About Us ∣ SINEW PHARMA INC.

About Sinew

SINEW PHARMA INC. (stock code: 6634.TWO), founded in June 2014, is a publicly-listed biotech company dedicated on the development of therapeutic products for solving urgent and important unmet medical needs.

Leveraging its expertise in three core technologies of "In vitro Co-culture Hepatic Cellular Models," "Hepatic Metabolic Enzyme Activity Regulation Models" and "Pharmacokinetic-driven New Drug Development System”, SINEW is focused on two main disease areas:

Metabolic dysfunction–associated steatohepatitis (MASH) and its associated conditions, such as liver cirrhosis and liver cancer.
Acetaminophen-induced hepatotoxicity and severe liver injury.

Driven by the demands in these disease areas, SINEW aspires to become a leading pharmaceutical company by actively engaging in R&D for MASH drug development as well as for the world's first new acetaminophen with high liver safety.

Current pipeline includes six products, two of which are dedicated to MASH treatment, three aim to address liver toxicity issues arising from the widely used painkiller acetaminophen and its combinations, and one serves as an antidote for acetaminophen overdose.

Company Strategy

R&D

R&D strategy

Manufacturing

Manufacturing strategy

Marketing

Marketing strategy

R&D strategy

SINEW not only leverages its expertise in three core technologies — "In vitro Co-culture Hepatic Cellular Models," "Hepatic Metabolic Enzyme Activity Regulation Models" and "Pharmacokinetic-driven New Drug Development System”— but also conducts thorough drug optimization for absorption, distribution, metabolism, and excretion. This process involves a comprehensive screening approach that spans in vitro, in vivo, toxicology, and clinical studies.

SINEW is adopting a comparable strategy as other pharmaceutical companies of concurrently developing several new drugs for MASH. This includes the development of SNP-610, a drug featuring an innovative combination of active ingredients for a new indication, as well as SNP-630, a new chemical entity (NCE). The rationale is to increase the probability of success for MASH drug development, as it is not yet confirmed whether the development of a single-target drug can completely cure MASH, a disease with complex etiology. Up until now, no drug has been approved globally for this condition.

In the area of non-hepatotoxic acetaminophen, SNP-810 has been successfully navigated robust animal testing designs, overcoming developmental and regulatory obstacles with favorable scientific data. The drug product quality (CMC) of SNP-810 has been recognized after obtaining approval as a generic drug in Taiwan and OTC monograph in the United States. This strategic approach, characterized by cost effectiveness and risk mitigation, has positioned SINEW with a competitive advantage, to choosing the most favorable path for attaining international pharmaceutical registrations.

Manufacturing strategy

SINEW is directing its efforts toward the R&D of drug development, and the responsibility for drug supply and production has been entrusted to contract development and manufacturing organizations (CDMOs) that is compliant to current Good Manufacturing Practice (cGMP) standards and applicable regulatory and statutory requirements.

Marketing strategy

SINEW is actively exploring partnerships for licensing, co-development and strategic alliance. Meanwhile, our patent strategy ensures the secure protection of pipeline assets, and we are open to discussions regarding intellectual property transfer. SINEW is also seeking experienced partners for regional regulatory application, pharmaceutical marketing and channel distribution to enable market and patient accessibility.