Pharmaceuticals
Aquedeon Medical Inc. Receives FDA Approval to Expand Clinical Trial of Duett Vascular Graft System
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. SUNNYVALE, Calif., Aug. 12, 2025 /PRNewswire/ -- Aquedeon Medical Inc. (AMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the expansion of its Investigationa...
2025-08-12 20:00
1491
Fosun Pharma's Small Molecule Innovative Drug XH-S004 Achieves Overseas Licensing for a Potential Total of $645 Million
SHANGHAI, Aug. 11, 2025 /PRNewswire/ -- On August 11, Fosun Pharma (SSE:600196, HKEX: 02196) announced that its subsidiary Fosun Pharma Industrial has signed a License Agreement withExpedition Therapeutics Inc.(Expedition) to grant Expedition the rights to develop, manufacture, and commercialize ...
2025-08-12 09:36
1682
AMI Pharm Advances AYP-101 to Phase 3, Paving the Way for a New Era in Fat-Reduction Injectable drugs
— Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling — Phase 3 clinical trial underway in South Korea, following strong safety and efficacy results in earlier studies — AMI Pharm positions itself for global expansion in the multi-billion-dollar ...
2025-08-11 20:00
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Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy
HONG KONG, Aug. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody deve...
2025-08-11 10:52
1508
Hugel launches botulinum toxin Letybo in Malaysia
- The company strengthens brand experience for local medical professionals through academic events and hands-on workshops - It will solidify the market position of premium toxin products through Malaysian partner Venusys Medical SEOUL, South Korea, Aug. 10, 2025 /PRNewswire/ -- Hugel Inc., a lea...
2025-08-11 08:30
1961
WuXi XDC Included in MSCI China All Share Index
SHANGHAI, Aug. 8, 2025 /PRNewswire/ -- WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, today announced its inclusion in the MSCI China All Share Index, which unders...
2025-08-08 17:32
1757
US NCI Sponsors Senhwa Biosciences' Second Program-IND Submitted for Clinical Trial Targeting MYC-Aberrant Lymphoma
TAIPEI and SAN DIEGO, Aug. 7, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that US National Cancer Institute (NCI) sponsors Senhwa's second ...
2025-08-07 14:35
1833
FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS)
* Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS) [1] * AVTOMZA received FDA approval in January 2025, for multiple inflammatory indications including r...
2025-08-06 20:00
2088
The U.S. FDA Granted Fast Track Designation to Dizal's Birelentinib for Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
* Birelentinib (DZD8586) received Fast Track Designation from the U.S. FDA for relapsed/refractory CLL/SLL * Supporting data from a pooled analysis of phase I/II studies of birelentinib showed an objective response rate of 84.2% in heavily pretreated CLL/SLL patients SHANGHAI, Aug. 6, 2025 /P...
2025-08-06 19:02
1666
WuXi AppTec Named Constituent of the FTSE4Good Index Series for Third Consecutive Year
SHANGHAI, Aug. 5, 2025 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, today announced its inclusion in the FTSE4Good Index Series for the third consecutive year....
2025-08-06 08:00
2157
Sanyou Bio Wins the "2025 Best Customer Satisfaction CRO Award"
SHANGHAI, Aug. 5, 2025 /PRNewswire/ -- The highly anticipated 7th China Bio Innovation Expo was recently held in grand fashion in Suzhou. At the awards ceremony onAugust 1, Sanyou Bio was honored with the "2025 Best Customer Satisfaction CRO Award" in recognition of its deep expertise and outstan...
2025-08-05 22:00
2473
iNtRON Bio, Demonstrated Toxin-Neutralizing Effect of IMPA™ Phage Engineering Technology in Colorectal Cancer Model and Completed the US Patent Application
• Successful validation of payloaded anti-colibactin toxin phage using IMPA™ technology • Demonstrated 'Dual-target Therapeutic Strategy' by bacterial eradication and toxin neutralization • Filed the US patent application for the candidate substance and preclinical studies including PoC unde...
2025-08-05 20:00
1593
Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Small Molecule Oral GLP-1R Agonist, ASC30, in Participants with Obesity or Overweight
- 13-week U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of two oral formulations of ASC30, a once-daily tablet, in 125 participants with obesity or overweight. - All 125 participants enrolled in just over one month; topline data expected in the fourth ...
2025-08-05 18:50
1576
Fapon Biopharma Announces the enrollment of the First Patient in the Phase I Clinical Trial of FP008, A First-in-Class Immunotherapy for Solid Tumors
DONGGUAN, China, Aug 5, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech in developing therapeutic antibodies and fusion proteins, is delighted to announce the completion of the first patient enrollment inChina for its Phase I clinical trial of FP008 , a first-in-class immunotherapy for solid tum...
2025-08-05 16:30
1559
WuXi XDC Achieves GMP Release of Newly Launched DP3 Facility at Wuxi Site, Scaling Further Drug Product Manufacturing Capacity
WUXI, China, Aug. 4, 2025 /PRNewswire/ -- WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, announced that the Drug Product 3 ("DP3") facility at the Wuxi site has c...
2025-08-05 10:13
1646
Innovent Receives U.S. FDA Approval for IND Application of Oral GLP-1R Agonist IBI3032
SAN FRANCISCO and SUZHOU, China, Aug. 4, 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, cardiovascular and metabolic, autoimmune,...
2025-08-05 08:00
1667
Raytone Biotech Announces First Patient Dosed in Clinical Trial of RTP-008 for Dry Eye Disease
BEIJING, Aug. 3, 2025 /PRNewswire/ -- Raytone Biotech, a clinical-stage biotechnology company dedicated to innovative ophthalmic therapies, announced that it successfully completed the first patient dosing in its clinical trial of RTP-008 during Q2 2025. RTP-008 is a bioabsorbable tacrolimus lacr...
2025-08-04 14:29
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Akeso Announces Approval to Initiate Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
HONG KONG, Aug. 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by bothChina's National Medical Products Administration (NMPA) and the ...
2025-08-04 13:56
1824
Mabwell Announces IND Application Acceptance for CDH17-Targeting ADC 7MW4911 from Both NMPA and FDA
SHANGHAI, Aug. 1, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received Investigational New Drug (IND) application acceptance fromChina's Na...
2025-08-01 22:00
3517
Atombeat and BioDuro Announce Strategic Partnership to Launch an AI-Powered Platform for Accelerated Peptide Drug Discovery
SAN DIEGO, Aug. 1, 2025 /PRNewswire/ -- On July 30, 2025, Atombeat Inc., a leading force in AI for drug discovery, andBioDuro, a globally trusted Contract Research, Development, and Manufacturing Organization (CRDMO),announced a strategic collaboration to an AI powered platform for accelerated pe...
2025-08-01 18:08
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