Photocure ASA

Regulatory Filings • Nov 29, 2023

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Press Release - Oslo, Norway, November 29, 2023: Photocure ASA (OSE: PHO), the

Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:

688176) communicated today that the National Medical Products Administration

(NMPA) accepted the new drug application (NDA) for Hexvix[®] (APL-1706) in

China. Hexvix, a pharmaceutical product used in the detection of bladder cancer,

was licensed to Asieris by Photocure in January 2021, for the registration and

commercialization of Hexvix in mainland China and Taiwan.

Results of the Hexvix (APL-1706) Phase III clinical trial in China were

presented at the 43[rd] Congress of the Société Internationale d'Urologie (SIU)

last month, as a late-breaking abstract. The study confirmed that, in a Chinese

patient population, Hexvix blue light cystoscopy (BLC[®]) outperformed white

light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases

of carcinoma in situ (CIS), and exhibited good tolerability.

The highly statistically significant results corroborate the findings of

Photocure's own randomized controlled trials (RCTs) that demonstrated the

clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection

and a favorable tolerability profile with no serious adverse events. Moreover,

Asieris' Phase III Hexvix trial is the first RCT that was conducted with high

definition 4K blue light capital equipment.

Hexvix is currently the only approved optical imaging agent for diagnosing and

surgical management of patients with bladder cancer worldwide. The combined use

of Hexvix (APL-1706) and BLC for the management of non-muscle invasive bladder

cancer (NMIBC) has been included in the global expert consensus guidelines and

Chinese Urological Association Guideline. The drug has not yet been approved for

market launch in China.

"We are glad to see our partners at Asieris driving the submission process with

conviction and speed. The acceptance of the Hexvix submission by NMPA is the

positive outcome of months of collaboration between the Asieris and Photocure

teams", said Dan Schneider, President and CEO of Photocure. "We believe that BLC

can make a difference which evident in the robust clinical data from many years

of experience and the recent Chinese RCT data presented at SIU earlier this

year. Both companies remain committed to bringing Blue Light Cystoscopy with

Hexvix to more patients with bladder cancer and elevate the standard of care."

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.

Read Asieris' full media release here: https://asieris.com/asieris-announces

-nmpa-has-accepted-the-new-drug-application-for-apl-1706-an-imaging-drug-for

-diagnosing-and-management-of-bladder-cancer/

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 1 720 000 prevalent cases (5-year prevalence rate)[1a],

573 000 new cases and more than 200 000 deaths in 2020.[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 [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, 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: 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