Asieris' diagnostic and postoperative monitoring drug Hikewei was approved by CDE to be included in the clinical real-world data application pilot

Asieris Pharmaceuticals (stock code: 688176.
SH), a global innovative company focusing on urogenital tumors, recently announced that the Hainan Provincial Food and Drug Administration, based on the opinions of the Center for Drug Evaluation (CDE) of the State Drug Administration of China, has The drug Hexvix for bladder cancer diagnosis and postoperative monitoring was included in the pilot application of real-world data in drug clinical practice
.
Hikeway became the ninth drug pilot variety to carry out real-world data research on drug clinical trials
.
According to the latest global cancer data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020, bladder cancer is one of the ten most common cancers in the world
.
According to Frost & Sullivan, in China, the number of new bladder cancer patients reached 86,000 in 2020, and is expected to increase to 101,000 by 2025, with a compound growth rate of 3.
4% during the period
.
At the same time, because the life cycle of bladder cancer patients can be as long as 7.
5 years [1], it is estimated that there will be more than 600,000 bladder cancer patients in China in 2020
.
According to data from Frost & Sullivan, bladder cancer patients have a longer survival period and a high recurrence rate.
Taking NMIBC, which accounts for 75%, as an example, the recurrence rate of NMIBC patients within five years after transurethral resection of bladder tumor (TURBT) is approximately 60%, the 5-year risk of recurrence in high-risk NMIBC is even as high as 80%, and the risk of progression is as high as 50%
.
Patients need to undergo multiple surgical treatments and long-term drug treatment, and at the same time, with frequent and long-term cystoscopy follow-up examinations for good prognosis management
.
Studies have shown that compared with white light cystoscopy, the combined use of Hikewei® and blue light cystoscopy can significantly increase the detection rate of bladder papillary carcinoma by 24.
9%, including 20.
7% for primary patients and 27.
7% for recurrent patients.

.
Not only that, due to the flat shape of bladder carcinoma in situ (CIS), it is difficult to observe directly through white light microscope.
The use of Hackway® combined with blue light cystoscope can increase the detection rate of CIS by 26.
7%, among which the increase of 28.
0% for primary patients.
%, increased by 25.
0 % for relapsed patients[2]
.
Another study showed that the recurrence rate of patients treated with Hikewei® and blue light cystoscopy was reduced by 16% compared with white light surgery [3]
.
Hackway® is approved in the US and many European countries
.
The combined use of Hikeway® and blue light cystoscopy as a method for the management of NMIBC has been included in the global expert consensus guidelines and the Chinese guidelines for the diagnosis and treatment of urology and andrology
.
In January 2021, Asieris signed a "Distribution Agreement" with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialist company located in Oslo, Norway, and obtained the exclusive registration and commercialization of Hikeway® in mainland China and Taiwan.
rights
.
In December 2021, Hikewei® took the lead in landing in Hainan Boao Lecheng International Medical Tourism Pilot Zone, and issued China's first prescription in Hainan Provincial People's Hospital, successfully completing the first patient operation
.
Yong Xue, MD, Chief Medical Officer of Asieris, said: "Real-world data is playing an increasingly important role in clinical research, and this project is expected to accelerate the clinical development and registration process of Hikeway®, so that patients can receive appropriate treatment
.
[1].
Martine Ploeg Katja KH Aben Lambertus A.
Kiemeney: The present and future burden of urinary bladder cancer in the world, World J Urol (2009) 27:289–293; No.
of Pages 291 [2].
Maximilian Burger et al.
Photodynamic Diagnosis of Non–muscle-invasive Bladder Cancer with Hexaminolevulinate Cystoscopy: A meta-analysis of Detection and Recurrencebased on Raw data, EURURO-5062; No.
of Pages 9 [3].
Arnulf Stenz et al.
Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients With Non-muscle Invasive Bladder Cancer, The Journal of Urology Vol.
184, 1907-1914, November 2010