Pharmaceuticals
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
2930
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
3033
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
3111
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
3612
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
2232
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
2207
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
2714
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
2908
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
2405
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
1699
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
2365
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
4110
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
3436
Energenesis Biomedical Announces Positive Phase I Results for ENERGI-F705PD, a Potential Disease-Modifying Treatment for Parkinson's Disease
* The Phase I trial of ENERGI-F705PD tablet was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of the investigational drug in 24 healthy subjects. * The results confirmed the favorable safety and tolerability profile of ...
2025-08-01 15:52
2737
Chipscreen Biosciences' Brain-Penetrant Aurora B Selective Inhibitor CS231295 Tablet Receives FDA IND Approval, Advancing Global Clinical Development
SHENZHEN, China, July 31, 2025 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") announced that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) ...
2025-07-31 17:55
3285
Akeso Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC
HONG KONG, July 30, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment o...
2025-07-31 09:46
2666
BON Launches AI-Powered New Drug Research and Development
XI'AN, China, July 30, 2025 /PRNewswire/ -- Bon Natural Life Limited (Nasdaq: BON) ("BON" or "the Company"), a leading provider of bio-ingredient solutions for the natural health and personal care industries, today announced the official launch of its AI-driven drug research and development (R&D)...
2025-07-30 21:00
3828
Harbour BioMed to Present Phase II Data of HBM4003 and Tislelizumab Combination in MSS Metastatic Colorectal Cancer at ESMO 2025
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 29, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced that it will present Phase II ...
2025-07-30 08:01
2895
Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat
* CBL-514, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. andCanada in Q3 2025. * CBL-514 is the first 505(b)(1) inve...
2025-07-28 17:51
5652
Alteogen Receives Positive CHMP Opinion for Aflibercept Biosimilar, 'EYLUXVI® (ALT-L9)'
* CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing EYLUXVI® to the reference product Eylea® * Upon approval, EYLUXVI® will be Alteogen's second biosimilar product, following a Herceptin® biosimilar by Alteogen's license partner Qilu Pharm...
2025-07-28 14:00
4041
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