{"schema":"hottub-news/story/v1","story":"st_anv6gflv74js6hjaqtba","title":"[BioS]HLB파나진, ‘HPV 분자진단’ 멕시코 의료기기 \"허가\"","title_en":"[BioS] HLB Panajin, 'HPV molecular diagnosis' Mexico medical device 'approval'","outlets":4,"brief":null,"page":"https://hottub.news/stories/story-anv6gflv74","count":5,"items":[{"id":"n_urc76g4b4zgbe7bchlca","seq":9687067,"kind":"article","title":"[BioS]HLB파나진, ‘HPV 분자진단’ 멕시코 의료기기 \"허가\"","title_en":"[BioS] HLB Panajin, 'HPV molecular diagnosis' Mexico medical device 'approval'","url":"https://www.etoday.co.kr/news/view/2646764","summary":"HLB파나진(HLB Panagene)은 HPV 분자진단 제품인 'PANA RealTyper HPV Kit'가 멕시코 의약품 규제당국인 연방위생위험보호위...","published":"2026-11-11T02:09:00Z","seen":"2026-11-11T02:20:01Z","lang":"ko","country":"KR","source":{"id":"kite-etoday-co-kr-278ce9","name":"etoday.co.kr","domain":"rss.etoday.co.kr"},"via":"kite-etoday-co-kr-278ce9","topics":["bios"],"authors":["이효빈","author"],"entities":[{"id":"Q184627","name":"human papillomavirus infection","type":"other"},{"id":"Q96","name":"Mexico","type":"place"}],"story":"st_anv6gflv74js6hjaqtba","category":"health","category_p":0.3199999928474426,"category2":"science-technology","sentiment":"neutral","tone":0.18000000715255737,"political":0.07000000029802322},{"id":"n_2rgynq3nagrz3taypdmq","seq":9690032,"kind":"article","title":"HLB파나진, HPV 분자진단 키트 멕시코 품목허가 획득","url":"https://www.pharmnews.com/news/articleView.html?idxno=307815","summary":"[팜뉴스=홍효정 기자] HLB파나진(대표 장인근)은 인유두종바이러스(HPV) 분자진단 제품 \\'PANA RealTyper HPV Kit\\'가 멕시코 연방보건위생보호국(COFEPRIS)으로부터 품목허가를 획득했다고 11일 밝혔다.허가 받은 제품은 위험도에 따라 1~3등급으로 관리하는 멕시코 의료기기 분류체계상 중등도 위험도인 2등급(Class II)에 해당한다.PANA RealTyper HPV Kit는 자궁경부암의 주요 원인체인 HPV 감염 여부를 확인하는 체외진단 분석기기다. 다중 중합효소연쇄반응(Multiplex PCR) 기술을 적용","published":"2026-11-11T01:33:50Z","seen":"2026-11-11T02:59:01Z","lang":"ko","source":{"id":"kite-cdn-pharmnews-com-3e2457","name":"cdn.pharmnews.com","domain":"cdn.pharmnews.com"},"via":"kite-cdn-pharmnews-com-3e2457","topics":["medicine","산업"],"authors":["홍효정 기자"],"story":"st_anv6gflv74js6hjaqtba","category":"health","category_p":0.20000000298023224,"sentiment":"neutral","tone":0.23999999463558197,"political":0.05999999865889549},{"id":"n_f62z22hudhqqzbmpjzqq","seq":9680623,"kind":"article","title":"HLB파나진, HPV 진단제품 멕시코 품목허가 획득","url":"https://www.medipana.com/news/articleView.html?idxno=421496","summary":"HLB파나진이 인유두종바이러스(HPV) 분자진단 제품의 멕시코 품목허가를 획득하며 중남미 체외진단 시장 진출을 확대한다. 회사는 이번 허가를 시작으로 감염성 질환과 암 진단제품의 현지 인허가를 추가로 추진할 계획이다. 11일 HLB파나진에 따르면 회사의 HPV 분자진단 제품 \\'PANA RealTyper HPV Kit\\'가 멕시코 연방보건위생보호국(COFEPRIS)으로부터 품목허가를 받았다. 이번에 허가받은 제품은 멕시코 의료기기 분류체계상 2등급(Class II)에 해당하는 체외진단 의료기기다. 멕시코는 의료기기를 위험도에 따라 1","published":"2026-11-11T01:05:32Z","seen":"2026-11-11T01:58:01Z","lang":"ko","source":{"id":"kite-cdn-medipana-com-912f9c","name":"cdn.medipana.com","domain":"cdn.medipana.com"},"via":"kite-cdn-medipana-com-912f9c","topics":["medicine","메디시안"],"authors":["최인환 기자"],"story":"st_anv6gflv74js6hjaqtba","category":"economy-business","category_p":0.25,"category2":"health","sentiment":"neutral","tone":0.23000000417232513,"political":0.05999999865889549},{"id":"n_igo5vdy5tgwcyuibyqiq","seq":9672267,"kind":"article","title":"HLB파나진, HPV 진단제품 멕시코 허가","url":"https://www.newspim.com/news/view/20261111000172","published":"2026-11-11T00:30:00Z","seen":"2026-11-11T01:29:01Z","lang":"ko","country":"KR","source":{"id":"newspim.com","name":"newspim.com","domain":"newspim.com","outlet":{"wikidata":"Q24855610","name":"NewsPim","type":"newspaper","country":"KR","designations":["newspaper"]}},"via":"gdelt-gkg-translingual","topics":["economy","politics","technology"],"story":"st_anv6gflv74js6hjaqtba","category":"health","category_p":0.23000000417232513,"category2":"crime-law","sentiment":"neutral","tone":-0.05000000074505806,"political":0.07000000029802322},{"id":"n_anv6gflv74js6hjaqtba","seq":9670943,"kind":"article","title":"HLB파나진, 멕시코서 HPV 분자진단 허가 획득…중남미 체외진단 공략","url":"https://www.etoday.co.kr/news/view/2646640","summary":"COFEPRIS 2등급 의료기기 승인…자궁경부암 원인 바이러스·유전자형 동시 감별 감염병·표적항암 진단 키트 추가 인허가 추진…...","published":"2026-11-11T00:21:00Z","seen":"2026-11-11T01:17:01Z","lang":"ko","country":"KR","source":{"id":"kite-etoday-co-kr-278ce9","name":"etoday.co.kr","domain":"rss.etoday.co.kr"},"via":"kite-etoday-co-kr-278ce9","topics":["일반"],"authors":["조남호","author"],"story":"st_anv6gflv74js6hjaqtba","category":"health","category_p":0.33000001311302185,"sentiment":"neutral","tone":0.20000000298023224,"political":0.07999999821186066}]}