Pharmaceuticals
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
1832
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
1379
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
1632
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
1504
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
1670
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
1715
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
1597
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
1835
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
1401
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
1995
Zhimeng Biopharma's Investigational Drug Approved to Initiate Phase 2 Epilepsy Clinical Trial in China
SHANGHAI, Sept. 11, 2025 /PRNewswire/ -- Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma") announced that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has recently received clinical trial approval from the Center for Drug Evaluation (CDE) ofChina's Nat...
2025-09-12 00:00
1849
C-Ray Therapeutics Supports Mednovo's Phase III Clinical Trial with First Patient Dosed for Lutetium [177Lu] Oxodotreotide Injection
CHENGDU, China, Sept. 10, 2025 /PRNewswire/ -- August 22, 2025, Mednovo Group Co., Ltd. ("Mednovo") announced that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection, a Class 3 targeted radiotherapeutic drug. As the exclusive...
2025-09-10 21:30
1141
LakeShore Biopharma Announces Appointment of Independent Financial Advisor and Legal Counsel to the Special Committee
BEIJING, Sept. 10, 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 ...
2025-09-10 20:10
1303
ImmVira Announces First-in-Human Data of Engineered Exosome MVR-EX105 for Fat Reduction and Muscle Preservation by Topical Application at 2025 Annual Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders
SUZHOU, China, Sept. 9, 2025 /PRNewswire/ -- ImmVira Group ("ImmVira" or the "Company") recently announced that its lead engineered exosome candidate, MVR-EX105 ("EX105") is featured in a poster presentation at the 2025 Annual Congress of the International Federation for the Surgery of Obesity an...
2025-09-10 10:49
1178
iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001
CHENGDU, China, Sept. 9, 2025 /PRNewswire/ -- iRegene Therapeutics (Chengdu) Co., Ltd. ("iRegene" or the "Company"), a biotechnology company pioneering chemically induced allogeneic cell therapy, announced on September 4th the successful completion of its Series B+ financing round, co-led by Nort...
2025-09-09 21:00
1320
Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC
SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in...
2025-09-09 18:00
1271
WuXi Biologics Launches Green CRDMO White Paper to Advance Sustainability in Biologics Industry
* End-to-end Green CRDMO solutions to enable global clients for broader positive impact * Span from biologics research, development, manufacturing, and overall operations * Integration with lean management and digitalization for continuous excellence * A comprehensive ecosystem featuring ...
2025-09-09 18:00
2670
Nobel Laureate Headlines Global Discussion in Cell & Gene Therapy in London
PISCATAWAY, N.J., Sept. 8, 2025 /PRNewswire/ -- Cell and gene therapies (CGT) are advancing rapidly and are reshaping the future of medicine. From CRISPR-based genome editing to new applications of in vivo and ex vivo cell therapies, scientific breakthroughs are increasingly moving from the labor...
2025-09-08 20:49
1238
Remplir™ Study Delivers Compelling 81% Success Rate
Data to support US sales roll out and EU + UK regulatory submissions * Interim results from a new Remplir™ study demonstrated a compelling overall treatment success rate of 81.1% following nerve repair procedures. * Real World Evidence (RWE) patient data collected in the study confirms Ortho...
2025-09-08 17:32
1542
Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332
* The overall survival (OS) hazard ratio (HR) in the HARMONi trial was 0.78, with a nominal p-value of 0.0332 * In the North American patients, the OS HR was 0.70 * The HARMONi trial has already demonstrated clinically meaningful and statistically significant progression-free survival (PFS) ...
2025-09-07 18:08
1770
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