Vinobelin wins reimbursement 1 month after approval

Amid concerns over treatment gaps after successive withdrawals of vinorelbine products

Company credits strong administrative support…” commercial supply scheduled to begin in early September”

Chong Kun Dang's vinorelbine-based anticancer agent Vinobelin Inj. will be added to Korea's National Health Insurance reimbursement list just 1 month after receiving marketing authorization.

With successive withdrawals of other vinorelbine products from the market mounting concerns over a therapeutic vacuum, Chong Kun Dang has stepped in to fill the void.

According to industry sources on the 30th, Vinobelin Inj. (vinorelbine tartrate), which was approved on June 30, will be listed for reimbursement only about one month after its approval.

Both the 13.85 mg and 69.25 mg strengths will be reimbursed. Having met all reimbursement requirements, the products will be priced at KRW 24,210 and KRW 80,186, respectively.

Chong Kun Dang said the swift reimbursement process was possible thanks to full administrative support from the government and that commercial supply is expected to begin in early September.

A Chong Kun Dang official said, "We began developing an alternative after learning that supply of this essential medicine would be discontinued. From the time we submitted the marketing authorization application late last year, we received substantial support and attention from the Ministry of Food and Drug Safety, the Korea Orphan & Essential Drug Center, the Health Insurance Review and Assessment Service, and the Ministry of Health and Welfare. We expect to be able to start supply in early September."

Vinobelin Inj. is designated as a National Essential Medicine in Korea. Although the market is relatively small and profitability is limited, vinorelbine has long served as a standard treatment and demand remains in routine clinical practice.

While other treatment options are available for non-small cell lung cancer and breast cancer, cytotoxic chemotherapy such as vinorelbine continues to play an important role in patients who are refractory to immuno-oncology drugs or who lack actionable genetic mutations.

However, the domestic supply chain has been under strain for several years. The problem began in 2022 when Alvogen Korea withdrew ‘Alvogen Vinorelbine Inj.' from the market.

Pfizer Korea subsequently discontinued supply of ‘Pfizer Vinorelbine Tartrate Inj.' after its product approval expired in 2023. Last year, Bukwang Pharmaceutical also halted production of ‘Navelbine Inj.,’ making it difficult to secure vinorelbine products in Korea from January this year.

With no pharmaceutical company willing to supply the essential anticancer drug due to API procurement challenges and poor commercial viability, Chong Kun Dang has stepped in with Vinobelin Inj. to help address the treatment gap.

As a result, the government actively supported the project throughout the regulatory process, allowing not only marketing approval but also reimbursement listing to be completed in an exceptionally short period.