Korea's first locally-developed new drug Sunpla Injection, a gastric cancer treatment developed by SK Chemicals, has officially lost its approval status, marking the end of the landmark anticancer drug that had spurred new drug development in Korea.
According to industry watchers, the Ministry of Food and Drug Safety canceled the product approval of SK Chemicals' Sunpla because the company did not renew the request for the product's approval.
The expiry date of Sunpla's items was December 31, 2022. For renewal, SK Chemical would have had to submit data by the end of June last year. However, there was no renewal application until June 30, the drug ministry revoked the item approval.
Sunpla was the first locally-developed new drug approved in 1999. SK Chemicals developed the treatment to replace cisplatin, one of the representative products of platinum complex anticancer drugs still in use today.
The development phase was not easy as it took the company a decade and 8 billion won ($6.2 million) in R&D funds to develop Sunpla.
The development of Sunpla has been evaluated by many in the industry as an event that raised the status of Korea's pharmaceutical industry as a new drug development country,
It helped the country gain international competitiveness by moving away from simply importing or imitating foreign new drugs.
Despite such high historical value, the sales performance of Sunpla has been poor. The drug accumulated less than 10 billion won in sales between 1999 and 2009 when the company stopped manufacturing due to severe competition and falling sales.
Experts said the cancer treatment paradigm shifted in 2000 due to the advent of targeted anticancer.
With the ministry revoking the sales approval of Sunpla, the number of new locally developed drugs that have lost sales approval has increased to five.
HK inno.N was the first to lose sales approval for a locally developed new drug withdrawing Pseudovaccine injection (pseudomonas aeruginosa preventive vaccine), in 2009, followed by Dongwha Pharmaceutical pulling out the nation's third new drug Milican Injection (hepatic cancer treatment) in 2012.
Dong-A ST withdrew the nation's 24th new drug Sivextro (antibiotic) in 2020.
The drug ministry also revoked sales approval for Kolon Life Science's Invossa-K in 2019 for mislabeling.