From 'Reclaza' to 'Pexuclue'... '2021 K-Bio' Grown with 5 New Drugs

Reklaza, Regkirona, Bronpass, Rolontis, Pexuclu Approved Domestically
Approval of 6 COVID-19 Vaccines and Domestic Therapeutics

[Asia Economy Reporter Chunhee Lee] Last year, five domestically developed new drugs were approved in a single year, marking the highest record since data collection began, indicating rapid growth in the domestic pharmaceutical and bio industries.

On the 8th, the Ministry of Food and Drug Safety (MFDS) announced that it had published the "2021 Pharmaceutical Approval Report" on the 7th, containing this information. According to the report, a total of 2,270 pharmaceutical items were approved or reported last year. The MFDS highlighted the following key features: ▲a record high of 5 domestically developed new drugs approved ▲6 COVID-19 vaccines approved ▲first approval of a domestically developed COVID-19 treatment ▲significant decrease in generic drugs, with half of the drugs being of 'new composition' ▲'circulatory system drugs' ranked first among therapeutic groups with an increasing trend ▲full-scale operation of the advanced biopharmaceuticals' entire lifecycle safety management system.

A total of 37 new drug items (28 ingredients) were approved last year. Among these, 5 items/ingredients were domestically developed new drugs, marking the highest since related data collection began in 1999. This also ended the harsh period during which no domestically developed new drugs were approved for two consecutive years from 2019 to last year. The five newly approved items are: ▲non-small cell lung cancer treatment 'Reclaza Tab' (Yuhan Corporation) ▲COVID-19 antibody treatment 'Rekkirona Inj.' (Celltrion) ▲neutropenia treatment 'Rolontis Prefilled Syringe Inj.' (Hanmi Pharmaceutical) ▲acute bronchitis treatment 'Bronpass Tab' (Hallim Pharmaceutical) ▲gastroesophageal reflux disease treatment 'Pexclu Tab' (Daewoong Pharmaceutical).

Notably, among these, Rekkirona Inj. was the first domestically developed COVID-19 treatment to receive approval in Korea. It is a recombinant neutralizing antibody treatment produced by selecting neutralizing antibody genes present in the blood of recovered COVID-19 patients, inserting these genes into host cells capable of mass production (recombination), and culturing the cells for large-scale production. It received conditional approval in February last year and full approval in September. The MFDS explained, "It is the third COVID-19 treatment worldwide to have its safety and efficacy verified by a pharmaceutical regulatory authority."

Since the AstraZeneca (AZ) vaccine was first approved domestically in February last year, Pfizer, Janssen, and Moderna vaccines have also been approved, marking progress in COVID-19 vaccine approvals. Notably, AZ's 'Korea AstraZeneca Vaxzevria Inj.' and Moderna's 'Spikevax Inj.' were contract-manufactured (CMO) domestically by SK Bioscience and Samsung Biologics, respectively.

Approvals for cell and gene therapies (CGT), which have recently attracted industry attention, were also actively carried out. Fifteen previously approved cell therapy items were re-approved under the "Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support Act," which has been in effect since August 2020, and three gene therapy items were newly approved.

Meanwhile, the number of approved and reported generic drug items significantly decreased. From 2,613 cases in 2020, it dropped by 41% to 1,535 cases last year. The MFDS analyzed that this decline was due to the revised Pharmaceutical Affairs Act, which has limited the number of items that can use the same clinical (bioequivalence) test data to three, effective from July last year.

This content was produced with the assistance of AI translation services.