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    Home > Medical News > Medical World News > Inventory of domestic new drug pipeline with the fastest progress in 2020

    Inventory of domestic new drug pipeline with the fastest progress in 2020

    • Last Update: 2020-01-03
    • Source: Internet
    • Author: User
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    In 2019, China's nmpa approved the listing of 51 new drugs, including 12 innovative drugs from China, plus 4 bio similar drugs from local enterprises, which ended up perfectly In 2020, what is the power of new drugs in China to look forward to? Figure 1 New drug types of NDA / bla (left) and phase III clinical stage (right) Class 1 new drugs still occupy the mainstream of new drug development, but the proportion begins to decrease Since 2015, the clinical application of biological products has started to show explosive growth Five years later, it has gradually entered phase III clinical Whether it is new biological products or biological similar drugs, 2020 will be the warm-up period of fierce competition in the biological drug market Fig 2 layout of new drugs in NDA / BLA and phase III clinical stage Hengrui pharmaceutical, hausen pharmaceutical and Zhengda Tianqing are all domestic pharmaceutical enterprises that have established a research and development team of biological drugs gradually after the establishment of small molecule R & D, with class 1 chemical drugs as the main focus and biological drugs as the supplement, occupying the top three in the layout of NDA / BLA and phase III clinical new drugs in 2020 At the same time, more small new drug companies are about to enter the harvest period Fuhong Hanlin, Shenzhou cell, baiaotai, Xinda biology, etc., which focus on the development of biological drugs, are rapidly among the top 8 new drugs to be approved for market The founders of cornerstone pharmaceutical, Geli pharmaceutical and Baiji Shenzhou, who have working experience in multinational pharmaceutical enterprises and focus on the unicorn pharmaceutical enterprise in a disease field, will soon reap the company's first new drug on the market, and face the challenge of production and market promotion Figure 3 indication distribution of new drugs in clinical stage (right) of NDA (left) and phase III In addition, the distribution of indications in phase III clinical is more diversified: with a number of bio similar drugs used for rheumatoid arthritis and psoriasis, as well as bio drugs mainly used for postmenopausal osteoporosis in women, the proportion of immune system diseases and musculoskeletal diseases has increased significantly in phase III clinical stage at the same time; New drugs began to enter the chronic disease-related complications, including chronic kidney disease, non dialysis anemia and diabetic lower extremity skin ulcer; antiviral drugs, in addition to hepatitis C drugs in the NDA stage, also added new drugs for hepatitis B and HIV; the development of new drugs for nervous system diseases is very difficult, and the NDA stage is mainly the same as that of ramazolam toluene sulfonate for injection approved by Hengrui at the end of 2019 At present, the proportion of GABA receptor agonists in phase III clinical practice has decreased, mainly including the slow-release tablets of anshufaxine hydrochloride for depression, the new drug B1101 with the fastest development of stroke, and the tablets of succinohydroaminoacridine for mild to moderate Alzheimer's disease Continuous heating of anti-tumor therapy Due to the accumulation of basic research, the field of anti-tumor treatment has become the field with the fastest development of new technology and the hottest investment intensity in the pharmaceutical industry China is no exception In addition to 10 new anti-tumor molecular bodies and 6 anti-tumor biological analogues in NDA / BLA stage, the research and development of new anti-tumor drugs continue to be high in class 1 new drugs (including new molecular bodies and new biological products) in phase III clinical Table 1 class 1 new anti-tumor drugs in phase III clinical Solid tumor is the main battlefield of class I clinical anti-tumor new drugs, including the highest cancer types in China, including lung cancer, breast cancer, gastric cancer, etc The number of small molecule drugs and biological drugs is 16 and 14, respectively, basically the same Among them, PD-1 / L1 antibody has contributed 10 seats to biological drugs At present, China's PD-1 / L1 competitive market is "three imported and four domestic" However, even if we add atezolizumab, which is applying for listing in China, PD-1 / L1 antibody of many pharmaceutical enterprises in the second tier of China has entered into III In the future, the competition pattern will become "four imported and N domestic" How to overtake in a curve is more important for the selection of phase III clinical indications Compared with the first tier company, which plays a safety card, the second tier company has the choice of more challenging indications such as gastric cancer, liver cancer, extensive small cell lung cancer, bile duct cancer and so on In addition to the preparation of PD-1 / L1 antibody, other "fast follow" drugs have made new progress BioTek's her2-adc-bat8001 is currently the fastest-growing new ADC in China, and 2019 is the year of ADC's fire Ds-8201, the first three in total, has been approved by FDA for its amazing clinical data in the treatment of HER2 positive and refractory breast cancer In addition to therapeutic drugs, there are also supplements for the lack of adjuvant drugs for cancer treatment The first phase of clinical application of Qilu pharmaceutical and denosumab biological analogues from Jiangsu Taikang biological Co., Ltd has indications for solid tumor bone metastasis or osteoporosis Breast cancer, prostate cancer and lung cancer are the three major cancers with high incidence of bone metastasis, and they are also the cancers with high incidence in cancer population in China The original research Denosumab was not approved for this indication in China In the case of tumor treatment still based on chemotherapy, Shengbai needle g-csfs will always be a big cake The efficacy of Enjin's pefigeristine has been very good but not listed in China At present, the domestic long-term G-CSF market is mainly divided by Qilu, Shiyao and Hengrui Jiannenglong f-627 is a fusion protein injection At present, phase III clinical trials are conducted in China and the United States at the same time Biological analogues are called the next gold mine in the biopharmaceutical industry 23 anti-tumor biological analogues in clinical phase III are covered by four star targets of VEGF, EGFR, HER2 and CD20, 2019 In, the first bevacizumab biosimilars of Qilu pharmaceutical, the first rituximab biosimilars of Fuhong hanlinli and the first adamumumab biosimilars of baiaotai were approved for marketing It is expected that the first trastuzumab biosimilars will be approved in 2020 Familiar inhibitors of AR, VEGF and EGFR still account for a certain proportion in phase III small molecule new drugs, and alk and PARP inhibitors are also in catch-up state On January 1, 2020, Zejing pharmaceutical announced that donafinil and sorafenil were head to head for the first-line treatment of advanced HCC phase III clinical research to reach the main end point of total survival extension However, dulanamin, casein and recombinant human tumor necrosis factor related apoptosis inducing ligand for injection, which are more challenging targets, have a slower clinical progress China has a large number of chronic patients, including diabetes, hepatitis, rheumatism and immunity Long-term drug use creates a large market How can new drugs with similar mechanism compete in differentiation? Or only need to be separated from the market into a large cake or a small cake In any case, more patients can be healthy Table 2 new drugs for type 2 diabetes in phase III clinical At present, the new type II diabetes drug at the stage of NDA is only the micro core organism of ciglitaza sodium At present, there is no PPAR full agonist on the market in the world There are still many unknown fields in its specific mechanism of action and long-term safety and effectiveness that make it difficult to develop Most Chinese pharmaceutical companies still focus on the star target of diabetes ddp-4, GLP-1, sglt-2 The domestic market of these target antidiabetic drugs is mainly occupied by foreign enterprises, and some of them have entered the medical insurance through negotiation at the end of 2019 Due to the long drug cycle of diabetes patients, these new drugs in clinical phase III are expected to obtain certain market space before a large number of generic drugs go on the market Hualing hms5552 tablet is a new type of glucose activator, which aims at single drug or combination as the first-line treatment of type 2 diabetes There are also rheumatic and immune diseases In October 2019, the general office of the health care Commission issued a notice to establish a rheumatic and immune department in the general hospital The rheumatic and immune department, including more than 200 diseases, began to meet the golden age of development The common diseases include rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, Sjogren's syndrome, gout, osteoarthritis and so on At present, the new drugs mainly aimed at rheumatoid arthritis, psoriasis and other diseases listed in China are all foreign enterprises The drugs in clinical phase III are TNF - α, IL-6R The new biological products are only used as recombinant human interleukin-1 receptor antagonists of vinorelbine in rheumatoid arthritis It is very difficult to explore new targets in the field of cardiovascular diseases In 2019, the most important progress is PCSK9 RNAi drug inclisiran, which shows long-term efficacy and safety, and also adds evidence for the development of other PCSK9 monoclonal antibodies Amgen and Sanofi's PCSK9 monoclonal antibodies just entered China At present, the fastest clinical development of PCSK9 monoclonal antibody produced in China is Xinda ibi306 injection, III The homozygous type of familial hypercholesterolemia was first selected in the clinical stage.
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