With the 42nd and 43rd domestically developed new drugs approved this year, industry attention is growing over who will take the next homegrown new drug title. With three candidates currently under marketing authorization review by the Ministery of Food and Drug Safety, there is a possibility that the number of domestic new drug approvals this year will set a record high.
According to the pharmaceutical industry on the 11th, the Ministery of Food and Drug Safety is reviewing marketing authorization for Hanmi Pharmaceutical's obesity treatment "Efpeglenatide," CellBion's prostate cancer treatment "Pocuvotide," and the dry eye treatment "Recoplavone," jointly developed by Aju Pharm and GL PharmTech.
Development of homegrown new drugs has recently regained momentum. After four items were approved in 2015, there was one each in 2016 and 2017, two in 2018, and none in 2019 and 2020. The number rose again to four in 2021 and two in 2022, but fell back to zero in 2023.
By contrast, the increase has been clear lately. Last year, three domestic new drugs were approved: GC Biopharma's anthrax vaccine "Barytrax" (No. 39), Medytox's submental fat reduction injection "Newviju" (No. 40), and SK Biopharmaceuticals' epilepsy treatment "Cenobamate (U.S. brand name Xcopri, No. 41)." This year, two items have already been approved, and additional candidates are under review by the Ministery of Food and Drug Safety, raising the likelihood that the number of domestic new drug approvals will reach an all-time high this year.
The Ministery of Food and Drug Safety last month approved Curocell's first domestic chimeric antigen receptor T-cell (CAR-T) therapy "Limcato inj. (Anbalcaptagen autoleucel)" as the 42nd homegrown new drug. Early this month, it approved FutureChem's prostate cancer diagnostic radiopharmaceutical (RPT) "ProstaView injection (Florasthamine)" as the 43rd domestic new drug.
Among the next candidates for domestic new drugs, Hanmi Pharmaceutical's "Efpeglenatide" is drawing the most attention. It is the first glucagon-like peptide (GLP)-1 class obesity and metabolic disease treatment independently developed by a Korean pharmaceutical company, and the firm applied to the Ministery of Food and Drug Safety for marketing authorization in Dec. last year. The company is targeting approval in the second half of this year and launch within the year.
CellBion's prostate cancer radiopharmaceutical therapy "Pocuvotide" is also cited as a strong contender. Pocuvotide applied for conditional marketing authorization in Dec. last year and is drawing attention in line with the recently growing market for radiopharmaceutical therapies.
The dry eye treatment "Recoplavone," jointly developed by Aju Pharm and GL PharmTech, is also under authorization review. Recoplavone is characterized by inducing ocular surface recovery through multiple mechanisms, including increasing tear secretion, promoting production of mucin, a key component of mucus, anti-inflammatory action, and corneal epithelial regeneration. If approved, it will become the first domestic new drug for dry eye. The company is aiming for approval in the second half of this year and launch in the second half of next year.
Follow-on candidates are also waiting. AbClon recently completed phase 2 dosing of the CAR-T therapy "Nespecell," under development for patients with relapsed or refractory diffuse large B-cell lymphoma, and plans to apply to the Ministery of Food and Drug Safety for conditional marketing authorization within the year.