https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html
På denne linken legger NMPA ut alt av godkjenninger, inkl. Medical Device. Da kan de som vil følge med selv fremover sjekke når f.eks. Richard Wolf sin søknad blir godkjent.
Listene kommer hver morgen/formiddag, mandag - fredag og en lørdag her og der.
Når lederne for både kolposkopi foreningen og gynekologforeningen i Kina går ut og kaller dette et gjennombrudd og et mulig paradigmeskifte da er det noe mer enn pyntede pressemeldingsord. Her snakker vi tung faglig forankring på øverste nivå. Det mest interessante for meg er tre ting.
For det første at de eksplisitt snakker om å flytte behandling fra kirurgi til ikke invasiv terapi. Det er ikke bare nytt produkt. Det er endring i praksis.
For det andre fertilitetsbevaring. I Kina er det et politisk og samfunnsmessig sensitivt tema. Når de løfter det så tydelig betyr det at dette treffer en nerve. Og for det tredje at de sier nær 60 % kan utsette eller unngå kirurgi. Det er et konkret og klinisk relevant tall og ikke bare en visjon.
I tillegg sier CEO rett ut at kommersialiseringsplanen allerede er satt i gang. Det oser ikke av forsiktig pilotering. Det oser av utrulling. For meg begynner dette å ligne mer på et reelt behandlingsskifte enn “bare” en royalty case. Hvis dette får fotfeste i kinesisk praksis kan det bli langt mer betydningsfullt enn mange kanskje har priset inn.
Er det Photocure som har rettighetene for Cevira i EU og US fortsatt?
Ja, Asieris har kjøpt global lisens av PHO.
For international markets, the marketing authorization application (MAA) for CEVIRA® was accepted for review by the European Medicines Agency (EMA) in February this year. The company has also reached an agreement with the U.S. FDA on the design of a separate Phase III trial to support CEVIRA®’s potential U.S. approval. Meanwhile, Asieris is actively seeking overseas commercialization partners.
Den jobben blir vel litt enklere når produktet er godkjent i Kina 
For Photocure er det akkurat bare “en royality case” 
Så er jeg enig i at i Kina er det potensiale for behandling av vesentlig større del av populasjonen enn EU, i et 10-15 års perspektiv. HVP Vaksinasjon i Kina tar jo i vei nå.
PUBLISHED: 7 APRIL 2026MEDICAL INFORMATIONREAL WORLD EVIDENCE
Oslo, Norway, April 7, 2026: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces publication of results from the BRAVO study in the peer-reviewed journal Urological Oncology this week, titled “COSTS OF CARE AND ONCOLOGIC OUTCOMES ASSOCIATED WITH BLUE LIGHT CYSTOSCOPY IN AN EQUAL ACCESS SETTING: RESULTS FROM THE BRAVO STUDY”. The study demonstrates that Blue Light Cystoscopy (BLC®) achieves cost neutrality over time compared to White Light Cystoscopy (WLC) in non-muscle invasive bladder cancer (NMIBC), despite higher initial treatment costs, driven by lower recurrence rates and reduced downstream costs of care.
BRAVO (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched retrospective real-world evidence (RWE) study evaluating outcomes following BLC compared to WLC alone in 622 patients from the Veterans Affairs Healthcare System. The analysis compared total healthcare costs over 1, 2, and 5-year periods, incorporating the economic impact of disease recurrence in a longitudinal, equal-access care setting.
In this real-world analysis:
The Veterans’ Affairs (VA) Healthcare system, which provides equal access to care and enables long-term patient follow-up, offers a robust real-world model to assess both clinical and economic outcomes.
The findings from the BRAVO study reinforce the clinical and economic value of BLC. By reducing recurrence, BLC not only improves patient outcomes but also helps optimize total cost of care over time. This study adds to the growing body of real-world evidence supporting broader adoption of BLC as a standard of care in NMIBC management.
Read the full publication here: Costs of care and oncologic outcomes associated with blue light cystoscopy in an equal access setting: Results from the BRAVO study - ScienceDirect
Asieris publishes Annual Report and shares Market approval of Richard Wolf System blue equipment in China
Oslo, Norway, April 17, 2026: Photocure’s partner Asieris today communicated publication of their 2025 annual report in a media release. Beyond progress with Cevira® and Hexvix®, in this release, Asieris share that Richard Wolf’s System blue equipment has been approved for the Chinese market this month:
“ In urologic oncology, Hexvix®, China’s first approved blue-light imaging agent for bladder cancer, has opened a new era of blue-light diagnosis and treatment for bladder cancer in the country. The SYSTEM BLUE blue-light cystoscopy system, developed by Asieris’ partner R.WOLF, received market approval in April 2026 and is expected to work in synergy with Hexvix to benefit patients. In parallel, Asieris is advancing the global development of a single-use flexible blue-light cystoscope. The product has been submitted for registration in the European Union and has been formally accepted for review.”
Read Asieris’ full media release here: https://asieris.com/asieris-pharmaceuticals-releases-2025-annual-report：flagship-product-approval-marks-inflection-point-commercialization-2-0-drives-growth/
[April 24, Beijing] Recently, SYSTEM BLUE, a blue light cystoscopy system from Richard Wolf GmbH (a partner of Asieris Pharmaceuticals), received marketing approval from the National Medical Products Administration (NMPA) in China. This system, used in combination with Asieris Pharmaceuticals’ previously approved blue light imaging agent, Hexvix ® , forms a complete “Blue Light Combination” for the detection of bladder cancer. This will provide Chinese bladder cancer patients with more accurate diagnoses and more thorough treatments, potentially aligning China’s clinical standards with international frontiers and ushering in a new era of blue light diagnosis and treatment.
Bladder cancer is one of the most common malignancies of the urinary system in China. Non-muscle invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed cases, and its diagnosis and management rely heavily on the accuracy of cystoscopic examinations. However, traditional white light cystoscopy (WLC) has limited capability in detecting tiny lesions and carcinoma in situ (CIS), meaning some lesions are easily missed, leading to incomplete resections and postoperative recurrence.
Blue Light Cystoscopy (BLC) technology is a vital supplement to the international “gold standard” for precision bladder cancer diagnosis. Its principle involves instilling a photosensitizer (Hexvix®) into the bladder before surgery. Under blue-light illumination, suspicious lesions fluoresce red, creating a sharp contrast against the blue background of normal tissue and significantly enhancing lesion visualization. Hexvix® (Generic name: Hexaminolevulinate Hydrochloride for Intravesical Solution) was approved by the NMPA in November 2024, becoming the first blue light imaging agent approved for bladder cancer diagnosis in China.
Clinical research data show that Hexvix® used with blue light cystoscopy (Richard Wolf System blue) detected at least one additional bladder cancer lesion in 43.3% of cases and improved the detection rate of high-risk CIS by 9.6 percentage points. A meta-analysis found the combination reduced the risk of post-operative residual tumor by 54%, while seven-year follow-up data showed an average of 1.2 fewer surgeries per patient and prolonged recurrence-free survival (RFS) by up to seven months.
Professor Ye Dingwei from Fudan University affiliated Tumor Hospital stated: “The approval of the Blue Light Cystoscopy system in China is not just a technical breakthrough, but a major upgrade in the diagnosis and treatment paradigm for bladder cancer in China. For a long time, the insufficient identification of tiny lesions and CIS under white light has been a key bottleneck leading to high recurrence rates in NMIBC. The ‘Blue Light Combination’ uses fluorescent contrast imaging to ‘make invisible lesions visible and unclear boundaries clear,’ improving treatment precision from the source. In 2026, we have reason to call this the ‘Blue Light Era’ for precision bladder cancer treatment in China.”
Professor Wang Shaogang of Tongji Hospital, affiliated with Huazhong University of Science and Technology, pointed out: “The prognosis of bladder cancer patients depends not only on the tumor itself but also on the precision of every clinical operation. The core value of the Blue Light Combination is that it elevates diagnostic sensitivity from ‘visible to the naked eye’ to ‘visible at the molecular level.’ Clinical evidence shows that blue-light-assisted detection is significantly superior to traditional white light, especially for hidden high-risk CIS lesions. More accurate detection means more thorough resection, which in turn leads to lower recurrence risk and fewer invasive interventions.”
It is reported that Asieris Pharmaceuticals is also advancing the development and registration of its self-developed portable disposable blue light flexible cystoscope, APLD-2304. This product aims to bring blue light technology out of the operating room and into outpatient and follow-up settings. In December 2025, the company submitted a medical device registration application for APLD-2304 to the European Union and has initiated domestic registration plans to expedite its approval in the Chinese market.
Professor Xue Wei of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, stated: “The implementation of the Blue Light Cystoscopy system in China fills a long-standing technical gap. However, our focus should not stop there. Technical introduction is only the first step; the key is how to make this technology more widely available, easier to operate, and deeply integrated into various diagnosis and treatment scenarios. We are pleased to see Chinese innovators like Asieris Pharmaceuticals not only pushing for the implementation of imaging agents and equipment but also actively exploring the independent R&D of portable and disposable blue light flexible scopes. This path meets the clinical demand for convenience and accessibility, ensuring that precision diagnosis reaches more hospitals and benefits a broader patient population.”
Richard Wolf China: The recent NMPA approval marks a significant milestone in the successful and close partnership between Richard Wolf and Asieris. We are equally delighted to announce this breakthrough and look forward to commencing the immediate sales and marketing launch across all regions in China. This product innovation – uniting our advanced hardware with the specialized pharmaceutical – is set to provide substantial added value in the detection and treatment of bladder cancer, ultimately ensuring significantly improved outcomes for patients.
About Richard Wolf:
Richard Wolf GmbH is a medium-sized medical technology company with over 1,800 employees, along with eighteen subsidiaries and 130 foreign agencies worldwide. The company develops, produces, and distributes numerous products for endoscopy and extracorporeal shock wave treatment in human medicine. Integrated operating room systems round out the product range.
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and women’s health. We strive to improve human health to preserve patients’ dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.
Blue Light Cystoscopy System Approved for Marketing in China; “Blue Light Era” for Precision Treatment of Bladder Cancer Begins
[April 24, Beijing] Recently, SYSTEM BLUE, a blue light cystoscopy system from Richard Wolf GmbH (a partner of Asieris Pharmaceuticals), received marketing approval from the National Medical Products Administration (NMPA) in China. This system, used in combination with Asieris Pharmaceuticals’ previously approved blue light imaging agent, Hexvix ® , forms a complete “Blue Light Combination” for the detection of bladder cancer. This will provide Chinese bladder cancer patients with more accurate diagnoses and more thorough treatments, potentially aligning China’s clinical standards with international frontiers and ushering in a new era of blue light diagnosis and treatment.
Bladder cancer is one of the most common malignancies of the urinary system in China. Non-muscle invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed cases, and its diagnosis and management rely heavily on the accuracy of cystoscopic examinations. However, traditional white light cystoscopy (WLC) has limited capability in detecting tiny lesions and carcinoma in situ (CIS), meaning some lesions are easily missed, leading to incomplete resections and postoperative recurrence.
Blue Light Cystoscopy (BLC) technology is a vital supplement to the international “gold standard” for precision bladder cancer diagnosis. Its principle involves instilling a photosensitizer (Hexvix®) into the bladder before surgery. Under blue-light illumination, suspicious lesions fluoresce red, creating a sharp contrast against the blue background of normal tissue and significantly enhancing lesion visualization. Hexvix® (Generic name: Hexaminolevulinate Hydrochloride for Intravesical Solution) was approved by the NMPA in November 2024, becoming the first blue light imaging agent approved for bladder cancer diagnosis in China.
Clinical research data show that Hexvix® used with blue light cystoscopy (Richard Wolf System blue) detected at least one additional bladder cancer lesion in 43.3% of cases and improved the detection rate of high-risk CIS by 9.6 percentage points. A meta-analysis found the combination reduced the risk of post-operative residual tumor by 54%, while seven-year follow-up data showed an average of 1.2 fewer surgeries per patient and prolonged recurrence-free survival (RFS) by up to seven months.
Professor Ye Dingwei from Fudan University affiliated Tumor Hospital stated: “The approval of the Blue Light Cystoscopy system in China is not just a technical breakthrough, but a major upgrade in the diagnosis and treatment paradigm for bladder cancer in China. For a long time, the insufficient identification of tiny lesions and CIS under white light has been a key bottleneck leading to high recurrence rates in NMIBC. The ‘Blue Light Combination’ uses fluorescent contrast imaging to ‘make invisible lesions visible and unclear boundaries clear,’ improving treatment precision from the source. In 2026, we have reason to call this the ‘Blue Light Era’ for precision bladder cancer treatment in China.”
Professor Wang Shaogang of Tongji Hospital, affiliated with Huazhong University of Science and Technology, pointed out: “The prognosis of bladder cancer patients depends not only on the tumor itself but also on the precision of every clinical operation. The core value of the Blue Light Combination is that it elevates diagnostic sensitivity from ‘visible to the naked eye’ to ‘visible at the molecular level.’ Clinical evidence shows that blue-light-assisted detection is significantly superior to traditional white light, especially for hidden high-risk CIS lesions. More accurate detection means more thorough resection, which in turn leads to lower recurrence risk and fewer invasive interventions.”
It is reported that Asieris Pharmaceuticals is also advancing the development and registration of its self-developed portable disposable blue light flexible cystoscope, APLD-2304. This product aims to bring blue light technology out of the operating room and into outpatient and follow-up settings. In December 2025, the company submitted a medical device registration application for APLD-2304 to the European Union and has initiated domestic registration plans to expedite its approval in the Chinese market.
Professor Xue Wei of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, stated: “The implementation of the Blue Light Cystoscopy system in China fills a long-standing technical gap. However, our focus should not stop there. Technical introduction is only the first step; the key is how to make this technology more widely available, easier to operate, and deeply integrated into various diagnosis and treatment scenarios. We are pleased to see Chinese innovators like Asieris Pharmaceuticals not only pushing for the implementation of imaging agents and equipment but also actively exploring the independent R&D of portable and disposable blue light flexible scopes. This path meets the clinical demand for convenience and accessibility, ensuring that precision diagnosis reaches more hospitals and benefits a broader patient population.”
Richard Wolf China: The recent NMPA approval marks a significant milestone in the successful and close partnership between Richard Wolf and Asieris. We are equally delighted to announce this breakthrough and look forward to commencing the immediate sales and marketing launch across all regions in China. This product innovation – uniting our advanced hardware with the specialized pharmaceutical – is set to provide substantial added value in the detection and treatment of bladder cancer, ultimately ensuring significantly improved outcomes for patients.
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