HLK Pharmaceuticals
HLK Pharma, established in 2016, is an innovative pharmaceutical company focused on high-end formulation research and development. With a core team of renowned scientists and experts from the US, the company specializes in the development and industrialization of differentiated 'innovative drugs + modified innovative drugs'. It leverages advanced platform technologies and a cross-border development platform to create best-in-class new drugs, aiming to improve patient outcomes and promote health globally. The company emphasizes clinical needs and technological innovation, with a strong technical advantage in poorly soluble drug oral formulations, and aims to develop international standards of new drugs and reformulated drugs in fields such as oncology, neurological, immune, and allergic diseases.
Industries
Nr. of Employees
small (1-50)
HLK Pharmaceuticals
Products
Clinical-stage formulation-enabled drug candidates
A portfolio of internally developed and partnered drug candidates across oncology, neurology, immunology and allergy that have been advanced using formulation platforms to clinical stages.
Clinical-stage formulation-enabled drug candidates
A portfolio of internally developed and partnered drug candidates across oncology, neurology, immunology and allergy that have been advanced using formulation platforms to clinical stages.
Services
Formulation development (preclinical to clinical)
End-to-end formulation services including preformulation, prototype development, biopharmaceutics optimization and scale-up for clinical supply.
CMC development and technology transfer
CMC strategy development, process optimization and technology transfer to manufacturing partners for clinical and commercial production.
Novel delivery system development (peptides, oligonucleotides, conjugates)
Design and development of delivery strategies for peptides, siRNA/oligonucleotides and conjugated small molecules across multiple administration routes.
Regulatory strategy and filing support (including 505(b)(2))
Regulatory planning and support for filings aligned to US and China standards, including development strategies suitable for 505(b)(2) pathway submissions.
Technology licensing and partnering
Licensing of formulation platforms and partnership development for CMC projects and commercialization in APAC/global markets.
Preclinical ADME and DDI assessment support
Support for pharmacokinetics, drug metabolism and drug–drug interaction studies, including microbiome-related disposition assessment to guide development decisions.
Formulation development (preclinical to clinical)
End-to-end formulation services including preformulation, prototype development, biopharmaceutics optimization and scale-up for clinical supply.
CMC development and technology transfer
CMC strategy development, process optimization and technology transfer to manufacturing partners for clinical and commercial production.
Novel delivery system development (peptides, oligonucleotides, conjugates)
Design and development of delivery strategies for peptides, siRNA/oligonucleotides and conjugated small molecules across multiple administration routes.
Regulatory strategy and filing support (including 505(b)(2))
Regulatory planning and support for filings aligned to US and China standards, including development strategies suitable for 505(b)(2) pathway submissions.
Technology licensing and partnering
Licensing of formulation platforms and partnership development for CMC projects and commercialization in APAC/global markets.
Preclinical ADME and DDI assessment support
Support for pharmacokinetics, drug metabolism and drug–drug interaction studies, including microbiome-related disposition assessment to guide development decisions.
Expertise Areas
- Formulation development for poorly soluble drugs
- Oral drug delivery and lipid-based delivery systems
- Controlled-release and modified-release formulations
- Delivery technologies for peptides and oligonucleotides
Key Technologies
- Spray-drying for amorphous solid dispersions
- Hot-melt extrusion
- Self-emulsifying drug delivery systems (SEDDS)
- Nano-milling / nanogrinding