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【South Korea】Samchundang Pharm Targets Global Expansion with Biosimilars and Oral Drug Delivery Platform

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Editor's note

This report highlights Samchundang Pharm's biosimilar and oral drug delivery platforms, with sourcing signals from signed contracts across the US, Europe, and Asia. Buyers should note the regulatory reliance on 505(b)(2) pathways for oral tirzepatide and the supply-chain risk of patent-dependent market entry timelines.

Samchundang Pharm is accelerating its global market expansion by commercializing its biosimilar pipeline and proprietary drug delivery platforms, including the S-PASS oral conversion technology for injectable drugs. The company aims to secure overseas partnerships and diversify its portfolio, offering new sourcing opportunities for medical aesthetics and pharmaceutical buyers interested in advanced injectable-to-oral alternatives.

Commercial Biosimilar Pipeline

The core commercial product is the Eylea biosimilar SCD411, already sold in Canada, Europe, and South Korea. Contracts have been signed for the US, Europe, Japan, Canada, MENA, and LATAM regions. The low-dose 2mg version has generated revenue in Canada, while the high-dose 8mg version is under development. Samchundang plans a three-tier entry into the anti-VEGF market: low-dose Eylea (launched 2025), high-dose Eylea (target 2029), and Vabysmo biosimilar (target 2033), subject to patent and market conditions.

S-PASS Oral Drug Delivery Platform

The S-PASS platform converts injectable drugs into oral formulations, targeting oral insulin, oral GLP-1, and oral antibody drugs. Samchundang estimates the addressable market for oral insulin at $30 billion and oral GLP-1 at $141 billion. Oral insulin is entering global Phase 1 trials for type 1 diabetes, with a planned approval date of May 28, 2026. Development milestones include Phase 1 in 2026, Phase 2 for type 1/2 diabetes in 2027, Phase 3 entry in 2028, and completion in 2029.

Oral Semaglutide and Tirzepatide Pipelines

Oral semaglutide (SCD0509) completed bioequivalence studies in 2025, with sales targets set for Canada and emerging markets in 2027, South Korea in 2029, and the US, Europe, and Japan in 2031. Oral tirzepatide is scheduled for non-clinical validation in Q2 2026, followed by human pilot studies and clinical contract in Q4 2026, with formal clinical trial applications in 2027. The company plans to leverage 505(b)(2) regulatory pathways using existing safety and efficacy data for injectable tirzepatide.

Long-Acting Injectable and Subcutaneous Conversion Platforms

Samchundang's long-acting injectable platform targets products like octreotide LAR and leuprolide depot, with a market size estimated at $6.4 billion. The subcutaneous conversion platform focuses on converting intravenous formulations of Keytruda and Opdivo to subcutaneous versions, using rHuPH20 technology. Global partnerships for this platform are under discussion, with updates to be disclosed upon confirmation.

What Buyers Should Watch

For medical aesthetics and pharmaceutical buyers, Samchundang's S-PASS platform offers potential for oral alternatives to injectable GLP-1 drugs, which are increasingly used in aesthetic weight management. The company's biosimilar SCD411 provides a cost-effective option for anti-VEGF treatments in ophthalmology, relevant for clinics offering aesthetic eye care. Partnerships with established distributors like Apotex (Canada) and Fresenius Kabi (US) signal reliable supply chains. Buyers should monitor regulatory approvals and patent expirations, particularly for high-dose Eylea and Vabysmo biosimilars, to time procurement decisions.

Source: Read the original report | Published: June 15, 2026