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Product Pipeline

Women's Health

Product
Target/Type
Region
Pre-Clinical
IND Enabling
Phase I
Phase II
Pivotal/Phase III
NDA
Marketed
APL-1702 (CEVIRA®)
Photodynamic drug-device combination product
Global
Obtained NMPA approval
China
Cervical high grade squamous intraepithelial lesions (CIN2)   Partner:
EMA Marketing Review & Approval
Europe
Cervical high grade squamous intraepithelial lesions (CIN2)
Plans to submit Phase III clinical trial application to FDA
USA
Cervical high grade squamous intraepithelial lesions (CIN2)
HPV virus clearance indication

Breast Cancer and Gynecological Tumors

Product
Target/Type
Region
Pre-Clinical
IND Enabling
Phase I
Phase II
Pivotal/Phase III
NDA
Marketed
APL-2302
USP1
Global
Ovarian cancer, breast cancer, etc
APL-2501
CLDN6/9(ADC)
Global
Ovarian Cancer, etc
AT-018
Undisclosed
Global
Breast cancer, etc.
AT-021
Undisclosed
Global
Breast cancer and other solid tumors

Urological Diseases

Product
Target/Type
Region
Pre-Clinical
IND Enabling
Phase I
Phase II
Pivotal/Phase III
NDA
Marketed
APL-1706
Photosensitizer
China
NMIBC diagnosis and operation   Partner:
APLD-2304
View Details
Second generation blue light cystoscope
Global
Europe Review
NMIBC diagnosis and operation  
APL-1202
MetAP2
Global
China
NMIBC (First-line monotherapy)
USA, China
Neoadjuvant therapy for MIBC
APL-2401
FGFR2/3
Global
Urological tumors
AT-014
Undisclosed
Global
Urological Tumors
AT-020
Undisclosed
Global
Multiple Solid Tumors

Other Diseases

Product
Target/Type
Region
Pre-Clinical
IND Enabling
Phase I
Phase II
Pivotal/Phase III
NDA
Marketed
APL-1202
MetAP2
Global
China
Free-living Amoebae Infections
APL-1401
DBH
Global
USA, China
Moderately to severely active ulcerative colitis (UC).
APL-2301
Antibiotic
Global
Australia
Acinetobacter baumannii infection

Bladder Cancer

Lack of oral therapy for non-muscle invasive bladder cancer (NMIBC) patients with improved patient compliance and less adverse effects from intravesical administration.

Precancerous Cervical Dysplasia

In urgent need of safe and effective options for patients with cervical precancerous lesions, currently treated by traditional surgical methods.

Single-Use Flexible Cystoscope

Asieris-BL-C001

Intended purpose

The flexible cystoscope with PDD filter is used for endoscopic imaging during diagnosis in
urology. Flexible cystoscope is designed for short-term use in endoscopic interventions
performed through natural orifices.

Product Features:

  • PDD fluorescence imaging: Enables endoscopic imaging during non-muscle invasive bladder carcinoma (NMIBC) diagnostic procedure.
  • Single-use design: Reducing the risk of cross-infection
  • Flexible cystoscope design: Enhancing patient diagnostic comfort
  • Compatible with portable image processor: Used in clinics and hospitals

Technical Specifications:

Sterilization

Method of Sterilization

EO

Operating Environment

Operating Temperature

10°C ~40°C

Relative Humidity

30 %~85% RH, non-condensing

Atmospheric Pressure Limitation

70kPa~106kPa

Storage Environment

Operating Temperature

10°C ~35°C

Relative Humidity

10 %~95% RH, non-condensing

Atmospheric Pressure Limitation

50kPa ~ 106kPa

Clinical Benefits:

Bladder carcinomas can be easily overlooked using conventional cystoscopy on account of
their superficial growth or their minimal expansion. The emission spectrum is tuned of the
photosensitizer used for much stronger tumor fluorescence light sources.

Asieris has designed a blue light cystoscope that, when used with Hexvix®, can diagnose non-muscle invasive bladder carcinoma (NMIBC) to reduce the risk of progression and relapses in NMIBC. Therefore, blue light cystoscopy has the benefit of improving the additional detection of bladder cancer. Tumorous tissue is displayed in fluorescent red. The rest of the bladder wall appears bright and highly-contrasted, and this permits an outstanding overview.

Product photograph

Reporting

If user and/or patient that any serious incidents occur in relation to the device, please inform
manufacturer through the contact information, and report to the competent authority of the
Member State in which the user and/or patient is established.

Disclaimer: The device is under regulatory review and is not approved for sale or use in any country. This information is provided as a mandatory disclosure pursuant to EU MDR requirements and is not for clinical use or commercial promotion.