0OIR Regulatory Filing For House Dust Mite Allergy Tablet Accepted For Review In China
03 Febrero 2023 - 5:48AM
UK Regulatory
TIDMALK TIDMB
ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that its
Biologics License Application (BLA) for its house dust mite (HDM)
sublingual allergy immunotherapy (AIT) tablet has been accepted for
review by the National Medical Products Administration (NMPA) in
China. The BLA, for treatment of persistent moderate-to-severe HDM
allergic rhinitis in patients aged 12--65 was submitted in late
December 2022.
Søren Niegel, ALK's Executive Vice President, Commercial
Operations, says: "This is an important step forward for ALK's
efforts to bring new, evidence-based treatment options to the
millions of people with moderate to severe allergy and their
doctors in China asking for better solutions. In line with our
previously communicated plans, we are investing in better allergy
care with great determination in China, and we see a potential
future launch of our ACARIZAX(R) tablet, the first AIT tablet in
China, as an important contributor to our long-term growth
ambitions."
Around 100 million people in China are affected by HDM allergy,
while just 500,000 are receiving allergy immunotherapy (AIT)
treatment today. Total HDM AIT annual sales are already estimated
at more than DKK 1 billion and China is well on its way to becoming
the world's largest market for HDM AIT. More than 70% of the market
is based on sublingual AIT.
ALK's current product range in China includes the SCIT product
Alutard SQ(R) and diagnostics. To speed up the adoption of its
existing offering and prepare the market ahead of the planned
introduction of the HDM tablet, ALK continues to ramp up its local
presence. In 2022, the local organisation was significantly
expanded, while the number of hospitals and pharmacies near
hospitals using ALK's products grew by more than 50% to over 500.
Furthermore, ALK accelerated its efforts to educate physicians in
co-operation with medical associations in China
Recently, ALK made the HDM tablet available in China's Boao
Lecheng Medical Pilot Zone, where first prescriptions have been
issued. ALK expects to gain valuable input from prescribers and
patients in this pilot zone ahead of a nationwide launch of the
tablet subject to approval by the authorities.
In early 2022, the Chinese authorities issued a regulatory
waiver allowing ALK to file for approval of the HDM tablet by
utilising clinical data obtained outside China and without
finalising a Phase III registration trial with Chinese subjects
which had to be paused in 2020 due to COVID. The waiver permits
further data in Chinese patients to be obtained as a follow-up
activity, after the HDM tablet's potential approval and launch. The
Chinese regulatory review process is anticipated to complete in
2024 so that, subject to approval, the wider market introduction
could follow shortly hereafter.
The HDM tablet is marketed as ACARIZAX(R) in Europe and a number
of international markets, as ODACTRA(R) in the USA and as
MITICURE(TM) in Japan.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile
+45 2261 2525
Media: Maiken Riise Andersen, tel. +45 5054 1434
This information is information that ALK-Abelló A/S is obliged
to make public pursuant to the EU Market Abuse Regulation.
About ALK
ALK is a global specialty pharmaceutical company focused on
allergy and allergic asthma. It markets allergy immunotherapy
treatments and other products and services for people with allergy
and allergy doctors. Headquartered in Hørsholm, Denmark, ALK
employs around 2,700 people worldwide and is listed on Nasdaq
Copenhagen. Find more information at www.alk.net.
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(END) Dow Jones Newswires
February 03, 2023 06:48 ET (11:48 GMT)
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