Photocure: Partner announces First Patient Procedure with Hexvix in China under Special Access Program
Press release – Oslo, Norway, December 27, 2021: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner and exclusive distributor, Asieris MediTech in mainland China and Taiwan has communicated the first patient experience with Hexvix® in the Bo’ao Lecheng International Medical Tourism Pilot Zone in Hainan Province. Asieris communicated that Hexvix received its first prescription in China by Hainan General Hospital and the first patient procedure was completed on December 26.
With this pilot program Asieris intends to gain further experience and build networks, in which special access policies allow for foreign drug usage and real-world data collection in advance of obtaining regulatory approval. The first clinical use of Hexvix in China under the special access program was supported by an online conference to engage Urology experts.
Prior to this event, Asieris had obtained authorization for a first usage of Hexvix in this pilot zone, positioned as an international medical tourism destination, a cutting-edge medical R&D and transformation base as well as a gathering place for national new medical institutions.
“To address the urgent clinical needs in bladder cancer and leverage the support from pilot policies and medical institutions in Bo’ao, Hainan, Asieris has taken the lead to introduce global leading innovative drug Hexvix into Bo’ao Lecheng,” said Kevin Pan, CEO of Asieris. “It is another important milestone that Asieris has achieved in promoting the integrated solution of diagnosis and treatment. Asieris will continue to advance the launch of Hexvix in China, allowing patients to benefit from this cutting-edge diagnostic technology as early as possible.
The patient procedure was performed by the urology team of Hainan General Hospital, and remotely guided by Professor Ye Dingwei, Vice President of Fudan University Shanghai Cancer Center. In the release, Professor Ye commented “Hexvix provides a new option for the diagnosis and treatment of bladder cancer. There is a large number of patients with bladder cancer, the recurrence rate is high, and the unmet needs must be addressed. I look forward to the launch of this product as early as possible to offer a more effective choice for patients early.”
Read Asieris’ full media release here: https://asieris.com/bladder-cancer-diagnosis-drug-hexvix-completed-first-patient-procedure-in-boao-lecheng/
The Hainan Bo’ao Lecheng International Medical Tourism Pilot Zone (the "Pilot Zone") was established with the approval of the State Council in 2013 and granted certain preferential policies. It aims to gather international and domestic advanced medical tourism services and international cutting-edge medical scientific and technological achievements, and to create a cluster region for international medical technology service.
"We continue to be impressed by our partner Asieris. Its teams demonstrate complete dedication to bringing the Hexvix product to China as fast as possible to meet urologists’ and patients’ needs. The acceptance of Hexvix within the Hainan pilot zone is a milestone on this journey and the special access program will bring valuable experience and knowledge for how to succeed with Hexvix throughout mainland China and Taiwan once regulatory approvals are received,” said Dan Schneider, President and CEO of Photocure. ”It is a privilege to join forces with Asieris to ensure we provide best-in-class bladder cancer diagnosis and treatment solutions for patients in China.”
Note to editors:
All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA
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 [April 2021].
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, Canada, Chile, Australia and New Zealand. Please refer to https://photocure.com/partnering-with-photocure/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