In Q220Q3, clinical events of 3 heavy drugs deserve attention

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Pharmaceutical Network Market Analysis: What are the new trends in the research and listing process of new drugs of large pharmaceutical companies? Evaluate Vantage Research has counted non-Covid-19 drug research-related events to be launched by major drugmakers in the third quarter, including three heavyweight drugs of interest in Q2020Q3: Aducanumab of Yanjian, IDE-cel of BMS/Bluebird Bio, and Yescarta of Gilead, all of which will submit applications or complete phased clinical studies in the current quarterAducanumabIndications: Alzheimer's DiseaseClinical Process: Expected to be filed with Q3 this year
2026 forecast sales: $2,987 million
end of 2019, YanJian and Aeshian jointly announced that, after discussions with the FDA and outside experts, plans to submit a biopharmaceutical application for Alzheimer's disease (AD) next year for the research on a new drug , BLAIn early 2020, He filed a bioproduct licensing application (BLA) with the FDA, but announced a delay in AprilAducanumab's (BIIB037) BLA will be delayed until q3 this year, and Yan Jian plans to further communicate with the FDA about the drug's listing through a Category C meeting, according to the first quarter reportIn May, he added that the company had completed construction at a plant in Solotoun, Switzerland, and expected to begin mass production of Aducanumab by mid-2021Ide-celIndications: Multiple myelomaClinical Process: Resubmit applications by the end of July (part of the new base CVR)2026 forecast sales: $1,452 million
ide-cel of BMS/Bluebird Bio also submitted a BLA to the FDA in March, the first type of BMMA target submitted for regulatory approval and a CAR-T cell therapy for the treatment of multiple myeloma (MM)However, the FDA rejected the drug's listing application because of insufficient information on the Chemical, Manufacturing and Control (CMC) module, delaying the listingThe company said Ide-cel's plan would be submitted no later than the end of Julythe drug was approved by the EMA in late May, despite the FDA's "wall"And the EMA has confirmed its initial MAA and has initiated a review processIn addition, the drug has been granted accelerated approval by the EMA, and the MAA review time has been reduced to 150 daysThe industry believes that the successful approval of the drug in Europe would mean that the world's first BCMA-CAR-T treatment would be launchedBut there are more than one contender for the BCMA-CAR-T treatment application, with the exception of BMS/Bluebird Creatures, jansen/Legendary Creatures also catching upmultiple myeloma (MM) is the second most common hematologic malignancy after non-Hodgkin's lymphoma, according todataThe MM market is expected to reach $29 billion in 2027BCMA is currently a very focused target for MM firepower, who first seize the market, meaning that more conducive to the future commercialization of drugsYescartaIndications: Diffuse Large B Cell Lymphoma Clinical Process: Zuma-7 and SOC, H2 Data 2026 Forecast Sales: $1,331 million
Gilead's Yescarta was approved by the FDA as early as 2017 for the treatment of recurrent or refractive large B cell lymphoma (LBCL) adult patients who received two or more system therapy Sales of the drug reached $456 million in 2019, up 73% year-on-year , Yescarta is in the stage of indications The industry expects q3 to see interim data for the ZUMA-7 clinical trial, and by 2021, Gilead may submit a regulatory application for Yescarta's second-line treatment, DLBCL, to extend the drug's range of applications on lymphoma from third to second-tier.