ArkBio submits to HKEX, specializing in respiratory and pediatric disease treatments

According to the disclosure by the Hong Kong Stock Exchange on September 15, Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") has submitted an application for listing on the Main Board of the Hong Kong Stock Exchange, with J.P. Morgan and CITIC Securities acting as joint sponsors.

According to its prospectus, ArkBio is a biopharmaceutical company founded in 2013 that focuses on discovering and developing therapies to address medical needs in respiratory and pediatric diseases. The company’s drug candidates target acute, chronic, and end-stage respiratory and pediatric conditions that currently lack effective treatment options.

Under the leadership of its founder and CEO, Dr. Wu, and an outstanding scientific management team, the company has built a pipeline of six drug candidates. These include an RSV portfolio featuring its core product, Ziresovir—the world’s first therapeutic specifically targeting respiratory syncytial virus (RSV) infection to have reached the New Drug Application (NDA) stage—as well as AK0610, a Phase II monoclonal antibody (mAb) for preventing RSV infection. The pipeline also consists of additional core assets such as AK3280 for idiopathic pulmonary fibrosis (IPF), which is in post-Phase II proof-of-concept (PoC) clinical trials, and AK0901 for attention deficit hyperactivity disorder (ADHD), currently in the NDA stage.

The company is also developing drug candidates in other related disease areas, including AK0705 for the treatment of chronic obstructive pulmonary disease (COPD) and AK0406 for the treatment of influenza. ArkBio noted in its prospectus that it may fail to successfully develop its pipeline products (including its core product Ziresovir and AK3280) or derive meaningful economic value from them.

ArkBio believes the following competitive strengths distinguish it from its competitors: (i) globally leading innovation in RSV treatment and prevention; (ii) a potential best-in-class, next-generation Phase III-ready asset for IPF; (iii) a novel ADHD therapy addressing critical unmet needs in the Chinese market; (iv) a dual-engine R&D strategy supported by established global business development capabilities and multi-platform in-house research expertise to drive next-generation product innovation; and (v) an exceptional R&D leadership team backed by renowned stakeholders.

Financially, ArkBio reported losses of approximately RMB 270 million (2023 full year), RMB 197 million (2024 full year), RMB 87.507 million (first half of 2024), and RMB 104 million (first half of 2025).

Source: Zhitong Financial