The year of the outbreak of biosimilardrugs, the fierce competition can not be underestimated

The drug and the body biomolecule binding site is the drug target, the discovery of new drug target is a breakthrough in the development of new drugs, so monoclonal antibody drugs have become one of the fastest growing areas of pharmaceutical, but also the global biomedical technology market, one of the most profitable varietiesMonoclonal antibodies have been one of the largest categories in the global biopharmaceutical market since 2013, according to the Frost Sullivan reportThe global mono-anti-market segment accounted for 55.3% of the global biopharmaceutical market in 2018, with a CAGR of 13.2% from 2014 to 2018the world has listed monoclonal antibody drugs sales of more than 1 billion U.Sdollars, more than 20, of which the top 10 are:Adamu monoantigen, invrisie monoantigen, rituxii mono-resistance, quto-bea monoantigen, beva-bea-mono-resistance, Navuliu mono-resistance, Utek mono-resistance, tino mono-resistance, Paboli single resistance, thunder-bead mono-
China's monoclonal antibody drug market is in a period of rapid development, although many drugs on the market in Europe and the United States have not yet been approved in China, but in recent years the State Drug Administration has accelerated the process of drug research and development approval, currently seven domestic mono-anti-resistant varieties have been approved in ChinaAt the same time, starting from 2017, the national health insurance procurement in the single anti-drug coverage significantly expanded, which is conducive to improve the penetration of the future single anti-drug, and further promote the expansion of China's single anti-drug marketstar product Adamu mono-resistance (Sumerle) core patent expired in China in 2016, the first Adamu mono-anti-biosimilar drug, Baiotai bio-production of Greeli, has been approved in China on November 7, 2019, because the research and development of biosimilar drugs is lower than the original research drug, with a more obvious price advantageAt present, domestic enterprises Cinda Bio, Haizheng Pharmaceuticals, Fuhong Hanxuan and other enterprises Adamu single anti-biosimilar drugs are also waiting for approval, the Chinese market Adamu single anti-penetration rate will be rapidly improved, the market size is expected to increase rapidlypD-1/PD-L1 as a broad-spectrum anti-tumor monoantigen, as of June 2019, a total of 9 products, including 6 PD-1 and 3 PD-L1, were approved worldwideThe Navuliyu monoantigen of Baishi Shiguibao and the Paboli-Zhu monoantigen of Mersadong were first approved in the United States in 2014 and have been approved for treatment of a variety of indications including melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urethral skin cancer, colorectal cancer, hepatocellular cancer, etcAs of June 2019, Junshi Bio's Tomi, Cinda Bio's Daboshu and Hengrui Pharmaceuticals' Erika have approved the listing approval of the State Drug Administrationthe first PCSK9 (a liver-derived secretion protein) inhibitor class of new fat-lowering drug, and the Eloyu monoantigen developed by Amgen was approved by the State Drug Administration in July 2018 for the treatment of adults or adolescents over 12 years of age with pure-fit family hypercholesterolemia and the treatment of adult atherosclerosis cardiovascular disease, which reduces the risk of myocardial infarction, stroke and coronary blood reconstructionrisk tips
1High technical barriers monoclonal antibody drugs are high input, high output of the industry, the production process is mainly flow and culture and continuous irrigation culture, due to foreign enterprises on the domestic long-term technical blockade, resulting in China's monoclonal antibody large-scale production technology lags behind foreign countries, it is more difficult to achieve industrialization However, it is believed that Da Bio's annual report revealed that the company already has three sets of 1000 literbioreactors used to produce The burgeons® (Sindili mono-anti-injection), six sets of 3000 liters of stainless steel bioreactor second production facilities have completed the drug production quality management practice (GMP) commissioning and verification, the current total production capacity can reach 21,000 liters 2 Research and development investment in large biopharmaceutical structure is generally more complex than chemical drugs, bio-innovative drugs need 10 to 15 years of research and development and clinical trial time, research and development cycle is difficult to develop, long return cycle Even biosimilars require significant investment, with research and development spending of more than 1.2 billion yuan in 2018, 19 products under development, and PD-1 product suis approved for listing in the Chinese market on March 8, 2019, with sales of 331 million yuan as of June 30, 2019, according to Cinda Bio's 2018 annual report 3 Product competition is fierce
monoclonal antibody drugs of foreign pharmaceutical companies have been on the market for many years, in research and development, marketing, production has a very large advantage, China's antibody pharmaceutical companies directly face competition with foreign large pharmaceutical companies And domestic enterprises have entered the field of single anti-drug, according to Insight data show that since 2014, the number of domestic antibody drug declaration clinical and approved clinical has increased rapidly, the number of domestic antibody drug declaration clinical has reached 79 in 2019; 4 The impact of clinical application sand and health insurance control most monoclonal antibody drugs in the world are not first-line drugs, mainly used in patients with advanced cancer, directly affectmarket penetration With the implementation of a series of policies related to drug prices, such as government medical insurance drug negotiation and centralized procurement, the market price level of the whole drug is on a downward trend, which directly affects the profits of pharmaceutical enterprises.