Non-Clinical Safety Evaluation (Toxicology)_Breath Smooth Biotech Hangzhou CO.,LTD.

Non-Clinical Safety Evaluation (Toxicology)

Local Toxicity Study
Single-Dose and Repeat-Dose Toxicity Studies
Safety Pharmacology Studies
Toxicokinetics (TK) Study
Reproductive Toxicity Study
Genotoxicity Study
Immunogenicity and Immunotoxicity Studies

Some Evaluated Products Received Clinical Trial Approvals/Production Approvals

MDI
DPI
Neb
Spray

Mometasone Formoterol inhalation Aerosol
Budesonide Formoterol Inhalation Aerosol
Budesonide Inhalation Aerosol
Bencycloquidium Bromide Inhalation Aerosol
Ipratropium Bromide Inhalation Aerosol
101BHG-D01 Inhalation Aerosol

Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation
Tiotropium Bromide Powder for Inhalation
Salbutamol Sulfate Powder for Inhalation
Glycopyrronium Bromide Powder for Inhalation
Indacaterol and Glycopyrronium Bromide Powder for Inhalation
Aclidinium Bromide Powder for Inhalation
HRG2005 Powder for Inhalation
Ciclesonide and Formoterol Powder for Inhalation
Indacaterol Maleate Powder for Inhalation

Fluticasone Propionate Inhalation Suspension
Ambroxol Hydrochloride Solution for Inhalation
Compound Ipratropium Bromide Solution for Inhalation
Salbutamol Sulfate Inhalation Solution
Levalbuterol Hydrochloride Nebuliser Solution
Terbutaline Sulfate Nebuliser Solution
Ipratropium Bromide Solution for Inhalation
Budesonide Suspension for Inhalation
Tobramycin Inhalation Solution
Formoterol Fumarate Inhalation Solution
Levalbuterol Hydrochloride/Ipratropium Bromide Inhalation Solution
Acetylcysteine Inhalation Solution
XYP-001
B4 Inhalation Solution
Revefenacin Inhalation Solution

Fluticasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray
Budesonide Nasal Spray
Fluticasone propionate Nasal spray
101BHG-D01 Nasal Spray

Achievements

19
clinical trial approvals

clinical trial approvals

19 products successfully obtained CTAs based on our local toxicity testing.
14
production approvals

production approvals

14 products received production approvals supported by our local toxicity data.
4
Completed full-set inhalation toxicology studies for Category 1 innovative drugs

Completed full-set inhalation toxicology studies for Category 1 innovative drugs

Performed 4 complete long-term toxicity programs (both rodent and non-rodent models), single-dose and repeat-dose toxicity studies, safety pharmacology evaluations, toxicokinetic (TK) assessments
9M
Comprehensive inhalation long-term toxicity studies

Comprehensive inhalation long-term toxicity studies

Conducted inhalation long-term toxicity studies (including 6-month and 9-month duration studies)

Hangzhou Medical College Safety Evaluation Research Center

Hangzhou Medical College Safety Evaluation Research Center (National Zhejiang New Drug Safety Evaluation Center | Zhejiang Academy of Medical Sciences Safety Evaluation Center | Zhejiang Key Laboratory of Drug Safety Evaluation Technology), established in 1997. As one of China's first five GLP centers certified GLP certification from CNAS and full accreditation by AAALAC International.

Expert Team

• 3 CDE (Center for Drug Evaluation) review experts from NMPA

• 1 senior GLP certification inspector from NMPA

• 1 health food evaluation expert from SAMR

• 1 member of China Expert Working Group for ICH Guidelines

• 1 CNAS GLP technical expert, 1 CNAS laboratory accreditation assessor

• 10+ drug evaluation/inspection experts for Zhejiang Province

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Breath Smooth Biotech Hangzhou CO.,LTD.