What new drugs will be approved for marketing in China in 2020?

The insight database screened 15 new drug varieties that are expected to be approved in 2020, They are respectively lanalurenmab injection of Takeda pharmaceutical, enmetuzumab for injection of Roche, etacept for injection of Rongchang biology, vibutoximab injection and zanbutinib capsule of Baiji Shenzhou, beilintuomab for injection of Pfizer, kw-136 of Caine technology Capsule, avatrappa tablet of Fosun medicine, ometinib mesylate tablet of hausen, pratrassa injection of allos company, ensatinib hydrochloride capsule of Beida pharmaceutical, radium chloride [223ra] of Bayer, sinimod tablet of Novartis, fluzopali capsule of Hengrui, and suofentinib capsule of Huangyi medicine< br / > Takeda pharmaceutical < br / > lanadelumab injection < br / > lanadelumab injection (English trade name: takhzyro ®) is the first monoclonal antibody for the treatment of hereditary angioedema (HAE), which comes from shire, a manufacturer of rare diseases under Takeda pharmaceuticalIt was hosted by CDE on March 29, 2019< br / > hae is a rare genetic diseaseHae can cause recurrent edema in patients, causing weakness and pain in the body, including limbs, gastrointestinal tract and upper respiratory tract, and even life-threatening in severe casesLanalu mAb injection is the only monoclonal antibody drug that can specifically bind and inhibit plasma kallikreinAs a preventive treatment drug, lanalu mAb injection has been approved by the U.SFDA on August 23, 2018 for use in patients aged 12 and over with hae to prevent the onset of vascular edema< br / > at present, it is in the first round of hair and tonic stage, and it is expected that Q2 will be approved in 2020 < br / > Roche < br / > trametulin for injection < br / > trametulin for injection (the drug name in the United States is kadcyla ®) is developed by Roche pharmaceutical, kadcyla is a HER2 targeted therapy method, which will be approved for market in 2013, It is the first and only antibody drug conjugate approved as a single preparation for the treatment of HER2 positive metastatic breast cancer patients who have received Herceptin and paclitaxel chemotherapy (alone or in combination)It was hosted by CDE on March 27, 2019, and entered the priority review channel on June 2019< br / > at present, the first round of supplementary information is under reviewIt is expected that Q2 will be approved in 2020 < br / > Rongchang biology < br / > tetrahydrop for injection < br / > tetrahydrop for injection (rc18, trade name: tai'ai) is a double target biological new drug independently developed by Rongchang biology targeting BLyS and April, which is used to treat systemic lupus erythematosusIt was hosted by CDE on November 13, 2019, and included in the priority review procedure on December 10, 2019 for innovative drugs with obvious treatment advantages< br / > at the 4th China Pharmaceutical Innovation and investment conference, Rongchang biology announced the detailed clinical trial data of taitacipu in systemic lupus erythematosusTaitacipu vs placebo sri4 were 79.2% vs 32.0% respectively, with statistically significant difference, reaching the main end point of clinical trial, and the clinical data was extremely bright< br / > at present, the drug is under the review of a new report taskIt is expected that Q3 will be approved in 2020 < br / > Baiji Shenzhou < br / > vituximab vedotin injection < br / > vituximab vedotin (English trade name is adcetris ®) is an anti-CD30 antibody drug conjugate jointly developed by Takeda and Seattle genetics, Inc, For the treatment of recurrent / refractory CD30 positive Hodgkin's lymphoma (HL) or systemic anaplastic large cell lymphoma (salcl) < br / > the drug was approved in 2015 and 2017 in the United States for the treatment of Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (salcl), as well as cutaneous anaplastic large cell lymphoma (PCALCL) and mycosis fungoides (MF) expressing CD30 In a number of studies, it has been shown that compared with the existing chemotherapy regimen, vibutoximab can significantly improve the survival of patients, including relapsed / refractory Hodgkin's lymphoma and systemic anaplastic large cell lymphoma, and increase the 5-year survival rate to 41% and 60%, respectively < br / > the drug was undertaken by CDE on April 28, 2019 In June 2019, it was included in the priority review procedure on the basis of innovative drugs with obvious treatment advantages At present, it is in the first round of hair and tonic stage It is expected that Q3 will be approved in 2020 < br / > Pfizer < br / > bilintomab for injection < br / > bilintomab for injection (English trade name: blincyto ®) is a bispecific antibody heavy drug developed by Amgen One end of it is combined with CD19 antigen expressed on the surface of B cells, and the other end is combined with CD3 receptor on the surface of T cells, It can collect T cells near cancer cells and promote their killing to cancer cells < br / > blincyto was approved for the first time in the world in December 2014 At present, it has been approved to treat patients with relapsed / refractory B-cell all It is the first FDA approved drug to destroy leukemia cells through human T cells The global sales of the bispecific antibody from 2016 to 2019 / 3Q were US $115 million, US $175 million, US $230 million and US $231 million respectively < br / > the domestic listing application will be undertaken by CDE on October 29, 2019, and will be included in the priority review procedure in December 2019 At present, it is under the review of new reporting task It is expected that Q4 will be approved in 2020 < br / > Kaine technology < br / > kw-136 capsule < br / > kw-136 capsule is a class 1 new drug with independent intellectual property rights of Kaine technology It is a full genotype NS5A replication complex inhibitor for the treatment of hepatitis C It was undertaken by CDE on June 22, 2019, and entered the priority review channel as a major project in September 2019 < br / > both kw-136 capsule and dacatavir currently on the market in the United States are NS5A replication complex inhibitors At present, the combination of the two drugs is one of the first choice for the treatment of chronic hepatitis C It does not need to add interferon and ribavirin, which can alleviate the pain caused by the side effects of drugs It is also the first full genotype program in China After being put on the market, there is no need to detect the genotype, which can reduce the economic burden of patients and simplify the diagnosis and treatment process < br / > the drug is currently in the process of on-site inspection It is expected that Q1 will be approved in 2020 < br / > Baiji Shenzhou < br / > zanbutinib capsule < br / > zanbutinib capsule (Chinese generic name: zebutinib) is a highly selective BKT inhibitor independently developed by Baiji Shenzhou On November 15, 2019, zebutini was approved by the FDA of the United States to treat patients with mantle cell lymphoma (MCL) who had received at least one treatment before It has become the first new anti-cancer drug independently developed by Chinese enterprises and approved to be listed in the FDA, realizing the "zero breakthrough" of China's original anti-cancer drug < br / > zebotinib in the treatment of relapsed / refractory mantle cell lymphoma (R / R MCL) (acceptance No.: cxhs1800024) and relapsed / refractory chronic lymphocytic leukemia small lymphocytic lymphoma (R / R CLL / SLL) (acceptance No.: cxhs1800030) were reported to the market in August and October 2018 respectively, and were included in the priority review and approval at the end of 18 years < br / > at present, the processing status of two indications nmpa is under review and approval, cxhs1800024 is under production site inspection, Q1 is expected to be approved in 2020, the second round of cxhs1800030 supplementary information is in review, Q2 is expected to be approved in 2020 < br / > Fosun medicine < br / > avatrompag < br / > avatrompag, The trade name is Doptelet AkaRx, which is the exclusive drug AkaRx of fosstar medicine to help develop AkaRx in Chinese mainland and Hongkong It is used in the treatment of adult chronic liver disease (CLD) patients with low platelet count (thrombocytopenia), who received medical or dental surgery The drug was approved in the public market in the year of the first year < br / > the drug was undertaken by CDE on April 8, 2019 and officially included in the priority review in May 2019 At present, it is in the first round of CDE and has completed the field verification of clinical trials It is expected that Q3 will be approved in 2020 < br / > Haosen pharmaceutical < br / > ometinib mesylate tablets < br / > ometinib is a new third-generation EGFR-TKI developed by Haosen pharmaceutical with independent intellectual property rights, which can irreversibly and selectively inhibit EGFR sensitive mutations and EGFR T790M resistant mutations < br / > on September 7, 2019, the World Lung Cancer Congress (wclc) published the latest clinical data of ometinib phase II As of the date of data publication, 182 patients (74.6%) were still receiving treatment 160 of 242 patients confirmed partial response through independent central evaluation The objective remission rate of ometinib in phase II was 68.4% (95% CI: 62.2-74.2) DCR: 93.4% (95% CI: 89.6-96.2) < br / > in April 2019, hausen submitted the conditional listing application of ometinib mesylate, which was included in the priority review in June 2019, and is intended to be used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), mainly for the EGFR T790M resistant mutation At present, the drug is in the first round of supplementary information review It is expected that in 2020, Q2 will be approved by < br / > allos company < br / > pratraxate injection < br / > pratraxate (English trade name is folotyn ®) is an orphan drug developed by allos company and approved by FDA for listing in 2009, It is the first dihydrofolate reductase inhibitor for the treatment of peripheral T cell lymphoma (PTCL) PTCL is identified as a rare disease in the United States, with an annual incidence of about 9500 patients, and has a higher incidence rate in Asian countries In clinic, pratraxar is very important for the treatment of patients with recurrent or refractory peripheral T-cell lymphoma < br / > the drug was submitted to the market on January 2, 2019 for undertaking by CDE, and entered the priority review channel in March 2019 It is currently in the review and approval process, and has completed the clinical field verification It is expected that Q2 in 2020 will be approved < br / > Beida pharmaceutical < br / > ensartanib hydrochloride capsule < br / > ensartanib (English Name: ensartanib, code: x-396), It is a new molecular entity compound jointly developed by Beida pharmaceutical and its holding subsidiary xcoveryholdings, Inc with completely independent intellectual property rights It is a new generation of ALK inhibitor with strong effect and high selectivity < br / > on December 26, 2018, ensatinib submitted an application for listing, and on January 2, 2019, it was undertaken by CDE It is applicable to patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with clozatinib before or who are resistant to clozatinib and have positive anaplastic lymphoma kinase (ALK) It entered the priority review channel in February of the same year and is currently in the second round of CDE development and supplement stage It is expected that Q2 will be approved in 2020 < br / > Bayer < br / > radium chloride [223ra] < br / > radium chloride [223ra] (trade name xofigo) is a radiotherapeutic drug developed by Bayer It is approved to be used for castration resistance of prostate cancer patients with bone metastasis symptoms and approved by FDA on May 15, 2013, In recent years, the market sales increased steadily, and the annual sales revenue in 2017 reached 408 million euros < br / > it can improve the survival of patients and has good safety by emitting α particles to act on cancer cells with bone metastasis It is reported that its active part simulates calcium ion and selectively targets bone, especially bone metastasis area, by forming complex with hydroxyapatite (HAP) in bone The high let (linear energy transfer) radiation emitted by RA 233 (α - emitter) can cause high-frequency double strand DNA breaks in adjacent tumor cells, thus producing a strong cytotoxic effect < br / > Bayer submitted the application for listing radium chloride 223ra injection on November 23, 2018, which was not approved On August 23, 2019, Bayer submitted another listing application to obtain