Wie sollte man diese Zitate des Biontech Vorstands übersetzen und interpretieren?
"This process will be accelerated this year as we bring our new Chief Commercial Officer on Board. Ultimately, we are building our organization to support multiple oncology launches beginning in 2026."
"We aim to have potentially 10 plus pivotal trials running by year end 2024 which we believe will change the picture of the company going forward. Besides having a strong franchise in infectious diseases, we aim to have multiple oncology products reaching the market by 2026 onwards."
"..., our aim is to transform medicine through successive waves of innovation. We remain focused on our near-term goal to have 10 plus potentially registrational trials initiated by year end 2024, and to continue to ramp up our commercial readiness activities. Over the midterm, we aim to enter the commercial stage in oncology by 2026 with our first product candidates while advancing our pipeline of late-stage and novel combination therapies."
"Generally speaking, though, we do now -- we have a strong balance sheet. We do want to retain more of the economics as a general matter of strategy. So I think that the -- those partnering decisions are going to really be made on an asset by asset basis, while at the same time we do commit to actually build a commercial presence in oncology in the major markets. And so that is going to be a priority over the next couple of years.
I'll let Jens speak a little bit to the profitability point, but I'll just say high level at the outset that we do see, as you've alluded, that there's an opportunity here with the pipeline that we're building and advancing now into late stage studies to deliver long term sustained growth driven by successive product launches.
We've indicated 2026 as a significant time point in those plans, but really, the plans go beyond that. And that's why we put out the target of having 10 approvals in oncology by 2030 highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products. And so that -- our priority is to get on that long term growth trajectory. And, of course, being profitable is important, but the focus right now is really getting on that growth trajectory."
Quelle: Q1 Call Webcast und Transcript
https://investors.biontech.de/events/...etails/2024-q1-earnings-call/
Weiterer Tipp: Einfach den ganzen Absatz mit Anführungszeichen kopieren und in Google suchen.
Deutsche Übersetzung:
https://c.web.de/@337557335905933015/NE0YB1zMQZK-WoXyssXDWw
Tipp: Q1-Datei öffnen und Strg F drücken und nach 2026 suchen.
"So, I think, for 2026, we have a couple of different programs that potentially could launch in that timeframe. And the first of which is BNT323, our HER2 ADC, and we've highlighted the potential for -- we think for an accelerated approval in second and third line endometrial cancer. So that would be one asset where we're expecting data next year. And if that timeline is confirmed with further FDA discussions, we think that could be a '26 launch opportunity.
In addition, we've highlighted the potential for an accelerated pathway with our BNT122 iNeST in adjuvant colorectal cancer. We still have further discussions to take place with the FDA, but based on the current study design and the pace of enrollment, we do think that there is the potential if the data is strong also for data to be for submission and potentially launch in that sort of timeframe, most likely towards the end of the year or early '27, but it could fall in '26."
"At the recent ESMO GI Conference, we disclosed findings from the biomarker substudy of our ongoing Phase 2 iNeST trial, BNT122-01, involving patients with Stage 2 high-risk of Stage III colorectal cancer who remain ctDNA positive, following the surgical excision of the localized cancer. Upon completion of standard-of-care adjuvant chemotherapy, these patients receive BNT122, our individualized vaccine, in contrast to the conventional wait-and-watch approach.
In the subset of 12 patients who were accessible for immunogenicity analysis, a high magnitude de novo T-cell response against at least one vaccine-encoded neoantigen was observed in all patients. These T-cell responses were amplified with successive vaccination cycles. Notably, in several patients, the T-cell responses were sustained even after two years of follow-up. All 12 patients involved in the immunogenicity analysis remained disease-free at the time of data cutoff. Enrollment for the main part of the colorectal cancer study is underway to establish the safety and efficacy of BNT122 in patients with ctDNA positive Stage II, Stage III colorectal cancer as opposed to the standard wait-and-watch strategy. We anticipate presenting the result from this randomized Phase 2 study by late 2025 or early '26."
Quelle: Q2 Call Webcast und Transkript.
https://investors.biontech.de/de/events/...ails/2024-q2-earnings-call
https://tinyurl.com/BNTX2024
Gemäß Pressemitteilungen und oben verlinkter Aufstellung (via KI) sind 9 (in Worten: neun) Onkologie-Projekte bei den Aufsichtsbehörden FDA (USA) und EMA (EU) für besondere beschleunigte Zulassungsverfahren angemeldet, genehmigt und werden (gemäß der Pressemitteilung) zumindest teilweise sogar bei der Datenerfassung unterstützt. Außerdem gibt es mit den Behörden in UK/GB (England) spezielle Abkommen zur beschleunigten Zulassung von Onkologie-Medikationen.
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