Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.
Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.
Hypersialylation in tumor cells is a potent mechanism of tumor immune evasion, pushing cancer progression by suppressing both innate and adaptive antitumor immunity. Shanghai Henlius Biotech Inc. has developed an engineered human sialidase enzyme fused to an anti-B7-H3 nanobody, named E-688 or HLX-316, that improves tumor desialylation, durability and efficacy both in vitro and in vivo, while maintaining a safe profile.
Shanghai Henlius Biotech Inc. has presented preclinical data on HLX-403, its novel anti-CDH17 antibody-drug conjugate (ADC), highlighting its potential for gastrointestinal cancers. A first-in-human trial is expected to commence in the third quarter of this year.
China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
Shanghai Henlius Biotech Inc. has entered into an exclusive global license agreement with U-mab Biopharma (Lianyungang) Co. Ltd., securing rights to a monoclonal antibody (mAb) targeting interleukin-1 receptor accessory protein (IL-1RAP) for inflammatory and autoimmune diseases.
Shanghai Henlius Biotech Inc. has announced acceptance of IND applications by China’s National Medical Products Administration (NMPA) for three differentiated candidates for the treatment of solid tumors.
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
