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

Since 2019, the State Drug Administration has approved 32 new drugs (excluding new indications) Although the number is far less than that of the same period last year, the CDE review has been accelerated for three years, which has greatly improved the accessibility of new drugs in China Moreover, new drugs that meet the time of listing also seize the opportunity to adjust the medical insurance catalog, and enter the national medical insurance catalog for the first time Step to reduce the burden of domestic patients' drug expenditure 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 Expected approval time of No.1 entetrazumab (kadcyla): in 2020q1, entetrazumab developed by Roche and immunogen is the first HER2 antibody coupling drug approved by FDA, which is used for single drug treatment of advanced metastatic HER2 + breast cancer receiving trastuzumab and / or paclitaxel Enmetrastuzumab was obtained by connecting trastuzumab with cytotoxic compound DM1 through thioether Enmetrazumab combined with HER2 can trigger receptor-mediated endocytosis When the antibody was partially degraded by lysosomes, DM1 was released to kill tumor cells The results of Emilia study in patients with recurrent and metastatic HER2 positive breast cancer showed that trastuzumab vs lapatinib + capecitabine combination showed a median progression free survival advantage (9.6 vs 6.4 months) Source: nextpharma - clinical results: nemetratuzumab submitted a new drug listing application (jxss1900012, jxss1900013) in March 2019, and was included in the priority review and approval process in July Currently, it has undergone a round of supplement, and is expected to be approved in 2020q1 No.2 expected approval time of brukinsa: in 2020q1, the first Btk inhibitor with 100% occupation of peripheral blood cells was developed by Baiji Shenzhou, and its selectivity for Btk was higher than that of irutini On November 14, 2019, it was approved by FDA for the treatment of mantle cell lymphoma In the phase II clinical trial (bgb-3111-206) for mantle cell lymphoma, 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% Source: nextpharma - clinical results: 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 approval procedures After two rounds of supplement, it is expected that 2020q1 will be approved for the treatment of mantle cell lymphoma No.3 estimated approval time of trimetinist / tafinlar: 2020q1 trimetinide and darafinil are developed by GSK and transferred to Novartis in 2015 Both drugs target RAS-RAF-MEK-ERK signal transduction pathway Trimetinib is the first MEK inhibitor approved for marketing, and darafinil is a BRAF inhibitor Trimetazidine / darafinil combination was first approved for marketing in the United States in May 2013 At present, the approved indications include melanoma, non-small cell lung cancer and undifferentiated thyroid cancer It is also the only FDA approved targeted therapy for BRAF V600E mutation positive non-small cell lung cancer In the phase II clinical trial (brf113928) for patients with BRAF V600E mutation positive NSCLC, the orr of trimetinib / darafinil combination reached 64% In 2018, the portfolio generated $1.16 billion in sales 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 Expected approval time of no.4-acarbrazyme: 2020q1-acarbrazyme β was developed by Genzyme, a subsidiary of Sanofi, and was first listed in Europe in 2001, and in the United States in 2003 as an enzyme replacement therapy for the treatment of fabrizyme's disease Fabry's disease 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 insufficient, 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 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 Expected approval time of No.5 ensatinib: 2020q1 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 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 Estimated approval time of No.6 lanazyro: 2020q1 lanazyro is a kind of monoclonal antibody targeting plasma kallikrein (KLK) It was developed by dyax Corp, a subsidiary of Takeda, for the treatment of hereditary angioedema It was recognized as a breakthrough therapy in the United States and approved by FDA in August 2018 Hereditary angioedema is a primary complement deficiency disease characterized by paroxysmal, self limited and localized non depressed edema under the whole skin and mucosa It has been 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 the uncontrolled kallikrein will lead to edema, The incidence rate is about 1 cases per 10000-50000 people 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 No.7 expected approval time of ometinib: in 2020q2, ometinib developed by hausen is an EGFR T790M inhibitor, and its main indication is non-small cell lung cancer with EGFR T790M mutation 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 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% Source: nextpharma - clinical results: ometinib submitted its listing application (cxhs1900011) in April 2019, and then was included in the special approval and priority review and approval procedures Currently, it is in the stage of one round of issuance and supplement It is expected that 2020q2 will be approved, and it is expected to become the first domestic third-generation EGFR inhibitor Expected approval time of No.8 vectoroximab (adcetris): 2020q2 At present, vibutoximab is the only antibody coupling drug targeting CD30, which is developed by Takeda and listed in the United States in 2011 It is the first new drug of anaplastic large cell lymphoma approved by FDA in recent 40 years, and also the first-line treatment drug for classic Hodgkin's lymphoma and peripheral T-cell lymphoma 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, two-year progression free survival was significantly improved (82.1% vs 77.2%) decreased the risk of disease progression and death (HR 0.77, P = 0.04) Vibutuximab was applied for listing in April 2019 (jxss1900015), and was included in the priority review and approval process in June It is still under review and is expected to be approved in 2020q2 The expected approval time of no.9-vyvio: 2020q2-vyvio is an α 4 β 7 integrin monoclonal antibody, which can specifically bind α 4 β 7 integrin and block the interaction between α 4 β 7 and MAdCAM-1 It 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 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 Source: nextpharma - clinical results 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 Expected approval time of No.10 gusekumab (tremfya): 2020q2 Johnson's gusekumab is the first approved IL-23 monoclonal antibody By selectively inhibiting P19 subunit of IL-23 instead of P40 subunit, the activity of IL-23 can be more completely inhibited It was approved for marketing in the United States in July 2017 and in Europe in November of the same year for the treatment of plaque psoriasis and psoriatic arthritis In the head-to-head phase III clinical trial (eclipse) for the treatment of plaque psoriasis, the response rates of pasi90 to gusekumab and to IL-17A were 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 The global sales of gusekumab in 2018 is US $540 million, which is expected to grow rapidly in the future The drug was included in the first batch of clinically urgent overseas new drugs list, and the listing application (jxss1900035) was submitted in June 2019 Currently, it is under review and is expected to be approved in 2020q2 No.11 crysvita is expected to be approved in 2020q2 It was jointly developed by ultragenyx pharmaceutical and Kyowa Hakko Kirin It was approved in the United States and Europe in 2018 for the treatment of X-linked hypophosphatemia (XLH) It is the first FGF23 monoclonal antibody approved for marketing XLH is a rare hereditary, progressive and life-long bone disease, which is caused by PHEX gene mutation PHEX loss of function leads to the increase of FGF23 level, and insufficient reabsorption of kidney phosphorus, which leads to low blood phosphorus There are about 48000 patients in developed countries Broshumab, the only drug for XLH, has been awarded breakthrough therapy by FDA XLH