Pharmaceuticals
Doer Biologics Completes Enrollment of the Phase 2 Clinical Study of DR10624 for Treatment of Severe Hypertriglyceridemia
HANGZHOU, China, March 9, 2025 /PRNewswire/ -- Zhejiang Doer Biologics Co., Ltd. ("Doer Bio"), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers,today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting...
2025-03-10 10:53
2101
RiboX Therapeutics Announces First Patient Dosed in Phase I/IIa Clinical Trial of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation
PRINCETON, N.J., March 9, 2025 /PRNewswire/ -- RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, today announced that the first patient was dosed last week in its first-in-human (FIH) Phase I/...
2025-03-10 09:30
2460
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
* OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by theFDA * Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] * The ava...
2025-03-10 07:16
2833
GenAssist Ltd Announces FDA Clearance of Investigational New Drug Application for GEN6050X, a Globally First-in-Class Base Editing Drug for Duchenne Muscular Dystrophy
SUZHOU, China, March 6, 2025 /PRNewswire/ -- On March 06, 2025, GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has receivedclearance from the U.S Food and Drug Administration(FDA) for its Investigational...
2025-03-06 17:00
1862
Akeso Announces Completion of Patient Enrollment in The Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma
HONG KONG, March 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibod...
2025-03-06 08:30
2332
CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL
* Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. * CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor...
2025-03-06 08:10
2446
SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.
HIGHLIGHTS * Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. * Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC...
2025-03-05 21:44
2809
SanyouBio Launches 73 Whole-Series Bispecific Reference Antibody Products, Facilitating New Breakthroughs in Bispecific Drug Development
SHANGHAI, March 5, 2025 /PRNewswire/ -- SanyouBio announced today the official launch of 73 whole-series bispecific antibody reference products, covering globally approved and representative clinical-stage bispecific antibody drugs. The launch of this product series will provide robust support fo...
2025-03-05 20:00
2090
XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC
- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple ind...
2025-03-05 13:00
2210
Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] * The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences fr...
2025-03-04 12:28
2556
Raziel and Fosun Pharma (by JuveStar an affiliate company of Fosun Pharma) Initiate Phase 3 Registration Trial in China for Submental Fat Reduction ("double chin")
REROVOT, Israel, March 3, 2025 /PRNewswire/ -- Raziel Therapeutics, a pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market, announces phase 3 study initiation inChina for the treatment of fat reduction in the submental area. Submental fat...
2025-03-04 09:00
1916
CStone Announces First Patient Dosed in Global Multicenter Phase I Clinical Trial of CS2009, a PD-1/VEGF/CTLA-4 Trispecific Antibody
SUZHOU, China, March 3, 2025 /PRNewswire/ --CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced thatthe first patient has been successfully dosed in the global multicenter P...
2025-03-04 08:10
3231
METiS Pharmaceuticals Appoints Mark Herbert as Chief Business Officer
HANGZHOU, China, March 3, 2025 /PRNewswire/ -- METiS Pharmaceuticals, a clinical-stage, AI-driven biotechnology company specializing in innovative drug delivery technologies, today announced the appointment ofMark Herbert as Chief Business Officer (CBO), effectiveJanuary 22, 2025. In this role, M...
2025-03-03 16:20
2231
CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA
SHANGHAI, March 2, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical ...
2025-03-03 08:15
2407
Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025
SAN DIEGO, March 2, 2025 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio"), a leading biotech company dedicated to developing innovative biologic treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly...
2025-03-03 02:00
1930
EMSRUN Medical Strengthens Middle East Footprint with Innovative Emergency Care Solutions at IDEX & NAVDEX 2025
ABU DHABI, UAE, March 1, 2025 /PRNewswire/ -- EMSRUN Medical
2025-03-01 20:06
3471
CARsgen's Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in a Patient with Autoimmune Disease
SHANGHAI, Feb. 27, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that KJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, has a...
2025-02-28 08:15
2480
Akeso Announces First ADC Drug Clinical Trial, Marking a New Era for "IO 2.0 + ADC" Strategy
HONG KONG, Feb. 27, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies inAustralia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate)...
2025-02-27 16:58
2019
WuXi Biologics Again Passed GMP Inspection by Japan PMDA
WUXI, China, Feb. 26, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has again passed the GMP inspection byJapan's Pharmaceuticals and Medical Devices Agency (PMDA) for it...
2025-02-27 12:30
2340
Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)
Bringing New Hope to Chinese Dialysis Patients with Hyperphosphatemia SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development...
2025-02-26 18:33
2459
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