IPO News | New Element Pharmaceutical plans to list Hong Kong stocks, China Securities Regulatory Commission requires additional explanation of the basic situation of new shareholders in the last 12 months and other matters

Zhitong Finance App learned that on October 31, the China Securities Regulatory Commission announced the “Requirements for Supplementary Materials for Overseas Issuance and Listing Filing (October 27, 2025 to October 31, 2025)”. The International Department of the China Securities Regulatory Commission has issued supplementary material requirements for 9 companies. Among them, New Element Pharmaceuticals is required to provide additional information on matters such as the basic situation of new shareholders in the last 12 months. According to reports, New Element Pharmaceuticals submitted a listing application to the main board of the Hong Kong Stock Exchange on September 15, 2025, and CITIC Securities is its sole sponsor.

The China Securities Regulatory Commission requested Xinyuan Pharmaceutical to further explain the following matters, and ask lawyers to check and issue clear legal opinions:

1. Please explain the reasons and criteria for the inconsistent determination of controlling shareholders in the filing materials, and issue clear conclusions on the determination of controlling shareholders before and after listing.

2. Please explain the basic situation of the new shareholders added in the last 12 months, the reasons for the shareholding, the share price and the basis for pricing, and whether there were any abnormalities in share consideration or transfer of benefits.

3. Please explain whether the shares held by shareholders who intend to participate in the “full circulation” have been pledged, frozen, or have other rights defects.

According to the prospectus, New Element Pharmaceutical, founded in 2012, is a biotechnology company focusing on developing globally competitive and commercially valuable treatments in the fields of metabolism, inflammation and cardiovascular disease. It covers the whole process of care for gout patients, comprehensively solving problems such as hyperuricemia, chronic gout, acute gout, gout stone dissolution, and chronic kidney disease (“CKD”) associated with hyperuricemia. The company has established a system including two clinical-stage products and multiple pre-clinical projects.

ABP-671, the core product independently developed by the company, has a unique chemical structure, which eliminates the risk of hepatotoxicity compared with phenbromalone and derivatives based on its parent nuclei. Furthermore, ABP-671 is more selective in targeting and has better efficacy in lowering uric acid. Currently, ABP-671 is simultaneously undergoing phase 2b/3 clinical trials for the treatment of gout and hyperuricemia in the US and China, and is expected to be the best class 1 innovative uric acid transporter 1 (“URAT1”) inhibitor targeting the first-line treatment market. ABP-671 has also shown promising preclinical results in a number of indications other than gout and hyperuricemia, including combined hyperuricemia CKD and refractory gout (or gout stone gout).