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UCB presents positive results from GEMZ phase 3 study at AES…

[ 메디채널 김갑성 기자 ] Seizure reduction: phase 3 study achieved primary endpoint as fenfluramine demonstrated a statistically significant reduction in countable motor seizure frequency (CMSF) compared with placebo1 Holistic benefit: secondary endpoints showed significant and clinically meaningful improvements in Clinical Global Impression–Improvement (CGI-I) in patients treated with fenfluramine compared with placebo1 Fenfluramine was generally well tolerated, with no new safety signals identified1 UCB plans to submit for regulatory approval of fenfluramine for the treatment of seizures asso
- 김갑성 기자
- 2025-12-08 15:25
GC Biopharma Ships First Doses of World's First Recombinant A…

- First anthrax vaccine developed using recombinant DNA technology- Annual production capacity of up to 10 million doses at GC Biopharma's facility YONGIN, South Korea, Dec. 8, 2025 -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, today announced the first shipment of BARYTHRAX inj., the world's first recombinant anthrax vaccine. The product, jointly developed by the Korea Disease Control and Prevention Agency (KDCA) and GC Biopharma, was granted regulatory approval in April as Korea's 39th locally developed new drug. The initial su
- 김갑성 기자
- 2025-12-08 14:36
CARsgen Announces Data of Allogeneic BCMA CAR-T Cell The…

SHANGHAI, Dec. 8, 2025 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that clinical data from its allogeneic BCMA-targeted CAR T-cell product candidate, CT0596, for the treatment of relapsed/refractory multiple myeloma (R/R MM) was presented in a poster at the 67th American Society of Hematology (ASH) Annual Meeting. The poster was titled "A First-in-Human Study of CT0596, an Allogeneic CAR T-Cell Therapy Targeting BCMA, in Patients with Relapsed/Refractory Multiple Myeloma." The publ
- 김갑성 기자
- 2025-12-08 10:08
Median PFS Trending Beyond One Year: Leads Biolabs' LB…

NANJING, China, Dec. 8, 2025 -- From December 6 to 9, 2025, the 67th Annual Meeting of the American Society of Hematology ("ASH") was held in Orlando, Florida, USA. Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) delivered an oral presentation on the opening day of the conference featuring the Phase I/II clinical results of LBL-034, a GPRC5D/CD3 bispecific antibody with a unique 2:1 structure and conditional activation, independently developed using the proprietary LeadsBody platform, for the treatment of relapsed/refractor
- 김갑성 기자
- 2025-12-08 10:00
IASO Bio Presents Updated Results for Equecabtagene Auto…

SHANGHAI and NANJING, China and PLEASANTON, Calif., Dec. 8, 2025 -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, announced the oral presentation of updated clinical data for its independently developed, fully human BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (Eque-cel), for the treatment of transplant-ineligible patients with high-risk newly diagnosed multiple my
- 김갑성 기자
- 2025-12-08 09:57
ASH 2025 Oral Presentation: Innovent Biologics Announces In…

SAN FRANCISCO and SUZHOU, China, Dec. 8, 2025 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced the initial data of the first-in-human trial of IBI3003, a novel trispecific antibody targeting G protein-coupled receptor C5D (GPRC5D), B-cell maturation antigen (BCMA), and CD3 for the treatment of relapsed or refractory multiple myeloma (R/R MM)
- 김갑성 기자
- 2025-12-08 09:02
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) d…

SINGAPORE, Dec. 8, 2025 First and only chemotherapy-free combination in the first-line setting to demonstrate an overall survival benefit versus osimertinib among Asian patients. Median overall survival not yet reached and is projected to exceed four years, which would surpass osimertinib monotherapy by more than one year. -- Johnson & Johnson today announced final overall survival (OS) results from the Asia patients of the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib monotherapy showed amivantamab plus lazertinib led to a clinically meanin
- 김갑성 기자
- 2025-12-08 09:00
Investment of Approx. USD 460,000 for the Development of a Proto…

TOKYO, Dec. 8, 2025 -- The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately JPY 70 million (USD 460,0001) for the development of a prototype detection test for mpox (formerly known as monkeypox2). Mpox is a viral infectious disease that has been spreading in the Democratic Republic of the Congo (DRC) and across sub-Saharan Africa. According to a situation report by the World Health Organization (WHO), more than 170,000 cases of mpox were confirmed in 141 countries between January 2022 and October 20253. WHO also reported that surveillance d
- 김갑성 기자
- 2025-12-08 09:00
CARsgen Announces Data of Allogeneic BCMA CAR-T Cell The…

SHANGHAI, Dec. 8, 2025 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that clinical data from its allogeneic BCMA-targeted CAR T-cell product candidate, CT0596, for the treatment of relapsed/refractory multiple myeloma (R/R MM) was presented in a poster at the 67th American Society of Hematology5 achieved PR or better. Six patients (ASH) Annual Meeting. The poster was titled "A First-in-Human Study of CT0596, an Allogeneic CAR T-Cell Therapy Targeting BCMA, in Patients with Relapsed/Refra
- 김갑성 기자
- 2025-12-08 08:15
RESPIREE SECURES SINGAPORE HSA APPROVAL FOR ITS AI-ENABLED 1BIO™A…

SINGAPORE, Dec. 8, 2025 -- AI/ML health-tech startup Respiree has received approval from the Health Sciences Authority (HSA) for its 1Bio™AI-Acute toolbox as a Class B software-as-a-medical device (SaMD). The solution is designed to support healthcare professionals in identifying acute inpatient deterioration using AI-enabled machine learning models. Compared to the current standard of care, 1Bio™AI-Acute delivers significantly higher precision in acute deterioration notifications, resulting in fewer false alerts and more efficient clinical support. The 1Bio™AI-Acute system use
- 김갑성 기자
- 2025-12-08 08:00

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발행인 : 최희정 | 편집인 : 김갑성 |
등록번호: 서울특별시 아53302 | 등록일 2020-09-25 | 전화번호 02-565-7119 |
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UPDATE: 2025년 12월 10일 19시 00분