HLB Panagen Receives Malaysian Approval for 'Panamutyper EGFR'

HLB Panagen announced on the 15th that it has obtained approval from the Malaysian Medical Device Authority (MDA) for its independently developed product 'PANAMutyperTM EGFR' and will officially enter the Malaysian cancer molecular diagnostics market.

PANAMutyper EGFR is a product capable of detecting mutations in lung cancer cells and others through liquid biopsy. In 2023, PANAMutyper EGFR was also the first in Korea to receive approval from the Ministry of Food and Drug Safety as the original companion diagnostic (Original CDx) for Yuhan Corporation's lung cancer treatment drug 'Leclaza (active ingredient: Lazertinib)'.

According to the global market research firm Fortune Business Insights, the worldwide companion diagnostics market size is expected to grow from $8.51 billion last year to $22.37 billion by 2032.

HLB Panagen plans to accelerate its entry into the Southeast Asian molecular diagnostics market based on the approval obtained in Malaysia. This is regarded as a recognition of the technical excellence of PANAMutyper EGFR, which provides high accuracy and reliability in diagnosing lung cancer. The company is currently discussing cooperation with major hospitals in Malaysia and expects to expand its market share through these partnerships.

HLB Panagen supplies PANAMutyper EGFR in 26 countries, having obtained not only approval from the Korean Ministry of Food and Drug Safety but also certification from the European Medicines Agency (EMA) (CE) and approval from the Saudi Food and Drug Authority (SFDA).

In addition to PANAMutyper EGFR technology, the company is expanding its product portfolio by developing numerous infectious disease diagnostic products. It continues to increase sales in overseas markets through highly sensitive HPV (human papillomavirus) and STD (sexually transmitted disease) diagnostic products. Through this, it is further strengthening its diagnostic solution portfolio in the fields of cancer and infectious diseases.

Choi Jae-jin, Executive Director of HLB Panagen's Marketing Strategy Headquarters, said, "We will expand the market share of cancer diagnostic kits in the Southeast Asian market following the approval in Malaysia," and added, "We will continue to grow in the global market as well."