Hexvix® Has Obtained the Approval from the NMPA for Phase Ⅲ Clinical Trial

Shanghai, China, February 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 Hexvix®, a drug for the diagnosis of bladder cancer, has obtained the clinical trial application (CTA) approval from the National Medical Products Administration (NMPA) of China.

The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix® and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC) (CIS, Ta, T1).

This study will be led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, will serve as the Principal Investigator to lead a team of top experts in the field of bladder cancer in China to carry out this study. The company plans to file a new drug application with the NMPA in the future pending clinical trial progress and meaningful data.

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 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® 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, OSE:PHO), a bladder cancer specialist 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 and the operation on the first patient was completed.

“We are very glad that the Phase Ⅲ trial of Hexvix® has been approved by the NMPA.” said Dr. Yong Xue, Chief Medical Officer of Asieris.“We will accelerate the clinical trial process so that doctors and patients in China will have access to this breakthrough 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 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.