New Stock News | AnnouUda submits application to Hong Kong Stock Exchange, ranks third in China's NIPT market.

According to the disclosure by the Hong Kong Stock Exchange on March 25th, Annoroad Gene Technology (Beijing) Co., Ltd. (referred to as Annoroad) has submitted its application for listing on the main board of the Hong Kong Stock Exchange, with China International Capital Corporation (CICC) and Guotai Junan International as its joint sponsors. According to the prospectus, Annoroad is a company focused on molecular diagnostics-based IVD medical devices and omics life science research services, specializing in NGS-based prenatal testing IVD products. The company's clinical sequencing solutions include self-produced IVD test kits based on genetic sequencing, genetic sequencers, and bioinformatics analysis software, as well as supporting technical and laboratory design services. Customers mainly include hospitals and Independent Clinical Laboratories (ICL) accredited for prenatal diagnosis. These institutional customers purchase the company's IVD products, and the company charges fees based on the number and type of IVD products purchased by these customers. Subsequently, subjects request testing services from hospitals or ICL, where the entire in-house diagnostic workflow, including sampling, library construction, sequencing, analysis, and reporting, is carried out. Annoroad's solution integrates the company's cutting-edge sequencing technology and bioinformatics analysis capabilities with a specialized professional support team to simplify the workflow of genetic sequencing and analysis, enabling early detection of genetic abnormalities and providing more accurate diagnostic results. Annoroad has a first-mover advantage in developing and commercializing IVD products in the field of reproductive health based on molecular diagnostics. The company's NIPT test kit (designed to detect three of the most common chromosomal diseases - trisomy 21, 18, and 13) obtained Class III medical device certification in 2017, making the company one of the few in China to achieve this milestone. As a result, the company has solidified its position in the prenatal testing market and captured a significant market share. According to data from Questica Consultancy, based on sample testing volume, the company ranked third in the Chinese NIPT market in 2023, with market share continuing to grow by 9.6%, 11.6%, and 12.1% in 2021, 2022, and 2023 respectively. Comparing to traditional prenatal testing methods (such as amniocentesis and serum screening), Annoroad's NIPT test kit can detect genetic abnormalities related to fetal cfDNA in small peripheral blood samples, greatly reducing the risk of miscarriage associated with invasive sampling procedures, while achieving 100% sensitivity and 99.9% specificity. Recognizing the demand for in vitro diagnostic (IVD) products for disease diagnosis caused by chromosomal copy number variations (CNV), Annoroad has developed the CNV-seq test kit, obtaining Class III medical device certification in 2024. Compared to traditional karyotyping analysis, the company's CNV-seq test kit provides additional detection range and higher accuracy in detecting birth defects. It is the first amniocentesis-based CNV-seq test kit approved by the National Medical Products Administration, further consolidating the company's leading position in IVD product development and prenatal testing market. In addition, the company is one of the few that combines a complete set of IVD products with nationally approved test kits, sequencers, and bioinformatics analysis software compatible with the test kits. The company's independently developed NextSeq 550AR sequencer is a compact, versatile, and user-friendly sequencer based on NGS technology. Annoroad is equipped with a complete set of advanced sequencing technologies and industry-leading bioinformatics analysis capabilities, capable of performing various sequencing tasks, including third-generation sequencing, single-cell sequencing, Hi-C sequencing, spatiotemporal transcriptomics sequencing, epigenomics sequencing, animal and plant resequencing, and transcriptome sequencing, covering various life science research topics such as forestry, agriculture, medicinal plants, marine species, insects, and mammals. As of December 31st, 2024, the company has helped publish approximately 400 SCI-indexed articles with a cumulative impact factor exceeding 5,000, with over 20 articles contributed to high-impact journals such as Cell, Nature, and Science, with a cumulative impact factor exceeding 500. According to Questica Consultancy, the company is one of the leading providers of comprehensive sequencing platforms for scientific research, capable of meeting various multi-omics research needs. Based on revenue estimates for 2023, the company has a 4.2% market share as a provider of scientific research sequencing solutions. Financially, in 2022, 2023, and 2024, Annoroad's operating revenues were approximately RMB 435 million, RMB 475 million, and RMB 518 million respectively, with net losses of approximately RMB 67 million, RMB 240 million, and RMB 126 million in each respective year. According to the risk factors section in Annoroad's prospectus, if the company fails to timely develop new IVD products based on molecular diagnostics or deploy cutting-edge sequencing technology to meet evolving customer demands, the company may lose its competitiveness.