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Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints

HONG KONG, Aug. 25, 2025 -- Akeso Inc. (9926.HK) ("Akeso" or "the Company") today announced positive results from its Phase 3 clinical trial of gumokimab (AK111), a novel, fully human anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis (AS). The study successfully met all primary efficacy endpoints, including ASAS20 and subgroup analyses, as well as the key secondary endpoint ASAS40. Furthermore, several pre-specified secondary endpoints demonstrated both statistically significant and clinically meaningful improvements, further supporting th
- 김갑성 기자
- 2025-08-25 13:46
Cambrex Expands Peptide Manufacturing Capabilities in Waltham, Massachusetts

EAST RUTHERFORD, N.J., Aug. 25, 2025 -- Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced that Snapdragon Chemistry, a Cambrex company, has expanded its active pharmaceutical ingredient (API) facility in Waltham, Massachusetts to further support the development and manufacturing of peptide therapies. The new GMP manufacturing suite increases the overall facility footprint by 20% and includes an ISO-7 cleanroom for preparative HPLC chromatography and lyophilization, cold storage for raw materials and a product storage suite. Wi
- 김갑성 기자
- 2025-08-25 12:01
캠브렉스, 매사추세츠주 월섬에서 펩타이드 제조 역량 확장

이스트 러더퍼드, 뉴저지, 2025년 8월 25일 -- 글로벌 의약품 위수탁개발생산(CDMO) 선도 기업인 캠브렉스(Cambrex)가 오늘 자회사인 스냅드래곤 케미스트리(Snapdragon Chemistry)의 매사추세츠주 월섬 소재 원료의약품(API) 생산 시설을 확장하여 펩타이드 치료제 개발 및 생산 지원 역량을 더욱 강화했다고 발표했다. 새로운 GMP(Good Manufacturing Practice) 제조 라인은 전체 시설 면적을 20% 확장했으며, 정제용 HPLC 크로마토그래피 및 동결건조를 위한 ISO-7 등급 클린룸, 원자재 및 완제품 보관을 위한 저온 보관소를 포함한다. 이번 투자를 완료함으로써 스냅드래곤은 고체상 펩타이드 합성(SPPS), 액체상 펩타이드 합성(LPPS) 또는 하이브리드 접근법을 활용해 펩타이드 프로젝트의 개발부터 GMP 제조까지 지원할 수 있게 됐다. 에릭 팡(Dr. Eric Fang) 스냅드래곤 케미스트리 총괄 매니저는 "우리는 펩타이드 신약 후보 개발을 위해 3단계 전략을 염두에 두고 이 시설을 설계했다"며 "개념 증명 단계에서는 자동화된 SPPS 기술을
- 김갑성 기자
- 2025-08-25 12:01
Manulife Hong Kong and Macau Strengthens Leadership Team to Advance Health, Product, and Strategy

HONG KONG, Aug. 25, 2025 -- Manulife Hong Kong and Macau are pleased to announce three senior leadership appointments that underscore its commitment to executing strategic priorities and accelerating business growth. Danny Lee has been named Chief Health Officer, KC Cheung as Chief Product Officer, and Louisa Li as Chief Strategy Officer and Head of Macau Branch. These appointments reflect the company's sharpened focus on advancing its health proposition, driving product innovation, strengthening strategic planning, and accelerating expansion in the Macau market. Danny Lee Appointed Ch
- 김갑성 기자
- 2025-08-25 12:00
Harbour BioMed Appoints Yajie Li as Chief Medical Officer

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Aug. 25, 2025 -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced the appointment of Yajie Li as Chief Medical Officer (CMO). Ms. Li will be based in Shanghai and report directly to Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. In this role, Ms. Li will lead clinical development, regulatory strategy, and medical affair
- 김갑성 기자
- 2025-08-25 09:00
Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, Aug. 25, 2025 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major therapeutic areas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lun
- 김갑성 기자
- 2025-08-25 08:00
MALAYSIA HEALTHCARE TRAVEL COUNCIL LAUNCHES MH WELLNESS FAIR 2025, CHAMPIONING HEALTHY YOUTHS

KUALA LUMPUR, Malaysia, Aug. 23, 2025 -- The Malaysia Healthcare Travel Council (MHTC) today launches the first edition of its MH Wellness Fair 2025 series, themed "Young & Healthy Champions", in conjunction with the United Nations' International Youth Day that is celebrated every 12th August. The fair celebrates and empowers young people to take charge of their health and wellbeing. Held at The Campus, Ampang, the fair brings together leading health experts, fitness innovators, cultural performers, and wellness brands under one roof. With the aim of empowering co
- 김갑성 기자
- 2025-08-23 17:46
엔젤얼라인 테크놀로지, "특허 침해 아냐, 적극 방어할 것"

샌클레멘테, 캘리포니아주, 2025년 8월 23일 -- 엔젤얼라인 테크놀로지(Angelalign Technology, 이하 "엔젤")가 얼라인 테크놀로지(Align Technology, ALGN)의 특허 침해 의혹을 전면 부인하며 적극적인 방어 의지를 피력했다. 엔젤의 리치 허쉬랜드(Rich Hirschland) 최고상업책임자(CCO) 겸 수석부사장은 "앤젤은 20년 넘게 임상을 중심으로 혁신을 일궈 온 역사가 있다. 경쟁사의 특허 위반 의혹 제기는 경솔하고 실익이 전혀 없는 것"이라며 "앤젤은 창립 이후 특허 관련 법규 준수에 막대한 투자를 했다. 이번 소송에서 승소를 확신한다"고 말했다. 앤젤은 오랫동안 클리어 얼라이너 분야에서 혁신을 선도했다. 첨단 제품으로는 수상 경력을 자랑하는 angelButton™과 angelHook, A6 하악 전진 시스템(올해 출시 10주년), angelKid 시스템, Intelligent Root System이 있다. 앤젤은 공정하고 건전한 경쟁을 통해 의사와 환자에게 기여하고자 최선을 다하고 있다
- 김갑성 기자
- 2025-08-22 23:04
WINVEST GROUP SUBSIDIARY IQI MEDIA PARTNERS WITH BIOCALTH TO DRIVE DIRECT-TO-CONSUMER SALES

RENO, Nev., Aug. 22, 2025 -- Winvest Group Limited (OTCQB: WNLV) ("Winvest"), an investment holding company with diverse media, entertainment, and technology portfolios, is pleased to announced that its subsidiary IQI Media Inc. has partnered with BioCalth International Inc., a world leader in the development of proprietary health supplements, to help BioCalth grow its direct-to-consumer sales. The two companies have entered into a content management agreement with profit-sharing incentives that they hope will lead to a long-term relationship marked by increased reven
- 김갑성 기자
- 2025-08-22 20:00
Antengene Announces 2025 Interim Financial Results Highlighting Encouraging Data from Mid/Late-Stage Clinical Programs and Its Innovative TCE Technology Platform

The Phase I/II CLINCH study of ATG-022 (CLDN18.2 antibody-drug conjugate) demonstrated promising results, showing robust clinical efficacy and a favorable safety profile in patients with gastric/gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels. Supported by these results, ATG-022 was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The Phase I/II STAMINA study of ATG-037 (Oral CD73 small molecule inhibitor) is progressing smoothly. The la
- 김갑성 기자
- 2025-08-22 18:14

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발행인 : 최희정 | 편집인 : 김갑성 |
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UPDATE: 2025년 09월 05일 13시 00분