Pharmaceuticals
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
2159
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
2124
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
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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
3392
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
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/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
4202
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
4252
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
4797
Six Abstracts of Kelun-Biotech's Clinical Studies Published at the 2025 ASCO Annual Meeting
CHENGDU, China, May 23, 2025 /PRNewswire/ -- The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is scheduled to take place in Chicago, Illinois, USA from May 30 to June 3. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the "Company") will present results from six cl...
2025-05-23 17:24
4781
England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy
First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure1-3 NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial4 ST. GALLEN, Switzerland, May 23, 2025 /PRNewswi...
2025-05-23 16:16
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ADVANCING ENDOSCOPIC EXCELLENCE
Pantai Hospital Kuala Lumpur Reaches 50 POEM Cases, Leading the Way in Minimally Invasive, Incisionless Treatment KUALA LUMPUR, Malaysia, May 23, 2025 /PRNewswire/ -- Pantai Hospital Kuala Lumpur (PHKL) proudly celebrates a major milestone in its endoscopic journey, having successfully performe...
2025-05-23 14:28
2040
Antengene to Present Latest Clinical Results from Two Studies in CPI-resistant Solid Tumors at ASCO 2025
* ATG-037, an oral small molecule CD73 inhibitor, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), achieved an overall response rate (ORR) of 36.4% and disease control rate (DCR) of 100% in checkpoint inhibitor (CPI)-resistant melanoma patients in the ongoing STAMINA-01 t...
2025-05-23 12:31
4600
Nona Biosciences Collaboration Partner Pfizer Announces Presentation of Phase 1 Clinical Study Design on MesoC2, an MSLN-Targeting ADC, at the 2025 ASCO Annual Meeting
CAMBRIDGE, Mass., May 23, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to I TM), today announced that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC...
2025-05-23 12:21
3268
Everest Medicines Announces NEFECON® Inclusion in China's Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)
SHANGHAI, May 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics,announced that NEFECON® has been included in the "Clin...
2025-05-23 11:39
2788
FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418
Phase 1/2 first-in-human clinical study planned this year SHANGHAI and SAN DIEGO, May 22, 2025 /PRNewswire/ -- Duality Biotherapeutics ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, to...
2025-05-23 10:44
2245
Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) Presented Preclinical Data on GNTbm-38, an Novel Epigenetic Immune Activator, at the 2025 ASCO Annual Meeting
TAIPEI, May 23, 2025 /PRNewswire/ -- GNTbm (stock code: 7427, Taiwan) announced the preclinical data on GNTbm-38, an novel epigenetic immune activator for cancer immunotherapy. GNTbm-38 was presented as posters at the 2025 American Association of Clinical Oncology (ASCO) Annual Meeting, which ...
2025-05-23 08:00
2430
Eisai to Present E7386, Co-created by PRISM BioLab and Eisai, at the ASCO (American Society of Clinical Oncology) Annual Meeting
Abstract Released for E7386, Co-Developed Through Collaborative Research Between Eisai and PRISM TOKYO, May 22, 2025 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI...
2025-05-23 08:00
3341
CARsgen's Satri-cel Abstract Available on ASCO Website
SHANGHAI, May 22, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that an abstract of the research results of the confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-...
2025-05-23 08:00
2167
Porton Advanced Announces Collaboration with TongEYE to Accelerate Development of iPSC-RPEC transplantation therapy
SUZHOU, China, May 22, 2025 /PRNewswire/ -- Porton Advanced, a leading contract development and manufacturing organization (CDMO) specializing in advanced therapy medicinal products (ATMPs), is pleased to announce its partnership with TongEye Medical Technology (TongEYE), an innovator focusing on...
2025-05-22 21:00
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Fourth NDA for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation
CHENGDU, China, May 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new indication application (the "Application") for the Company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotec...
2025-05-22 10:09
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