In 2021, the Ministry of Food and Drug Safety (MFDS) approved 25 novel drugs.
According to the MFDS’s information platform (https://nedrug.mfds.go.kr/), out of the 2,000 drugs that were approved in Korea by 27 December 2021, only 34 drugs from 20 companies were classified as new drugs.
Among them, if drugs with different formulations are unified, the actual number of drugs classified as new drugs will be reduced to 25.
Novartis and AstraZeneca were granted three new drugs each, the most approvals among the 20 companies.
Novartis has been approved for Zolgensma, an SMA treatment, Kymriah, a CAR-T treatment, and Piqray, a PIK3CA-mutated breast cancer treatment. Most of them are at the center of controversy over high prices.
Recently, the treatment of patients with inherited retinal disease, Luxturna, and a kinase inhibitor that targets MET, Tabrecta, have also been approved, but they were not classified as new drugs.
AstraZeneca has been approved for three drugs: Evrenzo, a treatment for anemia, Calquence, a treatment for chronic lymphocytic leukemia, and AstraZeneca Korea Covid-19 Vaccine, a vaccine for COVID-19.
AstraZeneca also received approvals for Breztri, triple therapy inhaler for COPD, and Koselugo, the treatment of patients with neurofibromatosis, but they were not classified as new drugs.
Followed by Novartis and AstraZeneca, Pfizer was approved for two drugs, Cibinqo, a medicine to treat severe atopic dermatitis, and Cominarty, a vaccine for COVID-19.
Moreover, Galderma was approved for AKLIEF Cream, GSK for Shingrix, GC Pharma for Moderna Spikevax, DuChemBio for FACBC, Mitsubishi Tanabe Pharma Korea for Dysval, Bausch Health Korea for Vyzulta Eye Drops, Bayer Korea for Verquvo, Bukwang Pharmaceutical for Ozanex Cream, Bixink for Nerlynx, Celltrion for Regkirona, Yuhan Corporation for Leclaza, Hana Pharmaceutical for Byfavo, Takeda Pharmaceuticals Korea for Takhzyro, Janssen Korea for Covid-19 Vaccine Janssen, Teva-Handok for Ajovy, Hanlim Pharmaceutical for Bronpass, and Hanmi Pharmaceutical for Rolontis Prefilled Syringe.
