Photocure: Asieris har fullført fase III Hexvix inklusjonene!
Photocure Partner Asieris announces completion of enrollment for Hexvix Phase III clinical trial in China
Press Release – Oslo, Norway, July 6, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated today that it has completed patient enrollment for the Hexvix® Phase III bridging trial.
The objective of the multicenter Phase III trial is to support regulatory approval of Hexvix in Mainland China. The bridging trial is intended to confirm results from prior clinical trials regarding the safety and detection benefits of blue light cystoscopy (BLC®) with Hexvix compared to white light cystoscopy in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization.
This study is being led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, is serving as the Principal Investigator, leading a team of top experts in the field of bladder cancer in China to carry out this study. Asieris plans to file a new drug application with the National Medical Products Administration (NMPA) in the future, pending clinical trial progress and meaningful data.
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 phase III 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.
Read Asieris’ full media release here: https://asieris.com/hexvix-a-diagnostic-drug-for-bladder-cancer-of-asieris-has-completed-the-phase-iii-bridging-trial-enrollment/
Press Release – Oslo, Norway, July 6, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated today that it has completed patient enrollment for the Hexvix® Phase III bridging trial.
The objective of the multicenter Phase III trial is to support regulatory approval of Hexvix in Mainland China. The bridging trial is intended to confirm results from prior clinical trials regarding the safety and detection benefits of blue light cystoscopy (BLC®) with Hexvix compared to white light cystoscopy in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization.
This study is being led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, is serving as the Principal Investigator, leading a team of top experts in the field of bladder cancer in China to carry out this study. Asieris plans to file a new drug application with the National Medical Products Administration (NMPA) in the future, pending clinical trial progress and meaningful data.
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 phase III 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.
Read Asieris’ full media release here: https://asieris.com/hexvix-a-diagnostic-drug-for-bladder-cancer-of-asieris-has-completed-the-phase-iii-bridging-trial-enrollment/
Merlin
06.07.2023 kl 12:17
3896
Ingen direkte milestones nå. Men Asieris ligger foran tidsskjemaet og ser ut til å levere bedre enn forventet. De har også en partner som leverer engangsskop. Dermed slutt på problemer med desinfisering og ventetid. Se video her der det ledningsuavhengige, oppladbare, høyoppløselige, moderne og meget praktiske engangsskopet presenteres.. https://uroviu.com/
Portable. The reusable, battery-powered sterile platform is always ready when you need it, providing crisp, detailed images and consistent performance.
Low cost. Single-use cystoscopes and hysteroscope eliminate large capital investment and annual service contracts, while not requiring resources and materials for disinfection..
Quality you can count on. The portable, all-in-one platform is always ready to use, improves workflow, saves staff time, and avoids scheduling delays.
PHO: Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan
2021-01-26 08:36:35
Agreement Expands Photocure's Hexvix[®]/Cysview[®] Franchise Footprint to over
30 Countries
Oslo, Norway January 26, 2021, Photocure ASA (PHO:OSE): The Bladder Cancer
Company focused on delivering transformative solutions to improve the lives of
bladder cancer patients, announces that it has entered into a partnership
agreement with Asieris MediTech Co., Ltd. (Asieris), a division of Jiangsu
Yahong Meditech Co., Ltd., whereby Asieris has obtained exclusive rights to
register and commercialize Hexvix[®] in Mainland China and Taiwan.
Based on the Agreement, Photocure will receive an upfront payment of USD 750,000
from Asieris for the rights to Hexvix in the designated territories, as well as
payments of up to USD 1.4 million for the achievement of certain regulatory
milestones including market approvals in Mainland China and Taiwan. The Company
will manufacture and supply Hexvix, and receive a transfer price from Asieris
representing a markup on product provided under the Agreement. Photocure will
also receive royalties on product sales.
"Expanding our business geographically is a strategic priority at Photocure, and
we are very pleased to partner with Asieris to commercialize Hexvix in both
Mainland China and Taiwan," said Dan Schneider, President and CEO of Photocure.
"This marks our second strategic agreement with Asieris, a well-run and well
-capitalized company that is executing ahead of plan on the clinical development
of Cevira[®,] which we licensed to them in July 2019. Asieris solely focuses on
the development and commercialization of innovative products in the field of
genitourinary diseases, and we look forward to collaborating with them to bring
the important benefits of Hexvix to patients suffering from bladder cancer in
Mainland China and Taiwan."
Asieris will fund all costs to secure regulatory approvals of Hexvix in Mainland
China and Taiwan, and expects to begin the regulatory processes immediately.
Given the current market approvals of Hexvix/Cysview in both the U.S. and Europe
based on well-documented evidence of safety and efficacy, Asieris plans to
explore regulatory pathways for expedited approvals in Mainland China and
Taiwan. During the regulatory review and approval process for Hexvix, Asieris
plans to initiate launch preparations including reimbursement applications and
collaborations with blue light cystoscopy (BLC[®]) equipment providers. Asieris
is responsible for all costs related to commercialization of Hexvix in the
designated territories. Photocure will provide regulatory dossier information to
support the application and regulatory review process, and will also provide
training to Asieris' employees, global promotional materials, and commercial
support.
"Photocure is a global leader in bladder cancer management, and we are very
excited to add a second product from Photocure to our pipeline. We want to make
this breakthrough technology available to physicians and patients in China as
soon as possible." said Kevin Pan Ph.D., Founder and CEO of Asieris. "Hexvix
adds a great deal of synergy to Asieris' strategic focus on genitourinary
cancers and other diseases. Together with our drug candidates for NMIBC
treatment in the clinical development, Asieris is building up a combination of
potentially the most advanced technologies in order to provide the best care for
NMIBC patients in China."
According to GloboCan, the reported incidence of bladder cancer in Mainland
China is approximately 85 000 new patients annually, which is slightly higher
than that in the U.S., but with a healthcare system that is still developing.
There are significant differences in incidence rates between urban and rural
areas, with access to specialty care mainly available in urban areas. The burden
of bladder cancer in Mainland China is expected to increase in the next few
years according to a study published in Cancer Management and
Research (https://doi.org/10.2147/CMAR.S189220).
Portable. The reusable, battery-powered sterile platform is always ready when you need it, providing crisp, detailed images and consistent performance.
Low cost. Single-use cystoscopes and hysteroscope eliminate large capital investment and annual service contracts, while not requiring resources and materials for disinfection..
Quality you can count on. The portable, all-in-one platform is always ready to use, improves workflow, saves staff time, and avoids scheduling delays.
PHO: Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan
2021-01-26 08:36:35
Agreement Expands Photocure's Hexvix[®]/Cysview[®] Franchise Footprint to over
30 Countries
Oslo, Norway January 26, 2021, Photocure ASA (PHO:OSE): The Bladder Cancer
Company focused on delivering transformative solutions to improve the lives of
bladder cancer patients, announces that it has entered into a partnership
agreement with Asieris MediTech Co., Ltd. (Asieris), a division of Jiangsu
Yahong Meditech Co., Ltd., whereby Asieris has obtained exclusive rights to
register and commercialize Hexvix[®] in Mainland China and Taiwan.
Based on the Agreement, Photocure will receive an upfront payment of USD 750,000
from Asieris for the rights to Hexvix in the designated territories, as well as
payments of up to USD 1.4 million for the achievement of certain regulatory
milestones including market approvals in Mainland China and Taiwan. The Company
will manufacture and supply Hexvix, and receive a transfer price from Asieris
representing a markup on product provided under the Agreement. Photocure will
also receive royalties on product sales.
"Expanding our business geographically is a strategic priority at Photocure, and
we are very pleased to partner with Asieris to commercialize Hexvix in both
Mainland China and Taiwan," said Dan Schneider, President and CEO of Photocure.
"This marks our second strategic agreement with Asieris, a well-run and well
-capitalized company that is executing ahead of plan on the clinical development
of Cevira[®,] which we licensed to them in July 2019. Asieris solely focuses on
the development and commercialization of innovative products in the field of
genitourinary diseases, and we look forward to collaborating with them to bring
the important benefits of Hexvix to patients suffering from bladder cancer in
Mainland China and Taiwan."
Asieris will fund all costs to secure regulatory approvals of Hexvix in Mainland
China and Taiwan, and expects to begin the regulatory processes immediately.
Given the current market approvals of Hexvix/Cysview in both the U.S. and Europe
based on well-documented evidence of safety and efficacy, Asieris plans to
explore regulatory pathways for expedited approvals in Mainland China and
Taiwan. During the regulatory review and approval process for Hexvix, Asieris
plans to initiate launch preparations including reimbursement applications and
collaborations with blue light cystoscopy (BLC[®]) equipment providers. Asieris
is responsible for all costs related to commercialization of Hexvix in the
designated territories. Photocure will provide regulatory dossier information to
support the application and regulatory review process, and will also provide
training to Asieris' employees, global promotional materials, and commercial
support.
"Photocure is a global leader in bladder cancer management, and we are very
excited to add a second product from Photocure to our pipeline. We want to make
this breakthrough technology available to physicians and patients in China as
soon as possible." said Kevin Pan Ph.D., Founder and CEO of Asieris. "Hexvix
adds a great deal of synergy to Asieris' strategic focus on genitourinary
cancers and other diseases. Together with our drug candidates for NMIBC
treatment in the clinical development, Asieris is building up a combination of
potentially the most advanced technologies in order to provide the best care for
NMIBC patients in China."
According to GloboCan, the reported incidence of bladder cancer in Mainland
China is approximately 85 000 new patients annually, which is slightly higher
than that in the U.S., but with a healthcare system that is still developing.
There are significant differences in incidence rates between urban and rural
areas, with access to specialty care mainly available in urban areas. The burden
of bladder cancer in Mainland China is expected to increase in the next few
years according to a study published in Cancer Management and
Research (https://doi.org/10.2147/CMAR.S189220).
Redigert 06.07.2023 kl 12:45
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Star
20.09.2023 kl 15:43
3401
Press Release - Oslo, Norway, September 20, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today that the multinational Cevira[®] Phase III
clinical trial has been completed and successfully met its primary endpoint.
Cevira (APL-1702) is a photodynamic drug-device combination product in
development for the non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), licensed to Asieris by Photocure.
The results of the study will be submitted to the Chinese National Medical
Products Administration (NMPA) as part of a new drug application (NDA) in the
coming months.
This study is a prospective, randomized, double-blind, placebo-controlled
international multicenter Phase III clinical trial designed to evaluate the
efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by
Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences, and has enrolled 402 participants. The
trial met its primary endpoint, together with a robust safety profile.
Comprehensive data from this study will be presented at forthcoming academic
conferences and published in scientific journals.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said "This
milestone marks a significant leap forward in the management of HSIL, with the
potential to transform care in this domain. Moreover, tackling precancerous
cervical conditions is pivotal for early prevention of cervical cancer and is an
integral part of the three-tier cancer prevention system. Asieris
Pharmaceuticals is committed to playing an active role in advancing China's
Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy
China 2030, aligning our efforts with the WHO's global strategy to accelerate
the elimination of cervical cancer."
"It is exciting to see that the Phase III clinical trial for Cevira has met its
primary endpoint. There are many patients globally who can benefit from a non
-surgical approach to treating high-grade squamous intraepithelial lesions
(HSIL). Given the high unmet need and the importance of novel therapies to
improve HSIL clinical outcomes, Photocure will continue to support Asieris, as
our partner advances to the next stages of product development and regulatory
approval," said Anders Neijber, Photocure's Chief Medical Officer.
According to the Global Cancer Statistics 2020, there were 604,127 new cases of
cervical cancer in women, with 341,831 deaths worldwide, ranking it as the
fourth most prevalent malignancy among females.[1] In China, cervical cancer
ranks as the second most common malignancy among women.
The primary cause of cervical cancer is persistent HPV infection, leading to
precancerous cervical lesions. Alarmingly, approximately 20 percent of
individuals with HSIL may progress to invasive cervical cancer within a span of
10 years.[2 ]According to Frost & Sullivan, the number of HSIL patients is
projected to reach 16.6 million globally and 2.2 million in China by 2030.
Read Asieris' full media release here: https://asieris.com/the-first-non-vaccine
-investigational-product-for-cervical-hsil-has-achieved-its-primary-endpoint/
[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al.
Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 ;71(3):209-49.
[2] Expert Committee of Colposcopy and Cervical Pathology Branch (CSCCP) of
Chinese Eugenics Association. Expert consensus on cervical cancer screening and
abnormal management in China (II). Chinese Journal of Obstetrics and Gynecology,
2017, 18(3):286-288. (in Chinese)
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 Cevira[®]
Cevira[®] (APL-1702) is a photodynamic drug-device combination product in
development. Based on the principles of photodynamic therapy, the Cevira product
aims to use a photosensitizer in combination with light activation to produce a
therapeutic effect as a non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), including all human papilloma virus (HPV) sub
-types.
Photocure developed Cevira through Phase I and Phase II trials, and the global
rights for development and commercialization were out-licensed to Asieris
Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III
clinical trial for APL-1702 (Cevira), Clinical trial number:
NCT04484415 (https://classic.clinicaltrials.gov/ct2/show/NCT04484415).
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
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma
company specializing in discovering, developing and commercializing innovative
drugs for the treatment of genitourinary tumors and other related diseases.
For further information, please contact:
Dan Schneider
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has communicated today that the multinational Cevira[®] Phase III
clinical trial has been completed and successfully met its primary endpoint.
Cevira (APL-1702) is a photodynamic drug-device combination product in
development for the non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), licensed to Asieris by Photocure.
The results of the study will be submitted to the Chinese National Medical
Products Administration (NMPA) as part of a new drug application (NDA) in the
coming months.
This study is a prospective, randomized, double-blind, placebo-controlled
international multicenter Phase III clinical trial designed to evaluate the
efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by
Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences, and has enrolled 402 participants. The
trial met its primary endpoint, together with a robust safety profile.
Comprehensive data from this study will be presented at forthcoming academic
conferences and published in scientific journals.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said "This
milestone marks a significant leap forward in the management of HSIL, with the
potential to transform care in this domain. Moreover, tackling precancerous
cervical conditions is pivotal for early prevention of cervical cancer and is an
integral part of the three-tier cancer prevention system. Asieris
Pharmaceuticals is committed to playing an active role in advancing China's
Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy
China 2030, aligning our efforts with the WHO's global strategy to accelerate
the elimination of cervical cancer."
"It is exciting to see that the Phase III clinical trial for Cevira has met its
primary endpoint. There are many patients globally who can benefit from a non
-surgical approach to treating high-grade squamous intraepithelial lesions
(HSIL). Given the high unmet need and the importance of novel therapies to
improve HSIL clinical outcomes, Photocure will continue to support Asieris, as
our partner advances to the next stages of product development and regulatory
approval," said Anders Neijber, Photocure's Chief Medical Officer.
According to the Global Cancer Statistics 2020, there were 604,127 new cases of
cervical cancer in women, with 341,831 deaths worldwide, ranking it as the
fourth most prevalent malignancy among females.[1] In China, cervical cancer
ranks as the second most common malignancy among women.
The primary cause of cervical cancer is persistent HPV infection, leading to
precancerous cervical lesions. Alarmingly, approximately 20 percent of
individuals with HSIL may progress to invasive cervical cancer within a span of
10 years.[2 ]According to Frost & Sullivan, the number of HSIL patients is
projected to reach 16.6 million globally and 2.2 million in China by 2030.
Read Asieris' full media release here: https://asieris.com/the-first-non-vaccine
-investigational-product-for-cervical-hsil-has-achieved-its-primary-endpoint/
[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al.
Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 ;71(3):209-49.
[2] Expert Committee of Colposcopy and Cervical Pathology Branch (CSCCP) of
Chinese Eugenics Association. Expert consensus on cervical cancer screening and
abnormal management in China (II). Chinese Journal of Obstetrics and Gynecology,
2017, 18(3):286-288. (in Chinese)
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 Cevira[®]
Cevira[®] (APL-1702) is a photodynamic drug-device combination product in
development. Based on the principles of photodynamic therapy, the Cevira product
aims to use a photosensitizer in combination with light activation to produce a
therapeutic effect as a non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), including all human papilloma virus (HPV) sub
-types.
Photocure developed Cevira through Phase I and Phase II trials, and the global
rights for development and commercialization were out-licensed to Asieris
Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III
clinical trial for APL-1702 (Cevira), Clinical trial number:
NCT04484415 (https://classic.clinicaltrials.gov/ct2/show/NCT04484415).
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
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma
company specializing in discovering, developing and commercializing innovative
drugs for the treatment of genitourinary tumors and other related diseases.
For further information, please contact:
Dan Schneider
skadi
20.09.2023 kl 16:52
3219
Hi Merlin, finnes det en milestone angående Hexvix som utløser engangsbetaling til Photocure på 60 millioner dollar?
Merlin
20.09.2023 kl 18:40
3029
Under the License Agreement with Asieris, Photocure
previously received a signing fee of USD 5.0 million
in 2019, two milestones totaling USD 3.0 million in
2020 and two milestones totaling USD 2.0 million in
2022. In Q2 2023, the Company received a USD 2.5
million milestone payment for the Cevira
development program. In addition, the Company
may receive a total of USD 15 million based upon the
achievement of certain clinical and regulatory
milestones in China, and up to USD 33.5 million for
certain clinical and regulatory milestones in the U.S.
and the EU, as well as contractual time-based
milestones. The approval of a second indication in
China, the U.S. and Europe would result in payments
of up to USD 14.0 million. Royalties on sales between
10% and 20% will apply in all markets, as well as
sales milestones up to USD 100 million on global
revenues.
https://cms.photocure.com/uploads/PHO_Q2_ER_54b8ea0e28.pdf
previously received a signing fee of USD 5.0 million
in 2019, two milestones totaling USD 3.0 million in
2020 and two milestones totaling USD 2.0 million in
2022. In Q2 2023, the Company received a USD 2.5
million milestone payment for the Cevira
development program. In addition, the Company
may receive a total of USD 15 million based upon the
achievement of certain clinical and regulatory
milestones in China, and up to USD 33.5 million for
certain clinical and regulatory milestones in the U.S.
and the EU, as well as contractual time-based
milestones. The approval of a second indication in
China, the U.S. and Europe would result in payments
of up to USD 14.0 million. Royalties on sales between
10% and 20% will apply in all markets, as well as
sales milestones up to USD 100 million on global
revenues.
https://cms.photocure.com/uploads/PHO_Q2_ER_54b8ea0e28.pdf
SomSa
20.09.2023 kl 22:37
2553
Snart må også komme Cysview data fra Kina-studien. Dette kan sette fyr på aksjen.
SomSa
20.09.2023 kl 23:06
2461
07.07.2023
Asieris Pharmaceuticals har fullført pasientinkluderingen til fase 3-studien på Photocure-legemidlet Hexvix/Cysview.
Studien er en såkalt brostudie, en «bridging trial», som skal bekrefte tidligere forskningsfunn, på den kinesiske befolkningen. Nå er alle pasientene inkludert i studien, melder Photocure.
https://medwatch.no/nyheter/legemidler_biotek/article16273533.ece