In an interview with Edaily and through written responses following a meeting at “BIO JAPAN 2026,” held in Yokohama, Japan, from the 7th to the 9th, Chugai Pharmaceutical stated, “We established a Korean subsidiary to build a system capable of handling all activities—from obtaining approval to commercialization—for innovative medicines created through the company’s proprietary new drug development capabilities,” and “We plan to review future commercialization strategies on a product-by-product basis.”
Chugai Pharmaceutical has previously conducted its business in Korea by granting product development and sales rights to local partners. However, once it establishes its Korean subsidiary (Chugai Pharma Korea) on the 2nd of next month, the company will be able to handle the entire process—from drug approval to direct sales—independently.
JWPHARMACEUTICAL: Decades of Collaboration… Existing Relationship to Be “Maintained”JWPHARMACEUTICAL and Chugai Pharmaceutical are well-known for
their long-standing collaborative relationship, built on deep ties and trust between the two companies’ founding families. In 1972, JWPHARMACEUTICAL successfully commercialized the gastric ulcer treatment “Arusarumin” in Korea using technology licensed from Chugai Pharmaceutical, and in 1974, it exported the basic intravenous solution “5% fructose solution” to Japan through Chugai Pharmaceutical.
The two companies expanded their relationship through research and development collaboration by jointly establishing the C&C New Drug Research Institute in 1992. Although JWPHARMACEUTICAL acquired Jukai Pharmaceutical’s stake in 2019, making C&C a wholly-owned subsidiary, the two companies’ business collaboration has continued.
Hemlibra is another flagship product that exemplifies the two companies’ long-standing partnership. JWPHARMACEUTICAL secured exclusive domestic sales rights for Hemlibra from Chugai Pharmaceutical in 2017 and received domestic approval in 2019. Since then, as the scope of coverage under the National Health Insurance has expanded, the range of use for Hemlibra among patients with hemophilia A in Korea has also broadened.
Consequently, following Chugai Pharmaceutical’s announcement of the establishment of its Korean subsidiary, attention focused on how the Hemlibra sales rights and the partnership with JWPHARMACEUTICAL would be maintained. Some expressed concerns that Chugai Pharmaceutical might reclaim the exclusive domestic sales rights to Hemlibra in order to handle sales directly through its Korean subsidiary.
In response, a representative from JuGa-i Pharmaceutical stated, “We plan to maintain our existing partnerships for products currently sold in Korea,” adding, “We have no further details to share at this time regarding the terms of individual contracts.” This implies that there are no immediate plans to change the collaborative structure for existing products.
However, the company added, “We plan to review future collaboration methods on a product-by-product basis,” leaving open the possibility of adopting different sales strategies for each product. This means that while the company will continue its collaboration with JWPHARMACEUTICAL on existing products, for new pipeline products, it may choose the most appropriate approach—either direct sales or partnership collaboration—depending on the product’s characteristics and market conditions.
NXT007 and Spasentan in the Spotlight… A Test of the Korean Subsidiary’s CapabilitiesIn this context, the follow-up pipeline products for which
theKorean
subsidiarycould directly handle the entire process—from approval to sales—include “NXT007,” a candidate treatment for hemophilia A, and “Spasentan,” a treatment for immunoglobulin A (IgA) nephropathy.
Regarding its pipeline, Jujae Pharmaceutical stated, “We currently have no information to share regarding development plans or approval timelines in Korea,” but added, “The Korean subsidiary was established to build the regulatory and commercialization capabilities necessary to supply Jujae Pharmaceutical’s future innovative pipeline to Korean patients.” While the company avoided giving a specific answer on the possibility of direct sales, this implies that it will be able to handle approval and commercialization independently going forward.
NXT007 has entered the phase of direct comparison with Hemlibra in global clinical trials. As of the first half of this year, two Phase 3 clinical trials have begun, bringing the total number of ongoing Phase 3 trials to three.
Spasentan is also included in the list of candidates for the Korean market. JooGae Pharmaceutical acquired Renalis Pharma to secure the development and commercialization rights for Spasentan in Japan, South Korea, and Taiwan. South Korea participated in the global Phase 3 clinical trial, and JooGae Pharmaceutical submitted a marketing authorization application in Japan in June of this year. Although the development and approval timeline for South Korea has not yet been disclosed, given that JooGae Pharmaceutical has identified Spasentan as one of its innovative pipeline candidates, it appears to be an asset with the potential for domestic commercialization in the near future.
Meanwhile, JW Pharmaceutical’s future domestic business strategy is expected to depend on which products the Korean subsidiary applies its direct sales capabilities to. As the Korean subsidiary gradually establishes capabilities for drug approval, import, and sales, it may pursue a dual approach of in-house commercialization and collaboration with domestic partners, taking into account market size and product characteristics. Analysts suggest that for products with a limited patient population or where existing distribution and sales networks are critical, collaborating with KOREAN DRUG CO., LTD. may be more efficient.
An official in the pharmaceutical and biotech industry stated, “Given the decades-long relationship with JWPHARMACEUTICAL, it will be difficult to abruptly change or eliminate existing collaborations,” but added, “For new products, there is a possibility of adopting a flexible structure where the company chooses between direct sales and partnerships depending on market potential and product characteristics.”
