Biotechnology
FDA Lifts Clinical Hold on NUZ-001
Highlights: * U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®'s lead investigational therapy for ALS * Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025 * IND supported by robust preclinical safety data and comprehensive manufacturing and ...
2025-10-06 14:06
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Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States
* The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA® (tocilizumab) * AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA * This launch stre...
2025-10-02 20:30
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AI Drug Discovery Pioneer, Nanyang Biologics Pte. Ltd., Enters into Business Combination Agreement with RF Acquisition Corp II in US$1.5B Transaction to Pursue Public Listing
* Nanyang Biologics Pte. Ltd., together with its subsidiaries (collectively, the "Company", "we" or "NYB"), offers a comprehensive drug discovery platform that integrates the wisdom of traditional medicine with state-of-the-art technologies. * Patented Flagship NB-A002 is a First-in-class DNA...
2025-10-02 19:50
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Full-Life Technologies Announces US$77 Million Financing to Accelerate Development of its Radiopharmaceutical Pipeline and Manufacturing Capabilities
* Series C led by Junson Capital along with new investor syndicate and existing shareholders * Funding will further advance Full-Life's global radiopharmaceutical pipeline and manufacturing capabilities inBelgium * Additional debt financing provides an alternative financing solution for Ful...
2025-09-30 08:00
1459
Viva Biotech Receives Frost & Sullivan's 2025 APAC Technology Innovation Leadership Recognition in the Integrated Intelligent Drug Discovery Industry
Viva Biotech is acknowledged for its pioneering AI-driven drug discovery platforms that accelerate timelines, reduce costs, and expand therapeutic innovation in the global pharmaceutical R&D ecosystem. SHANGHAI, Sept. 29, 2025 /PRNewswire/ -- Viva Biotech announced today that it has been honored...
2025-09-29 17:00
872
The 2025 BPD Singapore Conference Has Concluded Successfully! Jointly Embarking on a New Journey for Global Development
SINGAPORE, Sept. 26, 2025 /PRNewswire/ -- The 2025 BPD (Biopharmaceutical Bioprocess Development) Singapore Summit, which co-hosted by WuXi XDC (Stock Code: 2268.HK), was successfully concluded fromSeptember 24-26, 2025. The conference brought together leading biopharmaceutical companies and rese...
2025-09-27 10:45
3597
Jacobio Chairman and Concerted Parties Increase Shareholding by Nearly HK$100 Million, Demonstrating Confidence in Long-term Growth
BEIJING, SHANGHAI and BOSTON, Sept. 25, 2025 /PRNewswire/ -- Jacobio Pharmaceuticals (1167.HK)today announced that its Chairman and Chief Executive Officer, Dr. Yinxiang Wang, together with concerted parties, have recently increased their shareholding in the Company by 11.06 million shares, repr...
2025-09-26 08:47
1580
Bambusa Therapeutics Announces Highly Positive Healthy Volunteer Results and First Atopic Dermatitis Patient Dosed in Phase I Trial of BBT001
BOSTON, Sept. 25, 2025 /PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa Therapeutics), a clinical-stage biotechnology company pioneering next-generation bispecific antibodies for immunology and inflammation, today announced two landmark achievements for its lead program, BBT001. Last week, Ba...
2025-09-25 22:04
1723
WuXi Biologics Launches WuXia™4.0, Targeted Integration Cell Line Platform TrueSite TI™，to Accelerate Biologics Development with High Titer and Superior Stability
* TrueSite TI™, the fourth generation of WuXia™ cell line platform, leverages targeted integration technique to streamline clone screening and guarantees expression stability. * The platform has achieved an average mAb titer exceeding 8.0 g/L with over 99% of clonal cell lines maintaining sta...
2025-09-25 19:42
1567
Lunit, CellCarta Announce Global Alliance to Expand Access to Digital Pathology AI for Clinical Trials
SEOUL, South Korea and MONTREAL, Sept. 24, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and biomarkers for oncology therapeutics, today announced a strategic partnership with CellCarta, a globally recognized provider of CRO laboratory services for p...
2025-09-24 21:00
2040
HKeyBio Lauched the Most Comprehesive Non-human Primate Autoimmune & Allergic Disease Model Matrix to Redefining Clinical Translation
BOSTON and SUZHOU, China, Sept. 23, 2025 /PRNewswire/ -- HKeyBio, a CRO specializing in preclinical and translational autoimmune-drug development, today announced the launch ofHKEY-NHP-MATRIX2.0, a next-generation platform designed to improve the reliability of translating novel autoimmune and al...
2025-09-23 20:35
1555
GC Biopharma Submits IND Application for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea
YONGIN, South Korea, Sept. 22, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading South Korean pharmaceutical company, announced today that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) inSouth Korea for a Phase 1 clinical tria...
2025-09-23 09:41
1442
Lunit and Agilent Technologies Announce Collaboration to Enhance Development of Companion Diagnostic Solutions Powered with AI for Precision Medicine
Collaboration combines Lunit's AI expertise with Agilent's diagnostic leadership to revolutionize biomarker testing and enhance precision medicine capabilities SEOUL, South Korea, Sept. 22, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeuti...
2025-09-22 21:00
1844
Galux Demonstrates De Novo Antibody Design With Structural and Functional Validation Across Eight Targets
* Study confirms the novelty and atomic-level precision of de novo antibody design, including cryo-EM validation on a designed anti-PD-L1 antibody * Findings highlight broad therapeutic applicability across oncology, immune, and metabolic diseases SEOUL, South Korea, Sept. 22, 2025 /PRNewswire...
2025-09-22 21:00
1749
LakeShore Biopharma Announces Transition to OTC Market Following Nasdaq Delisting
BEIJING, Sept. 22, 2025 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious ...
2025-09-22 20:00
2940
Akeso Announces First Patient Dosed in Registrational Phase II Study of TIGIT/TGF-β Bifunctional Antibody Fusion Protein AK130 Combined with Ivonescimab for Advanced Pancreatic Cancer
HONG KONG, Sept. 22, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) has announced that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab ...
2025-09-22 14:51
1366
WuXi AppTec Implements Its First Interim Dividend Plan, Distributing RMB1.03 Billion in Cash Dividends
SHANGHAI, Sept. 21, 2025 /PRNewswire/ -- WuXi AppTec Co., Ltd. (Stock Codes: 603259.SH/2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, implemented its first interim dividend plan, d...
2025-09-22 08:00
1550
Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes
SAN FRANCISCO and SUZHOU, China, Sept. 19, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabol...
2025-09-19 18:01
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DarwinCell Showcases novel MSC-based drug ALT001 at the 150th American Neurological Association Annual Meeting
BALTIMORE, Sept. 19, 2025 /PRNewswire/ -- The 150th American Neurological Association Annual Meeting (ANA 2025) was successfully held inBaltimore, USA, fromSeptember 13 to 16, 2025. The conference brought together leading global experts, scholars, and industry leaders in the field of neuroscience...
2025-09-19 17:28
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2025 IMS | IASO Bio Highlights Three-Year Follow-Up Data of CAR-T Cell Therapy Fucaso for Multiple Myeloma Treatment
SHANGHAI, NANJING, China and PLEASANTON, Calif., Sept. 18, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies, today announced that the 36-month long-term foll...
2025-09-19 09:39
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