Pharmaceuticals
AccurEdit Therapeutics' ART001 Becomes China's First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene ...
2025-05-29 20:00
1665
Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval
Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral s...
2025-05-29 20:00
2295
AI Meets Audit Powerhouse: Qualifyze Launches Quality Insights Platform to Help Global Pharma Manage Supplier Site Risk
FRANKFURT, Germany, May 29, 2025 /PRNewswire/ -- Qualifyze, already the global leader in third-party audit services for the pharmaceutical industry, announces the launch ofQuality Insights Platform, an AI-powered platform that transforms the world's largest pharmaceutical audit database into a st...
2025-05-29 18:23
2226
CPHI & PMEC China Sees Surge in International Attendance as Global Pharma Trade Outlook Strengthens
Record international participation reflects renewed momentum in pharma
manufacturing and global sourcing, as easing tariffs fuel growth
SHANGHAI, May 29, 2025 /PRNewswire/ -- CPHI & PMEC China
2025-05-29 12:43
2227
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previo...
2025-05-29 11:47
1453
Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring Biologics Switching Treatment for Psoriasis Patients with Prior Inadequate Response to Anti-IL-17 Antibodies
SAN FRANCISCO and SUZHOU, China, May 29, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic...
2025-05-29 10:23
2753
Formosa Pharmaceuticals and Adalvo Limited Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain
TAIPEI, May 28, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Adalvo Limited ("Adalvo") in the European and Brazilian markets for exclusive rights to the commercialization of clobeta...
2025-05-28 20:00
1788
EpiVax Appoints Dr. Vibha Jawa to Lead Scientific Strategy as CSO
PROVIDENCE, R.I., May 28, 2025 /PRNewswire/ -- EpiVax, Inc., a leader in preclinical immunogenicity assessment for biologic therapeutics and vaccines, is pleased to announce the appointment ofVibha Jawa, PhD, FAAPS as Chief Scientific Officer. Dr. Jawa succeeds EpiVax founder and Executive Chairw...
2025-05-28 14:13
2255
Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
* EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6. * The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs ...
2025-05-28 14:00
1967
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) has granted Priority R...
2025-05-28 12:10
1948
Exclusive Global 20 Seats, China's Sole One! KT-939 Was Successfully Selected for 2025 NYSCC Inspiration Hive Zone
SUZHOU, China, May 28, 2025 /PRNewswire/ -- In the newly announced entry list of the Inspiration Hive zone at the 2025 New York Society of Cosmetic Chemists (NYSCC) exhibition, Kintor's innovative ingredient KT-939 has been selected as the only "Chinese Ingredient" among the numerous global ones....
2025-05-28 11:08
2091
HKSH Fosters Collaboration for Innovation at Asia Summit on Global Health 2025, Through Partnership with United Imaging to Elevate Medical Imaging Excellence
HONG KONG, May 27, 2025 /PRNewswire/ -- The HKSH Medical Group (HKSH) has for over a century been committed to acquiring the state-of-the-art, world-class technology and facilities to deliver excellent and advanced medical services. Mr. Wyman LI, Chief Operating Officer of HKSH Medical Group, Dire...
2025-05-27 21:00
2877
RemeGen: Telitacicept for the Treatment of Generalized Myasthenia Gravis Approved in China
YANTAI, China, May 27, 2025 /PRNewswire/ -- On May 27, RemeGen Co., Ltd.(688331.SH / 09995.HK) announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration (NMPA) for the treatment of adult patients with anti-acetylcholine recepto...
2025-05-27 16:30
2150
Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% * DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safet...
2025-05-26 18:06
2108
Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC
SHANGHAI, May 26, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the Chi...
2025-05-26 12:15
2529
Phase 3 Clinical Study of Mazdutide in Chinese Adults with Overweight or Obesity (GLORY-1) Published in The New England Journal of Medicine (NEJM)
SAN FRANCISCO and SUZHOU, China, May 26, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic...
2025-05-26 08:00
3362
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] * Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeabilit...
2025-05-24 01:47
4304
/DISREGARD RELEASE: Celltrion/
We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued21-May-2025 over PR Newswire. ...
2025-05-24 00:01
4189
Mabwell Announces Clinical Data of Multiple ADCs to be presented at 2025 ASCO Annual Meeting
SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clini...
2025-05-23 22:00
4236
UniXell Biotechnology announces the first patient dosed with UX-DA001, an investigational autologous iPSC based cell therapy for the treatment of Parkinson's disease, in its Phase 1 study
SHANGHAI, May 23, 2025 /PRNewswire/ -- Shanghai UniXell Biotechnology Co., Ltd. (UniXell Biotech), a biotech company dedicated to innovative cell therapies, announced the successful first administration of its proprietary Parkinson's disease cell drug UX-DA001 inChina in March 2025. The Phase I c...
2025-05-23 19:18
4781
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