Pharmaceuticals
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
1655
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
3415
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
2458
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
2106
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
2129
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
1865
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
2098
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
1992
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
1818
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
1869
NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
HONG KONG, July 28, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with ...
2025-07-28 12:14
3558
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
- First participants with obesity or overweight with at least one w eight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor agonist ASC30. - Ultra-long-acting SQ depot for...
2025-07-28 08:15
2035
Harbour BioMed Announces Positive Profit Alert for 2025 Interim Results
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 27, 2025 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a positive prof...
2025-07-28 08:11
2168
Phase II Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult Aga In China Reached Primary Endpoint
SUZHOU, China, July 25, 2025 /PRNewswire/ -- The Kintor Pharmaceutical Limited (the "Company") is pleased to announce that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of AGA has obtained top-line re...
2025-07-25 20:30
3442
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody dev...
2025-07-24 09:14
1458
HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma
* Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma, with an initial data readout expected in mid-2026 * HBM9378/WIN378 has the potential to be the first-to-market long-acting anti-TSLP antibody with twice-yearly dosing for asthma ...
2025-07-23 20:36
2198
Samsung Biologics reports second quarter 2025 financial results
* Recorded Q2'25 consolidated revenue of KRW 1,289.9 billion * Recorded Q2'25 consolidated operating profit of KRW 475.6 billion * Solid momentum sustained through capacity ramp-up and stable project execution INCHEON, South Korea, July 23, 2025 /PRNewswire/ -- Samsung Biologics (KRX: 207940...
2025-07-23 14:54
2176
METiS Technologies Showcases AI-Powered Nanodelivery Platform at the 2025 Controlled Release Society Annual Meeting
HANGZHOU, BEIJING, China and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- METiS Technologies, a global leader in AI-driven nanodelivery innovation, today announced the presentation of its latest research findings at the poster session of the 2025 Controlled Release Society (CRS) Annual Meeting...
2025-07-22 15:52
2488
DualityBio's Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation
SHANGHAI, July 21, 2025 /PRNewswire/ -- DualityBio (HKEX Stock Code: 9606.HK) announced thatthe U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. This designation is for the treatment of ad...
2025-07-22 10:25
2249
Bloomage Achieves FDA GMP Audit with Zero-Deficiency, Reinforcing Global Trust
PARSIPPANY, N.J., July 21, 2025 /PRNewswire/ -- Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has announced it successfully passed the U.S. Food and Drug Administration (FDA)'s on-site GMP audit with a "No Action Indicated" (NAI) result. This is the best ...
2025-07-21 21:00
1583
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