Beijing Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharma, recently received the 《Drug Clinical Trial Approval Notice》for SHR-3201 Injection issued by China’s NMPA, for the indication of Alzheimer’s disease (AD).
Medicilon’s support
As a strategic partner of Hengrui Pharma, Medicilon conducted GLP-compliant non-human primate toxicology studies for SHR-3201 Injection. The study data supports clinical trial submissions to NMPA, FDA and OECD, helping this novel candidate advance smoothly into clinical development.
As a strategic partner of Hengrui Pharma, Medicilon conducted GLP-compliant non-human primate toxicology studies for SHR-3201 Injection. The study data supports clinical trial submissions to NMPA, FDA and OECD, helping this novel candidate advance smoothly into clinical development.
Unmet Medical Need for AD Therapies
Breakthrough innovation is urgently needed to tackle AD
AD is a progressive neurodegenerative disorder that gradually impairs patients’ memory, judgment, cognition and learning ability, and represents the leading cause of dementia among the elderly. AD can alter patients’ mood, thinking, behavior, personality, temperament and self-perception, imposing heavy burdens on families and society. Current therapeutic options remain limited worldwide, leaving a substantial unmet clinical need for novel treatments for Alzheimer’s disease.
Targeted Clearance: A Novel Approach to AD
SHR-3201 Injection: Original innovation to address AD
SHR-3201 Injection is an internally discovered AD therapeutic developed by Hengrui Pharma. It targets and removes disease-related biomarkers in the brain to slow cognitive decline. To date, no comparable therapies have been approved for marketing globally.
The clinical approval of SHR-3201 further expands Hengrui Pharma’s pipeline in neurodegenerative diseases. It also validates the successful execution of the company’s original innovation strategy and robust capabilities in new drug R&D.
Platform Capabilities Enabling Preclinical CNS Drug Discovery
Medicilon delivers end-to-end preclinical R&D support for novel central nervous system therapeutics
The development of CNS innovative drugs faces multiple hurdles, including poor blood-brain barrier penetration, complex pharmacodynamic assessment and stringent safety requirements. Medicilon offers systematic, globally compliant preclinical solutions covering pharmacodynamics, pharmacokinetics and safety evaluation for CNS drug candidates. Our core capabilities are outlined below:
- Globally recognized quality system: GLP certifications from NMPA (China), FDA (US), OECD, alongside AAALAC international accreditation.
- Diverse laboratory animal resources: Non-human primates, canines, mice, rats, rabbits, guinea pigs, minipigs and more to support varied toxicology evaluations.
- 60+ CNS disease models: Including depression, convulsion, sedation-hypnosis-anxiety, Parkinson’s disease, pain, dementia, schizophrenia, etc.
- Broad drug modality coverage: Comprehensive evaluation services for small molecules, peptides, antibodies, ADCs, PDCs, nucleic acids, cell therapies and vaccines; as well as gene delivery and viral vector products such as LNPs, AAVs and oncolytic viruses.
- Versatile administration routes: Standard routes including PO and IV, plus specialized routes such as inhalation, intrathecal, ophthalmic, dermal and sublingual delivery.
- NAMs for alternative toxicology: Invested in New Approach Methodologies (NAMs) to deliver advanced, efficient alternatives for toxicology assessment.
- Flexible service models: Standalone study services or full end-to-end packages including toxicology study design, experimental execution, data analysis and IND dossier support.
Medicilon congratulates Hengrui Pharma on the advancement of SHR-3201 Injection into clinical trials. We look forward to smooth clinical progress for this candidate, which may one day bring a new therapeutic option to patients living with Alzheimer’s disease. Moving forward, Medicilon will continue to refine its preclinical R&D service platform, empowering more innovative assets to accelerate their journey from Target to IND.
