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Beskrivning
Land | Norge |
---|---|
Lista | Oslo Bors |
Sektor | Hälsovård |
Industri | Medicinteknik |
2023-11-29 10:06:00
Press Release - Oslo, Norway, November 29, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) communicated today that the National Medical Products Administration
(NMPA) accepted the new drug application (NDA) for Hexvix[®] (APL-1706) in
China. Hexvix, a pharmaceutical product used in the detection of bladder cancer,
was licensed to Asieris by Photocure in January 2021, for the registration and
commercialization of Hexvix in mainland China and Taiwan.
Results of the Hexvix (APL-1706) Phase III clinical trial in China were
presented at the 43[rd] Congress of the Société Internationale d'Urologie (SIU)
last month, as a late-breaking abstract. The study confirmed that, in a Chinese
patient population, Hexvix blue light cystoscopy (BLC[®]) outperformed white
light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases
of carcinoma in situ (CIS), and exhibited good tolerability.
The highly statistically significant results corroborate the findings of
Photocure's own randomized controlled trials (RCTs) that demonstrated the
clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection
and a favorable tolerability profile with no serious adverse events. Moreover,
Asieris' Phase III Hexvix trial is the first RCT that was conducted with high
definition 4K blue light capital equipment.
Hexvix is currently the only approved optical imaging agent for diagnosing and
surgical management of patients with bladder cancer worldwide. The combined use
of Hexvix (APL-1706) and BLC for the management of non-muscle invasive bladder
cancer (NMIBC) has been included in the global expert consensus guidelines and
Chinese Urological Association Guideline. The drug has not yet been approved for
market launch in China.
"We are glad to see our partners at Asieris driving the submission process with
conviction and speed. The acceptance of the Hexvix submission by NMPA is the
positive outcome of months of collaboration between the Asieris and Photocure
teams", said Dan Schneider, President and CEO of Photocure. "We believe that BLC
can make a difference which evident in the robust clinical data from many years
of experience and the recent Chinese RCT data presented at SIU earlier this
year. Both companies remain committed to bringing Blue Light Cystoscopy with
Hexvix to more patients with bladder cancer and elevate the standard of care."
Asieris Pharmaceuticals is a global biopharma company specializing in
discovering, developing and commercializing innovative drugs for the treatment
of genitourinary tumors and other related diseases.
Read Asieris' full media release here: https://asieris.com/asieris-announces
-nmpa-has-accepted-the-new-drug-application-for-apl-1706-an-imaging-drug-for
-diagnosing-and-management-of-bladder-cancer/
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.
About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths in 2020.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with up to 61% in year one and up to 78% over five years.[2]
Bladder cancer has the highest lifetime treatment costs per patient of all
cancers.[3]
Bladder cancer is a costly, potentially progressive disease for which patients
have to undergo multiple cystoscopies due to the high risk of recurrence. There
is an urgent need to improve both the diagnosis and the management of bladder
cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall. NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (75%) of all BC cases and include
the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has
grown into deeper layers of the bladder wall. These cancers, including subtypes
T2, T3 and T4, are more likely to spread and are harder to treat.[4]
[1] Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: https://gco.iarc.fr/today, accessed [January 2022].
[2] Babjuk M, et al. Eur Urol. 2019