Biotechnology
QL Biopharm reports Phase 2 results of a monthly dose study evaluating zovaglutide, a novel, extended half-life GLP-1 receptor agonist at EASD 2025
* Patients who received zovaglutide at a once-monthly dose of 160 mg experienced a 13.8% reduction in body weight at 24 weeks, highly comparable to reductions observed in patients who received 80 mg every other week (12.5%) * The overall safety and tolerability of zovaglutide were consistent ...
2025-09-18 21:00
1663
Innovent's Partner Ollin Announces Clinical Updates on IBI324 (OLN324, VEGF/ANG-2)
SAN FRANCISCO and SUZHOU, China, Sept. 18, 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 metabol...
2025-09-18 12:00
1723
Neuronata-R® Phase 3 Results Confirm Subgroup Benefit at PACTALS 2025, Strengthening Biomarker-Driven Pathway
Meaningful improvements confirmed in slow-progressor subgroup; biomarker reductions support precision-medicine approach and potential FDA accelerated pathway SEOUL, South Korea, Sept. 17, 2025 /PRNewswire/ -- CorestemChemon Inc. (KOSDAQ: 166480) announced today that it has presented key findings...
2025-09-18 10:28
1724
CARsgen Presents Updated Long-term Follow-up Results for Zevor-cel at IMS 2025
SHANGHAI, Sept. 17, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the updated long-term follow-up results of Phase I clinical trial of zevorcabtagene autoleucel (zevor-cel, R&D code...
2025-09-18 08:15
1997
Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025
--Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne compared with placebo. --Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Treatment emergent adverse events (TEAEs)...
2025-09-18 07:30
1674
MagicRNA's First-in-Human Clinical Data Demonstrating Feasibility of In Vivo CAR T Therapy in Systemic Lupus Erythematosus Published in The New England Journal of Medicine.
* First-ever clinical data supporting safety and efficacy of in vivo CAR-T Therapy in refractory systemic lupus erythematosus (SLE) patients. * Data shows low dose of HN2301 reprogrammed up to 60% of CD8+ CAR+ T-cells in the peripheral blood of patients, resulting in complete depletion of cir...
2025-09-18 05:09
1439
Mabwell Bioscience and Aditum Bio Announce Formation of Kalexo Bio to Advance Innovative siRNA Therapy for Cardiovascular Disorders
SHANGHAI and OAKLAND, Calif., Sept. 17, 2025 /PRNewswire/ -- Mabwell (Shanghai) Bioscience Co., Ltd. (688062.SH) and Aditum Bio today announced the launch of Kalexo Bio, a new company formed in conjunction with an exclusive global license agreement to develop2MW7141, a novel dual-target siRNA cand...
2025-09-17 20:00
1464
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
1946
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
1582
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
1283
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
1514
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
5058
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
1427
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
1551
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
1576
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
1519
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
1167
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
1779
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
1339
LakeShore Biopharma Announces Receipt of Delisting Determination Letter from Nasdaq
BEIJING, Sept. 12, 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 ...
2025-09-12 20:00
1916
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