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XG, '코첼라' 제대로 찢었다… 글로벌 관객 떼창
  • XG, '코첼라' 제대로 찢었다… 글로벌 관객 떼창
  • [이데일리 스타in 윤기백 기자] 그룹 XG가 ‘코첼라’ 첫 무대를 성공적으로 마치며 막강한 글로벌 영향력을 입증했다.XG(사진=XGALX)XG는 지난 13일(현지 시간) 미국 최대 음악 페스티벌 ‘코첼라’(Coachella Valley Music and Arts Festival)에 출격, ‘코첼라’ 최대 규모의 실내 무대인 사하라 스테이지의 피날레를 장식했다.이날 관객들의 뜨거운 호응 속 등장한 XG는 ‘헤소노오+엑스진’(HESONOO+X-GENE)을 시작으로 ‘워크 업’(WOKE UP), ‘걸 갱’(GRL GVNG) 무대로 현장 열기를 제대로 폭발시켰다. 이어 XG는 ‘레프트 라이트’(LEFT RIGHT), ‘인 더 레인’(IN THE RAIN), ‘이스 디스 러브’(IS THIS LOVE), ‘슈팅 스타’(SHOOTING STAR) 등 총 13곡의 압도적인 무대로 현지 관객들을 제대로 사로잡았다.특히 XG는 자신들의 색깔이 녹아든 강렬한 댄스 퍼포먼스로 현장 분위기를 절정으로 치닫게 했다. 밴드 사운드로 새롭게 편곡된 곡들과 ‘코첼라’를 위한 특별한 무대 연출로 구성된 XG의 무대는 공연 내내 관객들의 떼창과 환호를 이끌었다. 무대가 끝난 뒤에도 함성이 멈추지 않는 등 XG의 매서운 인기를 증명했다.XG는 “데뷔 때부터 꿈꿔온 무대다. 지금부터가 진짜 시작이라는 각오를 새롭게 다지게 됐다. 앞으로 많은 기대 부탁드린다”라고 소감을 밝혔다. 이후 X(엑스)에서 XG의 ‘코첼라’ 무대 해시태그가 세계 트렌드 5위, 미국 2위 등을 기록하면서 세계적인 화제성을 입증하기도 했다.XG는 오는 20일(현지 시간)에도 동일한 무대에 오른다. 여기에 XG는 월드투어 ‘더 퍼스트 하울’(The first HOWL) 미국 시애틀 추가 공연과 남미 공연(상파울루, 멕시코시티)을 앞두고 있다. 5월 14일에는 도쿄돔에 입성해 투어의 마지막을 장식할 예정이다.
2025.04.16 I 윤기백 기자
Daehwa Pharma stock hits year-high amid China sales optimism
  • Daehwa Pharma stock hits year-high amid China sales optimism[K-Bio Pulse]
  • [Yu Jin-hee, Edaily Reporter] SEOUL, South Korea-Shares of Daehwa Pharmaceutical surged to their highest point this year, driven by optimism around sales growth in China. Cytogen and NIBEC also posted significant gains on April 14, reflecting investor confidence in anticipated business developments.Daehwa Pharmaceutical‘s Recent Stock Price Flow. [Source=KG Zeroin’s MP Doctor]◇Daehwa Pharma hits year-high on positive PharmEdaily newsDaehwa Pharma‘s shares climbed the daily limit of 30%, closing at 17,680 won, up from the year’s opening price of 10,900 won-a 62.2% increase despite broader market challenges driven by negative global sentiments, particularly from the U.S.The stock surge was triggered by a pay-to-read PharmEdaily article published March 10, which highlighted Daehwa Pharma‘s launch of Liporaxel in China, described as “the world’s first oral cancer drug.” After the article became freely accessible online, subsequent similar reports further propelled investor interest, significantly boosting the stock price.Liporaxel, a novel oral formulation of the blockbuster cancer drug Taxol (paclitaxel), is marketed in China by Haihe Biopharma and local distributor 3S Bio. Haihe Biopharma received approval from China‘s National Medical Products Administration (NMPA) for Liporaxel as a treatment for gastric cancer last September and began sales in mid-February.Unlike intravenous formulations, Liporaxel requires no solvents, injection equipment, or premedication typically associated with infusion therapies, enhancing patient convenience significantly. The drug incorporates Daehwa’s proprietary lipid-based self-emulsifying drug delivery platform (DHLASED).Daehwa Pharma anticipates Liporaxel will significantly boost annual sales, already included in last year’s revenue of 141.4 billion won. The company has received a $25 million licensing fee from its Chinese partner, Haihe, of which $13 million has been paid so far. Daehwa is set to receive royalties for 10 years post-launch and plans to expand Liporaxel‘s indications from gastric cancer to metastatic and recurrent breast cancer.“We are actively exploring ways to enhance sales, such as securing local insurance coverage in China,” a Daehwa Pharma official said. “Considering the success of Lipusu, a lipid-based intravenous paclitaxel formulation by Lvye Pharma, we expect significant growth for Liporaxel.”Cytogen‘s Recent Stock Price Flow. [Source=KG Zeroin’s MP Doctor]◇Cytogen and NIBEC shares also rise on positive expectationsCytogen shares rose 16.25% to 3,720 won, reflecting optimism around improving earnings. The company expects its U.S.-based CLIA-certified laboratory, ExperTox, to benefit significantly from a recent court decision invalidating the FDA’s Laboratory Developed Test (LDT) regulations.Cytogen specializes in liquid biopsy technology, diagnosing cancer and other diseases through non-invasive methods like blood or urine tests. ExperTox, acquired by Cytogen in 2022, provides LDT approval support and joint development services to Korean firms seeking to enter the U.S. market. With the regulatory constraints lifted for at least one year, Cytogen expects heightened demand for these services.NIBEC also gained 13.67%, closing at 21,200 won, driven by investor anticipation of its first global licensing deal for peptide-based drug candidate NP-201. NP-201 targets fibrosis through a unique mechanism promoting tissue regeneration, potentially applicable to diseases like idiopathic pulmonary fibrosis and renal fibrosis.“NIBEC has received significant interest from international firms for NP-201 due to its therapeutic potential,” said Han Yang Securities analyst Oh Byeong-yong. “Discussions with a U.S. pharmaceutical company have progressed significantly, and a formal licensing agreement is likely to be finalized in the first half of this year.”
2025.04.16 I 유진희 기자
Peptron, Oncocross Hit Kosdaq Upper Limits as Obesity, AI Drug Themes Rally
  • Peptron, Oncocross Hit Kosdaq Upper Limits as Obesity, AI Drug Themes Rally
  • [Lim Jeong-yeo, Edaily Reporter] Shares of Peptron and Oncocross hit their daily upper limits on the Kosdaq on Friday, fueled by growing investor interest in obesity treatments and AI-driven drug development. T&R Biofab also posted strong gains, while Lameditech and AbClon --both recently featured in PharmEDAILY premium content--saw double-digit increases.(자료=KG제로인 엠피닥터)◇Peptron Surges on Obesity Drug MomentumAccording to MP Doctor, formerly MarketPoint under KG Zeroin, Peptron rose 29.99% to close at 164,700 won, extending its winning streak to four sessions. While no clear trigger was identified, the stock is widely viewed as a strong obesity-treatment player in the South Korean market.Peptron is advancing a long-acting drug delivery platform using microsphere technology. Its candidate PT403 is a biobetter of a GLP-1 receptor agonist, targeting diabetes and obesity. It is currently undergoing preclinical toxicity trials. Peptron aims to develop PT403 as the world’s first once-monthly or once-every-two-months treatment.Inventage Lab, another long-acting therapy developer, also saw gains, jumping 19% to 17,170 won.“We’re carrying out all development tasks as scheduled,” a Peptron official told PharmEdaily.◇AI Drug Developers Rise on Regulatory TailwindsOncocross rallied 29.92% to 11,420 won, benefiting from a broader move among AI drug discovery companies after the U.S. FDA signaled plans to phase out animal testing in favor of AI-based modeling.SyntekaBio advanced 19.57% to 7,700 won, while Lunit rose 9.4% to 49,450 won.Oncocross also gained attention after naming physician-scientist Kang Ji-hoon as co-CEO. Kang joined the company in 2020 and has overseen Oncocross’ drug discovery efforts. Prior to joining Oncocross, Kang earned his Ph.D. at Ulsan University and served as an oncologist at Asan Medical Center and Kangbuk Samsung Hospital.CEO Kim Yi-rang said that Oncocross was invited to speak at the upcoming World Orphan Drug Congress in Boston this month.◇T&R Biofab Soars on Personalized Bone Implant Study ResultsT&R Biofab surged 24.39% to 4,565 won after announcing positive clinical results for its 3D-printed biodegradable orbital implants and its intention to seek FDA approval.In a study led by Dr. Sah Ho-seok at Asan Medical Center, T&R Biofab’s implants tailored individually for a total of 40 patients led to almost no surgical adjustments and were shortened the surgery time to an average of just 20 seconds. The implants stimulate natural bone regeneration and are fully absorbed in to body over time. The study results went out in Scientific Reports, published by Nature Portfolio.The company also expects higher Q1 revenue following its acquisition of cosmetics firm Blisspack.◇Lameditech Rises on Laser-Based DiagnosticsLameditech jumped 21.05% to 8,970 won, buoyed by increased visibility after a previously paywalled PharmEdaily article was released to the public.Lameditech is the only Korean firm with MFDS approval for a laser-based blood collection device. Its product line, HandyRay, uses painless micro-laser to create tiny openings in the skin for blood sampling, reducing infection risk and eliminating the need for needles. The company plans to expand business into glucose-monitoring market later this year using the same platform technology.라메디텍 주가추이(자료=KG제로인 엠피닥터)◇AbClon Recovers as Fundamentals Gain FocusAbClon rose 10.56% to 9,320 won after PharmEdaily highlighted its growth potential despite being placed on the Kosdaq’s administrative watchlist for missing the 3 billion won sales requirement.The company posted 1 billion won in sales through April and is on track to exit the watchlist next year. It also holds around 10 billion won in cash and is advancing its CAR-T therapy AT101.AbClon also plans to present fresh data on its immunotherapy candidate AM105 at the American Association for Cancer Research (AACR) conference later this month in Chicago.앱클론 주가추이(자료=KG제로인 엠피닥터)
2025.04.15 I 임정요 기자
'빌보드 루키' 누에라, '서울 원더쇼' 무대 오른다
  • '빌보드 루키' 누에라, '서울 원더쇼' 무대 오른다
  • [이데일리 스타in 윤기백 기자] ‘빌보드 루키’ 누에라(NouerA)가 ‘서울 원더쇼’ 무대에 오른다.누에라(사진=누아엔터테인먼트)15일 누아엔터테인먼트에 따르면 누에라는 오는 30일 오후 7시 서울 상암 월드컵경기장에서 KBS ‘서울스프링페스타 개막기념 서울 원더쇼’ 녹화 무대에 올라 현장을 찾은 관객들을 만날 예정이다.누에라는 이날 공연에서 자신들의 특별한 퍼포먼스로 국내는 물론 글로벌 팬들의 눈과 귀를 사로잡을 전망. 특유의 강렬한 에너지는 물론 넘치는 매력을 통해 ‘빌보드 루키’라는 수식어를 입증하겠단 각오다.특히 앞서 누에라는 ‘2024 뮤직뱅크 글로벌 페스티벌 인 재팬’, ‘케이스타일 파티’(Kstyle PARTY) 등 굵직한 해외 공연 무대에 올라 뜨거운 환호를 받았던 만큼, 국내에서 펼쳐지는 이번 ‘서울 원더쇼’에도 비상한 관심이 쏟아지고 있다.누에라는 최근 데뷔 미니앨범 ‘챕터: 뉴 이즈 나우’(Chapter: New is Now)를 발표하고 활발한 활동을 펼치는 중이다. 누에라는 파워풀한 ‘N.I.N’(New is Now)에 완벽한 칼군무, 독특한 댄스 브레이크를 더해 큰 화제를 모았다.특히 이들의 데뷔앨범 ‘챕터: 뉴 이즈 나우’(Chapter: New is Now)의 경우 초동 16만 장 이상의 판매고를 올리며 남다른 저력을 드러냈으며, ‘N.I.N’으로 데뷔 첫 활동 만에 각종 음악 프로그램 1위 후보에 오르는 등 ‘글로벌 기대주’로 급부상했다.누에라는 정식 데뷔 전부터 미국 로스앤젤레스에서 개최된 ‘빌보드 No. 1s 파티’에 공식 초청을 받았다. 빌보드와 빌보드 코리아 선정 ‘2025년 K팝 루키’를 수상하며 화제를 모았다.
2025.04.15 I 윤기백 기자
3billion, Prestige BioPharma Jump on Tariff Optimism
  • 3billion, Prestige BioPharma Jump on Tariff Optimism[K-bio Pulse]
  • [Seok Jihoen, Edaily Reporter] South Korean biotech stocks rallied sharply Wednesday, buoyed by news of potential tariff relief on pharmaceutical imports. The KRX Healthcare Index, which tracks 71 pharmaceutical and biotech stocks, surged 5.43%, with 70 of the 71 constituents closing higher.3billion which generates over 70% of its revenue overseas, saw its stock jump more than 10%, driven by optimism that U.S. tariffs on drug imports may be deferred. Shares of Prestige BioPharmaalso gained over 10%, with investors hopeful the company’s essential drugs would remain shielded from trade friction. PeopleBio surged more than 12% after unveiling promising research on a blood based dementia diagnostic test.Recent Stock Performance of 3billion. (KG Zeroin’s MP Doctor)◇“Growing Regardless of Tariff Policy”According to MP Doctor, a stock analysis platform run by KG Zeroin, shares of 3billion closed at 5,920 won, up 620 won or 11.7% from the previous day. The company had not released any new announcements, but the rally was largely attributed to investor relief over the U.S. administration’s softened stance on drug import tariffs.CEO Changwon Keum told Edaily, “I believe the rebound was driven by easing concerns surrounding U.S. tariffs, which had previously weighed on the stock.” He added, “With more than 70% of our sales coming from overseas and a U.S. subsidiary already in place, our growth in the U.S. market is largely insulated from tariff risks.”Founded in 2016 as a spin-off from Macrogen, 3billion specializes in rare disease genetic testing powered by artificial intelligence. The company currently operates in more than 70 countries and plans to expand to 100 nations this year. Its AI platform analyzes 100,000 genetic variants in under five minutes with 99.4% accuracy.Overseas revenue accounted for 75% of total sales this year, up from 70% last year, fueled by rapid growth in North America and Asia. 3billion is also moving into AIbased drug discovery, with several candidates currently undergoing early-stage biological validation.“Alongside growth in diagnostics, our drug development pipeline will be another key point of interest for investors,” Keum said.Recent Stock Performance of Prestige Biopharma. (KG Zeroin’s MP Doctor)◇Prestige BioPharma Seen as “Tariff-Safe”Shares of Prestige BioPharma surged 12.3% to close at 13,700 won. The company is developing a novel pancreatic cancer therapy for the U.S. market, and sentiment was lifted by expectations that essential drugs like cancer treatments will be exempt from new tariffs proposed under the Trump administration.A company spokesperson said, “We don’t believe even Trump would go so far as to block cancer medications. Moreover, our biosimilar business stands to benefit from policies that aim to lower drug prices.”Industry officials widely expect essential medicines will be excluded even if drug tariffs are enforced. One source familiar with discussions with the U.S. Food and Drug Administration (FDA) said the agency is not anticipating tariffs on essential pharmaceuticals.Prestige BioPharma’s pipeline is heavily focused on cancer treatments. Its pancreatic cancer antibody drug PBP1510 is currently undergoing a Phase 1/2a clinical trial in the U.S. The company plans to apply for the FDA’s Fast Track designation upon completion to accelerate the development and approval process.The group is also pursuing U.S. current Good Manufacturing Practice (cGMP) certification through its CDMO arm, Prestige Biologics, which is preparing to launch the Avastin biosimilar HD204 in the U.S. The company obtained EU-GMP certification in 2022, and expects to secure U.S. cGMP approval this year through its state of the art single use manufacturing system.Recent Stock Performance of PeopleBio. (KG Zeroin’s MP Doctor)◇Dementia Test Boosts SharesPeopleBio stock rose 12.7% to 2,840 won after the company revealed new data on a blood-based diagnostic test for neurodegenerative diseases at the ADPD 2025 conference in Vienna, Austria.The test detects TDP-43 protein oligomers, a pathological hallmark of frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). TDP-43 is also known to cause LATE (Limbic-predominant Age-related TDP-43 Encephalopathy), a condition often misdiagnosed as Alzheimer’s disease due to overlapping symptoms.Unlike monomeric forms of the protein, TDP-43 oligomers are pathogenic. PeopleBio has developed a monoclonal antibody called 1T47 that selectively identifies these harmful aggregates. The test showed statistically significant results in patients with semantic dementia (SD)-a subtype of FTD marked by language deficits-offering potential for early diagnosis. FTD accounts for approximately 5-10% of all dementia cases, but up to 20-50% of early-onset dementia. The company emphasized that its findings support the potential of TDP-43-targeted blood diagnostics. Further clinical validation is planned with the goal of commercialization.CEO Seongmin Kang attributed the stock rally to “renewed investor interest amid a generally improving market sentiment.”
2025.04.12 I 석지헌 기자
Olix Soars on Hair-Loss Drug Hopes; SCD Pharm Drops on U.S. Tariff Woes
  • Olix Soars on Hair-Loss Drug Hopes; SCD Pharm Drops on U.S. Tariff Woes[K-Bio Pulse]
  • [NA Eun-kyung, Edaily Reporter] South Korean pharmaceutical and biotech stocks weakened sharply Wednesday after the Trump administration’s reciprocal tariffs took effect at 1:01 p.m. KST. Key healthcare indexes dropped more than 3% as fears over escalating U.S.-China trade tensions weighed on investor sentiment.The downturn comes as maAny domestic companies have promoted U.S. market entry as a key growth driver. But with the world’s largest healthcare market now entangled in tariff battles, optimism has given way to uncertainty.Only a few firms offering near-term tech licensing prospects, such as Olix and ABL Bio, managed to post gains amid a broad market pullback.Recent stock performance of OLIX (Source: KG Zeroin MP Doctor)◇Olix Soars on Expectations of a New Licensing Deal in H1Olix rose 15.36%, the highest among healthcare stocks. An Olix official said the rally was fueled by investor expectations for a pending joint R&D deal in skin and hair regeneration, which the company had hinted at late last year.In a Dec. 27 press release, Olix said it was finalizing a licensing deal for OLX702A, a potential treatment for metabolic dysfunction associated steatohepatitis (MASH) and obesity, and added that talks with a global company on skin and hair regeneration were progressing smoothly.The compound in question is believed to be OLX104C, a siRNA-based topical therapy for male-pattern baldness. Unlike conventional oral medications that may cause sexual side effects, OLX104C is designed for local dermal delivery, potentially minimizing systemic issues. In preclinical testing, a single dose provided effects lasting more than three weeks. Phase 1b/2a clinical trials are currently underway in Australia.◇SCD Pharm Tumbles on U.S. Tariff Concerns Over Taiwan-Based ManufacturingShares of Samchundang Pharm plunged 12.34% to 146,400 won, the biggest drop among South Korean healthcare stocks. The sell-off followed concerns over U.S. tariff hikes on Taiwanese imports, where the company plans to manufacture its Eylea biosimilar, SCD411.In December, SCD Pharm signed an exclusive supply and distribution agreement with Fresenius Kabi to sell the biosimilar in the United States and six Latin American countries. The company aims to submit its biologics license application to the FDA later this year, with a U.S. launch planned for late 2025.SCD Pharm said the drug will be manufactured at a Taiwanese contract development and manufacturing organization (CDMO), Adimmune and Mycenax, under existing agreements.However, the U.S. government recently classified Taiwan as a “worst offender” in trade policy, slapping it with a 32% tariff higher than the 25% expected for Korean exports.Given that biosimilars rely heavily on price competitiveness, tariffs of this scale could severely impact marketability. Biosimilars are typically priced 20~30% lower than originators, and such high tariffs could erode the cost advantage, especially since biosimilars lack the long-term patient data and brand recognition of their originator counterparts.◇Apt Neuro Science Gains on Political ConnectionsThe only other double-digit gainer in the sector was Apt Neuro Science, formerly Georim Energy, which surged 14.79%. However, the gain was likely driven by political speculation rather than business fundamentals.The company was recently classified as a “Lee Jae-myung theme stock” after hiring Choi Woong-ki, a former broadcasting adviser under Lee during his tenure as Gyeonggi Province governor and Democratic Party presidential candidate. Choi is now serving as Apt’s executive vice president for media strategy.The renewable energy firm, which previously generated around 20 billion won in annual revenue, is transforming into a biotech company under new ownership by Aprogen, which became its largest shareholder in January. Apt has launched a neurological disorders division, hired Dr. Jong Kyung Jung, head of Seoul National University’s genetic engineering research center, as its new president, and signed a joint development agreement with Aprogen for a Parkinson’s disease treatment.
2025.04.11 I 나은경 기자
누에라, '뮤뱅'부터 '더시즌즈'까지 kBS 접수
  • 누에라, '뮤뱅'부터 '더시즌즈'까지 kBS 접수
  • [이데일리 스타in 윤기백 기자] 그룹 누에라(NouerA)가 KBS를 접수한다.누에라(사진=누아엔터테인먼트)누에라는 11일 오후 10시 방송하는 KBS2 뮤직 토크쇼 ‘더 시즌즈-박보검의 칸타빌레’에 출연해 시청자들을 만날 예정이다.특히 누에라는 전매특허인 완벽한 퍼포먼스는 물론 박보검과의 깨알 입담까지 준비한 것으로 알려져 기대를 더한다. 앞서 다양한 콘텐츠를 통해 남다른 예능감을 보여준 누에라이기에 이날 방송에도 관심이 모이고 있다.누에라는 이에 앞서 KBS2 ‘뮤직뱅크’에도 등장해 데뷔 미니앨범 ‘뉴 이즈 나우’(New is Now)의 수록곡 ‘브링 더 크렁크’(Bring the Crunk) 무대를 선물할 예정. 자신들에게 뜨거운 사랑을 보내준 팬들을 위해 후속곡 활동을 결정한 것이라는 점에서 의미가 깊다.이처럼 누에라는 금요일 오후부터 밤까지 KBS의 간판 프로그램을 통해 색다른 매력을 드러낼 예정이다.누에라는 정식 데뷔 전부터 미국 로스앤젤레스에서 개최된 ‘빌보드 No. 1s 파티’에 공식 초청을 받았으며 빌보드와 빌보드 코리아 선정 ‘2025년 K팝 루키’를 수상, ‘빌보드 루키’라는 찬란한 수식어를 얻었다.이들은 또한 일본 팬 미팅을 성황리에 마무리한 것에 이어 ‘2024 뮤직뱅크 글로벌 페스티벌 인 재팬’에도 등장하며 새로운 K팝 세대를 이끌 그룹의 탄생을 선언했다.데뷔 앨범 역시 뜨거웠다. 약 16만 장의 초동 판매량으로 화제를 모은 것에 이어 타이틀곡 ‘N.I.N’(New is Now)에 완벽한 칼군무, 독특한 댄스 브레이크를 더해 국내는 물론 글로벌 팬들의 눈과 귀를 사로잡은 것. ‘빌보드 루키’란 별명 외에도 ‘2025 괴물 신인’, ‘퍼포먼스 맛집’이라는 호평을 이끌어냈다.누에라가 출연하는 KBS2 ‘뮤직뱅크’는 11일 오후 5시부터 방송하며, ‘더 시즌즈-박보검의 칸타빌레’는 오후 10시 만나볼 수 있다.
2025.04.11 I 윤기백 기자
Samsung Bioepis unveils new research on autoimmune biosimilars at IMKASID 2025
  • Samsung Bioepis unveils new research on autoimmune biosimilars at IMKASID 2025
  • [Kim Jinsoo, Edaily Reporter] Samsung Bioepis is presenting its latest research findings on autoimmune disease treatments at the 8th International Meeting of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025), held in Seoul from April 10 to 12.Samsung Bioepis_Lab. (Samsung Bioepis)The company said Wednesday it released two new abstracts: one on real-world data from South Korean patients prescribed its adalimumab biosimilar Adalloce, and another on projected cost savings associated with the introduction of its ustekinumab biosimilar in major European markets.The real-world study included 238 domestic patients who were prescribed Adalloce between September 2017 and June 2024. Among the 213 patients whose treatment effectiveness was assessable, Samsung Bioepis reported a reduction in average disease activity scores at week 24 across those with axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), and Crohn’s disease (CD) who were treated with adalimumab for the first time.Additionally, patients who switched to Adalloce from other adalimumab therapies showed comparable disease activity levels before and after switching, the company said.Based on these results, Samsung Bioepis concluded that Adalloce demonstrated consistent efficacy without new safety concerns in patients with axSpA, RA, CD, ulcerative colitis (UC), and psoriatic arthritis (PsA), aligning with outcomes from earlier clinical trials.The company also shared data projecting potential cost savings from introducing ustekinumab biosimilars used to treat autoimmune conditions like psoriasis (PsO), PsA, and CD in Germany, the U.K., and Sweden. The model compared drug expenditure under two scenarios: one with biosimilars in the market and one without.The analysis estimated that ustekinumab biosimilars could reduce healthcare spending by €440 million ($480 million) in Germany, €49.5 million ($54 million) in the U.K., and €36.8 million ($40 million) in Sweden over three years.Jihoon Kil, head of the Medical Team at Samsung Bioepis, said, “Research on biosimilar efficacy and cost-saving potential is a testament to our ongoing commitment to improving access to high-quality biologics.”At the conference, the company also opened a booth to engage with healthcare professionals and industry stakeholders, showcasing its immunology product portfolio and raising awareness about the benefits of biosimilars.Samsung Bioepis currently markets nine biosimilars in South Korea, four of which Etoloce, Remaloce, Adalloce, and Epzitek are sold directly to customers without commercial partners.
2025.04.10 I 김진수 기자
대만 증시 9% 급등, TSMC도 껑충…트럼프 관세 유예 영향
  • 대만 증시 9% 급등, TSMC도 껑충…트럼프 관세 유예 영향
  • [이데일리 김윤지 기자] 10일(현지시간 기준) 대만 증시가 급등하고 있다. 도널드 트럼프 미국 대통령이 중국을 제외한 주요 무역 상대국에 상호관세 부과 90일 유예를 발표한 영향이다.TSMC 본사.(사진=AFP)이날 오전 9시 9분 기준 대만 자취안(가권) 지수는 전거래일 대비 9.30% 오른 1만9008.80선에 거래되고 있다. 자취안 지수는 이날 5% 상승한 1선8256.47선에서 출발해 상승폭을 9%대까지 확대했다. 이에 단숨에 1만9000선을 회복했다. 대만 시가총액 1위 종목인 세계 최대 파운드리(반도체 위탁생산) 업체인 TSMC 주가도 10% 가까이 상승 중이다.자취안 지수는 지난 3~4일 청명절 연휴로 휴장하면서 지난 7일 뒤늦게 트럼프 대통령의 상호관세 발표를 소화했다. 자취안 지수는 7일 하루에만 9.7% 급락하면서 2만선이 붕괴됐고 3거래일 연속 하라면서 1만7000선까지 밀렸다. 이날 일본 증시 대표 주가지수인 닛케이225평균주가 또한 8%대 상승을 보여주고 있다. 전일 트럼프 대통령이 관세 유예를 발표한 후 뉴욕증시는 전반적으로 급등했다. 트럼프 대통령은 이날 오전 자신의 소셜미디어(SNS) 트루스소셜 계정에 “지금은 매수하기 딱 좋은 시점(THIS IS A GREAT TIME TO BUY)”이라고 게시글을 올렸다. 트럼프 대통령이 증시의 하락을 막아준다는 의미의 ‘트럼프 풋(Put)’으로 해석되면서 시장이 들썩이기 시작했다.이후 오후 들어 트럼프 대통령은 중국을 제외한 모든 교역국을 대상으로 상호관세를 90일간 유예하기로 했다고 발표했다. 그외 국가에 대해선 기본 관세 10%는 유지하되 상호관세는 유예하는 것으로 국가별 적정 관세를 협상하기 위한 차원이라고 트럼프 대통령은 설명했다. 이에 기술주 중심의 나스닥 종합지수는 12% 이상 상승하며 역대 두 번째로 큰 상승폭을 기록했다. 미국 7대 대형 기술주, 일명 ‘매그니피센트7’(애플·아마존·알파벳·메타·마이크로소프트·엔비디아·테슬라, 이하 M7)의 시가총액이 하루에만 1조8600억달러(약 2705조원) 불어났다.
2025.04.10 I 김윤지 기자
Excel Therapeutics, Alteogen Surge on Deal Hopes
  • Excel Therapeutics, Alteogen Surge on Deal Hopes[K-bio Pulse]
  • [Seungkwon kim, Edaily Reporter] Shares of Excel Therapeutics and KoBioLabs surged on Tuesday after news of global contract signings and U.S. patent developments. Alteogen also rebounded on investor optimism over potential multibillion-won royalties.◇ Excel Therapeutics Hits Upper Limit on Blue Magee DealExcel Therapeutics closed at 4,195 won, up 29.88%, on reports of a supply deal with the world’s top hyaluronic acid (HA) supplier, Blue Magee Biotech.The two firms signed an exclusive distribution agreement for T cell culture media in China, with expected annual sales exceeding 10 billion won. PharmEdaily had earlier reported the deal in an exclusive interview with Excel’s Executive Director Yoon Lee.Excel Therapeutics Stock Trend (Data: KG Zeroin)Blue Magee Biotech, listed on the Chinese stock market, reported annual sales of 1.3 trillion won in 2023. The company recently entered the culture media market via tech transfer from Japan’s Rohto Pharmaceutical but chose Excel for its more advanced third-generation media.“The CellCor media from Excel showed superior cell proliferation, safety, and efficacy compared to global competitors,” said Tingke, CEO of Blue Magee Biotech.China’s cell culture media market was estimated at 800 billion won in 2023 and is expected to surpass 1 trillion won this year.Excel plans to expand further in China by partnering with other major pharma firms and promoting both T cell and NK cell media. “We aim to establish our product as the standard in China,” said Lee.◇ KoBioLabs Also Hits Limit-Up on U.S. Patent GrantKoBioLabs closed at 5,110 won, up 29.86%, after announcing a U.S. patent registration for its microbiome-based liver disease treatment.KoBioLabs Stock Trend (Data: KG Zeroin)The company confirmed that a functional strain of Ruminococcus improved liver damage in patients with insulin resistance. The strain showed significant improvements in ALT/AST levels, liver-to-body weight ratio, and bile acid levels in the cecum, with no notable side effects.KoBioLabs now holds patents in six countries: Korea, Japan, China, Russia, Australia, and the U.S. “The U.S. patent solidifies our ability to assert exclusive rights in a key global market,” said a company official.◇ Alteogen Rebounds on Royalty ExpectationsAlteogen rose 8% to close at 361,000 won, reversing a previous drop. The stock’s rebound was partly driven by renewed expectations for royalties from its hyaluronidase technology ALT-B4, used in Keytruda SC, which succeeded in Phase 3 trials.PharmEdaily had previously published a pay-to-read article on the topic, which was made freely available on portals like Naver on Tuesday.Alteogen Stock Trend (Data: KG Zeroin)Alteogen is expected to receive Korea’s largest-ever milestones and royalties from a global pharma partner. With Keytruda’s 2024 projected sales at $29.5 billion, a 50% SC formulation conversion could yield 21 trillion won in sales. At royalty rates of 2?5%, this would mean annual revenue of 420 billion to 1 trillion won. If conversion hits 90%, royalties could reach up to 2.15 trillion won.“The drug met its clinical goals and is now at the FDA approval stage,” said an Alteogen spokesperson.
2025.04.10 I 김승권 기자
현대차, 뉴욕 휘트니미술관서 ‘마리나 저코우展’ 열어
  • 현대차, 뉴욕 휘트니미술관서 ‘마리나 저코우展’ 열어
  • [이데일리 정병묵 기자] 현대자동차와 미국 뉴욕 휘트니 미술관의 장기 파트너십 일환으로 열리는 두 번째 전시 ‘현대 테라스 커미션: 마리나 저코우: The River is a Circle’ 전이 9일(현지시간)부터 내년 초까지 개최된다. ‘현대 테라스 커미션’은 현대차와 휘트니 미술관이 예술가와 큐레이터에게 기존과는 다른 창조적 실험 기회를 제공하기 위해 지난해 10년 장기 파트너십을 맺고 진행하는 전시 프로그램으로 휘트니 미술관의 야외 전시장 중 가장 큰 규모인 5층 야외 테라스 전시장에서 조각, 퍼포먼스, 멀티미디어 등 다양한 장르를 아우르는 새로운 대규모 설치 작품을 매년 선보이고 있다.현대자동차·휘트니 미술관 파트너십 두 번째 전시(사진=현대차)현대자동차·휘트니 미술관 파트너십 두 번째 전시(사진=현대차)현대자동차·휘트니 미술관 파트너십 두 번째 전시(사진=현대차)현대자동차·휘트니 미술관 파트너십 두 번째 전시(사진=현대차)현대자동차·휘트니 미술관 파트너십 두 번째 전시(사진=현대차)‘현대 테라스 커미션’의 두 번째 작가로 참여한 마리나 저코우는 1962년 미국에서 태어나 현재 뉴욕을 기반으로 활동하고 있는 작가로 영상, 설치, 퍼포먼스 등 다양한 매체를 활용해 생태와 환경 및 인간과 자연의 관계에 대한 질문을 던지는 작품들을 주로 선보여 왔다.이번 전시회는 야외 테라스 벽면의 대형 미디어 월에 선보이는 애니메이션과 설치 작품을 통해 뉴욕 허드슨강을 중심으로 맨해튼 지역을 둘러싼 역사와 환경을 재구성해 주변 생태계의 다양성과 복합성을 살펴본다. 휘트니 미술관 디지털 아트 큐레이터 크리스티안 폴과 어시스턴트 데이비드 리스본이 기획을 맡았다.마리나 저코우는 뉴욕의 기후와 계절 변화 등의 데이터가 실시간으로 반영될 수 있도록 작품을 설계했으며 휘트니 미술관이 위치한 뉴욕 미트패킹 지역의 역사와 허드슨강의 생태적 요소들이 어우러진 애니메이션은 수평으로 분할된 화면 구성을 통해 관객들이 수면 위와 아래를 동시에 관측하는 듯한 경험을 제공한다.특히 작가는 허드슨강 공원 관리 기관과의 협업을 통해 레나페 교역소가 자리 잡았던 먼 과거부터 육류 가공업이 활발히 이뤄졌던 1970년대 그리고 지역 발전에 따른 젠트리피케이션(Gentrification)까지 뉴욕 맨해튼 미트패킹 지역의 히스토리를 조명함으로써 야외 전시장에서 미술관의 안과 밖을 연결하는 ‘현대 테라스 커미션’의 특징을 적극적으로 활용했다. 휘트니 미술관 디지털 아트 큐레이터 크리스티안 폴은 “마리나 저코우는 생태의 다양성 및 복합성이란 주제를 시적인 방식으로 표현해 온 작가”라며, “휘트니 미술관의 5층 야외 테라스 전시장은 지역 환경과 역사에 대한 탐구를 기반으로 한 작품을 선보이기에 최적의 장소로, 이번 신작을 통해 관객들이 미술관과 주변 환경을 다양한 관점에서 살펴볼 수 있기를 바란다”고 밝혔다.현대차 관계자는 “지속 가능한 미래를 위해 통합적 접근과 연대적 실천이 중요해지는 시기에 생태와 환경의 변화를 심도 있게 탐구하는 작가 마리나 저코우의 이번 ‘현대 테라스 커미션’ 전시가 관객들에게 경제, 사회, 환경 전반의 상관관계에 대한 새로운 예술적 관점을 제시하는 기회가 되기를 바란다”고 말했다.한편, 현대차는 ‘현대 테라스 커미션’ 외에 격년으로 진행되는 휘트니 미술관의 대표 프로그램인 ‘휘트니 비엔날레’를 공식 후원하고 있으며, 국립현대미술관(MMCA), 영국 테이트 미술관(Tate), 미국 LA 카운티 미술관(LACMA) 등 국내외 미술관과 공고한 파트너십을 지속하고 있다.또한, 최근에는 국내 지역 미술관 활성화를 위한 신규 파트너십 ‘현대 트랜스로컬 시리즈’를 통해 동시대 미술을 위한 다양한 시도를 이어가고 있다.
2025.04.10 I 정병묵 기자
日증시 급등해 3만3000선 회복…트럼프 입에 널뛰는 시장
  • 日증시 급등해 3만3000선 회복…트럼프 입에 널뛰는 시장
  • [이데일리 김윤지 기자] 10일 일본 증시가 급등하고 있다. 도널드 트럼프 미국 대통령이 중국을 제외한 주요 무역 상대국에 상호관세 부과 90일 유예를 발표한 영향이다.도쿄증권거래소 앞 전광판 (사진=AFP)이날 오전 9시 9분 기준 일본 증시 대표 주가지수인 닛케이225평균주가(이하 닛케이지수)는 전 거래일 대비 6.43% 상승한 3만3752.17를 기록하고 있다. 이날 닛케이 지수는 3만2321.21선에서 출발해 상승폭을 확대해나가고 있다.일본 니혼게이자이신문은 “트럼프 행정부가 상호관세 부과를 유예하면서 세계 경제 성장 둔화 우려에 대한 투자자들의 과도한 리스크 회피 심리가 완화되고 있다”고 짚었다. 다이와증권의 츠보이 유고 미국 주식 전략가는 “(트럼프 행정부의 관세 조치가)세계 경기 침체로 이어질 것이라는 비관적인 전망은 다소 완화되었지만 자율 반등의 범위를 넘어서지는 못하고 있다”고 지적했다.닛케이지수는 트럼프 대통령의 상호관세 발표 여파로 지난 3일 3만5000선이 깨지면서 급락해 7일까지 3거래일 연속 하락했다. 7일 하루만 8% 가까이 폭락했다. 다음날인 8일 6%대 급등했으나 전일 다시 반락했다. 전일 트럼프 대통령이 관세 유예를 발표한 후 뉴욕증시는 전반적으로 급등했다. 트럼프 대통령은 이날 오전 자신의 소셜미디어(SNS) 트루스소셜 계정에 “지금은 매수하기 딱 좋은 시점(THIS IS A GREAT TIME TO BUY)”이라고 게시글을 올렸다. 트럼프 대통령이 증시의 하락을 막아준다는 의미의 ‘트럼프 풋(Put)’으로 해석되면서 시장이 들썩이기 시작했다.이후 오후 들어 트럼프 대통령은 중국을 제외한 모든 교역국을 대상으로 상호관세를 90일간 유예하기로 했다고 발표했다. 그외 국가에 대해선 기본 관세 10%는 유지하되 상호관세는 유예하는 것으로 국가별 적정 관세를 협상하기 위한 차원이라고 트럼프 대통령은 설명했다. 이에 기술주 중심의 나스닥 종합지수는 12% 이상 상승하며 역대 두 번째로 큰 상승폭을 기록했다. 미국 7대 대형 기술주, 일명 ‘매그니피센트7’(애플·아마존·알파벳·메타·마이크로소프트·엔비디아·테슬라, 이하 M7)의 시가총액이 하루에만 1조8600억달러(약 2705조원) 불어났다.
2025.04.10 I 김윤지 기자
 K-Bio’s Cult Leaders and Blind Believers
  • [Yoo Sung’s Pharma National Wealth Theory] K-Bio’s Cult Leaders and Blind Believers
  • [By Yoo Sung, Head of Bio Platform Center, Edaily] Can a company that claims to be devoted to its business for decades, yet has no proper product or significant revenue to show for it, be considered a legitimate enterprise? And can we really consider investors sane when they blindly trust such a company’s promise that a blockbuster drug is always just around the corner?As irrational as it sounds, this is exactly what’s happening across South Korea’s biotech venture scene. The K-Bio landscape is still rife with companies that have never developed a single drug or successfully licensed out a technology in decades. Even more baffling is the loyal cohort of retail investors who never question these firms and continue to invest in them with unwavering faith.These companies, which undermine trust in the broader K-Bio industry, still manage to position themselves as promising drug developers. Despite negligible revenues from actual drug development and their supposed core business, they excel at raising funds through rights offerings and convertible bonds. Their behavior is more akin to a financial firm than a biotech startup.[Image=Using ChatGPT]Many such companies announce plans to develop every high-profile drug, from COVID-19 vaccines to miracle treatments. But drug development is never their true goal, it’s a ruse to boost stock prices and secure funding. These pseudo-biotech ventures survive like parasitic fungi in the K-Bio ecosystem, enabled by the industry’s opaque development timelines.Because drug development typically spans around 10 years, these companies have ample cover to dress up their deception. Only seasoned investors can see through the charade. Once public attention fades, the promised drugs quietly disappear, repeating a cycle that leaves the company older, but still without a single meaningful product. In truth, they never intended to develop a drug. Their real aim was to siphon off investment.When Biotech Feels Like a CultInvestors who devote themselves to these companies often resemble followers of a cult, incapable of rational judgment. When founders boldly claim they’re on the verge of success in new drug development or global tech transfers, these investors believe every word. For them, the CEO becomes a kind of guru, and no statement no matter how absurd is questioned.Over time, the relationship between investor and company becomes almost religious. Long-term commitment hardens into emotional attachment, then evolves into blind faith. Even when presented with irrefutable evidence that the company is fraudulent or failing, these investors rarely waver. Worse still, they often lash out at critics and staunchly defend the firm.But in investing, selective belief leads to certain losses. Ignoring red flags and clinging to fantasies is a recipe for failure. Any company that claims to be in drug development for decades without producing a single viable drug is the very definition of a counterfeit biotech venture.Investors who treat such companies as sacred institutions must wake up. These pseudo-biotech firms are all heading for bankruptcy, only the arrival time differs. Even if you became a long-term investor against your better judgment, it’s never too late to get out. The only way to minimize your losses is to jump ship before it sinks.
2025.04.10 I 류성 기자
트럼프 관세 유예에…미국 M7 시총 하루만에 1.8조달러↑
  • 트럼프 관세 유예에…미국 M7 시총 하루만에 1.8조달러↑
  • [이데일리 김윤지 기자] 9일(현지시간) 뉴욕증시 주요 빅테크 종목이 일제히 급등했다. 도널드 트럼프 미국 대통령이 중국을 제외한 주요 무역 상대국에 상호관세 부과 90일 유예를 발표한 영향이다.9일(현지시간) 뉴욕증권거래소에서 트레이더가 깜짝 놀란 표정을 짓고 있다. (사진=AFP)로이터통신 등에 따르면 미국 7대 대형 기술주, 일명 ‘매그니피센트7’(애플·아마존·알파벳·메타·마이크로소프트·엔비디아·테슬라, 이하 M7)의 시가총액이 하루에만 1조달러(약 1400조원) 이상 불어났다. 이날 트럼프 대통령이 관세 유예를 발표한 후 뉴욕증시는 전반적으로 급등했다. 기술주 중심의 나스닥 종합지수는 12% 이상 상승하며 역대 두 번째로 큰 상승폭을 기록했다.애플은 전거래일 대비 15.33% 오른 198.85달러에 거래를 마쳤다. 이는 1998년 1월 이후 최대 주가 상승률이다. 시가총액은 4000억달러(약 581조원) 가까이 불어난 2조 9903억달러(약 4349조원)를 기록해 전날 마이크로소프트(MS)에 내줬던 시총 1위 자리를 되찾았다. 인공지능(AI) 칩 선두주자 엔비디아도 전거래일 대비 18.72% 상승한 114.33달러에 마무리됐다. 시총은 4400억달러(약 639조원)가까이 늘어났다. 이외 외에도 MS(10.13%), 아마존(11.98%), 메타(14.76%), 알파벳(9.68%), 테슬라(22.69%) 모두 날아올랐다. M7 종목들의 시총은 모두 1조8600억달러(약 2705조원) 증가했다. 그동안 시장을 이끌어온 M7 종목들은 최근 몇 달간 AI 투자 열풍에 대한 의구심과 트럼프 행정부의 관세 정책으로 인한 무역 전쟁 우려로 부진한 흐름을 보여줬다. 이들 종목들은 2024년 말 정점을 찍은 이후 현재까지 총 약 5조 달러의 시가총액을 잃었으며, 지난 2일 트럼프 대통령이 중국을 포함한 주요 교역국에 고율 상호관세를 부과한 이후 낙폭이 더 커졌다고 로이터는 전했다. 월가의 대표적인 ‘기술주 강세론자’로 분류되는 웨드부시 증권의 댄 아이브스 애널리스트는 트럼프 대통령의 90일 상호관세 유예 발표에 대해 “이번 조치는 기술주들에 절실히 필요했던 숨 고르기로 모두 벼랑 끝에서 한 발 물러났다”면서도 “애플의 공급망에 있어 중국은 여전히 가장 큰 변수로 남아 있다”고 지적했다.트럼프는 이날 오전 자신의 소셜미디어(SNS) 트루스소셜 계정에 “지금은 매수하기 딱 좋은 시점(THIS IS A GREAT TIME TO BUY)”이라고 게시글을 올렸다. 트럼프 대통령이 증시의 하락을 막아준다는 의미의 ‘트럼프 풋(Put)’으로 해석되면서 시장이 들썩이기 시작했다. 이후 오후 들어 트럼프 대통령은 중국을 제외한 모든 교역국을 대상으로 상호관세를 90일간 유예하기로 했다고 발표했다. 기본 관세 10%는 유지하되 상호관세는 유예하는 것으로 국가별 적정 관세를 협상하기 위한 차원이라고 트럼프 대통령은 설명했다. 대신 중국산 수입품에 대해선 관세를 125%로 올리며 중국을 더욱 압박했다.
2025.04.10 I 김윤지 기자
  • "변동성 큰 시장서 방어주 부각"…비자·마스터카드·페이팔
  • [이데일리 이주영 기자] 변동성이 큰 거시환경에서 결제 관련주들이 방어적인 역할을 할 것이라는 분석이 나왔다.9일(현지시간) 에버코어ISI는 보고서를 통해 비자(V)와 마스터카드(MA), 페이팔(PYPL)에 대해 이같이 평가하며 커버를 시작했다.세 종목에 대한 투자의견은 나란히 ‘시장 평균 수익률’로 제시하면서도 에버코어IS는 비자에 대해서는 ‘방어주의 강자’라고, 마스터카드는 밸류에이션에, 페이팔은 턴어라운드 여부에 주목한다고 밝혔다.먼저 비자에 대해서는 장기적 성장 모델이 그대로 유지되는 가운데 “고급 와인처럼 비자는 나이가 들수록 더 좋아진다”고 표현하기도 했다.이들이 제시한 비자에 대한 목표주가는 330달러였으며, 현재 가격대는 여전히 매력적인 구간으로 초과 수익률 달성이 가능할 것이라고 내다봤다.단기적으로 봤을 떄는 비자보다 마스터카드가 더욱 메리트가 있다는 게 에버코어ISI의 설명이다.특히 비자보다 마스터카드가 변동성은 크지만 역사적으로 더 빠른 매출 성장을 보이는데다 올해 더 나은 실적이 기대된다는 게 이들의 분석이다.페이팔은 대규모 소비자 및 판매자 확보가 강점이라며 에버코어ISI는 목표주가 65달러를 제시했다.그러나 이 종목은 브랜드 결제 부문에서 실행력이나 거시적인 요소에 대한 민감성에 취약하다는 약점을 갖고 있다고 해당 투자은행은 지적하기도 했다.
2025.04.09 I 이주영 기자
Hugel’s WELLAGE Makes Retail Debut at Costco in Canada
  • Hugel’s WELLAGE Makes Retail Debut at Costco in Canada
  • [NA Eun-kyung, Edaily Reporter] South Korean biopharmaceutical company Hugel said its clinical derma-cosmetic brand ‘Wellage’ has officially entered Costco stores in Canada, marking its first offline retail launch in North America.Hugel‘s clinical derma-cosmetic brand ’WELLAGE‘ (source: Hugel)The featured product is the “Real Hyaluronic Blue 100 Ampoule” set, which has become a steady seller both domestically and abroad since its 2020 launch. The product is known for its deep hydration and ability to improve inner skin dryness.In Korea, Wellage has shown continued sales growth through both online and offline channels, including Olive Young, Coupang and Musinsa. The brand expanded into Korean Costco stores in the second half of last year.Internationally, Wellage has been growing its presence across Asia ― including China, Japan, Hong Kong and Vietnam ― as well as on Amazon in the United States. The latest expansion into Costco includes not only the retail giant’s U.S. online store, but also brick-and-mortar locations in three major cities in Western Canada: Vancouver, Calgary and Kelowna.Hugel said the entry into one of the world’s largest retail networks is expected to serve as a key beachhead for Wellage’s growth in the North American beauty market.“We expect this first offline expansion in North America, following strong sales across major Asian markets, to enhance brand awareness and trust for Wellage,” a Hugel official said. “We will continue to highlight the strengths of K-beauty and solidify Wellage’s presence across global online and offline channels.”
2025.04.09 I 나은경 기자
ABL Bio Shares Surge on GSK Licensing Deal
  • ABL Bio Shares Surge on GSK Licensing Deal [K-Bio Pulse]
  • [Kim Jinsoo, Edaily Reporter] Shares of ABL Bio soared to the daily limit Friday after the company announced a 4 trillion won licensing deal with global pharmaceutical giant GSK. Meanwhile, Dt&CRO extended its rally, driven by speculation tied to upcoming presidential elections.In contrast, medical AI companies JLK and VUNO hit 52-week lows amid ongoing uncertainty, including concerns over potential U.S. tariffs.Recent Stock Performance of ABL Bio. (KG Zeroin’s MP Doctor)◇ABL Bio Soars on $3 Billion License-Out Deal with GSKAccording to KG Zeroin’s MP Doctor platform (formerly Market Point), ABL Bio shares surged from market open and closed at the daily upper limit, jumping 10,200 won to 44,250 won.ABL Bio said it signed a license-out agreement with GSK covering its blood-brain barrier (BBB)-penetrating platform Grabody-B. The deal is worth a total of 2.14 billion British pounds ($2.7 billion or 4.1 trillion won).Under the agreement, ABL Bio will receive £38.5 million ($48.7 million or 73.9 billion won) in upfront payments and £38.6 million in near-term milestones. Additional payments tied to development, regulatory, and commercialization milestones across multiple programs will follow.Excluding returned or canceled deals, this is the second-largest licensing agreement in South Korea’s biotech sector, following Alteogen’s 2020 deal with Merck & Co. (MSD).Grabody-B is a platform designed to help drugs cross the BBB, which acts as a defense shield against harmful substances but also blocks therapeutic agents. Grabody-B uses insulin-like growth factor 1 receptor (IGF1R) as a transport mechanism to deliver drugs into the brain.Under the agreement, the companies aim to develop multiple oligonucleotide- or polynucleotide-based therapies including siRNA and ASO drugs. ABL Bio will provide the core technology and know-how, while GSK takes charge of preclinical and clinical development, manufacturing, and commercialization.With this deal, ABL Bio’s cumulative license-out volume approaches 7 trillion won. Since 2018, the company has signed major licensing deals with Yuhan Corp. (59 billion won), Compass Therapeutics ($410 million in 2018 and $185 million in 2021), SystImmune ($363.5 million), and Sanofi ($1.06 billion in 2022).“This collaboration is expected to address unmet needs for patients suffering from degenerative brain diseases,” an ABL Bio official said.◇Dt&CRO Shares Climb on Political SpeculationDt&CRO’s share price jumped 20.51% to close at 8,930 won, continuing gains from the previous session when it hit the daily limit. The rally is attributed to the stock being labeled a “political theme stock” ahead of the presidential election.The company is often linked to candidate Han Dong-hoon, as independent board director Lee Sung-kyu shares an academic background with Han—both graduated from Seoul National University School of Law and Columbia Law School in the U.S.Dt&CRO positions itself as Korea’s first full-service CRO, covering everything from preclinical to clinical development. It offers services such as GLP toxicology testing, pharmacokinetics/pharmacodynamics (PK/PD), efficacy evaluation, analytical testing, bioequivalence studies, clinical trials, and regulatory consulting for FDA and EMA approvals.The company said there were “no specific issues related to core operations” affecting recent share movement.◇Medical AI Firms JLK, VUNO Hit Lows on Tariff JittersMedical AI firms JLK and VUNO both saw their shares tumble to new 52-week lows. JLK closed at 5,970 won, down 9.82%, after falling as low as 5,960 won during the session. VUNO dropped 11.01% to close at 16,240 won, with an intraday low of 16,190 won.The drop is largely attributed to concerns over potential U.S. tariffs. While JLK and VUNO’s AI solutions are categorized as software, not hardware, there is growing worry they could be affected by future customs decisions.JLK has secured 510(k) FDA clearances for seven AI-based solutions, including MEDIHUB Prostate, JBS-LVO, JLK-CTP, JLK-PWI, JLK-ICH, JLK-ailink, and SDH. The company is currently focused on establishing early-stage supply chain partnerships with hospitals in key regions.“The recent market downturn reflects broader external conditions rather than internal fundamentals,” a JLK official said.VUNO is expected to receive U.S. Food and Drug Administration (FDA) clearance for its cardiac arrest prediction solution, VUNO Med DeepCARS, in the first half of this year. The company plans to turn profitable through sales of the AI-powered device but may need to revise its strategy depending on future U.S. tariff decisions.“The recent drop in our stock price reflects turbulence in domestic and global markets,” a VUNO spokesperson said. “However, our flagship solutions are making visible progress in overseas markets, and regulatory processes that were previously stalled due to organizational changes at the FDA are now moving forward as a dedicated officer has been assigned.”The company added that it expects its share price to recover as regulatory progress accelerates and product rollout overseas gains traction.
2025.04.09 I 김진수 기자
Samsung Bioepis’ biosimilar EPYSQLI now available in the U.S.
  • Samsung Bioepis’ biosimilar EPYSQLI now available in the U.S.
  • [Lim Jeong-yeo, Edaily Reporter] EPYSQLI, a biosimilar to Soliris, is now available in the U.S. for 30% discounted price to the original, Teva Pharmaceuticals and Samsung Bioepis announced Tuesday.EPYSQLI is a biological treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria(PNH), atypical hemolytic uremic syndrome(aHUS) and generalized myasthenia gravis(gMG) in adult patients who are anti-acetylcholine receptor(AchR) antibody positive. EPISQLI(Photo=Samsung Bioepis)“Individuals living with rare diseases often have limited access to life-enhancing medicines,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “We are proud to launch EPYSQLI in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities,” Rainey said.“Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment. The availability of EPYSQLI means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product. Based on our robust track record supplying biosimilars in the U.S., we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, Executive Vice President and Head of Global Commercial Division of Samsung Bioepis. The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively.Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label. Two-thirds of patients discontinue eculizumab within an average of 1.5 years, which can be attributed to several factors including high treatment cost.Biosimilars, like EPYSQLI, are highly similar to their reference product with no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies. Biosimilars are approved according to the same standards of pharmaceutical quality that apply to all biological medicines, with comparable safety and efficacy to the reference product expected. The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients, Samsung Bioepis emphasized.In July 2024, EPYSQLI was approved by the U.S. Food and Drug Administration(FDA) as a biosimilar to Soliris for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody positive. The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris, following the expiration of exclusivity for the first interchangeable biosimilar. In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of EPYSQLI in the U.S. market. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing and supply, while Teva is responsible for the commercialization of the product in the U.S., leveraging its experience and extensive sales and marketing infrastructure.
2025.04.08 I 임정요 기자
K-Bio Stocks Fall as Tariff Concerns Offset Political Clarity
  • K-Bio Stocks Fall as Tariff Concerns Offset Political Clarity[K-Bio Pulse]
  • [NA Eun-kyung, Edaily Reporter] South Korean biotech stocks fell Friday despite the easing of political uncertainty following the impeachment of former President Yoon Suk-yeol, as investor focus shifted to looming tariff risks in the pharmaceutical sector.While shares linked to presidential hopefuls―including figures like Lee Jae-myung and Han Dong-hoon―saw gains, most pharmaceutical and biotech stocks underperformed amid concerns over potential U.S. trade measures on drug imports.◇Healthcare indexes fall across the boardAccording to MP Doctor by KG Zeroin, the KRX Healthcare Index closed at 3,709.39, down 0.37% from the previous session. The KRX 300 Healthcare Index dropped 0.50% to 3,343.85, and the KRX Bio Top 10 Index fell 1.19% to 2,302.95. The Kospi 200 Healthcare Index also lost 1.15% to close at 1,971.44.The only bright spot was the Kosdaq 150 Healthcare Index, which rose 0.69% to 4,420.44, supported by gains in Peptron, Voronoi, and CHA Biotech.Investors had expected healthcare stocks to rebound following the impeachment ruling, but comments by former U.S. President Donald Trump the previous day dampened sentiment. Trump said he would announce new tariffs targeting the pharmaceutical sector, raising concerns about future export barriers for Korean drugmakers.◇‘Han Dong-hoon themed stocks’ rallyDt&CRO, widely regarded as a “Han Dong-hoon-themed stock,” hit its daily limit to close at 7,410 won. Its parent company, Dt&C, rose 8.97%.Recent stock performance of Dt&CRO(Source: KG Zeroin MP Doctor)Dt&CRO, a contract research organization, is linked to Han due to its outside director Lee Sung-kyu, a classmate of the former justice minister at Seoul National University Law School and Columbia Law School. Lee, a partner at the law firm HwaWoo, was recently reappointed to Dt&CRO’s board.“There was no specific issue that drove today’s stock movement,” a Dt&CRO spokesperson said. “However, we recently opened a PK/PD center and brought in several high-level executives from global pharmaceutical firms earlier this year.”Among the new hires is Chief Strategy Officer Lim Yoon-ah, who previously worked at GSK, Sandoz, and Abbott. She is now leading the company’s integrated nonclinical-clinical strategy and global expansion efforts.Dt&C Biogroup plans to co-host an investor relations event on June 17 in Boston with its U.S. partner Radius Research, aiming to connect Korean biotech startups with major American venture capital firms.Another Han Dong-hoon-linked stock, NOUL, gained 7.61% to close at 2,970 won. The diagnostics company is tied to Han through its outside director Lee Sun-ji, who shares academic and professional ties with the former minister, including time at Kim & Chang law firm and Columbia Law School.◇‘Lee Jae-myung linked stock’ sees wild swingsShares of Orient Bio, considered a “Lee Jae-myung-themed stock,” tumbled 7.59% to 1,862 won after a volatile session. The stock surged to 2,500 won immediately following the impeachment ruling at 11:30 a.m., before falling back.Trading volume for Orient Bio exceeded 86 million shares, the highest among Kospi-listed firms excluding funds.The company, a subsidiary of Orient Watch, operates in biomedical research, lab equipment, and drug development. It became associated with Lee, leader of the Democratic Party, due to his past employment at an Orient Watch factory.Orient Bio is developing OND-1, an injectable hair loss treatment with a new mechanism of action. The company claims the product showed significantly higher efficacy in preclinical animal trials with lower toxicity than existing treatments like Propecia and Minoxidil.However, the project remains in the preclinical stage, and analysts say it is too early to gauge whether the company can rise above “theme stock” status. In January, Orient Bio signed a contract for primate toxicity studies as part of its preclinical development for OND-1.
2025.04.08 I 나은경 기자
SK Biopharmaceuticals Presents Key Cenobamate Study Results at AAN Annual Meeting
  • SK Biopharmaceuticals Presents Key Cenobamate Study Results at AAN Annual Meeting
  • [Kim Jinsoo, Edaily Reporter] SK Biopharmaceuticals announced Sunday that its U.S. subsidiary, SK Life Science, is presenting key findings on cenobamate (marketed in the U.S. as Xcopri) at the 77th Annual Meeting of the American Academy of Neurology (AAN), held April 5 in San Diego, California.(AAN Home page)The presentations include both clinical trial results and real-world data (RWD) supporting cenobamate’s role in reducing seizures and optimizing epilepsy management.The study involved a retrospective, multicenter analysis conducted in the United States with 37 adult patients (age 18 and older) with focal seizures. Patients had been taking cenobamate at a dose of 50 mg/day or higher as adjunctive therapy for at least two weeks. The researchers analyzed responsive neurostimulation (RNS) data from these patients.The study met its primary endpoint, showing a statistically significant reduction in epileptiform activity during the 12-week treatment period compared with the 8-week baseline. The frequency of epileptiform activity declined by approximately 84 percent, from a baseline average of 15.7 events per 28 days to 2.5 events per 29 days at the final assessment.The most commonly reported adverse events were dizziness and drowsiness. However, these effects were mitigated by gradual dose escalation of cenobamate or dose reduction of concomitant antiseizure medications (ASMs).“Seizure freedom remains a critical treatment goal for many people with epilepsy, though it is difficult to achieve,” said Louis Ferrari, vice president of medical affairs at SK Life Science. “This study is meaningful in that it evaluates the effectiveness of cenobamate and other adjunctive ASMs using RNS data as an objective measure.”SK Life Science is also presenting a total of six poster presentations at the conference, offering a comprehensive analysis of cenobamate’s efficacy, safety and therapeutic potential. The company aims to demonstrate the broad applicability of the treatment across diverse patient populations and to support future therapeutic strategies.
2025.04.07 I 김진수 기자
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