New Stock News | New Element Pharma Files Second Application with Hong Kong Exchange, Core Product ABP-671 Is Next-Generation URAT1 Inhibitor

Tongtong Finance APP learned that, according to the Hong Kong Stock Exchange disclosure on March 20, Hangzhou New Element Pharmaceutical Co., Ltd. (referred to as: New Element Pharma) has submitted an application for listing on the Main Board of the Hong Kong Stock Exchange, with CITIC Securities as its sole sponsor. This is the company’s second time submitting a listing application to the HKEX.

Company Overview

The prospectus shows that New Element Pharma 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 includes a core product ABP-671, a clinical-stage candidate ABP-745, and several preclinical candidates such as AT6616, ABP-6016, and ABP-6118.

The company’s self-developed core product, ABP-671, is a new generation URAT1 inhibitor with a rational design and a unique chemical structure that avoids the benzofuran scaffold common in traditional drugs like benzbromarone. ABP-671 prevents the formation of toxic metabolites associated with liver damage, minimizing hepatotoxicity risks while maintaining effective uric acid reduction. Additionally, ABP-671 has higher targeted selectivity and more impressive uric acid-lowering efficacy. Currently, ABP-671 is being simultaneously tested in Phase 2b/3 clinical trials in the US and China for gout treatment, with the potential to become a first-line innovative Class 1 URAT1 inhibitor.

In human plasma, approximately 90% of ABP-671 exists as the parent compound without producing toxic metabolites, enhancing efficacy while addressing liver toxicity caused by metabolites. Clinical trials have shown that ABP-671 significantly improves the dissolution of gout stones, reduces urate crystal burden, and lowers the risk of complications related to hyperuricemia.

As of March 11, 2026, these advantages are supported by clinical data from over 900 patients across the US, China, Australia, and other countries and regions. Data from Phase 1 (US), Phase 2a (Australia), and Phase 1/2a (China) trials indicate all adverse events were Grade 1 or Grade 2, with no hepatotoxicity observed.

In Phase 2b trials conducted in China and overseas, Grade 3 or higher adverse events were rare, generally mild, and similar across groups, with no liver or cardiovascular safety signals detected. These results demonstrate a safety profile superior to current first-line therapies and mainstream drugs.

Furthermore, literature data suggest that doses of 2-4 mg of ABP-671 may be as effective or even superior to the maximum approved dose (80 mg) of benzbromarone or febuxostat in lowering uric acid. Overseas Phase 2 clinical trials of ABP-671 showed significant improvement in treatment effects compared to placebo and 800 mg of allopurinol.

For indications involving hyperuricemia with CKD, New Element Pharma plans to initiate a Phase 2 MRCT in Q2 2026. The short-term target markets for ABP-671 are China and the US, with long-term goals including Europe. The company designs and selects countries for clinical trials to enhance patient diversity and obtain broader clinical data, facilitating regulatory submissions and market access in China, the US, and Australia, rather than immediate commercialization in these regions.

Financial Data

Other Income

Currently, the company has no approved products for commercial sale and has not generated 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.

R&D Expenses

In 2024 and 2025, R&D expenses were approximately RMB 338 million and RMB 180 million, respectively.

Industry Overview

In recent years, the global burden of gout has continued to increase. The number of patients rose from 53.3 million in 2019 to 66.2 million in 2024, with a CAGR of 4.4%. By 2033, the global patient population is expected to reach 91.6 million, with a CAGR of 3.7% from 2024 to 2033, with a more pronounced growth trend in China. The number of gout patients in China increased from 15.2 million in 2019 to 25.3 million in 2024, with a CAGR of 10.7%. It is projected to further rise to 44 million by 2033, with a CAGR of 6.4% from 2024 to 2033.

The global gout drug market shrank from USD 3.1 billion in 2019 to USD 2.7 billion in 2024, mainly due to safety concerns over febuxostat and declining sales volume caused by rising drug prices. However, it is expected to rebound significantly, reaching USD 9.3 billion by 2033, with a CAGR of 14.9% from 2024 to 2033. The Chinese gout drug market also declined from USD 500 million in 2019 to USD 300 million in 2024, mainly due to price reductions from centralized procurement policies. It is expected to recover rapidly, reaching USD 1.7 billion by 2033, with a CAGR of 20.4%, driven by rising prevalence, increased awareness, and new innovative therapies.

In the US, the gout drug market grew from USD 1.5 billion in 2019 to USD 2 billion in 2024, with a CAGR of 5.6%, mainly driven by increased sales of uric acid oxidase. The US market is projected to further expand to USD 5 billion by 2033, with a CAGR of 10.8% from 2024 to 2033, consistent with global growth trends.

Board of Directors

The board 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 owns approximately 29.4% of the company’s issued share capital.

Intermediary Team

Sole Sponsor: CITIC Leeon Securities Limited

Legal Advisors: For Hong Kong and US law: K&L Gates; For Chinese law: Jingtian & Gongcheng LLP

Legal Advisors for the Sponsor: For Hong Kong and US law: Smith Fiel LLP; For Chinese law: Jingtian & Gongcheng LLP

Auditors and Independent Accountants: Deloitte Touche Tohmatsu CPA Ltd.

Industry Consultant: Frost & Sullivan (Beijing) Consulting Co., Ltd., Shanghai Branch

Compliance Advisor: Xinbaili Financing Limited