https://www.koreatimes.co.kr/www/tech/2024/05/779_374825.html
HLB fails to win US FDA's approval for Rivoceranib liver cancer drug
Shares of all nine listed affiliates of HLB, a Kosdaq-listed biotech company, plunged on Friday to their daily price floors, as the U.S. Food and Drug Administration (FDA) rejected a new drug approval for Rivoceranib, the Korean firm’s liver cancer treat
www.koreatimes.co.kr
Shares of all nine listed affiliates of HLB, a Kosdaq-listed biotech company, plunged on Friday to their daily price floors, as the U.S. Food and Drug Administration (FDA) rejected a new drug approval for Rivoceranib, the Korean firm’s liver cancer treatment.
affiliate = affiliated company 자회사, 계열사
Kosdaq-listed 코스탁 상장된
plunge to = plummet to = dive to ~까지 떨어지다, ~까지 급락하다, ~로 곤두박질 치다
daily price floor 일일 하한가, 일일 가격 최저 한계
daily price ceiling 일일 상한가, 일일 가격 최고 한도
approval = green right = acceptance = assent = approbation = authorization = sacntion = ratificationn = permission = go-ahead 승인, 인정, 인가, 허가
liver cancer treatment 간암치료
HLB Chairman Jin Yang-gon said on his company’s official YouTube channel on Friday morning that he received a complete response letter (CRL) from the FDA at 6:45 a.m. that day, regarding the combination therapy of Rivoceranib and Camrelizumab, an anticancer drug made by Jiangsu Hengrui, HLB’s Chinese partner.
official YouTube channel 공식 유튜브 채널
receive a complete response letter 검토완공문을 받다
combination therapy 병용 치료
anticancer drug 항암약, 항암제
A CRL is a notice issued by the FDA indicating that an application will not be approved in its present form. After the live streaming, investors of HLB affiliates, who anticipated a U.S. approval, dumped nearly 5 trillion won ($3.7 billion) worth of the biotech company's shares, indicating their disappointment at the decision.
notice = announcement = notification = pronouncement = statement = official document = official paper = official note 공고문, 공문, 알림
live streaming 온라인 생중계 방송, 생방송 스트리밍
anticipate = look forward to = expect = look to = hope = believe = ween 기대하다, 예상하다
dump = ditch = abandon = throw away = throw out = discard = get rid of = dispose of 버리다, 처리하다, 없애다, 던지다
nearly = roughly = about = c. = circa = in the neighborhood of = in the order of = of the order of = approximately 대략, 약
disappolintment at ~에 대한 실망
at the decision 그 결정
Before the announcement, HLB’s stock price rose gradually throughout this year from 43,050 won on Jan. 2 to 95,800 won on Thursday, allowing the pharmaceutical firm to become the second-largest company on the secondary Kosdaq market in terms of market cap.
stock price 주식 가격
throughout the year 일년 내내
pharmaceutical firm 제약 회사
the second-largest 두번째로 큰
market cap = market capitalization 시가총액
However, HLB’s market cap fell below 9 trillion won on Friday from over 12 trillion won a day earlier.Jin attributed the FDA’s rejection mainly to problems related to Camrelizumab, saying that the U.S. authorities appear dissatisfied with the Chinese firm’s response to criticism of its manufacturing process.
attribute A to B ~는 A을 B의 탓으로 보다, ~는 A을 B때문이라고 여기다
appear dissatisfied with ~에 실망한 것처럼 보이다
response to ~에 대한 답장
manufacturing process 제조 공정, 제조 과정
“The FDA did not mention any problems related to Rivoceranib,” he said. “Jiangsu Hengrui needs to fix some problems, so we will talk with the company immediately to settle this matter.” The chairman added that the ongoing Russo-Ukrainian War blocked the FDA officials from inspecting Russian and Ukrainian hospitals, where clinical trials had been done to check whether the therapy is also effective for Caucasians.
talk with ~와 이야기하다
immediately = instantly = at once = straight = directly = right now = right away = squarely = shortly after 즉시, 즉
fix the problem = settle the matter = sort out the matter = resolve the issue = solve the matter 일을 해결하다, 문제를 해결하다
clinical trials 임상 시험
“All of our employees did our best to meet the expectation of our shareholders by getting the new drug approval from the U.S. this time,” he said. “We deeply apologize for another delay in the launch of our new drug.”
do one's best = do everything in one's power = do all one can = spare no efforts = leave no stone unturned 최선을 다하다, 모든 수단을 동원하다
meet the expectations = live up to expectations = cater to one's expectations 기대를 충족하다. 기대를 부응하다
deeply apologize = apologize profusely 깊이 사과드린다, 거듭 사과드린다
delay in ~하는데 지연이나 지체
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