Pharmaceuticals

CARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596

SHANGHAI, Dec. 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administr...

2025-12-29 08:10 1666

China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval

* TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. * The TABOSUN® and TYVYT® c...

2025-12-25 16:45 1900

Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies

* Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2). * The study will evaluate CBL-514 in combination with Zepbound® (Eli Lilly) in...

2025-12-25 10:05 1654

Mabwell Receives IND Clearance for Novel Anti-ST2 Monoclonal Antibody 9MW1911 to Initiate Phase IIa Study

SHANGHAI, Dec. 24, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has received IND clearance from the U.S. Food and Drug Administration (FDA) for its self-developed anti-ST2 monoclonal antibody (R&...

2025-12-24 22:00 1981

Hakka Medicine Goes Global: Jiaying Pharmaceutical Launches the Global Promotion Plan for Hakka Medicine in Hong Kong

HONG KONG, Dec. 24, 2025 /PRNewswire/ -- Recently, Guangdong Jiaying Pharmaceutical Co., Ltd. held the "First Hakka Medicine Historical and Cultural Symposium" and the "Jiaying Hakka Medicine - Double-ingredient Throat Wind Relief Powder Product Promotion Conference" inHong Kong SAR. Centered on ...

2025-12-24 10:00 1511

Nona Biosciences Expands Integrated Discovery-to-Clinical Capabilities Through Strategic Platform Growth

CAMBRIDGE, Mass., Dec. 23, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, today announced the expansion of its integrated discovery and development framework to support early clinical development an...

2025-12-24 09:20 1763

Senhwa Biosciences Highlights AI-Validated Oncology Platform and Strategic Clinical Collaborations Targeting Next-Generation Immuno-Oncology products at Its 2025 Annual Investor Conference

TAIPEI and SAN DIEGO, Dec. 23, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage companies focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today outlined continued progress across its AI-enabled drug developm...

2025-12-23 20:00 2601

Fapon Biopharma Publishes Pioneering Research in Cell Reports Medicine on FP008, an anti-PD 1 X IL-10M Fusion Protein for Cancer Immunotherapy

DONGGUAN, China, Dec. 23, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech in developing therapeutic biologics including cytokine-antibody fusion proteins and T-cell engagers, announced the publication of pioneering research on FP008, a novel fusion protein inCell Reports Medicine. The peer-review...

2025-12-23 13:03 2471

TraceLink Wins 2025 Merit Award -- Recognized for Healthcare Innovation for the Third Consecutive Year

TraceLink has been named a winner of the 2025 Merit Awards for Healthcare Innovation, marking its third consecutive year of recognition. The award honors TraceLink's continued leadership in transforming the life sciences and healthcare supply chain through OPUS—its industrial no-code platform tha...

2025-12-22 23:00 2137

Kazia Therapeutics Regains Full Nasdaq Listing Compliance

Restoration of Nasdaq compliance follows $50 million institutional financing and reinforces balance-sheet strength SYDNEY, Dec. 22, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA), a clinical-stage oncology company focused on developing innovative therap...

2025-12-22 21:00 4803

Guardant Health Japan receives regulatory approval of Guardant360® CDx liquid biopsy as companion diagnostic for imlunestrant in metastatic or recurrent breast cancer previously treated with endocrine therapy

Guardant360® CDx is the first companion diagnostic to be approved in Japan to identify ESR1 mutations in patients with hormone receptor-positive, HER2-negative breast cancer for treatment with imlunestrant TOKYO, Dec. 22, 2025 /PRNewswire/ -- Guardant Health Japan Corp. today announced that the...

2025-12-22 16:00 2330

Menarini Silicon Biosystems announces PACE trial biomarker analysis results confirming clinical utility of CELLSEARCH® CTC enumeration to guide treatment decisions in a specific metastatic breast cancer subtype

The secondary analysis of the PACE trial highlights the value of counting Circulating Tumor Cells (CTCs) in the blood to help guide treatment escalation or de-escalation in patients with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer whose disease progressed after...

2025-12-22 16:00 2262

Fosun International Honored with TVB's Highest Accolade, "Outstanding ESG Award"

HONG KONG, Dec. 22, 2025 /PRNewswire/ -- On 19 December 2025, the TVB ESG Awards 2025 Presentation Ceremony, hosted by Television Broadcasts Limited ("TVB"), was held at the Hong Kong Convention and Exhibition Center. Fosun International was honored with the highest accolade, the "Outstanding ESG...

2025-12-22 09:00 4548

Wong To Yick Unveils Revitalised Official Website

Launching a New No.1 Brand Chapter with Ambassador Joey Yung Enhanced Authenticity Guidance & Usage Education for Elevated Consumer Confidence    [High-resolution promotional photo download: Here ] HONG KONG,...

2025-12-22 09:00 1673

Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today provides a precision medicine portfolio update in relation to: * TLX591-CDx (Illuccix® in approved jurisdictions, 68Ga-PSMA-11): Positive data from Phase ...

2025-12-22 05:40 2247

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 clinical trial for the treatment of recurrent glioblas...

2025-12-21 20:20 2362

Jacobio Pharma Enters Global Exclusive License Agreement with AstraZeneca for Pan-KRAS Inhibitor JAB-23E73

BEIJING, SHANGHAI and BOSTON, Dec. 21, 2025 /PRNewswire/ -- Jacobio Pharma (1167.HK,) today announced that it has entered an agreement with AstraZeneca for its proprietary Pan-KRAS inhibitor JAB-23E73. AstraZeneca will receive exclusive development and commercialisation rights outside ofChina, wh...

2025-12-21 20:15 2461

Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Breakthrough Therapy Designation by the FDA for the Treatment of PROC

SUZHOU, China, Dec. 20, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003, independently developed by the Company, and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC P...

2025-12-20 12:54 5164

WuXi Biologics Achieves CDP Highest "A" Ratings in Both Climate Change and Water Security

SHANGHAI, Dec. 19, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK) announced that it has been named to the CDP "A" lists for both Climate Change and Water Security for 2025, underscoring its leadership in environmental stewardship and transparent disclosure. Climate Change Leadership Being recogn...

2025-12-19 17:30 3989

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NM...

2025-12-19 09:46 3580
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