HLK Pharmacin
Pharmacin is dedicated to improving patient outcomes by developing best-in-class therapeutics using innovative technology. Founded in 2016 and headquartered in Shenzhen, China, with subsidiaries in Suzhou, China, and New Haven, Connecticut, USA, the company focuses on fast, cost-effective drug development, including reformulation and repurposing of existing drugs. Their global strategy emphasizes unmet medical needs across therapeutic areas such as oncology, cardiovascular, immunology, and allergy.
Industries
Nr. of Employees
small (1-50)
HLK Pharmacin
470 James Street, Suite 007, New Haven, CT 06513 USA
Products
Lead 505(b)(2) reformulated oncology/hematology product (clinical-stage)
A reformulated therapeutic developed via the 505(b)(2) regulatory pathway; clinical development completed to IND clearance with plans toward NDA filing.
Lead 505(b)(2) reformulated oncology/hematology product (clinical-stage)
A reformulated therapeutic developed via the 505(b)(2) regulatory pathway; clinical development completed to IND clearance with plans toward NDA filing.
Services
Assessment of API solubility, pH profile, polymorphism, stability and developability to inform formulation and CMC strategy.
End-to-end formulation services including conventional oral and parenteral dosage forms and non-conventional approaches such as amorphous solid dispersions and SEDDS.
Process development, scale-up and manufacturing-ready development for clinical and commercial supply, including scalable spray-drying and extrusion processes.
Support for regulatory strategy and preparation of filings including INDs and 505(b)(2) pathway development toward NDA submission.
Stability studies and forced-degradation testing to characterize chemical and physical stability under stress conditions and support shelf-life assignment.
Strategic partnerships, out-licensing of reformulated products, and co-development agreements for international and regional markets.
Assessment of API solubility, pH profile, polymorphism, stability and developability to inform formulation and CMC strategy.
End-to-end formulation services including conventional oral and parenteral dosage forms and non-conventional approaches such as amorphous solid dispersions and SEDDS.
Process development, scale-up and manufacturing-ready development for clinical and commercial supply, including scalable spray-drying and extrusion processes.
Support for regulatory strategy and preparation of filings including INDs and 505(b)(2) pathway development toward NDA submission.
Stability studies and forced-degradation testing to characterize chemical and physical stability under stress conditions and support shelf-life assignment.
Strategic partnerships, out-licensing of reformulated products, and co-development agreements for international and regional markets.
Expertise Areas
- Formulation development for poorly soluble drugs
- Amorphous solid dispersion technologies
- Drug delivery systems (oral, parenteral, buccal, nasal, transdermal)
- Preformulation and solid form selection
Key Technologies
- Spray-drying for amorphous solid dispersions
- Melt extrusion
- Jet milling and nanomilling
- Self-emulsifying drug delivery systems (SEDDS)