New stock news | New Element Pharma submits a second filing to the Hong Kong Stock Exchange. Its core product ABP-671 is a new generation URAT1 inhibitor.

According to the disclosure on March 20th by the Hong Kong Stock Exchange, Hangzhou New Element Pharmaceutical Co., Ltd. (referred to as New Element Pharmaceutical) has submitted its listing application to the main board of the Hong Kong Stock Exchange, with CITIC SEC as its sole sponsor. This is the company's second submission to the Hong Kong Stock Exchange. Company Profile The prospectus shows that New Element Pharmaceutical was established in 2012 and is a biotechnology company focused on developing therapies in the fields of metabolism, inflammation, and cardiovascular diseases. As of March 11, 2026, the company's pipeline products include a core product ABP-671, another clinical stage candidate product ABP-745, as well as several preclinical stage candidate products such as AT6616, ABP-6016, and ABP-6118. The core product ABP-671 developed by New Element Pharmaceutical is a well-designed new generation URAT1 inhibitor with a unique chemical structure that avoids the common phenylfuran skeleton found in traditional drugs such as benzbromarone. ABP-671 can prevent the formation of toxic metabolites associated with liver damage, thereby minimizing the risk of hepatotoxicity while maintaining effective uric acid-lowering effects. In addition, ABP-671 exhibits higher target selectivity and more exciting uric acid-lowering effects. Currently, ABP-671 is undergoing Phase 2b/3 clinical trials for the treatment of gout in the United States and China, with the potential to become a leading class of innovative URAT1 inhibitors targeting the first-line treatment market. In the human plasma, around 90% of ABP-671 exists in the form of the parent compound and does not produce toxic metabolites, addressing the issue of liver toxicity caused by metabolites while enhancing the efficacy of the drug. In clinical trials, ABP-671 has shown significant improvements in dissolving gout stones, reducing urate crystal burden, and lowering the risk of complications associated with hyperuricemia. As of March 11, 2026, these advantages have been supported by clinical data from over 900 patients in the United States, China, Australia, and other countries and regions. Data from Phase 1 (United States), Phase 2a (Australia), and Phase 1/2a (China) clinical trials show that all adverse events were Grade 1 or Grade 2, with no hepatotoxicity observed. In Phase 2b clinical trials conducted in China and overseas, Grade 3 or higher adverse events were rare, generally mild, and similar between groups, with no observed liver or cardiovascular safety signals. These results demonstrate that its safety profile is superior to current first-line therapies and mainstream drugs. Furthermore, literature data suggests that a 2-4 mg dose of ABP-671 may be equivalent to or even better than the highest approved dose of benzbromarone or febuxostat (80 mg) in terms of uric acid-lowering efficacy. Overseas Phase 2b clinical trials of ABP-671 show significant improvements in treatment outcomes compared to placebo and allopurinol 800 mg treatment regimens. For indications of high uric acid blood levels with CKD, New Element Pharmaceutical plans to initiate a Phase 2 MRCT in the second quarter of 2026. The short-term target markets for ABP-671 are China and the United States, while the long-term targets include Europe. When designing and selecting countries for clinical trials, the company aims to enhance the diversity of patient populations and obtain broader clinical data to facilitate regulatory submissions and market access in target regions such as China, the United States, and Australia, rather than preparing for immediate commercialization in these countries. Financial Information Other income The company currently does not have any products approved for commercial sale nor generates any revenue from product sales. In 2024 and 2025, the company recorded other income of approximately RMB 7.718 million and RMB 4.821 million, respectively. Research and development expenses In 2024 and 2025, the company's research and development expenses were approximately RMB 338 million and RMB 180 million, respectively. Industry Overview In recent years, the global burden of gout patients has been increasing. The number of patients increased from 533 million in 2019 to 662 million in 2024, with a compound annual growth rate of 4.4%. It is expected that by 2033, the global number of patients will reach 916 million, corresponding to a compound annual growth rate of 3.7% from 2024 to 2033, with China showing a more pronounced growth trend. The number of gout patients in China increased from 152 million in 2019 to 253 million in 2024, with a compound annual growth rate of 10.7%. It is projected that by 2033, the number of gout patients will further rise to 440 million, with a compound annual growth rate of 6.4% from 2024 to 2033. The global market for gout drugs decreased from $31 billion in 2019 to $27 billion in 2024, mainly due to safety concerns about febuxostat and a decrease in sales volume due to price increases. However, it is expected to rebound significantly, reaching $93 billion by 2033, with a compound annual growth rate of 14.9% from 2024 to 2033. The Chinese gout drug market also experienced a decline, shrinking from $500 million in 2019 to $300 million in 2024, mainly affected by drug central procurement policies that lowered drug prices. The Chinese market is expected to recover rapidly, reaching $1.7 billion by 2033, with a compound annual growth rate of 20.4%, exceeding the global growth rate, driven by increasing prevalence rates, awareness, and new innovative therapies. Moreover, in the United States, the gout drug market increased from $1.5 billion in 2019 to $2 billion in 2024, with a compound annual growth rate of 5.6%, mainly driven by the increase in sales of xanthine oxidase inhibitors. The market size in the United States is expected to further increase to $5 billion by 2033, with a compound annual growth rate of 10.8% from 2024 to 2033, consistent with the global growth trajectory. Board of Directors Information The board of directors consists of nine directors, including two executive directors, four non-executive directors, and three independent non-executive directors. Shareholding Structure As of March 11, 2026, Dr. Shi directly holds approximately 29.4% of the issued share capital of the company. Intermediary Team Sole Sponsor: CITIC Securities Co., Ltd. Company Legal Counsel: K & L Gates LLP for Hong Kong and US law; Jincheng Tongda & Neal Law Firm for Chinese law. Legal Counsel for the Sole Sponsor: Smithfield Law Firm for Hong Kong and US law; JunHe LLP for Chinese law. Reporting Accountants and Independent Auditors: Deloitte Touche Tohmatsu CPA Ltd. Industry Consultants: Frost & Sullivan Consulting (Beijing) Co., Ltd., Shanghai Branch. Compliance Consultant: SOMERLEY CAP Ltd.