[Edaily Reporter Kwon Oh Seok ] SAM CHUN DANG PHARM CO. LTD(000250)SAM CHUN DANG PHARM CO. LTD is drastically restructuring its Japanese business operations for “Eylea,” a treatment for eye diseases, and accelerating its market expansion. By changing its local partner and securing product marketing authorization directly, the company has significantly strengthened its leadership in the business.(Photo courtesy of SAM CHUN DANG PHARM CO. LTD) SAM CHUN DANG PHARM CO. LTD announced on the 2nd that it has signed an exclusive sales and long-term supply agreement in Japan for “SCD411,” a biosimilar of the age-related macular degeneration treatment “Eylea” (active ingredient: aflibercept), with Daiichi Sankyo aespa (hereinafter “DSE”). This agreement follows the mutual termination of the contract with its previous Japanese partner, Senju Pharmaceutical, and the reorganization of the local business rights structure. Going beyond a simple change of sales agent, SAM CHUN DANG PHARM CO. LTD has transitioned to a model where it directly holds the product marketing authorization from Japanese authorities. Under the previous agreement with Senju Pharmaceutical, the local partner was the entity holding the product license; however, under this new agreement with DSE, SAM CHUN DANG PHARM CO. LTD assumes that role. As a result, SAM CHUN DANG PHARM CO. LTD states that it can now actively leverage the marketing capabilities of its local distribution network while gaining the strategic flexibility to respond swiftly to changes in market conditions. Under the terms of the agreement, DSE holds exclusive sales rights in Japan for SCD411 2mg pre-filled syringes (PFS) and vial formulations. SAM CHUN DANG PHARM CO. LTD has already completed the development and approval process for SCD411 in Japan and has obtained product approval in its own name by utilizing the foreign special approval system under the local Act on Pharmaceuticals and Medical Devices. As the Designated Manufacturer and Marketer (D-MAH), DSE will be solely responsible for local distribution, marketing promotions, and maintaining the approval. SAM CHUN DANG PHARM CO. LTD plans to rapidly expand its market share in Japan, focusing on ophthalmologists and major hospitals, by leveraging DSE’s strong sales network. The company intends to accelerate sales growth by ensuring a seamless supply chain from the product’s initial launch. Furthermore, SAM CHUN DANG PHARM CO. LTD is discussing plans to consolidate its partnership with DSE not only for the SCD411 biosimilar but also for its pipeline based on “S-PASS,” its proprietary oral drug delivery platform technology. The aim is to maximize operational efficiency by unifying its business operations in Japan under a single entity and to further solidify the medium- to long-term cooperative relationship. SAM CHUN DANG PHARM CO. LTD official emphasized, “Since we have already secured local approval, we will devote all our efforts to early market establishment and sales expansion by leveraging DSE’s formidable sales capabilities,” adding, “Through strategic cooperation encompassing both biosimilars and the S-PASS platform, we will develop Japan into a key global revenue hub.”
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