Pharmaceuticals
Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints
HONG KONG, Aug. 25, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) ("Akeso" or "the Company") today announced positive results from its Phase 3 clinical trial of gumokimab (AK111), a novel, fully human anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis (AS). The study ...
Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer
SAN FRANCISCO and SUZHOU, China, Aug. 24, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimm...
BioDlink's Bevacizumab Approved for Market Launch in Indonesia, Marking Fourth Consecutive Emerging Market Authorization
* Bevacizumab Injection officially approved by Indonesia's National Agency of Drug and Food Control (BPOM), following Nigeria, Pakistan, and Colombia – accelerating global commercialization * Approval in ASEAN's largest pharma market strengthens BioDlink's position as a global supplier of ant...
Cell therapy is promising in treating psychiatric disorders, such as depression. -- A proof-of-principle study published in "Cell Stem Cell" by the laboratory of Dr. Chen, founder of UniXell Biotech, suggests this.
SHANGHAI, Aug. 20, 2025 /PRNewswire/ -- On August 11, 2025, the research team led by Professor Yuejun Chen, founder of UniXell Biotech, published an article titled "Human stem cell-derived A10 dopaminergic neurons specifically integrate into mouse circuits and improve depression-like behaviors" i...
First Patient Dosed in Pivotal Phase III Trial of Cadonilimab (PD-1/CTLA-4) for Perioperative Treatment of Resectable Gastric Cancer
HONG KONG, Aug. 20, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the enrollment and dosing of the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody developed b...
Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from FDA
SHANGHAI, Aug. 19, 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 INDclearance from the U.S. Food and Drug Administration (FDA). The clearance enables ...
GC Biopharma Signs MOU with Thai Red Cross Society to Strengthen Collaboration on Plasma-Derived Therapies
YONGIN, South Korea, Aug. 18, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed a Memorandum of Understanding (MOU) with the Thai Red Cross Society (TRCS) to cooperate on workforce training for the production of plasma-deri...
Ascletis Announces the Combination of ASC47 and ASC31, its Dual GLP-1R/GIPR Peptide Agonist, Demonstrated Significantly Greater Weight Loss Compared to the Combination of ASC47 and Tirzepatide in an Animal Model of Obesity
- Combination of a low dose of ASC47 with ASC31, a novel peptide agonist targeting bothGLP-1 receptor (GLP-1R) and GIP receptor (GIPR), resulted in a 44.8% reduction in body weight after 14 days of treatment in a diet-induced obese (DIO) mouse model. - Combination of a low dose of ASC47 with A...
Novel Gene Therapy for ALS cleared for global trials in China and the U.S.
BEIJING, Aug. 15, 2025 /PRNewswire/ -- SineuGene Therapeutics Co., Ltd. ("SineuGene"), clinical-stage biotechnology company that mainly focuses on gene therapies for neurological disorders, announced today thatChina's National Medical Products Administration (NMPA) has cleared the Investigational...
CARsgen Therapeutics Announces 2025 Interim Results
SHANGHAI, Aug. 14, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Interim Results. Business Highlights * Cash and bank balances were around RMB1,261 million as of June 30,...
BioDlink Accelerates Global Expansion with Bevacizumab Launch in Colombia and Pakistan
- BioDlink's bevacizumab injection secures marketing authorization in Colombia andPakistan following its recent approval in Nigeria, marking key regulatory milestones in high-need emerging markets. - GMP certification in Brazil, Colombia, and Argentina spans the top three most populous countries...
Daewoong Therapeutics Microneedle Patch Achieves Best-in-Class Bioavailability, Proving the Strength of Its Drug-Delivery Platform
* More than 80% relative bioavailability compared with injectable obesity therapy, well above the roughly 30% reported for existing microneedle patches and setting a new global benchmark * A potential game changer that addresses both the pain of injections and the low efficiency of oral form...
Ascletis Announces ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Treatment of Obesity, Demonstrated Greater Efficacy with Tirzepatide than Semaglutide in a Preclinical Model
- The combination of ASC47 low dose with tirzepatide in diet-induced obese (DIO) mice resulted in an 87% greater reduction in body weight compared to tirzepatide monotherapy. - ASC47 low dose in combination with tirzepatide demonstrated statistically significantly greater incre...
Mabwell Announces First Patient Dosed in the US Clinical Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated with ADCs
SHANGHAI, Aug. 12, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced the first patient dosing in the U.S. for a clinical study of its novel nectin-4-targeting antibody-drug conjugate (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW...
Aquedeon Medical Inc. Receives FDA Approval to Expand Clinical Trial of Duett Vascular Graft System
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. SUNNYVALE, Calif., Aug. 12, 2025 /PRNewswire/ -- Aquedeon Medical Inc. (AMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the expansion of its Investigationa...
Fosun Pharma's Small Molecule Innovative Drug XH-S004 Achieves Overseas Licensing for a Potential Total of $645 Million
SHANGHAI, Aug. 11, 2025 /PRNewswire/ -- On August 11, Fosun Pharma (SSE:600196, HKEX: 02196) announced that its subsidiary Fosun Pharma Industrial has signed a License Agreement withExpedition Therapeutics Inc.(Expedition) to grant Expedition the rights to develop, manufacture, and commercialize ...
AMI Pharm Advances AYP-101 to Phase 3, Paving the Way for a New Era in Fat-Reduction Injectable drugs
— Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling — Phase 3 clinical trial underway in South Korea, following strong safety and efficacy results in earlier studies — AMI Pharm positions itself for global expansion in the multi-billion-dollar ...
Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy
HONG KONG, Aug. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody deve...
Hugel launches botulinum toxin Letybo in Malaysia
- The company strengthens brand experience for local medical professionals through academic events and hands-on workshops - It will solidify the market position of premium toxin products through Malaysian partner Venusys Medical SEOUL, South Korea, Aug. 10, 2025 /PRNewswire/ -- Hugel Inc., a lea...
WuXi XDC Included in MSCI China All Share Index
SHANGHAI, Aug. 8, 2025 /PRNewswire/ -- WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, today announced its inclusion in the MSCI China All Share Index, which unders...
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