Hexvix® Has Obtained CDE Approval to Carry Out Clinical Real-World Evidence Study

Shanghai, China, March 11,2022 –Asieris Pharmaceuticals (688176.SH), a global innovative biopharma company specializing in discovering and developing innovative drugs for the treatment of genitourinary tumors and other major diseases, announced today that the Hainan Provincial Medical Products Administration, in accordance with advice from the National Medical Products Administration Center for Drug Evaluation (CDE), has approved the inclusion of Asieris’ drug Hexvix® ,a drug for the diagnosis of bladder cancer, in the clinical real-world evidence pilot study. Hexvix® became the ninth drug approved to take part in the clinical real-world evidence pilot study.

According to the 2020 global cancer data released by the World Health Organization’s International Agency for Research on Cancer (IARC), bladder cancer is one of the top 10 cancers with the highest incidents in the world. According to Frost & Sullivan, the number of new bladder cancer cases in China reached 86,000 in 2020, and is expected to rise to 101,000 in 2025, with a compound annual growth rate of 3.4% during that five-year period. As the survival period of bladder cancer patients was up to 7.5 years1, the total number of patients with bladder cancer in China was estimated to be more than 600,000 in 2020.

According to Frost & Sullivan, patients with bladder cancer have a long survival period and a high recurrence rate. NMIBC accounts for 75% of all bladder cancer cases. The recurrence rate in NMIBC patients within five years after TURBT is about 60%, and that in high-risk NMIBC patients is up to 80%, while the risk of disease progression is 50%. Patients need to receive multiple surgical treatments and chronic medication, as well as frequent and long-term surveillance cystoscopy to manage the disease.

Studies showed that the combined use of Hexvix® and BLC significantly increased the detection rate of papillary carcinoma by 24.9%, compared with white light cystoscopy. Specifically, it increased the detection rate of primary carcinoma by 20.7% and that of relapsed carcinoma by 27.7%. In addition, because the bladder carcinoma in situ (CIS) is flat and difficult to observe directly with white light cystoscopy, the use of Hexvix® combined with BLC increased the detection rate of CIS by 26.7%, specifically by 28.0% in patients with primary carcinoma and by 25.0% in patients with relapsed carcinoma.2 The results also showed that patients treated with Hexvix® and BLC had a 16% reduction in recurrence compared to those treated with white cystoscopy.3

Hexvix® has been approved in the United States and many European countries. The combined use of Hexvix® and blue light cystoscopy (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.
In January 2021, Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix® in mainland China and Taiwan. In December 2021, Hexvix® was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province and the first prescription in China was issued at Hainan General Hospital, with the first patient operated successfully.

“Real-world evidence plays an increasingly important role in clinical trials, and this project is expected to accelerate the clinical development and regulatory application of Hexvix®, allowing patients to receive appropriate treatment as soon as possible”, said Dr. Yong Xue, Chief Medical Officer of Asieris.

  1. Martine Ploeg · Katja K. H. Aben Lambertus A. Kiemeney: The present and future burden of urinary bladder cancer in the world, World J Urol (2009)27:289–293; No.of Pages 291
  2. Maximilian Burger et al. Photodynamic Diagnosis of Non–muscle-invasive Bladder Cancer with Hexaminolevulinate Cystoscopy: A Meta-analysis of Detection and RecurrenceBased on Raw Data, EURURO-5062; No. of Pages 9
  3. Arnulf Stenz et al. Hexaminolevulinate Guided Fluorescence Cystoscopy ReducesRecurrence in Patients With Non-muscle Invasive Bladder Cancer, The Journal ofUrology Vol. 184, 1907-1914, November 2010

About Asieris
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.