The world's first mRNA tumor vaccine meets phase three standards, and Sidis Pharmaceuticals (01244) rises 17% as it is re-evaluated against international benchmarks.
As the global tumor immunotherapy enters a new era of gene therapy, Sidu Pharmaceutical is expected to continue receiving catalysts for valuation reappraisal thanks to its differentiated pipeline layout and commercialization pace.
On August 19, a milestone was achieved in tumor immunotherapy. Moderna and Merck unveiled that the Phase III clinical trial INTerpath-001 for the tumor neoantigen mRNA vaccine mRNA-4157 combined with Keytruda for adjuvant treatment of melanoma reached its primary endpoint of RFS and a key secondary endpoint of DMFS. Following this news, Moderna's stock surged by 89%, while its partner Merck saw an 8% increase in share price. In the Hong Kong stock market, Sihuan Pharmaceutical (01244) closed at HKD 2.18 today, rising by 17.2%, becoming one of the key beneficiaries amid positive sentiment in the sector.
As an innovative pharmaceutical company deeply engaged in the treatment of cancer as a chronic disease, Sihuan Pharmaceutical has recently celebrated several significant business advancements, demonstrating its hard-core capabilities in sync with leading international tumor immunotherapy pathways: the results of a pivotal Phase III clinical study for the company's innovative immune drug Envda (envafolimab injection) were successfully presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; the companys independently developed radionuclide platform's first radioactive nuclide conjugated drug (RDC) 177Lu-PSMA-3D1015 injection completed the first dosing in an investigator-initiated trial (IIT).
Sihuan Pharmaceutical has established three major technology development platforms: In vivo CAR-T/NK, mRNA-LNP tumor vaccines, and radionuclide therapy. The universal mRNA-LNP tumor vaccine 3D124, leveraging AI-driven antigen screening and independently developed LNP delivery technology, overcomes international patent restrictions and significantly improves delivery efficiency, demonstrating remarkable tumor suppression effects in preclinical studies. This product aims to complete dual IND submissions in China and the U.S. by 2026; the new generation RDC targeting PSMA, 3D1015, shows clinical potential by achieving equivalent tumor suppression effects at a 1/4 dosage compared to approved products, with the first IIT dosing expected to be completed by August 2025. The in vivo CAR-T: 3D128, using CD7-LNP pathways, ranks among the global top tier, with transfection efficiency surpassing publicly available literature data, and its on-demand delivery pathway significantly enhances accessibility, while the LNP pathway exhibits high safety.
As global tumor immunotherapy enters a new era of gene therapy, Sihuan Pharmaceutical is poised to continue benefiting from catalysts for valuation reassessment, thanks to its differentiated pipeline layout and commercialization rhythm.
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