Regulatory Filings • Nov 5, 2024
Regulatory Filings
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Photocure Partner Asieris announces Marketing Approval by the National Medical Products Administration for Hexvix in China
Oslo, Norway, November 5, 2024: Photocure ASA (OSE: PHO), the Bladder Cancer
Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has
communicated today that its parent company Jiangsu Yahong Meditech Co., Ltd has
received the marketing authorization for Hexvix[®] in China:
The announcement states: Jiangsu Yahong Meditech Co., Ltd (hereinafter referred
to as the "Company") has received the "Drug Registration Certificate" issued by
the National Medical Products Administration, approving the marketing of the
company's APL-1706 (Hexaminolevulinate Hydrochloride For Intravesical Solution).
The relevant details of the drug are hereby announced as follows:
1. Basic Information of the Drug
Drug Name: Hexaminolevulinate Hydrochloride For Intravesical Solution
Trademark: ???[®]/Hexvix[®]
Drug Approval Number: ????HJ20240119
Indications: Used for cystoscopy in patients with bladder cancer (including in
situ cancer), including those with suspected or diagnosed bladder cancer based
on previous cystoscopy results, or patients requiring cystoscopy during follow
-up. This product is used in conjunction with blue light cystoscopy as an
adjunct to white light cystoscopy.
2. Drug-related Information
The active ingredient of APL-1706 is Hexaminolevulinate (HAL). APL-1706, when
used in conjunction with blue light cystoscopy, effectively increases the
detection rate of bladder cancer, especially in situ carcinoma (CIS), leading to
more complete surgical resections and thus reducing tumor recurrence rates.
Before use, the patient empties their bladder, and the doctor instills APL-1706
dissolved in solution into the patient's bladder. APL-1706 forms photoactive
intermediate products protoporphyrin IX (PpIX) and other photoactive porphyrins
(PAPs) inside cells, which preferentially accumulate in tumor cells. Upon
excitation by light at wavelengths of 360-450nm, the tumor tissue fluoresces
bright red, with clear boundaries, while normal background tissues appear deep
blue. This assists in the detection and surgery of tumors under cystoscopy. The
European Association of Urology (EAU), the American Urological Association
(AUA), the National Comprehensive Cancer Network (NCCN), the National Institute
for Health and Care Excellence (NICE) in the UK, the Chinese Urological
Association (CUA) of the Chinese Medical Association, the Chinese Society of
Clinical Oncology (CSCO), and the National Health Commission all recommend HAL
as the preferred drug for fluorescence cystoscopy in their bladder cancer
guidelines. They note that fluorescence cystoscopy can help detect tiny lesions
in bladder cancer patients, especially CIS lesions.
3. Risk Warning
APL-1706 is a drug manufactured outside of China. After obtaining approval for
marketing applications, activities such as overseas production, importation, and
sales can proceed. However, its sales will be influenced by the progress of
registration and market approval for blue light cystoscopes in China. Due to the
nature of the pharmaceutical industry, the production and commercialization of
drugs after obtaining marketing approval are subject to various factors such as
policy environment, market needs and competition, which introduce a certain
level of uncertainty. Investors are advised to make decisions cautiously, be
mindful of investment risks, and take precautions accordingly.
This serves as the official announcement.
Board of Directors of the Company
November 5th, 2024
Read the stock exchange note (in Chinese)
here: http://static.sse.com.cn/disclosure/listedinfo/announcement/c/new/2024-11
-06/688176_20241106_ZJ33.pdf (https://eur01.safelinks.protection.outlook.com/?url
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w%2F2024-11
-06%2F688176_20241106_ZJ33.pdf&data=05%7C02%7Cmaja.bergmann%40photocure.com%7C247
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eYyrbY%3D&reserved=0)
-----
Asieris Pharmaceuticals is a global biopharma company specializing in
discovering, developing and commercializing innovative drugs for the treatment
of genitourinary tumors and other related diseases.
In January 2021, Asieris entered into a license agreement with Photocure ASA to
obtain the exclusive registration and commercialization rights of Hexvix in
mainland China and Taiwan.
In December 2021, 2021, Hexvix obtained initial clinical use in the Boao Lecheng
International Medical Tourism Pilot Zone in Hainan Province, when the first
patient received blue light cystoscopy with Hexvix at the Hainan General
Hospital. The clinical trial obtained approval from the NMPA in the first
quarter of 2022 and Hexvix was subsequently included in the real-world clinical
data pilot program.
Richard Wolf's System Blue, which has potential to be the first blue-light
-enabled cystoscope approved in China, is currently under regulatory review by
the NMPA. This Richard Wolf PDD device was used in the phase III clinical trial
to develop Hexvix in China and the commercialization of Hexvix is dependent on
the regulatory approval in the local market.
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.
About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a],
614 000 new cases and more than 220 000 deaths in 2022.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with up to 61% in year one and up to 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 [February 2024].
[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, compared to standard white light cystoscopy alone, 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, New Zealand and Israel. 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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