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/
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.
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.
Som vanlig lite å utsette på pressemeldingene til Asieris. Proppfulle av info og eliteserie KOLs.
New health economic methodology published: comparing cost-effectiveness of BLC versus NBI imaging technology in bladder cancer
AUA 2026: new studies demonstrated Blue Light Cystoscopy benefits in high-risk NMIBC management and cost comparison study
World Reproductive Health Day: World’s First Non-Invasive Portable Cervical Photodynamic Therapy Technology Launched Across 26 Cities in China, Offering a Fertility-Preserving Treatment Option for Patients with Cervical Precancer
June 9 marked World Reproductive Health Day, an initiative aimed at raising awareness of women’s reproductive health and safeguarding women’s rights to safe and satisfying sexual lives, informed reproductive choices, and safe pregnancy and childbirth.
On this occasion, the world’s first approved non-surgical, non-invasive treatment for cervical intraepithelial neoplasia grade 2 (CIN2) has been introduced in 42 hospitals across 26 cities in China, including Beijing, Shanghai, Guangzhou, Wuhan, and Shenzhen. Participating institutions include the Obstetrics and Gynecology Hospital of Fudan University, Peking University People’s Hospital, Peking University First Hospital, Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and Shenzhen Maternity & Child Healthcare Hospital. This milestone enables women diagnosed with CIN2—particularly younger patients who wish to preserve their fertility—to access an innovative treatment option without undergoing surgery.
From Approval to Nationwide Availability: Expanding Patient Access to Innovation
10 Days, 70 Hospitals in 30 Cities Across China: World’s First Non-Invasive, Portable Cervical Photodynamic Therapy Fully Rolled Out, Exclusively Launched on JD Health
(Shanghai, China, June 15, 2026) – Just 10 days after the first shipment of the world’s first approved non-surgical, non-invasive treatment for Cervical Intraepithelial Neoplasia Grade 2 (CIN2) departed on June 5, the innovative therapy has been deployed in 70 hospitals across 30 cities nationwide and exclusively launched on JD Health. This allows CIN2 patients to access the innovative “no surgery, fertility-preserving” treatment locally without long-distance travel.
A Race Against Time: From First Shipment to Nationwide Expansion in 10 Days
Only three months after receiving regulatory approval, and just 10 days after the first shipment, the portable cervical photodynamic therapy system has demonstrated remarkable speed in reaching patients. Key milestones over the past 10 days include:
• June 5: The first batch of products cleared customs at Beijing port and was officially dispatched to hospitals and pharmacies nationwide; the world’s first prescription was issued in Beijing on the same day.
• June 10: Patients in the first 26 cities could receive treatment at local hospitals.
• June 15: Coverage expanded to 30 cities and went live on JD Health, extending from provincial capitals and first-tier cities to regional areas.
“I heard that non-invasive technology was available in Beijing and Shanghai. I never imagined that just 10 days later, our local hospital could also offer non-invasive treatment,” said a patient who just completed treatment in Guangxi. “No hospitalization needed – you just have the device placed and go home. So convenient!”
A Non-Invasive Revolution That Preserves Fertility: Moving Beyond ‘One-Size-Fits-All Surgery’
In recent years, China has been actively promoting a fertility-friendly society. Domestic and international guidelines have shifted from “preferring excisional treatment” to “treatment strategies focusing on fertility protection.” The 2026 edition of the Chinese Expert Consensus on CIN2 Management explicitly states that for CIN2 patients of childbearing age, immediate invasive treatment should be avoided whenever possible. The ideal treatment must simultaneously achieve effective lesion clearance, preserve fertility, and be “non-surgical.”
Professor Zhao Shaojie of Wuxi Maternal and Child Health Hospital, noted: “The core of CIN2 management is not a one-size-fits-all surgery, but precise risk stratification – promptly identifying and treating patients who truly need surgery, while properly managing those who can safely preserve fertility. This way, treating the virus and the lesion while preserving fertility is no longer an either-or choice.”
Professor Li Qiling of Xi’an Jiaotong University, further urged: “In clinical practice, some young patients with precancerous cervical lesions who desire fertility have seen their reproductive capacity affected by early cone biopsy procedures. We must not only control cervical cancer at the precancerous stage but also practice precise prevention and control. By leveraging precise diagnosis, precise screening, and whole-process management of cervical cancer, and actively applying new non-invasive technologies, we can reduce invasive treatments and protect patients’ fertility.”
As a portable photodynamic therapy system combining a drug and a device, the product is placed by a gynecologist in an outpatient setting. A single treatment session takes less than 10 minutes, allowing patients to “treat and go” – no hospitalization, no anesthesia. Compared with traditional LEEP or cold knife conization, it does not damage the basal cell layer of the cervix and fully preserves cervical structure and fertility。
Cervical Care Clinics Accelerate Rollout, Benefiting More Patients in Grassroots Communities
As the portable cervical photodynamic technology rapidly expands to more cities, an increasing number of hospitals are proactively incorporating non-invasive treatment into their standard clinical pathways for cervical precancerous lesions. Many have established or upgraded “Cervical Care Demonstration Clinics” to provide comprehensive services from screening and diagnosis to treatment and follow-up.
Professor Xiong Chunqiu of the Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital, stated: “In the past, there was often no intermediate option between ‘watchful waiting’ and ‘surgical excision.’ When patients are anxious about ‘watchful waiting,’ surgery becomes the default choice. Non-invasive technology fills this clinical gap, aligning with the national policy of building fertility-friendly hospitals – protecting fertility from the source.”
Professor Chen Yan of the First Affiliated Hospital of Anhui Medical University, commented: “The portable photodynamic non-invasive technology has taken non-surgical treatment for CIN2 to a new level, making the stepwise pathway of observation → non-invasive → surgery smoother. Building fertility-friendly hospitals is not just a slogan; it’s about helping more young women preserve their hope of fertility while effectively treating their disease.”
It is learned that the accessibility of portable cervical photodynamic technology continues to expand, with coverage expected to reach hundreds of hospitals in over 50 cities nationwide within the year. Meanwhile, a multi-center real-world study has been launched simultaneously, which will provide more Chinese data to optimize treatment standards and inform future guideline updates.
Building a fertility-friendly society requires both technological innovation and accessibility. From the June 5 dispatch to deployment in 30 cities by June 15, and the exclusive online launch on JD Health, this portable cervical photodynamic technology has turned the concept of “treating disease while preserving fertility” into a reality for more patients – all in just 10 days.
Hvis detta tempoet fortsetter tror jeg mange fortsatt undervurderer hvor fort et nytt behandlingsalternativ faktisk kan få fotfeste når leger, sykehus, distributører og myndigheter drar i samme retning.