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To-be Listed
Name
/
Code
Industry Offer Price Lot Size Entry Fee Closing Date
Grey Market Date
Listing Date
REFIRE
02570.HK
Electrical Components & Equipment 145-165 20 3,333 2024/12/03 2024/12/05 2024/12/06
Dmall
02586.HK
Application Software 30.21 100 N/A 2024/12/03 2024/12/05 2024/12/06
Summary
We are an RNA therapeutics biopharmaceutical company with product candidates in pre- clinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. We 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. Our core product STP705 demonstrated efficacy and safety in an oncology Phase I/II clinical trial for non-melanoma skin cancer and we 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, we 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, our 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.. We may not be able to ultimately develop and market our core product STP705 successfully.

OUR BUSINESS MODEL

We have built an international professional team for discovery and development of RNAi therapeutics and mRNA vaccines and therapeutics, based on our proprietary drug delivery technology platforms. Our target market is global with our current focus specifically on the U.S. and China markets, which are supported by our research and development facilities and manufacturing capabilities in both countries. We are adopting a clinical development strategy to conduct clinical trials for our 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.

Our initial focus is on oncology and fibrosis products, as well as antiviral products and products that leverage liver targeted drug delivery. We have developed in-house and own the global rights to STP705 and STP707, our lead product candidates, which demonstrates our capabilities in designing novel RNA therapeutics based on our proprietary delivery platforms and developing them into drugs to address unmet medical needs. Our proprietary delivery platforms include our PNP delivery platform, useful for local or systemic administration of RNAi therapeutics to targets beyond liver hepatocyte cells, our GalNAc RNAi delivery platforms for systemic administration of RNAi therapeutics to the liver, and our PLNP delivery platform for administration of mRNA vaccines and therapeutics. We exclusively in-licensed core patents covering our PNP delivery platform at an early stage and have conducted research and development in-house to enhance our PNP delivery platform and adapt it for formulating novel RNA therapeutics to treat a range of therapeutic indications. We have developed in-house and own the global rights to GalNAc RNAi delivery platforms. Our GalAheadTM delivery platform conjugates GalNAc moieties to unique RNAi trigger structures while our PDoV-GalNAc delivery platform conjugates GalNAc moieties to Peptide Docking Vehicle (PDoV) peptide linkers and up to two siRNAs conjugated to the peptide linker. Our PNP and GalNAc RNAi delivery platforms serve as a basis to expand our pipeline of early- stage product candidates. Our 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 pre- IND discussion with U.S. FDA and mRNA tumor vaccine and therapeutics programs, which use our proprietary PLNP delivery platform that we developed in-house and to which we own global rights. As of the Latest Practicable Date, we 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 our 16 product candidates separately from our delivery platforms.

Our long time (since 2008) and dual presence in the U.S and China allows us to navigate between both countries’ regulatory systems. We are subject to the regulation of competent authorities from the U.S. and China in light of our 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, we 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. We plan to commence clinical trials in China for isSCC, HTS, and liver cancer in 2022.

Source: Sirnaomics-B (02257) Prospectus (IPO Date : 2021/12/20)
Listing Market MAIN
Industry Biotechnology
Background Others
Major Business Area N/A
Corporate Information
Substantial Shareholders Yang Lu (10.60%)
Shanghai Chongshi Enterprise Management Partnership(LP) (5.21%)
Directors Yang Lu (Chairman and President and Chief Scientific Officer and Non-Executive Director)
Poon Hung Fai (Chief Executive Officer and Executive Director)
Jiankang Zhang (Non-Executive Director)
Mincong Huang (Non-Executive Director)
Shing Mo Han, Yvonne (Independent Non-Executive Director)
Monin Ung (Independent Non-Executive Director)
Yu Cheung Hoi (Independent Non-Executive Director)
Company Secretary Leung Ting Cheung
Yun Zhang
Principal Bankers The HongKong and Shanghai Banking Corporation Limited
DBS Bank (Hong Kong), Limited
DBS Bank Limited
Wells Fargo Bank N.A.
Solicitors Clifford Chance
Commerce & Finance Law Offices
Maples and Calder (Hong Kong) LLP
Auditors Deloitte Touche Tohmatsu
Registered Office 46th Floor, Hopewell Centre, 183 Queen’s Road East, Wanchai, Hong Kong
Share Registrars Computershare Hong Kong Investor Services Ltd. [Tel: (852) 2862-8628]
Share Registrars Tel No (852) 2862-8628
Internet Address http://www.sirnaomics.com
Email Address [email protected]
Tel No (852) 3180-9494
Fax No
 
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