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IRNAOMICS(2257.HK):A DIFFERENTIATED BIOTECH COMPANY IN RNAI THERAPEUTICS

招银国际 ·  Jan 12

Two well-verified proprietary RNAi delivery platforms. Sirnaomics is aclinical-stage RNA therapeutics company with a strong presence in both Asia and the US. Delivery platforms are critical to the intact delivery of RNA therapeutics to the cells where they are needed. Sirnaomics has developed two platforms of proprietary delivery technologies: (1) PNP delivery platform for local or systemic administration of RNAi therapeutics to target the activated endothelial cells, multiple liver cell types beyond liver hepatocyte, and (2) GalNAc-RNAi delivery platform GalAhead for subcutaneous administration of RNAi therapeutics to the liver hepatocyte. Based on the PNP platform, Sirnaomics is currently advancing RNAi therapeutics for oncology applications of two core products, STP705 and STP707. Additionally, STP122G represents the first drug candidate of GalAhead technology entering clinical development.

Prioritized innovative product pipeline. Based on the PNP delivery andGalAhead delivery platforms, Sirnaomics has developed a prioritized innovative product pipeline. Currently, the Company focuses specifically on the US and Asia markets with a strategy to conduct trials in the US first and then extending to Asian countries. The Company's lead drug candidate STP705, formulated for local administration for the treatment of Non- Melanoma Skin Cancer (NMSC), and STP707, formulated for systemic administration for the treatment of solid tumors respectively, have both achieved positive PhII clinical readouts. The Company's top priority is to bring STP705 for the treatment of isSCC toward commercialization. After completing an End-of-PhII meeting with the US FDA in 1H23, the Company is well-positioned to advance the PhIII confirmatory clinical development of STP705 for the treatment of isSCC with FDA's guidance. The PhII trial of STP705 in BCC is expected to have final data readout in 2H23. For medical aesthetics applications, with excellent safety and clear efficacy signals demonstrated in PhI study for fat reduction in adults undergoing abdominoplasty, the Company is preparing a communication package for consultation with FDA regarding the initiation of a PhII study, and is also in active discussion on potential collaborations. For STP707, with the positive interim data, the Company will explore collaboration of a PhII combination trial combining STP707 with novel approved cancer therapies such as immune checkpoint inhibitors as well as chemotherapy for solid tumors (i.e. CCA, HCC, melanoma or pancreatic cancer).

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