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Sirnaomics Ltd., 02257.HK - Company Profile
Chairman	Yang Lu
Share Issued (share)	88,000,000
Par Currency	U.S. Dollar
Par Value	0.001
Industry	Biotechnology
Corporate Profile	Business Summary: The group is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Performance for the year: In 2019, 2020 and the nine months ended September 30, 2021, the group recorded a total net loss of US$17.1 million, US$46.4 million and US$50.0 million, respectively. Business Review The group were founded in 2007 with the establishment of US Sirnaomics and currently have a presence in both China and the U.S., with research and development centers in both countries. the group’s core product STP705 demonstrated efficacy and safety in an oncology Phase I/II clinical trial for non-melanoma skin cancer and the group have further advanced STP705 in a Phase IIb clinical trial for squamous cell carcinoma in situ (isSCC), a Phase II clinical trial for treatment of skin basal cell carcinoma (BCC), a Phase II clinical trial for treatment of keloid and a Phase I/II clinical trial for treatment of hypertrophic scar (HTS). In addition, the group initiated a Phase I clinical trial using STP705 for treatment of liver cancer (basket) through a local injection based on an independent IND approval from US FDA. As of the Latest Practicable Date, the group’s core product STP705 is covered by two issued patents in the U.S. and five pending patent applications, including two in China and three in the U.S.. the group may not be able to ultimately develop and market the group’s core product STP705 successfully. THE GROUP’S BUSINESS MODEL The group have built an international professional team for discovery and development of RNAi therapeutics and mRNA vaccines and therapeutics, based on the group’s proprietary drug delivery technology platforms. the group’s target market is global with the group’s current focus specifically on the U.S. and China markets, which are supported by the group’s research and development facilities and manufacturing capabilities in both countries. The group is adopting a clinical development strategy to conduct clinical trials for the group’s product candidates initially in the U.S. and then to extend those trials into China, based on the differing medical needs of the two markets, for example, some orphan drug indications in the U.S. are more prevalent in the population in China. The group’s initial focus is on oncology and fibrosis products, as well as antiviral products and products that leverage liver targeted drug delivery. the group have developed in-house and own the global rights to STP705 and STP707, the group’s lead product candidates, which demonstrates the group’s capabilities in designing novel RNA therapeutics based on the group’s proprietary delivery platforms and developing them into drugs to address unmet medical needs. the group’s proprietary delivery platforms include the group’s PNP delivery platform, useful for local or systemic administration of RNAi therapeutics to targets beyond liver hepatocyte cells, the group’s GalNAc RNAi delivery platforms for systemic administration of RNAi therapeutics to the liver, and the group’s PLNP delivery platform for administration of mRNA vaccines and therapeutics. the group exclusively in-licensed core patents covering the group’s PNP delivery platform at an early stage and have conducted research and development in-house to enhance the group’s PNP delivery platform and adapt it for formulating novel RNA therapeutics to treat a range of therapeutic indications. the group have developed in-house and own the global rights to GalNAc RNAi delivery platforms. the group’s GalAheadTM delivery platform conjugates GalNAc moieties to unique RNAi trigger structures while the group’s PDoV-GalNAc delivery platform conjugates GalNAc moieties to Peptide Docking Vehicle (PDoV) peptide linkers and up to two siRNAs conjugated to the peptide linker. the group’s PNP and GalNAc RNAi delivery platforms serve as a basis to expand the group’s pipeline of earlystage product candidates. the group’s subsidiary RNAimmune develops mRNA-based vaccines and therapeutics, including an mRNA SARS-CoV-2 vaccine program using Delta variant spike protein-coding mRNA as an antigen with LNP delivery formulation, which is undergoing preIND discussion with U.S. FDA and mRNA tumor vaccine and therapeutics programs, which use the group’s proprietary PLNP delivery platform that the group developed in-house and to which the group own global rights. As of the Latest Practicable Date, the group own in aggregate six issued patents, including one in Europe and five in the U.S., and 40 pending patent applications, including seven in China, 21 in the U.S., one in Europe, two under the Patent Cooperation Treaty and nine in other jurisdictions, that cover the group’s 16 product candidates separately from the group’s delivery platforms. The group’s long time (since 2008) and dual presence in the U.S and China allows us to navigate between both countries’ regulatory systems. The group is subject to the regulation of competent authorities from the U.S. and China in light of the group’s dual presence in both countries. In China, NMPA is the primary regulatory agency for pharmaceutical products and businesses, and regulates across the life cycle of pharmaceutical products. In the U.S., FDA represents the counterpart of the NMPA regulating drugs and biologics. For details of relevant regulatory authorities, see “Regulatory Overview – Overview of Laws and Regulations in the PRC” and “Regulatory Overview – Overview of Laws and Regulations in the United States.” As of the Latest Practicable Date, the group had a regulatory and clinical team with five members in the U.S. and six in China with ample knowledge and experience with regard to regulatory filings in both countries managing the regulatory submission process in the U.S. and China. the group plan to commence clinical trials in China for isSCC, HTS, and liver cancer in 2022. Prospects: • Enhance and apply the group’s proprietary delivery platforms to advance the development of innovative therapeutic modalities for the treatment of a broad range of disease states and strengthen the group’s intellectual property position • Rapidly advance development of the group’s core product candidate STP705 through clinical trials toward market approvals in a broad range of indications in China and the U.S. • Develop and commercialize a diverse portfolio of transformative RNA products in a broad range of therapeutic areas, including both rare diseases and diseases with large patient populations • Build a fully integrated biopharmaceutical company by advancing the group’s capabilities in product development, expanding the group’s internal GMP manufacturing capabilities, and developing commercialization abilities, if the group’s product candidates are approved • Selectively pursue synergistic collaboration opportunities to maximize the potential of the group’s clinical product candidates

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