Ice fire two days! Legendary Bio IPO to u.S., Bluebird Fist Product Selling Rejected, CAR-T Market Pattern or Change

Guide: Can legendary creatures ascend to the top of the throne?After a period of silence, the CAR-T market is back in full swingthe rumors of a legendary bio-IPO in the U.Shave finally come to an endOn May 13, the technology company, which specializes in CAR-T therapy, officially announced that it had filed an F-1 prospectus with the Securities and Exchange CommissionIn fact, the news came back in March, during which the company completed a $150 million pre-IPO round of financing, with a post-investment valuation of $1.95 billionbut more interestingly, almost at the same time that Legendary Bio filed its listing application, the FDA rejected the listing application of IDE-cel, a BCMA-CAR-T product developed by BMS and BluebirdThe product, which was previously submitted to BLA in March, was once thought to be on the promise of the first BCMACAR-T treatment to go on saletoday, the Ide-cel listing faces unknown variables, and behind it, the legendary creature, who also holds BCMA-CAR-T heavy-duty therapy, can it turn its back to number one?1
Legendary Creatures: Paving the way for CAR-T products to go on sale? Founded in 2014,Legendary Bio is one of the independent brands of CRO's Kingsley, which is dedicated to the discovery and development of new cell therapies for blood tumors, infectious diseases and autoimmune diseasesIn 2018, legendary bio-BCMA-CAR-T therapy "LCAR-B38M" became the first CAR-T therapy to be approved for clinical trials in Chinafrom the latest data in the prospectus, the current legendary biological in the field of cell therapy has a number of pipelines in China and the United States clinical trials have entered the clinical phase II, Phase III, the fastest progress of which is BCMA-CAR-T therapy LCAR-B38Mthis CAR-T track's heavyweight product is a joint development of Legendary Bio and Jansen Bio for the treatment of multiple myelomaIn December 2017, Yangsen corporation paid legendary bio for the project a down payment of US$350 million and subsequent milestone payments, a partnership that set the record for the maximum down payment and the best conditions for cooperation in the foreign patent grant edited by Chinese pharmaceutical companies at that timewent well nextIn 2018, LCAR-B38M was approved by the FDA's IND after receiving the approval of the CFDA's first CAR-T clinical trial application, and by 2019, it will have been granted FDA-awarded orphan drug qualification, EMA priority drug approval, and FDA breakthrough therapy certificationIt is reported that LCAR-B38M is expected to be In 2020 Q3 to the U.SFDA to submit a BLA applicationin clinical data, the LCAR-B38M also showed a sustained lead over its peers on the CAR-T circuitAt the 61st annual meeting of the American Society of Hematology (ASH) at the end of 2019, Legendary Bio published clinical data on the CARTITUDE-1 study of LCAR-B38M for the treatment of patients with recurrent/refractory multiple myeloma (r/rMM)The results showed that LCAR-B38M achieved a 100% overall remission rate at a median follow-up time of 6 months, with 69% of patients achieving complete or better remission and 86% achieving very good partial or better remissionAnd from the latest DATA of CARTITUDE-1 given by Nanjing Legend on May 14th, the overall mitigation rate remained unchanged at 11.5 months, with the full mitigation rate rising from 69% announced five months ago to 86%So for now, after a more certain breakthrough in fist products, the reason seventy-one senameises the legendary creature's choice to go to the U.Sfor listingAfter all, once the LCAR-B38M is successfully approved for market, production, commercial ization, multi-party cooperation and so on, without the need for huge financial supportin addition,, the time required to list in the United States is relatively short, the progress is controlled, flexible financing methods also facilitate the legend to quickly replenish research and development funds, is conducive to the promotion of legendary research and development pipelineAt the same time, LCAR-B38M's future main sales market is in the United States, and is expected to be reported in the United States this year, so the United States is undoubtedly the legendary biological cooperation optionOf course, in the face of LCAR-B38M's filing of a listing application, and the expected profits from the new drug's launch, it is also time for the spin-off of Legendary Bio and the listing of Legendary Bio to the UNITED States for its parent company Kingsley, which has the largest share of Legendary Bio2
play will be played in the second half
and take a look at the bluebirds that were forced to stop dramatic scene, on May 13th, BMS and Bluebird again revised their existing co-operation agreement, according to the latest revision, BMS bought out bluebird's ownership of ide-cel outside the United States for $200 million Shortly after the news was announced, however, the FDA rejected ide-cel's application for a listing in fact, Bluebird ide-cel is the first BCMA-CAR-T therapy to be submitted for listing, which was submitted to the FDA on April 1 this year, also for the treatment of multiple myeloma The legendary bio-wielding FDA-granted orphan drug and EMA's priority drug approval stake are also available and approved earlier but from the current clinical data, ide-cel seems to be a little less good The submission of its listing application was based on the results of a key Phase 2 clinical trial (KarMMa) in which the objective remission rate (ORR) reached 73.4% and the full remission rate (CR) reached 31.3% of the total 128 patients who were able to assess the efficacy At the median follow-up time of 11.3 months, the non-progressive life span (PFS) of these patients reached 8.6 months However, the FDA's response to bluebird's failure to approve the application was based on the need to add information on submitting chemical, manufacturing and control (CMC) modules, rather than clinical data Of course, the Bluebirds were not discouraged, saying they would resubmit the BLA for a follow-up, with the planned submission no later than the end of July this year more noteworthy, the rejection of the ide-cel listing application does not seem to have affected the Bluebird's pace According to the latest news, on May 19 bluebird announced that it will issue 9,090,910 shares of common stock underwritten at a price of $55 per share, which is expected to close around May 21, 2020 had to say that at the BCMA-CAR-T circuit, two head businesses can be said to be chasing me, clenching In the second half of the year, the situation will no doubt become more tense as the two companies file listing applications first for now, listing in the U.S does push legendary creatures into the air But beneath the waves, the undercurrent is even more turbulent responsibility editor: penicillin this article is a drug intelligence network reprinted content, copyright belongs to the original author, the purpose of reproduction is to convey more information, does not represent the views of this platform If the content of the work, copyright and other issues, please contact this website message, we will delete the content in the first place related tags: U.S , IPO , Legendary Bio , Bluebird Bio , Fist Products Rejected , CAR-T
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