Regulatory Filings • Feb 11, 2022
Regulatory Filings
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Photocure Partner Asieris announces Approval to conduct a Phase III Clinical Trial for Hexvix in China
Oslo, Norway, February 11, 2022: Photocure ASA (PHO: OSE), The Bladder Cancer
Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has
obtained the Phase III clinical trial application (CTA) approval from the
National Medical Products Administration (NMPA) of China for Hexvix[®].
The study is a prospective, multicenter bridging trial aimed to investigate the
additional detection rate and safety of Hexvix[®] and blue light cystoscopy
(BLC[®]) versus white light cystoscopy in Chinese patients with non-muscle
invasive bladder cancer (NMIBC, tumor types CIS, Ta, T1). The study will be led
by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.
Professor Li Hanzhong, head of the Department of Surgery, 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.
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. The total number of
patients with bladder cancer in China was estimated to be higher than 600,000 in
2020. The use of BLC with Hexvix for the management of NMIBC is included in the
global expert consensus guidelines.
In January 2021, Asieris Pharmaceuticals entered into a license agreement with
Photocure, obtaining exclusive rights to register and commercialize 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:
the first patient in China received blue light cystoscopy with Hexvix at Hainan
General Hospital (https://photocure.com/news/photocure-partner-announces-first
-patient-procedure-with-hexvix-in-china-under-special-access-program-4149992).
"We are very glad that the phase ? 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."
"This clinical registration trial is a critical step toward giving bladder
cancer patients access to Hexvix in China. Hexvix is a diagnostic agent that has
been proven to improve the detection, and completeness of resection of tumors,
and can be an important solution in the management of disease", said Anders
Neijber, Vice President Global Medical Affairs and Clinical Development at
Photocure.
Read Asieris' full media release here: https://asieris.com/asieris-announced
-hexvix-a-drug-for-diagnosis-of-bladder-cancer%ef%bf%bc-has-obtained-the-ind
-approval-from-the-nmpa-for-phase-%e2%85%b2-clinical-trial/
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trademarks of Photocure ASA
This press release may contain product details and information which are not
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country of your origin.
About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000
prevalent cases (5-year prevalence rate)[1a], 573 000 new cases and more than
200 000 deaths annually in 2020.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with an average of 61% in year one and 78% over five years.[2]
Bladder cancer has the highest lifetime treatment costs per patient of all
cancers.[3]
Bladder cancer is a costly, potentially progressive disease for which patients
have to undergo multiple cystoscopies due to the high risk of recurrence. There
is an urgent need to improve both the diagnosis and the management of bladder
cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall. NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (75%) of all BC cases and include
the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has
grown into deeper layers of the bladder wall. These cancers, including subtypes
T2, T3 and T4, are more likely to spread and are harder to treat.[4]
[1] Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: https://gco.iarc.fr/today, accessed [January 2022].
[2] Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
[3] Sievert KD et al. World J Urol 2009;27:295-300
[4] Bladder Cancer. American Cancer
Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC
with Hexvix/Cysview[ ]improves the detection of tumors and leads to more
complete resection, fewer residual tumors and better management decisions.
Cysview[ ]is the tradename in the U.S. and Canada, Hexvix[ ]is the tradename in
all other markets. Photocure is commercializing Cysview/Hexvix directly in the
U.S. and Europe, and has strategic partnerships for the commercialization of
Hexvix/Cysview in China, Chile, Australia and New Zealand. Please refer to
https://photocure.com/partners/our-partners for further information on our
commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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