CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a...
Jyong Biotech Reports Transformative Period of Clinical Validation and Commercialization Attempt: Phase II Data Focuses on Dual Therapeutic Potential of MCS-8 in Oncology and Metabolic Health, Alongside Strategic Market Entry into Asia
- Comprehensive review of recent milestones highlights statistically significant efficacy in prostate cancer prevention, discovery of novel lipid-modulating properties, and the execution of high-value commercial partnerships in South Korea and...
Ractigen Therapeutics Announces First Patient Dosed in Phase II Clinical Trial of RAG-17 for SOD1-ALS
NANTONG, China, Jan. 13, 2026 /PRNewswire/ -- Ractigen Therapeutics is pleased to announce that the first patient has been dosed in the Phase II clinical trial of RAG-17, an innovative siRNA therapy targeting SOD1-mutated amyotrophic lateral...
Mabwell Announces First Patient Dosed in Phase II Trial of Anti-IL-11 Antibody for Pathological Scarring
SHANGHAI, Dec. 30, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Phase II clinical trial of its self-developed innovative anti-IL-11 monoclonal...
T-MAXIMUM Pharmaceutical's Allogeneic CAR-T Therapy MT027 Receives FDA IND Clearance to Proceed to Phase II clinical Trial for Recurrent Glioblastoma
BEIJING, Dec. 21, 2025 /PRNewswire/ -- T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II...
Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development
HMI-115 received FDA Fast Track Designation based on results from a Phase II clinical trial for endometriosis Mean dysmenorrhea pain score reduced by 42% Mean non-menstrual chronic pelvic pain score reduced by 52% Most patients maintained normal...
Lynk Pharmaceuticals Announces Key Phase II Clinical Results of LNK01004 for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis
HANGZHOU, China and SHANGHAI and BOSTON, Nov. 19, 2025 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company, today announced key results from its...
Simcere's IL-2 Mutant Fusion Protein SIM0278 Entered Phase II Clinical Trial Stage
NANJING, China, Nov. 10, 2025 /PRNewswire/ -- Simcere Pharmaceutical Group (2096.HK) announced that its regulatory T cells（Treg）-preferential IL-2 mutant Fc fusion protein (IL-2 mu-Fc), SIM0278, has officially entered a Phase II clinical study in...
ArkBio Initiates Phase II Clinical Trial of AK0610, a Preventive Monoclonal Antibody for Respiratory Syncytial Virus Infection
SHANGHAI, Oct. 30, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced the initiation of a Phase II clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus...
Global First-in-Class AT2R Antagonist TRD205 Advances to Phase II: First Patient Dosed in Chronic Post-Surgical Neuropathic Pain Trial
BEIJING, May 6, 2025 /PRNewswire/ -- Beijing Tide Pharmaceutical Co., Ltd., a subsidiary of Sino Biopharmaceutical Limited (1177.HK), has achieved a milestone in developing its first-in-class analgesic drug (research code: TRD205), a highly...