Photocure receives prestigious Innovation Prize from the Norwegian Cancer Society: Recognition for Groundbreaking Contributions in Bladder Cancer Diagnostics
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The impact of avoiding recurrence: New BRAVO Study abstract at SUO 2025 demonstrates Cost Neutrality in Blue Light versus White Light Cystoscopy comparison
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New publication: examining 12-months recurrence-free survival following photo coagulation of bladder tumor versus TUR-BT
Photocure announces the publication of the study “In-office laser coagulation of Ta bladder tumor compared to TUR-BT: 12 months follow-up randomized clinical trial” in the Journal of Urology last week. A first abstract of the study’s 12-month data had been presented at the European Association of Urology (EAU) 2024 congress. Photocure has supported this program and the specific study since 2016.
Laser III is a prospective, randomized, non-inferiority trial conducted in Denmark (NCT02886026) aimed to determine whether in-office photo coagulation bladder tumor (PC-BT) is non-inferior to standard TUR-BT regarding 12-months recurrence-free survival (RFS) in patients with recurrent Ta low grade bladder tumor. Both the office-based laser procedure and TUR-BT procedure were performed under BLC-guidance, comparing the procedures with the most complete detection technology and without compromising clinical or oncological safety. From 2016 to 2022 a randomized controlled clinical trial was performed comparing PC-BT with 980 nm diode laser under local anesthesia with gold standard TUR-BT under general anesthesia, in 300 patients in a hospital setting in Denmark.
Study results show 12 months recurrence-free survival was 43.5% after PC-BT and 43.0% after TUR-BT, the difference 0.5% in favor of TUR-BT met the noninferiority criterion.
The authors conclude: “Office-based laser photo coagulation of bladder tumor is non-inferior to TUR-BT regarding 12-months recurrence-free survival and is a safe, efficient treatment for recurrent Ta low-grade bladder tumors”
“ This is another quality clinical study supporting the utility of BLC for improving surgical performance, by enhancing detection of tumors and visibility of tumor margins, and its impact on clinical outcomes ,” said Anders Neijber Chief Medical Officer of Photocure.
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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
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Photocure’s stock performed strongly through 2025, with a year-end rally culminating in a mid-January peak before a subsequent pullback. Despite the correction, we continue to see multiple value-accretive catalysts in the pipeline, underpinned by strong underlying fundamentals and supportive of further upside potential. We therefore reiterate our BUY recommendation and raise our TP to NOK 90/sh. (85), viewing the post-correction valuation as an attractive entry point. Key risks include pending approvals, execution timelines and potential delays, regulatory developments, and commercialisation progress; however, at this stage we see no indications that these risks are evolving in a way that would materially undermine our investment case.
(Fra Nornes siste oppdatering idag.)
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Photocure ASA: Invitation to presentation of 4th quarter and preliminary full year 2025 financial results
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Asieris Announces European Medicines Agency Accepts Marketing Authorization Application for APL-1702
SHANGHAI, China, February 27, 2026 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company specializing in genitourinary tumors and women’s health, announced today that its marketing authorization application (MAA) for APL-1702 (CEVIRA) for the treatment of high-grade squamous intraepithelial lesions (HSIL) has been accepted by the European Medicines Agency (EMA).
APL-1702 is a globally first-in-class, China-originated photodynamic therapy(PDT) product. As a drug-device co-packaging product, it integrates hexaminolevulinate hydrochloride ointment with a disposable, single-use cervical photodynamic light applicator. Through its innovative localized drug delivery and intravaginally positioned cold light source, APL-1702 represents a breakthrough in the treatment paradigm of HSIL…
Designed for convenient “treat-and-go” outpatient use, the therapy is administered by gynecologists during a routine outpatient visit without the need for anesthesia, the entire placement procedure is typically completed within 10 minutes. After device placement, patients may immediately return to normal work and daily activities and are not required to remain in the hospital during the illumination period. Upon completion of treatment, the device can be safely removed by the patient at home.
This “short outpatient placement followed by at-home treatment completion” model substantially improves clinical efficiency and treatment accessibility, and supports broader implementation in primary and community healthcare settings.
Additionally, APL-1702 incorporates an innovative cold light source technology that enhances treatment comfort by maintaining tissue temperature at the treatment site below 42°C, Clinical data indicate that 97% of patients reported no pain in the cervical treatment area, with no observed cervical structural damage, thereby avoiding the risk of thermal injury associated with conventional photodynamic therapy, minimizing local irritation, and significantly improving overall patient tolerability.
APL-1702 Non-surgical Photodynamic Therapy Procedure Diagram: Easy administration for enhanced absorption; excellent patient compliance.
The MAA submitted to the EMA is primarily supported by data from an international, multicenter Phase III clinical trial of APL-1702, which included more than 20% patients from Europe.
The pivotal study results were formally published in December 2025 in Med , a Cell Press journal. The study was led by Academicians Lang Jinghe and Zhu Lan from Peking Union Medical College Hospital, with Professor Peter Hillemanns from Hannover Medical School serving as a senior author.
In addition, the clinical data were disseminated through invited oral presentations at several major international conferences, including the European Research Organization on Genital Infection and Neoplasia (EUROGIN) 2024, the Society of Gynecologic Oncology (SGO) Annual Meeting 2024, and the Photodynamic Therapy & Photodiagnosis Update 2024.
Further academic exchanges and scientific discussion with basic researchers and clinical specialists from China and abroad took place at the 27th National Clinical Oncology Conference & 2024 CSCO Annual Meeting, the International Papillomavirus Conference (IPVC) 2024, and the 37th Public Health Symposium 2025.
“The acceptance of APL-1702’s European marketing application in Europe further underscores Asieris’ strong and enduring commitment to addressing critical unmet medical needs on a global scale,” said Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals. “Building on our deep and proven expertise in the development of drug-device combination products, we have successfully advanced a truly non-invasive, patient-centred therapy from clinical research to the European regulatory review stage. This important milestone validates both our strategic focus and our ability to execute with discipline and rigor… We remain firmly committed to accelerating the global development of APL-1702, with the goal of bring this transformative treatment option to women worldwide and contributing meaningfully to global efforts toward cervical cancer elimination.”
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Fantastisk 
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At fucking last
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EMA har nå akseptert MAA for Cevira. Det er ikke godkjenning, men det betyr at søknaden er validert og inne i full regulatorisk review i Europa. Sammen med pågående NMPA prosess i Kina og publiserte Phase III data begynner dette å ligne et globalt produktløp og ikke bare en opsjon. For meg reduserer dette regulatorisk risiko betydelig og styrker hele Cevira caset.
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Cevira fremstår som de har stålkontroll på det regulatoriske, så jeg må si jeg anser at likelyhood of approval i Europa er skyhøy.
Ville prøve meg å se om jeg klarte å ettergå dette selv:
Regner med dette er url:
Engelsk oversetting i nettleseren:
Aha, og så helt nede på 69. plass ref screenshottet til @Haltopen . Ser legit ut! 
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Der kom den.
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Asieris: CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions
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Asieris: CEVIRA godkjent i Kina som førsteklasses ikke-invasiv behandling for precancerøse cervikale lesjoner
Pressemelding – Oslo, Norge, 3. mars 2026: Photocure ASA (OSE: PHO), blærekreftselskapet, kunngjør at partneren Asieris Pharmaceuticals (SSE: 688176) i dag har kommunisert at kjerneproduktet APL-1702 (handelsnavn: CEVIRA®) har mottatt legemiddelregistreringssertifikat fra Kinas nasjonale medisinske produktadministrasjon (NMPA), noe som muliggjør kommersiell lansering i Kina.
Cevira (APL-1702) er et fotodynamisk legemiddel-enhetskombinasjonsprodukt under utvikling for ikke-kirurgisk behandling av høygradige plateepiteliale intraepiteliale lesjoner (HSIL), lisensiert til Asieris av Photocure. Med Ceviras regulatoriske godkjenning i Kina er Photocure kvalifisert for en milepælsbetaling med ytterligere salgsmilepæler basert på fremtidig inntekt.
Kunngjøringen fra Asieris sier: «Som verdens første ikke-kirurgiske, ikke-invasive behandling for pasienter med cervikal intraepitelial neoplasi grad 2 (CIN2), forventes APL-1702 å fylle et kritisk klinisk gap i dette terapeutiske området og omdefinere et massivt, tidligere underforsynt marked for ikke-invasiv behandling av cervikal sykdom.
I mangel av andre godkjente ikke-invasive behandlingsalternativer har APL-1702 potensial til å omforme et behandlingslandskap som lenge har vært dominert av kirurgiske og andre invasive eller minimalt invasive inngrep. Det vil muliggjøre et skifte fra en «one-size-fits-all»-tilnærming til en som prioriterer ikke-invasiv behandling, og tilbyr en banebrytende løsning på dagens kliniske utfordringer.»
«Denne regulatoriske milepælen er en betydelig prestasjon for et ikke-kirurgisk organbevarende behandlingsalternativ som dekker et viktig udekket medisinsk behov», sa Anders Neijber, Photocures medisinske sjef.
Les hele pressemeldingen fra Asieris her: Asieris’ CEVIRA® Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions - Asieris Pharmaceuticals
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Dét var meldingen sin, det 
Wei Lihui, Chair of the Chinese Society for Colposcopy and Cervical Pathology (CSCCP), Honorary Director of the Department of Obstetrics and Gynecology at Peking University, and Professor at Peking University People’s Hospital, said, “The approval of CEVIRA® represents a breakthrough in the diagnosis and treatment of cervical diseases in China. It is the first time that an active intervention combining both efficacy and safety has become available for the conservative management of cervical precancerous lesions. This provides clinicians with a new and superior option for clinical decision-making and marks a critical step forward in advancing precision medicine while balancing disease control with patients’ fertility preservation needs. Notably, the post-approval clinical use of CEVIRA® is expected to reshape a treatment paradigm that has long relied on surgical and other invasive or minimally invasive approaches, enabling a shift from a ‘one-size-fits-all’ strategy toward a preference for optimized non-invasive treatment pathways.”
Di Wen, Chair of the Chinese Obstetricians and Gynecologists Association and Vice Chair of the Chinese Society of Obstetrics and Gynecology, and Professor at Renji Hospital, Shanghai Jiao Tong University School of Medicine, said, “The approval of CEVIRA® positions China at the global forefront of non-invasive gynecological therapies. It offers clinicians an effective option for proactive intervention. This outpatient, short-course, non-invasive treatment not only helps preserve the reproductive potential of women of childbearing age, but also substantially reduces surgical trauma and psychological burden. By embodying a truly patient-centered approach, its approval is expected to positively shape strategies for the prevention and management in gynecologic oncology.”
Professor Chen Fei, Chief Physician of Obstetrics and Gynecology at Peking Union Medical College Hospital and the China principal investigator of the international multicenter Phase III clinical study of CEVIRA®, said, “CEVIRA® offers distinct clinical advantages, including targeted lesion elimination, HPV clearance, and preservation of reproductive function. In particular, as a non-invasive therapy, it maximally preserves the anatomical structure and physiological integrity of the cervix, enabling nearly 60% of patients to delay or avoid surgery and providing patients with cervical precancerous lesions with a superior treatment option that effectively controls disease while maintaining fertility.”
[…]
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, “The approval of CEVIRA® represents a major milestone in our journey. Guided by our corporate mission of being patient-centric and driven by clinical value, we have maintained a strategic focus on women’s health and major diseases of the genitourinary system. We have initiated a comprehensive commercialization plan to ensure that this disruptive innovation benefits Chinese patients with cervical precancerous lesions as soon as possible. At the same time, we will accelerate the product’s global development and commercialization partnerships, while continuing to strengthen our photodynamic drug-device combination and other technology platforms, as well as the development of our pipeline assets. This approval opens an exciting new chapter for Asieris, and we are confident to deliver long-term, sustainable value to our investors.»
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