Kwangdong Pharmaceutical Secures First Generic Exclusivity for Tagrisso, Joining Chong Kun Dang in Race for Korea's KRW 110 Billion NSCLC Market
核心洞察
Kwangdong Pharmaceutical (搜索) obtained first generic exclusivity for its osimertinib product 'Ktinib Tab (搜索)' on April 30, becoming the second company after Chong Kun Dang (搜索) to achieve this milestone.
Both companies successfully circumvented Tagrisso's formulation patent (expiring January 2035) and will hold roughly 9-month market exclusivity starting from the substance patent expiry in 2033.
The domestic NSCLC market, currently dominated by AstraZeneca's Tagrisso and Yuhan's Leclaza, is expected to see intensified competition when generics launch in 2033.
Kwangdong Pharmaceutical (搜索) has obtained first generic exclusivity for its osimertinib mesylate product 'Ktinib Tab (搜索) (40mg, 80mg),' according to South Korea's Ministry of Food and Drug Safety. The approval, granted on April 30, marks the second such exclusivity following Chong Kun Dang (搜索)'s 'Otinib Tab (搜索),' which received approval on January 27, setting the stage for a two-company race to capture the KRW 110 billion non-small cell lung cancer (搜索) (NSCLC) treatment market upon patent expiry.
Ktinib Tab (搜索) carries identical indications to the original drug, AstraZeneca's Tagrisso (osimertinib). As a monotherapy, it is indicated for adjuvant treatment following complete resection in patients with NSCLC harboring EGFR (搜索) exon 19 deletions or exon 21 (L858R) substitution mutations; treatment of patients with unresectable locally advanced (Stage III) NSCLC harboring the same mutations whose disease has not progressed during or after platinum-based chemoradiotherapy; first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations; and treatment of patients with EGFR T790M-positive locally advanced or metastatic NSCLC who have previously been treated with an EGFR-TKI. As a combination therapy, it is indicated for first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitutions, in combination with pemetrexed and platinum-based chemotherapy.
Patent Circumvention and Market Exclusivity
Like Chong Kun Dang (搜索), Kwangdong succeeded in circumventing Tagrisso's formulation patent, which is set to expire in January 2035, thereby securing first generic exclusivity. Both companies achieved patent circumvention in September of last year by winning a passive scope confirmation trial regarding the formulation patent. AstraZeneca has since appealed, and a lawsuit to cancel the ruling is currently ongoing at the Intellectual Property High Court.
The approval applications were submitted simultaneously to the MFDS, meaning both companies met the requirements for exclusivity. The exclusivity period for Ktinib, during which sales of identical drugs are restricted, is set from December 28, 2033, to September 27, 2034. Since Tagrisso's substance patent remains valid until 2033, immediate market entry is not possible. However, both companies plan to enter the market immediately upon patent expiry, block latecomers, and capture the KRW 110 billion market.
Shifting Competitive Landscape
The domestic NSCLC treatment market is currently dominated by AstraZeneca's original drug Tagrisso and Yuhan's domestic new drug Leclaza, which are competing fiercely for market share. With Chong Kun Dang (搜索) and Kwangdong preparing to launch generics, the market landscape is expected to become increasingly complex.
A pharmaceutical industry insider analyzed, "Given the high commercial potential of the product, generic companies are continuing to challenge the patents. With Chong Kun Dang (搜索) and Kwangdong securing generic exclusivity, the generic market is highly likely to evolve into an initial two-horse race starting in 2033."