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ALK giver opdatering på registreringsprocessen for tabletten mod husstøvmideallergi i Kina

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ALK (ALKB:DC / OMX: ALK B / AKBLF) har i dag annonceret, at selskabet har besluttet at trække sin registreringsansøgning for tabletten mod husstøvmideallergi. ALK vil fortsat samarbejde med myndighederne for at opnå godkendelse af tabletten mod husstøvmideallergi i Kina, hvilket kan medføre yderligere kliniske data i kinesiske patienter.

Forsinkelsen i den regulatoriske godkendelsesproces har ikke indflydelse på ALKs forventninger til 2024 eller for selskabets muligheder for at opnå en EBIT-margin på 25% in 2025. Desuden påvirker forsinkelsen ikke ALKs muligheder for leve op til selskabets langsigtede finansielle vækstambitioner som tidligere kommunikeret.

Registreringsansøgningen vedrørende behandling af vedvarende moderat til svær allergisk rhinitis forårsaget af husstøvmider i 12-65-årige patienter blev accepteret til behandling af de kinesiske myndigheder i februar 2023. I marts 2022, forud for indsendelsen, gav de kinesiske myndigheder ALK dispensation, således at ALK kunne indsende registreringsansøgningen på basis af data fra kliniske forsøg uden for Kina uden at afslutte det lokale kliniske studie, som måtte sættes på pause i 2020 på grund af COVID.

Henriette Mersebach, ALKs koncerndirektør for Forskning & Udvikling, kommenterer på beslutningen om at trække ansøgningen: “Vi er forsat fast besluttede på at bringe nye innovative behandlinger til de millioner af kinesere, som lever med allergi, og til deres læger, som ønsker bedre allergibehandling. Vi vil samarbejde med myndighederne med henblik på at genindsende en opdateret registreringsansøgning så hurtigt som muligt. Den fortsatte udrulning af tabletten i visse dele af Kinas såkaldte Medical Pilot Zones er ikke påvirket og fortsætter efter planen. Dette vil give udvalgte læger og patienter adgang til behandlingen og til at få erfaringer hermed.”

ALKs kommercielle planer og aktiviteter i Kina vil blive tilpasset en ny lanceringstidslinje (tidligere planlagt til 2025), som vil blive fastlagt efter yderligere dialog med myndighederne. ALKs aktuelle forretning i Kina er fokuseret på det injektionsbaserede ALUTARD SQ®, hvor salget i gennemsnit er vokset med 30% årligt i de seneste år (CAGR 2020-23).

ALKs tablet mod husstøvmideallergi er godkendt i 43 lande på tværs af Europa, Nordamerika, Mellemøsten samt Asien og Stillehavsområdet til behandling af vedvarende moderat til svær allergisk rhinitis og i visse land også til behandling af allergisk astma forårsaget af husstøvmider.

ALK-Abelló A/S

Yderligere oplysninger kan fås ved henvendelse til:
Investor Relations: Per Plotnikof, tlf. +45 4574 7527, mobil +45 2261 2525
Medier: Maiken Riise Andersen, tlf. +45 5054 1434

Om ALK
ALK er en specialiseret global lægemiddelvirksomhed med fokus på allergi og allergisk astma. Virksomheden markedsfører allergivaccination og andre produkter og services til mennesker med allergi og allergilæger. ALK har hovedkontor i Hørsholm og beskæftiger omkring 2.900 medarbejdere på verdensplan. Selskabet er noteret på Nasdaq Copenhagen. Læs mere på www.alk.net.

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