These 16 blockbuster new drugs will be launched in China in 2020

At the end of 2019, let's review the heavyweight new drugs that are expected to be approved in China in 2020 for your reference< br / > No.1 < br / > expected approval time: 2020q1 < br / > emmetrozumab developed by Roche and immunogen is the first HER2 antibody coupling drug approved by FDA, which is used for single drug treatment of advanced transitional HER2 + breast cancer receiving trastuzumab and / or paclitaxel< br / > enmetrastuzumab was obtained by connecting trastuzumab with cytotoxic compound DM1 through thioetherEnmetrazumab, when combined with HER2, triggers receptor-mediated endocytosisWhen the antibody was partially degraded by lysosomes, DM1 was released to kill tumor cells< br / > the results of the Emilia study in patients with recurrent and metastatic HER2 positive breast cancer showed that trastuzumab vs lapatinib + capecitabine combination showed an advantage in median progression free survival (9.6 vs 6.4 months)< br / > source: nextpharma - clinical results < br / > enmetrozumab submitted a new drug listing application (jxss1900012, jxss1900013) in March 2019, and was included in the priority review and approval process in JulyAt present, it has undergone a round of supplement, and is expected to be approved in 2020q1< br / > No.2 < br / > brucinsa < br / > estimated approval time: 2020q1 < br / > zebutini developed by Baiji Shenzhou is the first Btk inhibitor to achieve 100% occupation of peripheral blood cells, and its selectivity to Btk is higher than that of irutiniOn November 14, 2019, it was approved by FDA for the treatment of mantle cell lymphomaIn the phase II clinical trial (bgb-3111-206), the orr was 84%, of which CR was 59% and PR was 25%The results of phase II clinical trial (bgb-3111-205) for chronic lymphoblastic leukemia and small lymphoid lymphoma showed that the main end point of orr was 84.6%, of which CR was 3.3%, PR was 59.3%, and PR for lymphocytosis was 22%< br / > source: nextpharma - clinical results < br / > zebutini has submitted the listing application (cxhs1800024, cxhs1800030) for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma in China, all of which have been included in the special approval and priority review and approval proceduresAfter two rounds of supplement, it is expected that 2020q1 will be approved for the treatment of mantle cell lymphoma< br / > No.3 < br / > mekinist / tafinlar < br / > estimated approval time: 2020q1 < br / > both trimetazidine and darafinil were developed by GSK and transferred to Novartis in 2015Both drugs target RAS-RAF-MEK-ERK signal transduction pathwayTrimetinib is the first MEK inhibitor approved for marketing, and darafinil is a BRAF inhibitor < br / > trimetazidine / darafinil combination was approved for marketing in the United States as early as may 2013 At present, the approved indications include melanoma, non-small cell lung cancer and thyroid undifferentiated cancer It is also the only FDA approved targeted therapy for BRAF V600E mutation positive non-small cell lung cancer < br / > in the phase II clinical trial (brf113928) for patients with BRAF V600E mutation positive non-small cell lung cancer, the orr of trimetazidine / darafinil combination reached 64% < br / > in 2018, the portfolio's sales reached $1.16 billion Trimetinib / darafinil portfolio applied for listing in January 2019, and was included in the priority review and approval process in March Currently, it is in a round of issuance and supplement stage, and is expected to be approved in 2020q1 < br / > No.4 < br / > estimated approval time: 2020q1 < br / > agrazyme β was developed by Genzyme, a subsidiary of Sanofi, and was first listed in Europe in 2001 It was listed in the United States in 2003 as an enzyme replacement therapy for the treatment of fabrizhao's disease < br / > brucellosis is a rare genetic disease with an estimated prevalence of 1 / 40000 Due to the mutation of gene encoding α - galactosidase a (α - gal-a), α - gal-a is deficient, the normal degradation of gl-3 is blocked, and the undegraded substrate accumulates in the lysosomes of various tissues, resulting in the dysfunction of related tissues At present, enzyme replacement therapy is mainly used < br / > in recent years, the sales volume of AGA β increased steadily, with sales volume of EUR 760 million in 2018 In China, Aga β has been listed in the list of clinically urgent overseas new drugs, and its listing application (jxss1800021, jxss1800022) was included in the priority review procedure in January 2019 At present, it is in the stage of one round of development and supplement, and it is expected that 2020q1 will be approved, which is expected to become the first drug for Fabry's disease in China < br / > No.5 < br / > ensatinib < br / > estimated approval time: 2020q1 < br / > ensatinib is the second generation of ALK inhibitor developed by Beida, which is used in patients with locally advanced or metastatic non-small cell lung cancer who have received the treatment of or are intolerant to the drug < br / > the positive rate of ALK fusion gene in NSCLC patients is about 3-8% At present, China's listed ALK inhibitors, including cretinib, seretinib and aletinib, have been included in the national medical insurance The results of phase II clinical trial (nct03215693) showed that the overall orr of ensatinib was 52.6%, and the median PFS was 11.2 months Ensatine submitted its listing application (cxhs1800045, cxhs1800046) in December 2018 and was included in the special approval and priority review approval procedures Currently, it is under review and is expected to be approved in 2020q1 < br / > No.6 < br / > estimated approval time: 2020q1 < br / > lanaru mAb is a kind of mAb targeting plasma kallikrein (KLK), developed by dyax Corp, a subsidiary of Takeda, for the treatment of hereditary angioedema It has been recognized as a breakthrough therapy in the United States and approved by FDA in August 2018 < br / > hereditary angioedema is a primary complement deficiency disease characterized by paroxysmal, self limited and localized non depressed edema under the whole skin and mucosa, which was included in the first batch of rare diseases catalogue in China The most common reason is the gene defect or mutation encoding C1-INH C1-INH is the main physiological inhibitor of kallikrein in the blood, and uncontrolled kallikrein will lead to edema, The incidence rate is about 1 cases per 10000-50000 people < br / > there is no clinical trial of lanalu mAb in China In March 2019, it directly submitted the application for listing of imported new drugs (jxss1900011), which is currently under review and is expected to be approved in 2020q1 < br / > No.7 < br / > ometinib < br / > estimated approval time: 2020q2 < br / > ometinib developed by hausen is an EGFR T790M inhibitor, the main indication is EGFR T790M mutant non-small cell lung cancer After treatment with EGFR inhibitors of the first or second generation, about 60% of patients with NSCLC had EGFR T790M mutation in the course of disease progression < br / > in the phase II clinical trial (nct02981108) in patients with advanced non-small cell lung cancer resistant to the first generation EGFR inhibitors, the orr of the subjects reached 66.1% < br / > source: nextpharma - clinical results < br / > ometinib submitted its listing application (cxhs1900011) in April 2019, which was then included in the special approval and priority review approval procedures Currently, it is in the first round of development and supplement It is expected that 2020q2 will be approved, and it is expected to become the first domestic third-generation EGFR inhibitor < br / > No.8 < br / > expected approval time: 2020q2 < br / > the only antibody conjugated drug targeting CD30, developed by Takeda and launched in the United States in 2011, is the first new drug for anaplastic large cell lymphoma approved by FDA in the past 40 years, It is also the first first-line treatment for classical Hodgkin's lymphoma and peripheral T-cell lymphoma < br / > about 62000 patients are diagnosed as Hodgkin's lymphoma every year in the world, of which 95% are classic type In an echelon-1 study of patients with primary stage III / IV Hodgkin's lymphoma, when compared with doxorubicin, vinblastine, dacarbazine and bleomycin combined with doxorubicin, vinblastine and dacarbazine, the 2-year progression free survival rate of the subjects was significantly increased (82.1% vs 77.2%), reducing the risk of disease progression and death (HR 0.77, P = 0.04) < br / > vibutoximab was applied for listing in April 2019 (jxss1900015), was included in the priority review and approval process in June, and is still under review, and is expected to be approved in 2020q2 < br / > No.9 < br / > entyvio < br / > estimated approval time: 2020q2 < br / > vitorbia is an α 4 β 7 integrin monoclonal antibody, which can specifically bind α 4 β 7 integrin, block the interaction between α 4 β 7 and MAdCAM-1, and is the first and only drug specifically targeting at intestinal inflammatory signaling pathway Vidozumab was developed by Takeda and was first marketed in the United States in 2014 The approved indications are ulcerative colitis and Crohn's disease < br / > in the world's first stage III Varsity clinical trial of biological products for ulcerative colitis, vidozumab showed superior efficacy compared with adalimumab, the clinical remission rate of the main end point was 31.3% vs 22.5% (P = 0.0061), and the safety was better < br / > source: nextpharma - clinical results < br / > in 2018, the sales volume of vidozumab is about US $2.5 billion In November 2018, vidozumab was included in the first batch of clinically urgent overseas new drugs list In June 2019, the application for listing of vidozumab (jxss1900032, jxss1900033) was undertaken by CDE and is still under review It is expected that 2020q2 will be approved < br / > No.10 < br / > tremfya < br / > expected approval time: 2020q2 < br / > Johnson & Johnson's gusekumab is the first approved IL-23 mAb, which can more completely inhibit the activity of IL-23 by selectively inhibiting the P19 subunit of IL-23 instead of P40 subunit It was approved for marketing in the United States in July 2017 and launched in Europe in November of the same year for the treatment of plaque psoriasis and psoriatic arthritis < br / > in the head-to-head phase III clinical trial (eclipse) for the treatment of plaque psoriasis, the response rate of pasi90 of gusekumab and serkuchiumab (IL-17A) was 84% vs 70% (P < 0.0001) at 48 weeks, respectively, showing the superiority of long-term treatment In the phase III discovery-2 clinical trial for psoriatic arthritis, ACR20 was 64.1% vs 32.9% (P < 0.001) compared with the basic treatment, and the tolerance was good < br / > the global sales of gusekumab in 2018 is US $540 million, which is expected to grow rapidly in the future The drug has been included in the list of the first batch of clinically urgently needed overseas new drugs, and the application for listing (JXSS1900035) was submitted in June 2019 At present, it is expected to be approved in 2020Q2 in the review < br / > No.11 < br / > crysvita < br / > estimated approval time: 2020q2 < br / > developed jointly by ultragenyx pharmaceutical and Kyowa Hakko Kirin, it was approved for the treatment of X-linked hypophosphatemia (XLH) in the United States and Europe in 2018, and it is the first FGF23 monoclonal antibody approved for marketing < br / > XLH is a rare hereditary, progressive and lifelong bone disease, which is caused by PHEX gene mutation PHEX loss of function leads to the increase of FGF23 level, and the deficiency of renal phosphorus reabsorption, which leads to low blood phosphorus There are about 48000 patients in developed countries < br / > broshumab is the only drug for XLH, and has been awarded breakthrough therapy by FDA There is no effective treatment plan for XLH in China In May 2019, broshumab was included in the list of the second batch of new drugs urgently needed abroad In August 2019, the listing application of broshumab was undertaken by CDE, and currently under review, 2020q2 is expected to be approved < br / > No.12 < br / > radium chloride [223ra] (xofigo) < br / > expected approval time: 2020q3 < br / > radium chloride [223ra] was developed by Bayer and approved for marketing in the United States in May 2013, for the treatment of advanced castration resistance to prostate cancer bone metastasis Radium chloride [223ra] is the only one approved by FDA