New stock news | Huaren Biological has submitted its third application to the Hong Kong Stock Exchange. Pro-101-1, used for the treatment of burns and scalds, has completed Phase IIb clinical trials in China.

According to the disclosure on August 15 by the Hong Kong Stock Exchange, Huaren Biotechnology (Qingdao) Co., Ltd. (referred to as "Huaren Biotechnology") submitted an application for listing on the main board of the Hong Kong Stock Exchange, with Huatai International and CITIC SEC acting as joint sponsors. The company had previously submitted applications to the Hong Kong Stock Exchange on April 29, 2024, and November 22, 2024. The prospectus shows that Huaren Biotechnology was established in 2012 and is a biopharmaceutical company headquartered in China. The company is focused on developing therapies, particularly protein drugs targeting medical needs and market opportunities. Its main focus is on discovering, developing, and commercializing therapies for wound healing, currently focusing on Platelet-Derived Growth Factor ("PDGF") drugs. As of the last practical date, the company's pipeline includes two core products, Pro-101-1 for treating burns and scalds and Pro-101-2 for treating diabetic foot ulcers ("diabetic foot"), as well as eight other candidate products. Pro-101-1 for treating burns and scalds has completed Phase IIb clinical trials in China and is in the process of finalizing the clinical trial report; while Pro-101-2 for treating diabetic foot is undergoing Phase II clinical trials in China. The company expects that once its PDGF candidate products are commercialized, its main market will be in China. In addition, the company plans to launch Pro-101-1 in the United States. In the prospectus, Huaren Biotechnology cautioned that the company may not be successful in developing and/or promoting its core products. PDGF is one of the growth factors secreted by platelets after injury. It promotes the generation of new blood vessels, regulates inflammation, stimulates cell proliferation and migration, ultimately leading to wound healing. PDGF-BB is one of the five dimer subtypes of PDGF, and rhPDGF-BB is a clinical form of PDGF-BB, a recombinant form of naturally occurring PDGF-BB. According to Frost & Sullivan reports, Pro-101-1 is the fastest progressing PDGF candidate drug for treating burns and scalds in China. Additionally, the company's other PDGF candidate products contain the same active substance rhPDGF-BB as the core products. PDGF drugs have been used as growth factor therapy products for diabetic foot for over 20 years, mainly in the United States. PDGF is the only recombinant growth factor approved by the FDA for topical use, especially for treating diabetic foot. Numerous clinical studies over the years have shown that PDGF drugs are effective in treating diabetic foot and have good safety. Furthermore, as of the last practical date, due to the high barriers to research and production of PDGF drugs, including (i) the difficulty of improving the PDGF gene sequence for production purposes, (ii) the complexity of producing purified PDGF, (iii) stringent quality control requirements to avoid protein aggregation and misfolding, and (iv) correct formulation and storage conditions to maximize protein activity, there are no commercial PDGF drugs in China. As of the last practical date, the company has submitted five patent applications for its core products, which are currently under review. In 2013, the company acquired two patents related to PDGF from CPE and the Institute of Biomedical Engineering of the Academy of Military Sciences, as well as technical data related to PDGF research for treating diabetic foot (later becoming Pro-101-2)("projects"). These patents are co-owned by the company and the Institute of Military Sciences, and the company does not have any other patents co-owned with the Institute of Military Sciences. The company jointly developed Pro-101-2 with the Institute of Military Sciences, and as of July 2021, the company obtained IND approval for Pro-101-2, a one-time approval for all stages of Pro-101-2 clinical development. Although the Institute of Military Sciences remains a joint applicant for Pro-101-2, they have not been involved in the clinical research or drug development work related to Pro-101-2 since July 2021. After completing clinical development, the company is expected to be the sole holder of the Pro-101-2 MAH license. Additionally, because the Institute of Military Sciences has transferred the technical data related to the projects to the company, and the company has exclusive rights to use and commercialize two PDGF-related patents, the Institute of Military Sciences does not have the right to authorize the technical data related to the projects or PDGF-related patents to third parties without the company's consent. As far as the board is aware, the Institute of Military Sciences has not conducted any research on the use of PDGF for treating diabetic foot within or outside of the projects. The Institute of Military Sciences is no longer involved in any clinical development or communication with regulatory authorities related to Pro-101-1 or other PDGF candidate products. Throughout the entire clinical development process of the company's core products, the company has independently conducted clinical trials of its core products and expects to independently conduct subsequent clinical trials. The company has also independently developed an early-stage mRNA candidate product pipeline and an ASO candidate product pipeline. Financially, in the fiscal year 2023 and 2024, Huaren Biotechnology achieved revenues of approximately RMB 472,000 and RMB 261,000 respectively; and in the fiscal year 2023, 2024 and the five months ending May 31, 2024 and 2025, the total comprehensive losses for the year/period were RMB 105 million, RMB 212 million, RMB 91.909 million, and RMB 72.423 million respectively.