New Stock News: Biopharmaceutical company Zehui Biotechnology has submitted an application to list on the main board of the Hong Kong Stock Exchange. The company has not yet made a profit and has incurred operating losses.

According to the Hong Kong Stock Exchange news on September 30th, Zehui Biotechnology Co., Ltd. (Zehui Biotech) submitted an application to the Hong Kong Stock Exchange main board, with CICC as the exclusive sponsor. The prospectus disclosed that Zehui Biotech is a biopharmaceutical company in the clinical research and development stage. Since its establishment in 2017, the company has been dedicated to developing innovative cell therapy products using pluripotent stem cells (PSC) to treat various diseases. As one of the first companies in China and globally to develop PSC-derived cell therapy products, according to Frost & Sullivan data, the company is one of the first in China to receive approval for investigational new drug (IND) applications for PSC-derived cell therapies and the only company in China with multiple PSC-derived cell therapy assets in Phase II clinical trials. Currently, the company's product portfolio includes core product ZH901, as well as main products ZH903, ZH902, and ZH906. As of the latest feasible date, the core product ZH901 has entered Phase II clinical trials, studying its use in treating AE-ILD, aGVHD, meniscus injuries, and ARDS. ZH903 and ZH902 are each main products currently undergoing investigator-initiated trials (IIT), for the treatment of Parkinson's disease and dry AMD, respectively. The company's main product ZH906 is for the treatment of corneal endothelial decompensation and is currently in the preclinical stage. It is stated that Zehui Biotech has developed a pluripotent stem cell-derived cell therapy product development platform (PROF), which consists of three independent and integrated technical platforms: the pluripotent stem cell seed cell platform (PROF-seed), the key functional cell screening and development platform (PROF-function), and the formulation optimization platform (PROF-formulator). Leveraging this integrated technical platform, the company has developed a comprehensive and differentiated product pipeline consisting of four types of PSC-derived cell therapy products, covering seven indications including acute exacerbations of interstitial lung disease (AE-ILD), acute graft-versus-host disease (aGVHD), meniscus injuries, acute respiratory distress syndrome (ARDS), Parkinson's disease, dry age-related macular degeneration (AMD), and corneal endothelial decompensation. In the prospectus, Zehui Biotech stated that the company plans to establish a manufacturing facility in Zhongshan City, Guangdong Province (Zhongshan Factory), with a total area of approximately 150,000 square meters and an expected annual production capacity of approximately 500,000 units of cell therapy product injections to support commercial production. As of the latest feasible date, the company is in the process of developing the construction plan for the Zhongshan Factory, with construction expected to commence by the end of 2024. The construction of the Zhongshan Factory is scheduled to be completed in the second half of 2026, after which it will begin trial operations. The Zhongshan Factory is expected to commence commercial production in 2030. Financially, the company currently does not have any approved products for commercial sale, nor has it generated any revenue from product sales. During the previous year, the company was not profitable and incurred operating losses. The company recorded losses of approximately 173 million, 196 million, and 237 million yuan in the periods of 2022, 2023, and the first half of 2024, respectively. Zehui Biotech stated that the company incurred losses due to significant research and development expenses and administrative costs.