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

Original: sound sir The insight database screened 15 new drug varieties that are expected to be approved in 2020, which are respectively lanalurenmab injection of Takeda pharmaceutical, enmetrastuzumab for injection of Roche, etacept for injection of Rongchang biology, vibutuximab injection and zambuteni capsule of Baiji Shenzhou, belintomab 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 Lanadelumab (English trade name is takhzyro ®) is the first monoclonal antibody for the treatment of hereditary angioedema (HAE) It comes from shire, a manufacturer of rare diseases under Takeda pharmaceutical It was hosted by CDE on March 29, 2019 Hae is a rare genetic disease Hae 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 cases Lanalu mAb injection is the only monoclonal antibody drug that can specifically bind and inhibit plasma kallikrein As a preventive treatment drug, lanalu mAb injection has been approved by the U.S FDA on August 23, 2018 for use in patients aged 12 and over with hae to prevent the onset of vascular edema At present, it is in the first round of development and supplement, and it is expected that Q2 will be approved in 2020 Trametuzumab injection is developed by Roche pharmaceutical Kadcyla is a HER2 targeted therapy, which was approved to market in 2013 It is the first and only HER2 approved as a single preparation for the treatment of chemotherapy (alone or in combination) of Herceptin and paclitaxel Antibody drug conjugates in patients with positive metastatic breast cancer It was hosted by CDE on March 27, 2019, and entered the priority review channel on June 2019 Currently in the first round of supplementary information review, it is expected that Q2 will be approved in 2020 RC 18 for injection (trade name: Tai AI) is a double target biological new drug independently developed by Rongchang biology to target BLyS and April, which is used to treat systemic lupus erythematosus It 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 At the 4th China Pharmaceutical Innovation and investment conference, Rongchang biology announced the detailed clinical trial data of taitacipu in systemic lupus erythematosus Taitacipu vs placebo sri4 were 79.2% vs 32.0% respectively, with statistically significant differences, reaching the main end point of clinical trial, and the clinical data were extremely bright At present, the drug is in the review of new reporting tasks, and it is expected to be approved by Q3 in 2020 Brentuximab vedotin (adcetris) is an anti-CD30 antibody drug conjugate developed jointly by Takeda and Seattle genetics, Inc., which is used to treat recurrent / refractory CD30 positive Hodgkin's lymphoma (HL) or systemic anaplastic large cell lymphoma (salcl) The drug was approved in the United States in 2015 and 2017 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 The drug was hosted by CDE on April 28, 2019, and was included in the priority review process in June 2019 on the basis of innovative drugs with obvious treatment advantages At present, it is in the first round of development and supplement, and it is expected that Q3 will be approved in 2020 Belintomab for injection (English trade name: blincyto ®) is a bispecific antibody weighing 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 on cancer cells Blincyto was approved for the first time in the world in December 2014 At present, it has been approved for the treatment of relapsed / refractory B-cell all patients 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 The domestic listing application was 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 tasks, and it is expected that Q4 will be approved in 2020 Kw-136 capsule is a class 1 new drug with independent intellectual property rights of Caine technology, and 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 Both kw-136 capsule and dacatavir currently marketed 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 The drug is currently under on-site inspection and is expected to be approved by Q1 in 2020 Zanbutinib capsule (Chinese 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 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 on the market in August and October 2018 respectively, and were included in the priority review and approval at the end of 18 years At present, two indications nmpa processing status are 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 Avatrompag (trade name: doplet ®) is a drug developed exclusively by Fosun Pharmaceutical to assist akarx in mainland China and Hong Kong It is used to treat the low platelet count (thrombocytopenia) of adult patients with chronic liver disease (CLD) who are scheduled to undergo medical or dental surgery The drug was approved by FDA in May 2018 The drug was hosted by CDE on April 8, 2019 and formally included in the priority review in May 2019 At present, it is in the first round of CDE, and has completed the on-site verification of clinical trials It is expected that Q3 will be approved in 2020 Ometinib is a new third-generation EGFR-TKI developed by hausen pharmaceutical with independent intellectual property rights, which can irreversibly and selectively inhibit EGFR sensitive mutations and EGFR T790M resistant mutations On September 7, 2019, the 2019 World Lung Cancer Congress (wclc) released the latest clinical data of ometinib phase II As of the date of data release, 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) In April 2019, hausen submitted the conditional listing application of ometinib mesylate, which was included in the priority review in June 2019 It is intended to be used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients, mainly for EGFR T790M resistant mutations At present, the drug is in the first round of supplementary information review, and it is expected that Q2 will be approved in 2020 Pralatrexate (English trade name is folotyn ®) is an orphan drug developed by allos company and approved by FDA in 2009 It is the first dihydrofolate reductase inhibitor for the treatment of peripheral T-cell lymphoma (PTCL) In the United States, PTCL has been identified as a rare disease, 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 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 under review and approval, and has completed the clinical site verification It is expected that Q2 in 2020 will be approved Ensartinib (English Name: ensartinib, code: x-396) is a new molecular entity compound jointly developed by Beida pharmaceutical and its holding subsidiary xcoveryholdings, Inc., which has completely independent intellectual property rights It is a new generation of ALK inhibitor with strong effect and high selectivity On December 26, 2018, ensatinib submitted an application for listing, and was undertaken by CDE on January 2, 2019 It is applicable to patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after previous treatment with clozatinib or who are resistant to clozatinib and are positive for 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 It is expected that Q2 will be approved in 2020 Radium chloride [223ra] (trade name xofigo) is a radiotherapeutic drug developed by Bayer It was approved to be used for castration resistance of prostate cancer patients with bone metastasis symptoms It was approved for listing by FDA on May 15, 2013 In recent years, the market sales increased steadily In 2017, the annual sales revenue reached 408 million euros 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 (a-emitter) can cause high-frequency double strand DNA breaks in adjacent tumor cells, thus producing a strong cytotoxic effect Bayer had submitted the application for listing radium chloride 223ra injection on November 23, 2018, which was not approved On August 23, 2019, Bayer again submitted its listing application to be undertaken by CDE, and entered the priority review channel in September 2019 The drug is currently under review in the new reporting task and is expected to be approved in Q3 2020 Siponimod is an oral multiple sclerosis (MS) drug developed by Novartis Its active ingredient, siponimod, can selectively