News
Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System
Kalos Medical Inc. announced that South Korea’s Ministry of Food and Drug Safety designated the company’s DENEX hypertension treatment system as an Innovative Medical Device.
Junshi Biosciences Announces Initiation of Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer
Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed.
Jacobio Pharma Presents Clinical Results of Glecirasib in Colorectal Cancer
Jacobio Pharma (1167.HK) announced clinical results of its novel KRAS G12C inhibitor glecirasib monotherapy and in combination therapy with cetuximab to treat KRAS G12C mutant advanced CRC (colorectal cancer) in Second JCA- AACR Precision Medicine International Conference.
Immuno-oncology company Biosyngen opens new cell therapy GMP facility in Singapore
Biosyngen, an immune-oncology company with technology targeting the unmet medical needs in solid tumour and lymphoma treatment, today announced the official opening of its latest Good Manufacturing Practice (GMP) facility in Singapore.
Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan’s “MITSUI LINK-Lab KASHIWA-NO-HA 1”
Astellas Pharma Inc. (TSE: 4503) and Mitsui Fudosan Co., Ltd. (TSE: 8801) announced today that Astellas will establish a "TME imaging and interactive research for innovation (TME iLab)" open innovation hub in October, 2023 in "MITSUI LINK-Lab KASHIWA-NO-HA 1" (Kashiwa City, Chiba Prefecture, "the Lab") operated by Mitsui Fudosan.
Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral ALPK1 Selective Kinase Inhibitor, DF-003
Drug Farm announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of DF-003, a first-in-class, oral, potent, highly selective ALPK1 inhibitor for clinical evaluation.
Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA
Harbour BioMed (HKEX: 02142) announced that the National Medical Products Administration (NMPA) of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG).
Sanyou Forms Partnership with Hangzhou Zhongmei Huadong Pharmaceutical, Catalyzing Innovative Drug Research and Development
Recently, Sanyou Biopharmaceuticals Co., Ltd. (hereinafter referred to as Sanyou) and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) (hereinafter referred to as Huadong Medicine), signed a license agreement for a collaboratively developed therapeutic biological product.
Caliway Announces Positive Data from CBL-0201EFP Phase 2-Stage 1 Study of CBL-514 in Treating Moderate to Severe Cellulite
Caliway Biopharmaceuticals (Caliway), a Taiwan-based biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, today announced that the CBL-0201EFP Phase 2-Stage 1 results demonstrated the significant cellulite severity improvement with a single CBL-514 treatment.
Henlius Holds its 1st Overseas Scientific Advisory Board Meeting of 2023
Henlius successfully held its first Overseas Scientific Advisory Board (SAB) meeting of 2023 in California, United States.
