Pharmaceuticals

Alteogen Receives European Commission Approval for Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

* EYLUXVI® is the second biosimilar approved for Alteogen following the launch of the Herceptin® biosimilar in China through its partner Qilu Pharmaceutical. DAEJEON, South Korea, Sept. 17, 2025 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the European Commission (EC) has ...

2025-09-17 15:40 1960

111, Inc. Announces Second Quarter 2025 Unaudited Financial Results

* Maintained Quarterly Operational Profitability * Operating Expenses as a Percentage of Revenues Decreased 20 Basis Points YoY * Maintained Positive Operating Cash Flow in the First Half of the Year SHANGHAI, Sept. 17, 2025 /PRNewswire/ -- 111, Inc. ("111" or the "Company") (NASDAQ: YI), a l...

2025-09-17 14:00 4324

Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)

WUXI, China, Sept. 17, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – have received GMP certification from Türkiye İlaç ve ...

2025-09-17 12:00 1606

Kexing Biopharm's Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Registered with FDA DMF

SHENZHEN, China, Sept. 16, 2025 /PRNewswire/ -- Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S. FDA. Exosomes, as a next-generation bioactive carr...

2025-09-17 10:30 1293

Malaysia Healthcare Week Debuts in Kuwait, Strengthening Malaysia-Kuwait Medical Partnership

Spearheaded by the Malaysia Healthcare Travel Council, the event builds momentum towards the Malaysia Year of Medical Tourism 2026. KUWAIT CITY, Kuwait, Sept. 17, 2025 /PRNewswire/ -- Building on Malaysia's established reputation as a premier global healthcare destination and as part of the stra...

2025-09-17 10:01 2721

Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting

-          ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment. -          ASC30 tablet's higher efficacy is supported by its higher oral drug exposures. -          ASC30 is safe and well tolerated with only mild-...

2025-09-17 07:30 1520

ShiraTronics Announces Positive 12-Month Follow-Up Results from RELIEV-CM Pilot Study, Demonstrating Sustained Clinical Benefit with Investigational Implantable Neuromodulation Therapy for Chronic Migraine

MINNEAPOLIS, Sept. 16, 2025 /PRNewswire/ -- ShiraTronics, Inc., a clinical-stage medical device company focused on developing novel neuromodulation therapies for chronic migraine, today announced compelling 12-month follow-up data from its RELIEV-CM Pilot Study. The findings demonstrate sustaine...

2025-09-16 19:00 1330

Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)

HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of acute myeloid leukemia (A...

2025-09-16 10:27 1435

Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the 34th EADV Congress 2025

SAN FRANCISCO and SUZHOU, China, Sept. 15, 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, autoimmune, cardiovascular and metaboli...

2025-09-16 09:00 1565

HitGen Partner BioAge Labs Initiates Phase 1 Clinical Study of BGE-102, a Novel Brain-Penetrant NLRP3 inhibitor

* BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technology platform, highlighting the value of DEL to accelerate innovative drug development. * The initiation of the BGE-102 Phase 1 clinical stud...

2025-09-15 21:30 1595

SI GROUP TO SHOWCASE SUSTAINABLE ADDITIVE INNOVATIONS AT K 2025

Industry Leader Presents Advanced Solutions for Plastics and Rubber THE WOODLANDS, Texas, Sept. 15, 2025 /PRNewswire/ -- SI Group, a leading global developer and manufacturer of performance additives, process solutions, pharmaceuticals, and chemical intermediates, will showcase its portfolio of ...

2025-09-15 20:30 1483

Korea reinforces biopharma leadership at Global Bio Conference 2025

SEOUL, South Korea, Sept. 15, 2025 /PRNewswire/ -- This is an article published in The Korea Herald: The Ministry of Food and Drug Safety on Thursday announced its successful hosting of the Global Bio Conference 2025 inSeoul last week, under the theme "Bio, Navigating Infinite Possibilities." T...

2025-09-15 20:30 1532

Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class P...

2025-09-15 12:11 1785

Jointly discovered KAT6i molecule originating from Australian research has initiated Phase 3 in HR+ HER2- Breast Cancer with Pfizer Inc

Australian scientists who discovered how to "turn off" genes that make cancer cells grow are celebrating the next phase of development – with Pfizer's first in class KAT6 inhibitor PF-07248144 now moving to the next stages of clinical investigation. MELBOURNE, Australia, Sept. 15, 2025 /PRNewswi...

2025-09-15 12:06 1374

Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations

SINGAPORE and GUANGZHOU, China, Sept. 15, 2025 /PRNewswire/ -- Lion TCR, a clinical-stage biotechnology company pioneering T-cell receptor (TCR)-based therapies, today announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initi...

2025-09-15 08:00 1531

Phrontline Biopharma Announces First Patient Dosed in Phase 1 Clinical Trial of TJ101

SHANGHAI and SUZHOU, China, Sept. 14, 2025 /PRNewswire/ -- Phrontline Biopharma , a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), today announced that the first patient has been successfully dosed in its Phase 1 clinical trial of TJ101, the com...

2025-09-15 08:00 1348

Real-World Evidence of NEFECON® to Be Presented in Seven New Abstracts at the 18th International lgAN Symposium

* 7 new NEFECON® real-world evidence abstracts will be presented at the 18th  International lgA Nephropathy Symposium (IIgANN 2025). * The newly released results, based on clinical practices at several leading hospitals inChina, offer a comprehensive overview of the efficacy and safety of NEFE...

2025-09-15 07:45 4694

LakeShore Biopharma Announces Receipt of Delisting Determination Letter from Nasdaq

BEIJING, Sept. 12, 2025 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious ...

2025-09-12 20:00 1921

The New Drug Application for KN026 (Anbenitamab Injection) Has Been Accepted by the National Medical Products Administration

SUZHOU, China, Sept. 12, 2025 /PRNewswire/ -- Alphamab Oncology (Stock Code: 9966.HK) announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharm...

2025-09-12 09:51 1504

Zhimeng Biopharma's Investigational Drug Approved to Initiate Phase 2 Epilepsy Clinical Trial in China

SHANGHAI, Sept. 11, 2025 /PRNewswire/ -- Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma") announced that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has recently received clinical trial approval from the Center for Drug Evaluation (CDE) ofChina's Nat...

2025-09-12 00:00 1725
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