Biotechnology
Alteogen Receives European Commission Approval for Aflibercept Biosimilar, EYLUXVI® (ALT-L9)
* EYLUXVI® is the second biosimilar approved for Alteogen following the launch of the Herceptin® biosimilar in China through its partner Qilu Pharmaceutical. DAEJEON, South Korea, Sept. 17, 2025 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the European Commission (EC) has ...
2025-09-17 15:40
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Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)
WUXI, China, Sept. 17, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – have received GMP certification from Türkiye İlaç ve ...
2025-09-17 12:00
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Kexing Biopharm's Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Registered with FDA DMF
SHENZHEN, China, Sept. 16, 2025 /PRNewswire/ -- Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S. FDA. Exosomes, as a next-generation bioactive carr...
2025-09-17 10:30
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Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting
- ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment. - ASC30 tablet's higher efficacy is supported by its higher oral drug exposures. - ASC30 is safe and well tolerated with only mild-...
2025-09-17 07:30
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New Scientific Review Highlights β-Lactoglobulin's Dual Benefits for Metabolic and Muscle Health
Emerging evidence positions this dairy protein as a powerful nutritional ingredient – and 21st.BIO's precision fermentation could make it more sustainable than ever. COPENHAGEN, Denmark, Sept. 16, 2025 /PRNewswire/ -- β-Lactoglobulin (BLG), the most abundant whey protein in cow's milk is drawing...
2025-09-16 21:47
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Lunit Showcases AI-Powered Cancer Ecosystem at APEC High-Level Meeting on Health and the Economy and World Bio Summit 2025
Lunit highlights global leadership in cancer AI alongside world health experts with dedicated APEC HLMHE session and WBS 2025 Leaders' Dialogue SEOUL, South Korea, Sept. 16, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announc...
2025-09-16 21:00
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ShiraTronics Announces Positive 12-Month Follow-Up Results from RELIEV-CM Pilot Study, Demonstrating Sustained Clinical Benefit with Investigational Implantable Neuromodulation Therapy for Chronic Migraine
MINNEAPOLIS, Sept. 16, 2025 /PRNewswire/ -- ShiraTronics, Inc., a clinical-stage medical device company focused on developing novel neuromodulation therapies for chronic migraine, today announced compelling 12-month follow-up data from its RELIEV-CM Pilot Study. The findings demonstrate sustaine...
2025-09-16 19:00
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Celebrating Cross-Border Partnerships in Healthcare, Asia Medical Week 2025 Convened Leaders in Bali to Strengthen Excellence and Preparedness
BALI, Indonesia, Sept. 16, 2025 /PRNewswire/ -- The Asia Medical Week (AMW) and the Asia Medical Innovation and Development Forum 2025 officially took place fromSeptember 12-13 in Bali with a mission to bring together healthcare leaders from acrossAsia to strengthen cross-border collaboration and...
2025-09-16 13:37
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Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)
HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of acute myeloid leukemia (A...
2025-09-16 10:27
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Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the 34th EADV Congress 2025
SAN FRANCISCO and SUZHOU, China, Sept. 15, 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 oncology, autoimmune, cardiovascular and metaboli...
2025-09-16 09:00
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HitGen Partner BioAge Labs Initiates Phase 1 Clinical Study of BGE-102, a Novel Brain-Penetrant NLRP3 inhibitor
* BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technology platform, highlighting the value of DEL to accelerate innovative drug development. * The initiation of the BGE-102 Phase 1 clinical stud...
2025-09-15 21:30
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Korea reinforces biopharma leadership at Global Bio Conference 2025
SEOUL, South Korea, Sept. 15, 2025 /PRNewswire/ -- This is an article published in The Korea Herald: The Ministry of Food and Drug Safety on Thursday announced its successful hosting of the Global Bio Conference 2025 inSeoul last week, under the theme "Bio, Navigating Infinite Possibilities." T...
2025-09-15 20:30
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Biostar Pharma Successively Achieved First Patient Dosing for Two Phase II/III Multiregional Clinical Trials of Utidelone Capsule (UTD2)
SAN FRANCISCO, Sept. 15, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative onco...
2025-09-15 20:00
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Rona Therapeutics Announces IND Filing of RN3161, a Highly Potent and Durable INHBE siRNA for Obesity
SHANGHAI and SANTA BARBARA, Calif., Sept. 15, 2025 /PRNewswire/ -- Rona Therapeutics, a global leader in developing next-generation RNAi therapeutics, announced today the successful submission of RN3161 to the Australian Human Research Ethics Committee (HREC).RN3161 is a proprietary GalNAc-conjug...
2025-09-15 20:00
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Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class P...
2025-09-15 12:11
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Jointly discovered KAT6i molecule originating from Australian research has initiated Phase 3 in HR+ HER2- Breast Cancer with Pfizer Inc
Australian scientists who discovered how to "turn off" genes that make cancer cells grow are celebrating the next phase of development – with Pfizer's first in class KAT6 inhibitor PF-07248144 now moving to the next stages of clinical investigation. MELBOURNE, Australia, Sept. 15, 2025 /PRNewswi...
2025-09-15 12:06
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MGI Tech Introduces DNBSEQ-T7+: A Next-Generation 'Data Mining Machine' for Genomics
SHENZHEN, China, Sept. 15, 2025 /PRNewswire/ -- MGI Tech Co., Ltd. (MGI), a company dedicated to developing core tools and technologies that drive innovation in life sciences, announced the launch of the DNBSEQ-T7+, its latest high-throughput sequencer. Designed to meet the rising demand for larg...
2025-09-15 11:53
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Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations
SINGAPORE and GUANGZHOU, China, Sept. 15, 2025 /PRNewswire/ -- Lion TCR, a clinical-stage biotechnology company pioneering T-cell receptor (TCR)-based therapies, today announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initi...
2025-09-15 08:00
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Phrontline Biopharma Announces First Patient Dosed in Phase 1 Clinical Trial of TJ101
SHANGHAI and SUZHOU, China, Sept. 14, 2025 /PRNewswire/ -- Phrontline Biopharma , a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), today announced that the first patient has been successfully dosed in its Phase 1 clinical trial of TJ101, the com...
2025-09-15 08:00
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Real-World Evidence of NEFECON® to Be Presented in Seven New Abstracts at the 18th International lgAN Symposium
* 7 new NEFECON® real-world evidence abstracts will be presented at the 18th International lgA Nephropathy Symposium (IIgANN 2025). * The newly released results, based on clinical practices at several leading hospitals inChina, offer a comprehensive overview of the efficacy and safety of NEFE...
2025-09-15 07:45
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