Biotechnology

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 1721

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 1722

Results of China Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis Selected for Oral Presentation at 2025 AANEM Annual Meeting

YANTAI, China, Sept. 18, 2025 /PRNewswire/ -- RemeGen (688331.SH/09995.HK) announced that the 48-week open-label extension (OLE) data from China Phase III clinical study of telitacicept (RC18, brand name: 泰爱®, a BLyS/APRIL dual-target fusion protein innovative drug independently developed by Reme...

2025-09-18 09:00 1762

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 1995

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 1434

Terra Oleo Emerges from Stealth with US$3.1M in Funding and Breakthrough Energy Fellow Selection to Reinvent Fats and Oils

SINGAPORE, Sept. 18, 2025 /PRNewswire/ -- Terra Oleo, a Singapore-based biotechnology company, today announced its emergence from stealth withUS$3.1 million in funding from a group of investors, and support from Breakthrough Energy's prestigious Fellows Program. As part of this highly selective g...

2025-09-18 00:00 3239

Skyhawk Therapeutics Announces Positive First Interim Results in Patients from its Phase 1 Clinical Trial of SKY-0515 as a Treatment for Huntington's Disease

SKY-0515 achieves dose-dependent reductions of mutant huntingtin (mHTT) protein, with 62% lowering at Day 84 on the 9mg daily oral dose Additional findings include dose-dependent reductions in PMS1 mRNA, excellent brain penetration, and a favorable safety profile SKY-0515's Phase 2/3 FALCON-HD t...

2025-09-17 20:44 1420

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 1463

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 1944

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 1573

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 1511

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 1531

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 5054

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 1303

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 1547

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 1422

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 1548

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 1564
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