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
1652
Alphamab Oncology Announces IND Application for Innovative PD-L1/αvβ6 Bispecific ADC JSKN022 was Officially Accepted by CDE
SUZHOU, China, Aug. 4, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, has been officially acce...
2025-08-04 09:28
2308
Alveolus Bio Secures Strategic Investment from Shilpa Medicare to Advance Groundbreaking Pulmonary Therapeutics
Shilpa Medicare Serves as Lead Investor, Positioning Alveolus Bio for Phase 2
Clinical Trials and First-in-Human Studies
CAMBRIDGE, Mass. and BIRMINGHAM, Ala. and RAICHUR, India, Aug. 4, 2025
/PRNewswire/ --Alveolus Bio
2025-08-04 08:00
2074
First Subject Enrolled in Phase 1 Clinical Trial for Luye Pharma's Investigational Antidepressant Targeting NET/DAT/GABAAR
SHANGHAI, Aug. 3, 2025 /PRNewswire/ -- Luye Pharma Group today announced that the first subject has been enrolled in a Phase 1 clinical trial inChina for its LY03021, which was filed throughChina's Class 1 pathway for innovative drugs. LY03021 is an inhibitor of the norepinephrine transporter (NE...
2025-08-03 18:23
2684
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
3404
Everest Medicines Expands Strategic Investment in I-MAB
- Everest will invest US$30.9 million (equivalent to approximately HK$242.6 million) in cash in I-Mab. Inclusive of I-MAB shares already held by Everest, the pro forma ownership will be 16.1%. - I-Mab's Claudin 18.2 x 4-1BB bispecific antibody, givastomig, demonstrated an impressive overall resp...
2025-08-01 21:02
3425
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
2452
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
2104
Norgine welcomes PBS listing in Australia of IFINWIL® (eflornithine) for patients with high-risk neuroblastoma (HRNB)
This news is for Australian Media only * Eflornithine is now reimbursed by the government under Australia's Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of eflornithine for post-maintenance treatment to prevent relapse in p...
2025-08-01 06:01
1960
Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Received U.S. FDA IND Approval to Initiate a Phase II Clinical Study for Platinum-Resistant Ovarian Cancer
SUZHOU, China, July 31, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study inthe United States (study n...
2025-07-31 18:36
2591
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
2112
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
1858
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
2090
Emerald Clinical Trials Confirms CEO Transition and Continuity Plan
SINGAPORE, July 30, 2025 /PRNewswire/ -- Emerald Clinical Trials, a leading global clinical research organization, today announced a leadership transition. Mary Gunn has stepped down effective immediately. The Board has appointedGlenn Kerkhof, a long-standing Board member and experienced CRO exec...
2025-07-30 20:00
2302
Dx&Vx Signs USD 220 Million Co-Development and License Agreement for mRNA Cancer Vaccine with U.S. Biotech Company
- First global out-licensing deal since founding — tangible return on new drug development investments - Significant milestone payments and future revenue expected — additional out-licensing of proprietary technologies anticipated SEOUL, South Korea, July 30, 2025 /PRNewswire/ -- Dx&Vx (DXVX) ha...
2025-07-30 20:00
2457
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
1989
Telix H1 2025 Results: Investor Webcast Notification
MELBOURNE, Australia and INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today advises that it will release its financial results for the half-year ended30 June 2025 on Thursday21 August 2025. An investor webcast and conference call wi...
2025-07-30 07:00
2901
Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress
PRINCETON, N.J. and TOKYO, July 29, 2025 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), wi...
2025-07-29 20:00
1999
Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Obtained Orphan Drug Designation from the U.S. FDA for the Treatment of GC/GEJ
SUZHOU, China, July 29, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and ga...
2025-07-29 10:37
1981
Antengene Announces XPOVIO® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug
- This approval for XPOVIO® in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy marks the third approved indication of the drug inChina. - XPOVIO® as a monotherapy in patients with relap...
2025-07-28 18:49
2507
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