Roche ace drug is completely blocked

Wen/Linan September 4, Dong'an Pharmaceuticals announced that the State Drug Administration has officially accepted the Bayval Pearl single anti-biosynthic drug TAB008 (commodity name: Park Xintin ®, English name: Pusintin) listing application.
Dongda Pharmaceuticals said that the NDA is mainly based on TAB008 to avetin ® as the control of the clinical data of two clinical studies, that is, in healthy subjects of pharmacological dynamics compared to the study and in patients with advanced or relapsed non-scaly non-small cell lung cancer safety and ability of the comparison study, both reached the preset main endpoint.
Beva bead monoantigen is a humanized anti-VEGF monoclonal antibody, is Roche's world's first widely used anti-angiogenesic drugs for a variety of tumors, by blocking VEGF to inhibit the angiogenesia of tumors, cut off the blood supply to the tumor area, inhibit tumor growth and metastasis, thereby producing anti-tumor effect.
At present, in addition to Qilu, Xinda's Beva Pearl single anti-injection has been approved for the market, Hengrui Pharmaceuticals, Green Leaf Pharmaceuticals, Baiotai, Beda Pharmaceuticals' Beva Pearl single-dose injections have been reported for production, if according to the time of production, Dongdao Pharmaceutical Park Xintin is expected to become the 7th Beva Pearl single anti-biosimilar drug.
addition, Jia and Biology, Fuhong Hanxuan, Zhengda Tianqing, Hualan Gene, Shenzhou Cells and Anke Bio equivalent products are currently in Phase 3 clinical trials.
2019, Avitin's global sales were about SFr7.07 billion, up 3.3 percent year-on-year, according to Roche.
data show that the domestic beval beads single anti-2017 sales of about 1.5 billion yuan.
roche's market share in China is expected to be severely squeezed as domestic beva beads of anti-injection biosynthic drugs are approved.
Roch's three "ace drugs" are completely blocked by Roche's super-heavy oncology "troika" - Anvitin (generic name: beva bead monoantigen), Melohua (generic name: lyxi monoantigen injection), Hessetin (generic name: injection of queto-bead monoantigen), these three drugs have long been the driving force of Roche's performance.
with the expiration of patents, biosimilar drugs approved and commercialized more and more, the current Roche three ace drugs are all affected by generic drugs.
: In addition to the growing number of generic drug players in China, the FDA has approved two models, with Amgen/Eljian Mvasi approved for listing in July 2019 and Pfizer Zirabev on December 31, 2019.
Lytoxi monoanti: In February 2019, China's first lysoxi monobial-like drug was approved for sale.
in the competition for the development of Lytoxi monoantigen-like drugs, in addition to Fuhong Hanxuan, there are Cynda Bio, Shenzhou Cell Engineering;
beads single resistance: In August 2020, china's first qutoju single anti-similar drugs were approved for market.
According to statistics, there are more than 10 domestic pharmaceutical companies are developing qutozhu single resistance, there are 7 pharmaceutical companies into Phase III clinical, involving Zhengda Tianqing, Hualan gene, Haizheng Pharmaceuticals, Jiahe Biology, Anke Biology, etc.; Hercetin biosimilars are Anjin/Eljian Kanjinti, Mylan/Baikang Ogivri, Pfizer Trazimera, Teva/Celltrion Herzuma, Mercedon/Samsung Biologics Ontruzant.
Roche copes with the decline in sales of the world's three most ace drugs? In 2019, Roche's Hessetine and Melohua began to decline, and only Anvetin is still growing.
, while sales have not fallen, are also facing a potential crisis.
patents in the U.S. and the European Union expire in 2019 and 2020, respectively.
Mvasi and Pfizer's Zirabev were approved for listing, further snapping up Avetin's market share.
Roche's first half of 2020 results show that hospitals have stopped treating new patients and delayed infusions for existing patients as a result of the new crown outbreak.
the arrival of the "black swan" and the competitive pressure of generic drugs, Avetin fell 18% Year-on-Year, Merohua down 23% YoY, Hercetin down 28% YoY.
, Melo's sales in China fell 12 per cent, caused by competition from bioso-like drugs and falling revenues from being included in the national health insurance system.
period of time, the industry out of 3 years 500 varieties will be collected, varieties covered with biological drugs, insulin.
with the three drugs more and more bio-similar drugs, it is expected that in the future Roche's tumor ace drugs will be collected, when a substantial price reduction is inevitable.
comes after industry analysts said Roche's new drug may offset a decline in sales of three aces, including Ocrevus, a new drug for multiple sclerosis, Perjeta, pD-1 cancer immunotherapy Tecentriq, and Hemophilia, a new drug for haemophilia.
, especially Ocrevus, has been hailed by Roche as the best product ever launched.
In addition, in response to the crisis, Roche in recent years plans to acquire a number of innovative pharmaceutical companies, such as Sanogan, Jeku, Intemr, etc., in order to consolidate the advantages of the original field of cancer tumors, but also enrich the field of liver disease, lung disease research and development pipeline of new drugs.
is particularly noteworthy that Roche's first SERD (estrogen-subject degradation agent) breast cancer candidate, ARN-810 Phase II, was quickly introduced as a second SERD candidate, RG6171, and successfully entered Clinical Phase III in 2020.