New stock news | Huarong Bio passed the hearing of the Hong Kong Stock Exchange with only two core products.
According to the disclosure by the Hong Kong Stock Exchange on December 10th, Hua'er Bio-Technology (Qingdao) Co., Ltd. - B (referred to as Hua'er Bio) has conducted a listing hearing on the Main Board of the Hong Kong Stock Exchange, with Huatai International and CITIC Securities as the joint sponsors.
According to the Hong Kong Stock Exchange disclosed on December 10th, Huar Biotechnology (Qingdao) Co., Ltd.-B (referred to as Huar Biotechnology) has conducted a listing hearing on the main board of the Hong Kong Stock Exchange, with Huatai International and CITIC SEC as joint sponsors.
According to the prospectus, the company was established in 2012 and is a biopharmaceutical company headquartered in China, dedicated to developing various therapies, focusing on developing protein drugs for indications with medical needs and market opportunities. The company's main focus is on discovering, developing, and commercializing therapies for wound healing, currently with a focus on Platelet-Derived Growth Factor (PDGF) drugs.
As of the last feasible date (December 5, 2025), the company's pipeline includes two core products: (i) Pro-101-1 for the treatment of deep second-degree burns, with completed statistical data analysis of phase IIb clinical trials; and (ii) Pro-101-2 for the treatment of diabetic foot ulcers (diabetic foot), currently in phase II clinical trials. The company also has eight other candidate products.
The company may not be successful in developing and/or commercializing its core products. The company only has two core products, Pro-101-1 and Pro-101-2. For Pro-101-1, some clinical trial data do not show statistical significance between the treatment group and the placebo group. In addition, since February 2022, the enrollment progress of subjects in the Pro-101-2 clinical trial has been slow, delaying the progress of the company's products.
Regarding the use of Pro-101-1 for the treatment of deep second-degree burns, there is no significant difference in statistical analysis based on the FAS. The company has reached an agreement with the drug regulatory center to extend the evaluation of the results of the phase IIb clinical trial and initiate a phase IIIa clinical trial as an exploratory evaluation of the phase IIb clinical trial. After completing this trial, the company will communicate with the drug regulatory center to seek guidance on Pro101-1. If allowed by the drug regulatory center, the company will initiate a phase IIIb clinical trial, which is expected to be a confirmatory clinical trial. Failure to start the phase IIIb clinical trial due to unsatisfactory results of the phase IIIa clinical trial will result in Pro-101-1 not progressing to NDA application approval in China. Therefore, the market potential of Pro-101-1 for the treatment of deep second-degree burns will be significantly limited.
The company's pipeline includes ten candidate products with market potential covering various indications, including two core products (Pro-101-1 and Pro-101-2). As of the last feasible date, Pro-101-1 for the treatment of deep and shallow second-degree burns has completed the last patient enrollment in phase IIb clinical trials in China and is in the process of finalizing the phase IIb clinical trial report; and Pro-101-2 for the treatment of diabetic foot ulcers is in phase II clinical trials in China. The company anticipates that once its PDGF candidate products are commercialized, its main market will be in China. In addition, the company plans to conduct phase III clinical trials for Pro-101-1 for the treatment of deep second-degree burns in the US and Japan, and launch the product in the US and Japan; the company plans to conduct phase III clinical trials for Pro-101-2 in the US and Japan, and launch the product in the US and Japan.
Financially, in the fiscal years of 2023, 2024, and the nine months ended September 30, 2025, the company's losses were approximately RMB 105 million, RMB 212 million, and RMB 134 million respectively.
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