Pharmaceuticals

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 4792

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 4325

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 4437

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 3672

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 2921

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 2749

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 3375

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 3478

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 2884

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 4075

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 3592

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 4239

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 3289

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 4103

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 2945

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 3039

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 3616

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 5925

Successful Completion of First CRS with HIPEC on a 60-year-old Woman with Advanced Peritoneal Carcinomatosis

KOLKATA, India, July 28, 2025 /PRNewswire/ -- In a landmark achievement, a 60-year-old woman with advanced primary peritoneal carcinomatosis was successfully treated withCytoreductive Surgery (CRS) combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC)at Manipal Hospital Dhakuria, under ...

2025-07-28 15:20 2480

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 4307
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