Pharmaceuticals
Alteogen Receives Positive CHMP Opinion for Aflibercept Biosimilar, 'EYLUXVI® (ALT-L9)'
* CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing EYLUXVI® to the reference product Eylea® * Upon approval, EYLUXVI® will be Alteogen's second biosimilar product, following a Herceptin® biosimilar by Alteogen's license partner Qilu Pharm...
2025-07-28 14:00
4307
NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
HONG KONG, July 28, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with ...
2025-07-28 12:14
4429
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
- First participants with obesity or overweight with at least one w eight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor agonist ASC30. - Ultra-long-acting SQ depot for...
2025-07-28 08:15
2964
Harbour BioMed Announces Positive Profit Alert for 2025 Interim Results
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 27, 2025 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a positive prof...
2025-07-28 08:11
3258
Phase II Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult Aga In China Reached Primary Endpoint
SUZHOU, China, July 25, 2025 /PRNewswire/ -- The Kintor Pharmaceutical Limited (the "Company") is pleased to announce that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of AGA has obtained top-line re...
2025-07-25 20:30
4226
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody dev...
2025-07-24 09:14
2355
HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma
* Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma, with an initial data readout expected in mid-2026 * HBM9378/WIN378 has the potential to be the first-to-market long-acting anti-TSLP antibody with twice-yearly dosing for asthma ...
2025-07-23 20:36
3187
Samsung Biologics reports second quarter 2025 financial results
* Recorded Q2'25 consolidated revenue of KRW 1,289.9 billion * Recorded Q2'25 consolidated operating profit of KRW 475.6 billion * Solid momentum sustained through capacity ramp-up and stable project execution INCHEON, South Korea, July 23, 2025 /PRNewswire/ -- Samsung Biologics (KRX: 207940...
2025-07-23 14:54
3549
METiS Technologies Showcases AI-Powered Nanodelivery Platform at the 2025 Controlled Release Society Annual Meeting
HANGZHOU, BEIJING, China and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- METiS Technologies, a global leader in AI-driven nanodelivery innovation, today announced the presentation of its latest research findings at the poster session of the 2025 Controlled Release Society (CRS) Annual Meeting...
2025-07-22 15:52
4445
DualityBio's Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation
SHANGHAI, July 21, 2025 /PRNewswire/ -- DualityBio (HKEX Stock Code: 9606.HK) announced thatthe U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. This designation is for the treatment of ad...
2025-07-22 10:25
3875
Bloomage Achieves FDA GMP Audit with Zero-Deficiency, Reinforcing Global Trust
PARSIPPANY, N.J., July 21, 2025 /PRNewswire/ -- Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has announced it successfully passed the U.S. Food and Drug Administration (FDA)'s on-site GMP audit with a "No Action Indicated" (NAI) result. This is the best ...
2025-07-21 21:00
2233
CorestemChemon Expands Global CRO Reach with ATG Lifetech, Targeting Next-Gen Preclinical Services
Strategic partnership to deliver transcriptomics-powered, organoid-based preclinical testing for high-impact drug discovery SEOUL, South Korea, July 20, 2025 /PRNewswire/ -- CorestemChemon, a leading GLP-certified preclinical CRO based inSouth Korea, has entered into a strategic partnership wit...
2025-07-21 10:54
2761
Co-PSMA trial: Recruitment successfully completed
SYDNEY, July 17, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that the Co-PSMA (NCT...
2025-07-17 21:01
4699
SK bioscience Submits IND for Phase 1/2 Clinical Trial of Adjuvanted Influenza Vaccine Candidate
* Company aims for technology advancement and platform expansion with Korea's first influenza vaccine using an adjuvant * Interim results from the Phase 1/2 trial expected by 2027, aimed at entering the high-immunogenicity vaccine market * "Our SKYCellflu platform with our adjuvanted vaccine...
2025-07-17 19:00
3570
GC Biopharma Receives Marketing Authorization for BARYCELA in Vietnam
YONGIN, South Korea, July 17, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean pharmaceutical company, announced that its varicella vaccine BARYCELA has received marketing authorization from the Drug Administration of Vietnam (DAV). Following domestic approval in 2020 and WHO Pre-Q...
2025-07-17 13:56
2657
Unlocking New Opportunities in Asia and the Greater Bay Area
SHANGHAI, July 16, 2025 /PRNewswire/ -- CPHI & PMEC China 2025 concluded in June with a record-breaking 109,056 attendees, fostering meaningful connections across the entire pharmaceutical supply chain. This remarkable success is a testament to the strong demand withinChina's thriving pharma indu...
2025-07-17 09:55
4117
Nature Medicine Published Phase 1 Results of Innovent Biologics' Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
SAN FRANCISCO and SUZHOU, China, July 16, 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 oncology, cardiovascular and metabolic, autoimmune...
2025-07-17 08:00
3716
SNB-101 Earns Government Backing as Promising Therapy for Small Cell Lung Cancer
SEONGNAM, South Korea, July 16, 2025 /PRNewswire/ -- In a strong endorsement of its cutting-edge drug delivery technology, SN BioScience announced that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initia...
2025-07-16 20:00
3612
WuXi Biologics Granted Highest Negligible-Risk ESG Rating from Morningstar Sustainalytics
* Best ESG rating tier of negligible-risk with a top 1% global ranking score * Industry and Regional ESG Top-Rated Company for five consecutive years * Leader in Green CRDMO to drive innovation for a healthier future SHANGHAI, July 16, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading ...
2025-07-16 18:00
2755
Senhwa Biosciences announces first patient dosed in NCI-sponsored pilot study of Pidnarulex (CX-5461) pharmacodynamics in patients with advanced solid tumors
TAIPEI and SAN DIEGO, July 15, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that its new drug Pidnarulex (CX-5461) has been selected by the U...
2025-07-16 10:32
3197
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