Multinational pharmaceutical companies continued to dominate Korea’s new drug market last year by winning nine out of 10 new drugs approvals.

According to the new drug data at the Ministry of Food and Drug Safety, the regulator approved 48 new drugs -- 35 synthetic drugs and 13 biological drugs – developed by 27 companies in 2021.

AstraZeneca Korea was the company that released the largest number of new drugs last year. The company received approval for eight new drugs in Korea, including a Covid-19 vaccine, blood cancer, neurofibroma, and anemia treatment.

Pfizer Korea and Novartis Korea followed AstraZeneca with six approvals.

Pfizer Korea released a vaccine for Covid-19, an anticancer drug, and treatment for atopic dermatitis.

Novartis Korea obtained nods for three advanced biomedicines in a series, called the “one-shot treatment,” as they could show efficacy with just a single administration and an anticancer drug.

In contrast, Korean companies stopped at scoring approvals for four new drugs in 2021.

Yuhan Corp.'s non-small cell lung cancer (NSCLC) treatment Leclaza (ingredient: lazertinib) was the first to receive approval in January, marking the first approval of a locally developed drug in three years since inno.N launched K-CAB in 2018.

Celltrion won approval for Regkirona, a Covid-19 antibody treatment, in March, Hanmi Pharmaceutical for Rolontis, a neutropenia treatment, in November, and Daewoong Pharmaceutical for Fexuclue, a treatment for gastroesophageal reflux disease (GERD), in December.

Other Korean pharmaceutical companies, such as Hana Pharmaceutical, Hanlim Pharmaceutical, and Bukwang Pharmaceutical, also received approval for new drugs. However, these were not counted as homegrown new drugs based on foreign licenses.

Hana received approval for Byfavo, a new anesthetic drug that received approval for the first time in 30 years since propofol, and Bukwang received approval for Ozanex Cream, a skin infection treatment.

Hana licensed in Byfavo from Paion, a German pharmaceutical company, and Bukwang licensed in Ozanex from Ferrer, a Spanish pharmaceutical company.

Hanlim also received approval for Bronpass, a bronchitis treatment, in April. However, it is hard to say that Bronpass is a new drug as its substance is a natural product.

Foreign drugmakers find it hard to get insurance benefits

While multinational pharmaceutical companies led the approval of new drugs, regulators provided insurance benefits for only three drugs, all of which were developed by Korean companies.

Yuhan's Leclaza received reimbursement as a non-small cell lung cancer treatment in July.

This drug applied for insurance benefits in December 2020 before product approval using the approval-evaluation linkage system and received reimbursement rights about six months after marketing approval.

The upper limit of Leclaza's insurance was originally 68,964 won ($57.6) per tablet, about 206,892 won per day based on the recommended daily dose.

After receiving health insurance benefits, the out-of-pocket rate was lowered to 5 percent of the amount, allowing patients to receive treatment by paying only about 10,000 won a day.

Hanmi's neutropenia treatment Rolontis and Hanlim bronchitis treatment Bronpass also received insurance benefits in November.

Patients had to pay 2.6 million won per year for uninsured administration of Rolontis. However, with an upper limit of the benefit of the drug set at 489,796 won per week, the annual patient burden has sharply dropped to 90,000 won.

Regulators set an upper limit of benefits for Bronpass at 183 won per tablet. Patients need to take one tablet at a time, twice a day. Patients have only to pay 1,300 won a year with the reimbursement, compared to the 6,000 won payment required without reimbursement. About 670,000 people are estimated to take the drug a year.