Who We Are
Sirnaomics is the first and only clinical-stage RNA therapeutics biopharmaceutical company with a strong presence in both China and the U.S.* that is discovering and developing innovative drugs for indications with significant unmet medical needs and large market opportunities. We were founded in 2007 with the establishment of US Sirnaomics in Gaithersburg, Maryland. We are the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for our core product, STP705.
Our product pipeline is deep as it has broad therapeutic utility across rare and large market diseases, including oncology, fibrosis-related diseases, as well as antiviral and cardiometabolic diseases. We now have five ongoing clinical trials in phase I/II stage and another at least 14 other product candidates in IND enabling or advanced preclinical studies.
Our proprietary delivery platforms for administration of RNA-based therapeutics are the foundation of our product pipeline, including our polypeptide nanoparticle delivery platform optimizable for local or systemic administration of RNAi therapeutics and targets beyond liver hepatocyte cells, our GalNAc-based delivery platforms for systemic administration and liver-targeting RNAi therapeutics, and our polypeptide lipid nanoparticle delivery platform useful for administration of mRNA vaccines and therapeutics.
Obtained Safe to Proceed Letter from FDA IND for STP707 in PSC
Initiated Phase I clinical trial STP707 in the U.S.
Listed and commenced trading on the Main Board of The Stock Exchange of Hong Kong Limited
Obtained IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 from FDA
Established co-development partnership with Walvax to license out the China rights of STP702
Completed Series E financing raising approximately US$106.7 million
Initiated Phase IIb study for STP705 for isSCC in the U.S.
Initiated Phase II clinical trial for STP705 for Keloid scarless healing in the U.S.
Initiated Phase I clinical trial for STP705 for live cancer in the U.S.
Obtained acceptance for review for STP705 for isSCC from NMPA
Obtained IND clearance for STP707 from FDA
Completed the overall construction and acceptance of the pilot production plant of polypeptide nanoparticle nucleic acid drugs in Sirnaomics Guangzhou and entered into the trial operation stage
Started the construction of Southern Headquarters of Sirnaomics, which is expected to be completed in 2021
Commencement of operation of RNAimmune
Completed Series D financing raising approximately US$104 million
Completed Phase I/II study for STP705 for isSCC in the U.S.
Initiated Phase II clinical trial for STP705 for BCC in the U.S.
Completed Series C financing raising US$48 million
Set up Sirnaomics Hong Kong
Completed Series B financing raising US$10 million
Achieved the first IND approval ofRNAi drug for STP705 treating HTS
Guangzhou Sirnaomics obtained the national innovation company certification
Guangzhou Sirnaomics and Jiangsu Zhengyuan started cooperation to develop a variety of atomization drug delivery devices
Obtained IND clearance for STP705 for hypertrophic scar from FDA
Suzhou Sirnaomics and Guangzhou Sirnaomics were selected as the “Significant New Drug Creation” in the 13th Five-Year Plan
Submitted to CFDA the IND application for China's first nucleic acid drug-STP705 for the treatment of hypertrophic scars
Suzhou Sirnaomics and Guangzhou Sirnaomics were selected as the “Significant New Drug Creation” in the 12th Five-Year Plan
Established Guangzhou Sirnaomics
Guangzhou Sirnaomics was selected as Guangzhou Entrepreneurship Leading Talent Project
Suzhou Sirnaomics was selected as Jiangsu Science and Technology Leading Talent Project
Suzhou Sirnaomics was certified as Suzhou Engineering Research Center for nucleic acid drugs by Suzhou Science and Technology Bureau
Established Suzhou Sirnaomics
Established US Sirnaomics
9issued patents in China
9issued patents in the U.S.
2issued patents in Europe
119pending patent applications, including:
19 Chinese patent applications
43 U.S. patent applications (including 32 U.S. provisional patent applications)
8 patent applications under the Patent Cooperation Treaty
6 patent applications in Europe
43 patent applications in other jurisdictions.
401 Professional Dr, STE 280 Gaithersburg, MD 20879, USA
218 Xinghu Street, STE A4-415 BioBay, Suzhou, CHINA
12 Luoxuan 3 Road, STE 4-306 Guangzhou International Bio-island Guangzhou, CHINA
46/F, Hopewell Centre, 183 Queen's Road East, Wanchai, Hong Kong
245 First Street, 18F
Cambridge, MA 02142, USA