Hexyl aminolevulinate hydrochloride

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

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水曜日, 11月 29, 2023

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- 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.

Key Points:

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- 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.
Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
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.

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

Retrieved on:

水曜日, 11月 29, 2023

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- 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.

Key Points:

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- 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.
Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
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.

Photocure Partner Asieris announces completion of enrollment for Hexvix Phase III clinical trial in China

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木曜日, 7月 6, 2023

Chinese Academy of Medical Sciences COVID-19 vaccine, Photocure, Peking Union Medical College Hospital, Medicine, Principal investigator, Clinical trial, NMIBC, Bladder cancer, SSE, National Medical Products Administration, Diagnosis, Hospital, III, NMPA, Safety, Pharmaceutical industry, Hexyl aminolevulinate hydrochloride

OSLO, Norway, July 6, 2023 /PRNewswire/ -- 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.

Key Points:

OSLO, Norway, July 6, 2023 /PRNewswire/ -- 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 clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization.
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.

Photocure Partner Asieris announces completion of enrollment for Hexvix Phase III clinical trial in China

Retrieved on:

木曜日, 7月 6, 2023

OSLO, Norway, July 6, 2023 /PRNewswire/ -- 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.

Key Points:

OSLO, Norway, July 6, 2023 /PRNewswire/ -- 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 clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization.
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.

Photocure ASA: Results for the first quarter of 2023

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水曜日, 5月 10, 2023

BLC, Hexyl aminolevulinate hydrochloride, Bank statement, Cropping system, EBIT, APM, Cevira, Cystoscopy, EBITDA, CEST, CFO, Growth, NOK, Renewable energy, Video game, Photocure

OSLO, Norway, May 10, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO) today reported Hexvix®/Cysview® revenues of NOK 105.9 million in the first quarter of 2023 (Q1 2022: NOK 81.4 million) and EBITDA of minus NOK 1.2 million (NOK -13.9 million).

Key Points:

OSLO, Norway, May 10, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO) today reported Hexvix®/Cysview® revenues of NOK 105.9 million in the first quarter of 2023 (Q1 2022: NOK 81.4 million) and EBITDA of minus NOK 1.2 million (NOK -13.9 million).
"Photocure delivered strong results in the first quarter of 2023, with revenue in both our North America and European territories rebounding significantly from the unusually soft fourth quarter last year.
Typically, the first quarter is seasonally lower than the preceding fourth quarter, however the recent pattern is indicative of unusual circumstances," says Dan Schneider, President & Chief Executive Officer of Photocure.
"In the U.S., we achieved a record first quarter with each month of Q1 2023 marking a new historic high.

Photocure ASA: Results for the first quarter of 2023

Retrieved on:

水曜日, 5月 10, 2023

BLC, Hexyl aminolevulinate hydrochloride, Bank statement, Cropping system, EBIT, APM, Cevira, Cystoscopy, EBITDA, CEST, CFO, Growth, NOK, Renewable energy, Video game, Photocure

OSLO, Norway, May 10, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO) today reported Hexvix®/Cysview® revenues of NOK 105.9 million in the first quarter of 2023 (Q1 2022: NOK 81.4 million) and EBITDA of minus NOK 1.2 million (NOK -13.9 million).

Key Points:

OSLO, Norway, May 10, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO) today reported Hexvix®/Cysview® revenues of NOK 105.9 million in the first quarter of 2023 (Q1 2022: NOK 81.4 million) and EBITDA of minus NOK 1.2 million (NOK -13.9 million).
"Photocure delivered strong results in the first quarter of 2023, with revenue in both our North America and European territories rebounding significantly from the unusually soft fourth quarter last year.
Typically, the first quarter is seasonally lower than the preceding fourth quarter, however the recent pattern is indicative of unusual circumstances," says Dan Schneider, President & Chief Executive Officer of Photocure.
"In the U.S., we achieved a record first quarter with each month of Q1 2023 marking a new historic high.

Photocure: Nordic registry clinical data and multiple scientific programs at AUA 2023 Congress reinforce the benefits of Blue Light Cystoscopy

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火曜日, 5月 2, 2023

This Nordic Registry study, which is supported by Photocure, included data from 319 patients and 436 Blue Light Flexible Cystoscopies performed in the surveillance of NMIBC.

Key Points:

This Nordic Registry study, which is supported by Photocure, included data from 319 patients and 436 Blue Light Flexible Cystoscopies performed in the surveillance of NMIBC.
The study results showed that flexible blue light cystoscopy with Hexvix®/Cysview®, as an adjunct to white light cystoscopy for surveillance of NMIBC, improves the detection of malignant lesions.
In the study, biopsies were taken from 452 lesions, showing malignancy in 126/409 (31%) lesions positive for blue light.
In 86 of the cystoscopies (20%), lesions were identified only by blue light.

Photocure: Nordic registry clinical data and multiple scientific programs at AUA 2023 Congress reinforce the benefits of Blue Light Cystoscopy

Retrieved on:

火曜日, 5月 2, 2023

This Nordic Registry study, which is supported by Photocure, included data from 319 patients and 436 Blue Light Flexible Cystoscopies performed in the surveillance of NMIBC.

Key Points:

This Nordic Registry study, which is supported by Photocure, included data from 319 patients and 436 Blue Light Flexible Cystoscopies performed in the surveillance of NMIBC.
The study results showed that flexible blue light cystoscopy with Hexvix®/Cysview®, as an adjunct to white light cystoscopy for surveillance of NMIBC, improves the detection of malignant lesions.
In the study, biopsies were taken from 452 lesions, showing malignancy in 126/409 (31%) lesions positive for blue light.
In 86 of the cystoscopies (20%), lesions were identified only by blue light.

Asieris' subsidiary makes significant progress in its commercialization strategy by obtaining the "Drug Distribution License"

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月曜日, 4月 10, 2023

Bladder cancer, Marketing, Certification, Acquisition, Patient, Diagnosis, Nishimoto Trading Co., Ltd., GSP, Pharmaceutical industry, Hexyl aminolevulinate hydrochloride

Hainan Asieris' acquisition of the Drug Distribution Licence is a critical step towards improvement in the quality of drug circulation services, standardizing and normalizing management, and promoting future drug imports and distribution.

Key Points:

Hainan Asieris' acquisition of the Drug Distribution Licence is a critical step towards improvement in the quality of drug circulation services, standardizing and normalizing management, and promoting future drug imports and distribution.
This is expected to enhance the quality and brand value of the company's products, and strengthen market competitiveness.
"We will also continue to improve our service level, promote our commercialization strategy, and provide patients with higher quality medical services and more competitive drug products.
Among them, Hexvix was listed in the special drug catalogue of the 2022 Lecheng Global Special Drug Insurance document.

Photocure: CMS improves Medicare reimbursement for Blue Light Cystoscopy with Cysview and expands access in the surveillance setting

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月曜日, 11月 7, 2022

In the HOPD setting, CMS for the first time has made a complexity adjustment for CPT 52000 (cystoscopy) and will maintain the current adjustment for CPT 52204 (cystoscopy + biopsy).

Key Points:

In the HOPD setting, CMS for the first time has made a complexity adjustment for CPT 52000 (cystoscopy) and will maintain the current adjustment for CPT 52204 (cystoscopy + biopsy).
The new Medicare reimbursement changes increase payment from $587.56 to $1,854.88 for CPT 52000 (cystoscopy) and from $3,140.04 to $3,205.12 for CPT 52204 (cystoscopy + biopsy) in the HOPD site of care.
The improved reimbursement is expected to increase patient access to blue light cystoscopy in the surveillance setting."
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC).