Sammons Pharma, drawing attention in the global pharmaceutical market for its innovative technology and pipeline, is securing future growth engines by recently announcing key research and development achievements. In particular, through the successful overseas expansion of its biosimilar for macular degeneration treatment and the 'S-PASS' oral drug development platform poised to replace injections, the company is broadening its scope to diabetes, obesity, and even cancer and vaccine fields. We will delve into Sammons Pharma's continuous challenges and achievements aimed at improving patients' quality of life and leading the global healthcare market amidst the rapidly changing pharmaceutical landscape.
One of Sammons Pharma's flagship achievements is the global market expansion of 'SCD411', a biosimilar for the macular degeneration treatment Eylea. SCD411, a biosimilar for a blockbuster drug treating macular degeneration, a major cause of age-related blindness, began overseas shipments starting with Canada in June 2025. Subsequently, it obtained marketing authorization in South Korea and Japan in September 2025 and signed supply and sales agreements in eight European countries, including France, in November 2025, formally entering the European market. Notably, the 'positive opinion' from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has raised expectations for final approval.
In the domestic market, SCD411 has been launched at an aggressive price of 198,000 won, significantly intensifying market competition compared to rival products. This is less than half the price of the original drug, and it is expected to greatly contribute to improving patients' access to treatment. Furthermore, in February 2026, additional supply contracts were signed with six Middle Eastern countries, including Saudi Arabia, further strengthening its global presence. Sammons Pharma aims to secure a high market share in key markets by combining its partner companies' sales networks with its price competitiveness.
Sammons Pharma is not resting on the success of SCD411 and is accelerating the development of a high-dose (8mg) formulation that circumvents the original drug's formulation patent. This high-dose formulation is planned to commence clinical trials in 2026, with full-scale global supply expected from the end of 2028. This is anticipated to be a key driver for securing a competitive edge in the macular degeneration treatment market in the long term and achieving sustained revenue growth. The profits secured through SCD411 are expected to serve as a powerful cash cow, securing the company's future growth engines, including the development of new platform technologies and investment in long-acting injectable facilities.
Sammons Pharma is focusing on developing innovative new drugs that will change the treatment paradigm centered on injections, based on its proprietary oral drug delivery platform technology, 'S-PASS (Smart-Pass)'. The S-PASS technology is designed to allow protein drugs to be absorbed directly into the bloodstream through the portal vein in the intestines without being degraded by stomach acid, aiming to maximize patient convenience. This is considered a highly challenging research area that global pharmaceutical companies have failed to succeed in for decades.
Sammons Pharma has entered full-scale global clinical trials by submitting the Clinical Trial Application (IND) for the European Phase 1/2 study of 'SCD0503', an oral insulin candidate utilizing the S-PASS platform, in March 2026. This trial will be conducted in patients with type 1 diabetes, aiming for an ultra-rapid onset of action (within 15 minutes) comparable to existing injectable drugs. If oral insulin is commercialized, it is expected to be a 'game-changer' in diabetes treatment by significantly reducing the pain and inconvenience for diabetic patients who must take injections for life. Korea Investment & Securities forecasts that if oral insulin is successful, market expansion to type 2 diabetes patients will also be possible within the approximately 40 trillion won global insulin market. Clinical results are expected to be available by the end of 2026. However, concerns remain about the difficult path to commercialization due to high manufacturing costs, low absorption rates, and past failures by other global pharmaceutical companies.
In addition to oral insulin, the S-PASS platform is also being utilized for the development of oral GLP-1 treatments for obesity and diabetes. Sammons Pharma is developing an oral GLP-1 pipeline based on semaglutide and signed a joint development and commercialization agreement with Daiichi Sankyo Espa in Japan in January 2026. Furthermore, negotiations with US and North American partners are in the final stages, with discussions involving upfront payments larger than the European agreement and exceptional profit-sharing terms, generating high expectations. The S-PASS technology is evaluated as a proprietary formulation technology that can circumvent the patents of original drugs, and it will play a crucial role in securing Sammons Pharma's exclusive position in the massive obesity and diabetes markets.
In addition to ophthalmic biosimilars and its oral platform, Sammons Pharma is diversifying its future growth engines by strengthening its long-acting injectable (LAI) pipeline. Since development began in 2017, the company has secured a total of four pipelines: two microsphere-based and two liposome-based long-acting injectables. These pipelines are expected to become important therapeutic options in various disease areas by improving patient compliance and administration convenience.
Among the microsphere-based pipelines, the one-month formulation of octreotide for acromegaly treatment is in the final stages of clinical trials, with plans to submit a marketing authorization application to the US Food and Drug Administration (FDA) in 2026. Contracts for the US and Canadian markets have already been signed. Additionally, the prostate cancer treatment leuprolide has demonstrated equivalence to the original drug with various administration cycle formulations, including one-month, three-month, four-month, and six-month options. For the liposome-based anticancer and fungal infection treatment pipelines, negotiations for technology transfer agreements with global partners are underway. These long-acting injectables will offer innovative therapeutic alternatives in chronic and severe disease areas where injection frequency is critical.
Sammons Pharma's S-PASS platform technology demonstrates potential for expansion beyond diabetes and obesity treatments into the fields of anticancer drugs and vaccines. Currently, research on converting injectable protein anticancer drugs into oral formulations is yielding significant preclinical data, holding the potential to dramatically improve patient convenience by transforming existing injectable protein anticancer drugs into oral medications. This boundless expandability of S-PASS technology will be a key driver for Sammons Pharma to evolve from a mere pharmaceutical company into a global 'bio-platform tech' enterprise. The company aims to achieve 205 billion won in operating profit by 2028 and establish itself as a top-tier global platform company.
Sammons Pharma is opening new horizons in the pharmaceutical and biotechnology industry with the successful global market establishment of its macular degeneration treatment 'SCD411' and the development of oral insulin and GLP-1 treatments through its innovative 'S-PASS' platform. Its diversified R&D strategy, including strengthening the long-acting injectable pipeline and expanding the S-PASS technology into anticancer drugs and vaccines, will drive Sammons Pharma's sustainable growth. While uncertainties inherent in new drug development and market expectations pose challenges, Sammons Pharma's unique technological prowess and unwavering commitment to innovation will significantly contribute to elevating the status of Korean bio-companies in the global healthcare market. We look forward to the innovative treatments Sammons Pharma will introduce in the future bringing positive changes to the lives of patients worldwide.
Q1: What are Sammons Pharma's main new drug pipelines?
A1: Sammons Pharma's main pipelines include the biosimilar for macular degeneration treatment 'SCD411', oral insulin (SCD0503) and oral GLP-1 obesity/diabetes treatments based on the proprietary S-PASS platform, and various long-acting injectables (for acromegaly, prostate cancer, etc.).
Q2: What are the characteristics of the S-PASS platform technology?
A2: S-PASS is a proprietary drug delivery platform that converts injectable protein drugs into oral formulations. It is designed to protect drugs from stomach acid and allow direct absorption into the bloodstream via the portal vein in the intestines, thereby overcoming the inconvenience of existing injections and maximizing patient convenience.
Q3: What is the status of the global market entry for the macular degeneration treatment SCD411?
A3: SCD411 began its first export to Canada in June 2025, followed by marketing authorization in South Korea and Japan in September. In November, supply agreements were signed with eight European countries including France, and in February 2026, additional agreements were made with six Middle Eastern countries including Saudi Arabia, accelerating its global market expansion.
Q4: What is the outlook for the commercialization of oral insulin development?
A4: Sammons Pharma entered European Phase 1/2 clinical trials in March 2026 and aims to obtain clinical results by the end of the year. If successful, it could bring revolutionary changes to diabetes treatment, but challenges remain for commercialization, including high manufacturing costs due to low absorption rates and a limited initial market (type 1 diabetes focus).
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