Photocure Partner Asieris announces CDE Approval for Hexvix Clinical Real-World Evidence Study in China

Rhea-AI Summary

Photocure ASA's partner, Asieris Pharmaceuticals, has received approval from the Hainan Provincial Medical Products Administration to conduct a real-world evidence study for Hexvix^® in Hainan, China. This follows a Phase III study approval granted last month. Asieris holds exclusive rights to register and commercialize Hexvix in mainland China and Taiwan, entering a license agreement with Photocure in January 2021. The combined use of Hexvix and blue light cystoscopy is endorsed in major clinical guidelines, and this approval will support data collection from the Hainan pilot study.

Positive

• Approval for a real-world evidence study could enhance data collection for Hexvix's clinical efficacy.
• Potential for increased market penetration in China, a significant opportunity given the high prevalence of bladder cancer.

Negative

• None.

OSLO, Norway, March 11, 2022 /PRNewswire/ -- Photocure ASA (PHO: OSE), The Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (688176.SH) has obtained approval to conduct a real-world evidence study for Hexvix® in Hainan, China, in addition to the Phase III study approved last month.

Asieris 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 Hexvix in the clinical real-world evidence pilot study.

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 with several patients receiving the procedure to date.

The recommendation of combined use of Hexvix and blue light cystoscopy (BLC^®) for the improved management of non-muscle invasive bladder cancer (NMIBC) has been included in all major clinical practice guidelines, including Chinese Urological Association Guideline. The present approval will allow Asieris to capture real world Hexvix data from the Hainan Pilot in addition to the results generated from the planned randomized controlled Phase III trial in China.

Read Asieris' full media release here: https://asieris.com/hexvix-has-obtained-cde-approval-to-carry-out-clinical-real-world-evidence-study/ 

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About Bladder Cancer

Bladder cancer ranks as the eighths 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

CONTACT:

For further information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Email: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: ed@photocure.com

David Moskowitz

Vice President, Investor Relations

Photocure ASA

Tel: +1 202 280 0888

Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/photocure/r/photocure-partner-asieris-announces-cde-approval-for-hexvix-clinical-real-world-evidence-study-in-ch,c3522675

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SOURCE Photocure

FAQ

What recent approval did Photocure's partner receive regarding Hexvix?

Asieris Pharmaceuticals received approval to conduct a real-world evidence study for Hexvix in Hainan, China.

How does the approval impact the commercialization of Hexvix in China?

The approval allows Asieris to gather real-world data, potentially strengthening Hexvix's market position in China.

When did Asieris enter a license agreement for Hexvix with Photocure?

Asieris entered into a license agreement with Photocure for Hexvix in January 2021.

What is the significance of the blue light cystoscopy in relation to Hexvix?

The combined use of Hexvix and blue light cystoscopy is recommended in major clinical guidelines for managing non-muscle invasive bladder cancer.