Pharmaceuticals
Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from NMPA
SHANGHAI, Oct. 14, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the National Medical Products Administration (NMPA) inChina to ini...
2025-10-14 20:00
2690
Clover Announces Positive Phase I Clinical Data for RSV-hMPV-PIV3 Combination Vaccines and for RSV Re-Vaccination in Older Adults
-- Results indicate potential best-in-class RSV+hMPV±PIV3 combination vaccines, with the potential ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection-- -- Increases in neutralizing antibodies of approximately 6-8 fold for RSV, 6-9 fol...
2025-10-14 18:18
2171
Thousand Oaks Biologics Shanghai ADC Site receives EU QP Declaration
SHANGHAI, Oct. 13, 2025 /PRNewswire/ -- Thousand Oaks Biologics' antibody-drug conjugate (ADC) manufacturing site successfully passed an audit conducted by a European Union Qualified Person (QP) and formally received a QP Declaration. This milestone certifies that the company's quality management...
2025-10-13 20:00
1425
ReviR Therapeutics Receives Orphan Drug Designation from FDA for RTX-117 to Treat Charcot-Marie-Tooth Disease
BRISBANE, Calif. , Oct. 13, 2025 /PRNewswire/ -- ReviR Therapeutics, a biotech company focused on developing novel treatments for neurogenetic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for RTX-117, its lead investigational...
2025-10-13 18:00
2057
GC Biopharma Secures CMO Rights for Shingles Vaccine from Curevo Vaccine
YONGIN, South Korea, Oct. 13, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed an agreement with Curevo Vaccine to secure contract manufacturing (CMO) rights for amezosvatein (development name: CRV-101), a recombinant shin...
2025-10-13 12:38
2886
Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development
- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC35 was approximately 14 days, 6-fold longer than tirzepatide, which supports once-monthly subcutaneous (SQ) dosing in humans. - In head-to-head NHP studies, drug exposures of ASC35 intravenous (I.V.) and SQ admin...
2025-10-13 08:10
2147
C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001
CHENGDU, China, Oct. 11, 2025 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co.,Ltd proudly congratulates its strategic partner,Biokin Pharmaceutical, on receiving implied approval from theNational Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injec...
2025-10-11 20:45
3138
Renalys Announces Completion of Primary Endpoint Data Collection for Phase III Clinical Trial of Sparsentan for Iga Nephropathy in Japan
TOKYO, Oct. 10, 2025 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku,Tokyo; "Renalys") announced today that it has completed data collection for the primary endpoint in the Phase III clinical trial of sparsentan (development code: RE-021) for IgA nephropathy inJapan. The primary endp...
2025-10-10 14:00
1479
WuXi Biologics Receives MSCI AAA ESG Rating for Third Consecutive Year
SHANGHAI, Oct. 9, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced it has received the esteemed AAA ESG rating from Morgan Stanley Capital International (MSCI) for the third consecutive year. This to...
2025-10-10 08:30
1919
Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)
* EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) * Celltrion plans to enter the U.S. ophthalmology market to m...
2025-10-10 06:56
3331
POMDOCTOR LIMITED Announces Closing of Initial Public Offering
GUANGZHOU, China, Oct. 9, 2025 /PRNewswire/ -- POMDOCTOR LIMITED (Nasdaq: POM) (the "Company" or "POMDOCTOR"), a leading online medical services platform for chronic diseases inChina, today announced the closing of its initial public offering (the "Offering") of 5,000,004 American Depositary Shar...
2025-10-10 04:05
3230
Samsung Biologics Introduces Optimized Manufacturing Framework, ExellenS™
* ExellenS TM applies optimized facility designs, equipment, and processes across all sites to ensure equivalency and speed * ExellenS TM combines the company's commitment to operational excellence with its core manufacturing competencies, guided by standardization, simplification, and scalab...
2025-10-09 19:00
2605
C-Ray Therapeutics (Shanghai) Co., Ltd. Presents Breakthrough Clinical Data of Novel Targeted Alpha Therapy 225Ac-PSMA-CY313 at EANM 2025
BARCELONA, Spain, Oct. 8, 2025 /PRNewswire/ -- During the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025), C-Ray Therapeutics (Shanghai) Co., Ltd. ("C-Ray Shanghai"), a company dedicated to the development of innovative targeted radiopharmaceuticals, announced pro...
2025-10-08 22:20
2080
POMDOCTOR LIMITED Announces Pricing of Initial Public Offering
GUANGZHOU, China, Oct. 8, 2025 /PRNewswire/ -- POMDOCTOR LIMITED (the "Company" or "POMDOCTOR"), a leading online medical services platform for chronic diseases inChina, today announced the pricing of its initial public offering (the "Offering") of 5,000,004 American Depositary Shares ("ADSs") at...
2025-10-08 20:00
2746
Hope Medicine Inc. Announces Successful Completion of a Global Phase 2 Study of a Potential First-in-Class Endometriosis Treatment
HMI-115 demonstrated statistically significant improvement in endometriosis pain The mean dysmenorrhea pain score was reduced by 42% The mean non-menstrual pelvic pain score was reduced by 52% Most of the patients had normal menstrual periods No typical peri-menopausal symptoms were reported Th...
2025-10-08 09:08
3018
CARsgen Presents Results on GPRC5D CAR-T CT071 in The Lancet Haematology
SHANGHAI, Oct. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the results of CT071 (an autologous CAR T-cell product targeting GPRC5D) for the treatment of relapsed/refractory mul...
2025-10-08 08:15
2145
Kazia Therapeutics Announces Collaboration and In-Licensing Agreement for First-in-Class PD-L1 Protein Degrader Program
SYDNEY, Oct. 7, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced an exclusive collaboration and in-licensing agreement (the "Agreement") with QIMR Berghofer for a first-in-class PD-L1 degrader program. The lead optimized...
2025-10-07 20:30
2705
FDA Lifts Clinical Hold on NUZ-001
Highlights: * U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®'s lead investigational therapy for ALS * Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025 * IND supported by robust preclinical safety data and comprehensive manufacturing and ...
2025-10-06 14:06
3325
MedHub-AI Announces National Reimbursement Approval in Japan for AutocathFFR™
TEL AVIV, Israel, Oct. 3, 2025 /PRNewswire/ -- MedHub-AI
2025-10-03 07:00
2059
Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States
* The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA® (tocilizumab) * AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA * This launch stre...
2025-10-02 20:30
2483
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