Har store forventninger om at godkjenning kommer i løpet av uka, eventuelt helgen!
Tvi tvi!
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Minder om denne som jeg lagde ind for ca 4 dage siden — stadig aktuel 
“Genpostet”
1702最耗时的“技术审评”和“综合审评”都已经在12月26日完成了，目前只剩下最后的行政盖章和制证下发。1月9日-1月16日是拿到批件的极高概率窗口期。这个时候震荡上行，唱空的越来越多也是好事
Den mest tidskrævende “tekniske gennemgang” og “omfattende gennemgang” af licens 1702 blev afsluttet den 26. december. Kun den endelige administrative stempling og certifikatudstedelse er tilbage. 9. januar til 16. januar er mulighedsvinduet med en meget høj sandsynlighed for at opnå godkendelse. I denne periode med opadgående volatilitet er det stigende antal pessimistiske stemmer faktisk en god ting.
Ser også ud som nogle investorer i Asieris aktien er gået i FOMO mode 
Som andre børser her og der og i Kina ---- ja så er der altid nogen der ved noget før vi andre 
Dansken
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New publication of Hexvix trial data from China: blue light cystoscopy with Hexvix significantly improves the detection of bladder cancer using modern HD equipment
Press release – Oslo, Norway, January 12th, 2026: Photocure announces the publication of the study “Hexaminolevulinate blue light cystoscopy improves bladder cancer detection in comparison to white light cystoscopy: a prospective, comparative, within-patient controlled multicenter phase III bridging study in China” in the Frontiers of Urology journal this week.
An abstract with data from this pivotal prospective randomized controlled multi-center Phase 3 trial was first presented at the Congress of the Société Internationale d’Urologie (SIU) in October 2023. Its main objective was to compare and show a significant improvement between Hexvix/Cysview® (hexaminolevulinate) blue light cystoscopy (BLC®) and white light cystoscopy (WLC) in the detection rate of bladder cancer, using Richard Wolf’s modern state-of-the-art “System blue” high-definition cystoscopy equipment.
Of the 158 enrolled patients, 97 patients had non-muscle-invasive bladder cancer. Patients received intravesical Hexvix/Cysview and underwent WLC and high-definition BLC. The primary efficacy endpoint was the proportion of patients with histology-confirmed tumors (Ta, T1, or CIS) who had at least one such tumor detected during BLC, but not during WLC. Secondary endpoints included detection of CIS, lesion detection rates, false positive rate, and safety.
Key findings: Compared with WLC, the proportion of patients with additional bladder cancer lesions detected by BLC was 43.3% (p＜0.0001). The proportion of patients with CIS lesions detected by BLC and not by WLC was 9.6%. Detection rates for CIS, Ta, T1 and T2-T4 tumors were 94.7%, 100%, 98.2% and 100% for BLC and 42.1%, 76.1%, 91.2% and 100% for WLC, respectively.
The study authors conclude that in the setting of modern high-definition equipment, blue light cystoscopy with Hexvix/Cysview significantly improves the detection of bladder cancer and with favorable safety.
“The detection rates for CIS from this trial in a contemporary clinical setting using modern HD equipment are convincing, and in line with prior regulatory trials with BLC. The use of full HD cystoscopy equipment even seems to widen the tumor detection gap comparing white light and blue light cystoscopy with Hexvix/Cysview. The difference in detection rates for CIS between BLC and WLC is 52.6% (18 out of 19 lesions, 94.7%, for BLC and 8 out of 19 lesions, 42.1%, for WLC). In 2025, we saw the evolution towards blue light cystoscopy use as best practice being recognized in the updates to several national urology guidelines. The role of enhanced cystoscopy for accurate staging and identifying CIS is increasing with the new emerging novel therapies in NMIBC,” said Anders Neijber, Chief Medical Officer at Photocure.
Read the full publication here: https://www.frontiersin.org/articles/10.3389/fruro.2025.1713128
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 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
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 [February 2024].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
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Likte denne spesielt godt!
The study authors conclude that in the setting of modern high-definition equipment, blue light cystoscopy with Hexvix/Cysview significantly improves the detection of bladder cancer and with favorable safety.
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Jaha, ikke akkurat den melding oss venter på, men godt å se at det er liv i noen hos Photocure enda.
Men hva er egentlig nytt med dagens melding??
Det nye er vel at Hexvix nå har formell vitenskapelig validering i Kina samt bevist overlegenhet selv mot HD white light og et kommersielt og regulatorisk grønt lys i verdens største marked så det er et strukturelt gjennombrudd og ikke bare PR.
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Det er slike studier som vil ta BLC sakte men sikkert mot SOC. At den er kjørt i Kina er et stort pluss gitt at Asieris skal rulle ut der.
Langt på vei, relativt misforstått å kimse av denne.
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Helt enig med deg @h3nk1 om at denne meldingen ikke er noe å kimse av. Poenget er jo akkurat som du sier; den er kjørt i Kina.
Det betyr at om Asieris fabler om å kjøpe Photocure så har Hexvix/Cysview høyere verdi og mindre risiko for kineserne i det regnestykket.
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Hexvix bruk i Kina er godkjent forlengst. Det rare er at det ikke er godkjent noen scope ennå. Hverken ridgid scope eller flexiscope. 
Richard Wolf venter vel på godkjenning «any day». Asieris utvikler sitt eget scope i parallell.
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“Asieris utvikler sitt eget scope i parallell.”
Hadde ikke fått dette med meg. Takk for infoen! 🫡
Tidsperspektiv?
Asieris har også rettighederne i Kina til UroVio’s Uro-3500 & Uro-G.
Shanghai, China, 20 February 2023 – Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the registration applications for the single-use, handheld electronic cystoscope cannula Uro-G and electronic endoscope image processor Uro-3500 it represents have been accepted by the National Medical Products Administration (NMPA).
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Det som er fremst i løypen er vel R. Wolf sitt. Deretter er planen å rulle ut bredere med sitt eget scope.
Et godt sammendrag over det som skjer hos Asieris, dog et halvt år gammelt. Basert på halvårsrapporten til Asieris.
«In urologic oncology, Hexvix®, China’s first approved imaging agent for bladder cancer, has ushered in a new era of blue-light cystoscopy. The company is actively supporting its partner R.WOLF in advancing the regulatory review of the SYSTEM BLUE blue-light cystoscopy system in China, with approval targeted by the end of 2025. Once approved, the system, combined with Hexvix®, is expected to improve outcomes for patients nationwide.
To expand market opportunities and strengthen strategic control, the company plans to introduce its single-use blue-light flexible cystoscope to China and accelerate regulatory approval. The aim is to allow patients to fully benefit from blue-light cystoscopy by avoiding unnecessary surgical trauma, preserving bladder function, enhancing quality of life, and reducing total five-year treatment costs through earlier diagnosis.
The company is refining its launch strategy for Hexvix®, initially targeting patients with strong willingness to pay out-of-pocket or coverage through commercial insurance, focusing on urology centers in top-tier and oncology hospitals in major cities. Over time, as clinical guidelines are updated and urology expert endorsements are established, coupled with the launch of single-use blue-light cystoscopes, the company plans to gradually expand penetration into urology centers across key hospitals nationwide, achieving broad access to blue-light cystoscopy.»
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Noen som har noen kontroll på mulig inntjening her for Photocure. Pris pr behandling, og Photocure sin andel.
Det har kommet mange innspill om dette hvis du leser tidligere innlegg. Helt eksakt vet jo ingen - det helt avgjørende er selvsagt hvordan Cevira event vil slå an.
Er vel ikke så mange innlegg om potensialet til hexvix i Kina
Når avtalen ble børsmeldt i 2021:
- mark up på produktsalg (ikke spesifisert nærmere)
- royalties på salg (ikke spesifisert nærmere)
I tillegg var det nevnt et par mindre milestones.
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Ja. Har sett den. Sier egentlig særdeles lite. Tenkte kanskje det var nevnt på presentasjon eller lignende tidligere. Hadde vært interessant å vite.
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Rigide var vel ventet godkendt i Kina inden udgangen af 2025 — Her er vi også på overtid 
DK
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Men Asieris har også søkt CE godkjenning av eget flexskop, noe jeg føler er veeldig underkommunisert betydning av.
“Shanghai, China, December 21, 2025 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced the submission of a CE Mark application for its portable blue light flexible cystoscope APLD-2304 (a company-led development) to the EU Notified Body BSI Group The Netherlands B.V.; the application has been accepted.”
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