News Release

Bladder cancer diagnosis drug Hexvix® completed first patient procedure in Bo’ao Lecheng

Shanghai, China, December 27, 2021- Asieris Pharmaceuticals, a global innovative biopharma company specializing in discovering and developing innovative drugs for the treatment of genitourinary tumors and other major diseases, today announced that Hexvix®, a drug for the diagnosis of bladder cancer, achieved the first clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province. Hexvix® was first prescribed and used in surgical procedure in a bladder cancer patient in China at Hainan General Hospital.

Hexvix® Prescription

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. In January 2021, Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE), a bladder cancer specialist company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix® in mainland China and Taiwan.

A 46-year-old Mr. Zhao with bladder cancer underwent transurethral resection of bladder tumor (TURBT) at Hainan General Hospital eight years ago and then again more than a year ago. Postoperative pathology showed that Mr. Zhao suffered from urothelial bladder cancer. A week ago, post-resection cystoscopy revealed follicular mucosa near the bladder neck. Thanks to the early access policies at Bo’ao Lecheng, Mr. Zhao became the first patient in China to use Hexvix® as a contrast agent and Wolf BLC for the procedure. Once the contrast agent was selectively absorbed by the tumor tissues, under the specific blue light, tumor lesions clearly showed red fluorescence that is significantly different from the normal tissues, thereby assisting the diagnosis and surgical resection under cystoscopy.

Procedure

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 incidence 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 the 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 beyond 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 was about 60%, and that in high-risk NMIBC patients was up to 80%, while the risk of disease progression was 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®

The operation was performed by the urology team of Hainan General Hospital, and remotely reviewed by Professor Ye Dingwei, Vice President of Fudan University Shanghai Cancer Center and Professor Li Hanzhong, Head of the Department of Surgery, Peking Union Medical College Hospital. Professor Ye said, “Hexvix® provides a new option for the diagnosis and treatment of bladder cancer. There is a large number of patients with bladder cancer, the recurrence rate is high, and the unmet needs must be addressed. I look forward to the launch of this product as early as possible to offer a more effective choice for patients early.”

Kang Xinli, Director of the Department of Urology at Hainan General Hospital, said, “We recognize the significant unmet clinical needs in bladder cancer, and are fully confident in the potential of Hexvix® for detection and diagnosis of bladder cancer. We look forward to advancing this innovative therapy in China.”

Dr. Kevin Pan, Founder and CEO of Asieris, said, “To address the urgent unmet medical needs of bladder cancer patients, and supported by Hannan’s government and medical institutions in Bo’ao, Asieris has successfully brought Hexvix®, the only drug approved worldwide for the diagnosis of bladder cancer, to Bo’ao Lecheng. It is an important milestone for Asieris in providing an integrated solution of diagnostic and therapeutic products to our focused patients. Asieris will vigorously advance the registration and launch of Hexvix® in China, so that our patients will benefit from this cutting-edge diagnostic technology as early as possible.”

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 Recurrence Based on Raw Data, EURURO-5062; No. of Pages 9 

3. Arnulf Stenz et al. Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients With Nonmuscle Invasive Bladder Cancer, The Journal of Urology Vol. 184, 1907-1914, November 2010

About Asieris

Asieris Pharmaceuticals, 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.