New stock news | Lu Peng Pharmaceuticals submits documents to Hong Kong Stock Exchange again, core products in NDA stage escorting

According to the disclosure from the Hong Kong Stock Exchange on May 28th, LuPeng Pharmaceuticals Limited (referred to as LuPeng Pharmaceuticals) submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC as the exclusive sponsor. The company had previously submitted a listing application to the Hong Kong Stock Exchange on October 31, 2025. Company Overview LuPeng Pharmaceuticals was established in 2015 and is a biopharmaceutical company with its proprietary BeyondX oral drug chemical platform. The company focuses on designing, discovering, clinically developing, and commercializing high bioavailability oral drugs for cancer and autoimmune diseases globally. As of the last practicable date, the company has built a product pipeline consisting of six key candidate products, three of which are core assets in the new drug application and clinical stages, namely core products LP-168, LP108, and LP-118. LP-168 (locotinib, currently in the NDA stage based on its Phase II clinical trial results) is a BTK inhibitor with a dual "covalent and non-covalent" binding mode. LP-168 has shown clinical benefits in various oncology and autoimmune diseases indications, including relapsed/refractory (R/R) Mantle Cell Lymphoma (MCL), relapsed/refractory Non-GCB Diffuse Large B-cell Lymphoma (DLBCL), and relapsed/refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). However, the potential clinical advantages of LP-168 are still subject to confirmation and validation through ongoing and future clinical trials. LuPeng Pharmaceuticals has obtained IND approval from the National Medical Products Administration for the combination therapy of LP-168 and LP-108 mature B-cell tumors, becoming one of the first companies in China to obtain IND approval for a combination therapy of BTK inhibitors and Bcl-2 inhibitors. In addition to oncology indications, LP-168 has strategically expanded into autoimmune indications, positioning the asset beyond anti-tumor effects, capturing significant value in the rapidly growing autoimmune treatment market. Clinical studies of LP-168 for CSU have been initiated and planned to expand to major autoimmune indications, including ITP, pMN, MS, and gMG. As of the last practicable date, the company holds a total of 71 patents and patent applications for its core products' technical solutions, including 55 granted patents and 16 submitted patent applications. Of the 55 granted patents, 3 were obtained in China, 7 in the United States, and 45 in other countries or regions. Of the 16 submitted patent applications, 2 were filed in China, 3 in the United States, and 11 in other countries or regions. Financial Information Revenue In the fiscal year 2025, the company generated revenue of approximately RMB 320.66 million. Losses In the fiscal years 2024 and 2025, the company recorded losses of approximately RMB 3.385 million and RMB 207 million, respectively. Industry Overview According to Zhaoshi Consulting data, the global BTK inhibitor drug market was worth $14 billion in 2025 and is expected to steadily increase to $20 billion in 2030 and $26.3 billion in 2035, with a compound annual growth rate (CAGR) of 6.6% from 2026 to 2030 and 5.6% from 2031 to 2035. As of the last practicable date, there are six approved or NDA-submitted BTK inhibitors for oncology indications, including LP-168. Although there are four other BTK inhibitors in clinical trials worldwide, they are all second or third-generation BTK inhibitors using a single covalent or non-covalent binding mode. With more BTK inhibitors being included in global treatment guidelines by NCCN and CSCO, the global BTK inhibitor drug market is showing a steady growth trend. From 2021 to 2025, the market's CAGR was 9.3%, increasing from $9.8 billion to $14 billion. It is expected to reach $20 billion in 2030 and $26.3 billion in 2035, with a CAGR of 6.6% from 2026 to 2030 and 5.6% from 2031 to 2035. The following figure illustrates the growth trend of the global BTK inhibitor drug market. The Chinese BTK inhibitor market has enormous growth potential. From 2021 to 2025, the market exhibited a strong CAGR of 18.4%, increasing from RMB 2.3 billion to RMB 4.5 billion. Looking ahead, the market size is expected to continue to expand significantly, reaching RMB 19.6 billion by 2035, with a CAGR of 18.0% from 2026 to 2030 and 11.9% from 2031 to 2035. The following figure illustrates the growth trend of the Chinese BTK inhibitor drug market. Board of Directors Information The main details of directors as of the last practicable date are listed in the table below: Share Structure JinsTan Holdings Limited is a limited company registered in the British Virgin Islands, fully owned by Dr. Tan as of the last practicable date. Therefore, under the Securities and Futures Ordinance, Dr. Tan is considered to have an interest in the 9,307,205 shares held in JinsTan Holdings Limited. As of the last practicable date, under a joint action arrangement, Dr. Tan and Ms. Li agreed to adjust their controlled voting rights to achieve joint action at the company's shareholders' meeting. Dr. Tan and Ms. Jin are spouses. Ms. Li and Dr. Chen are spouses. Therefore, under the Securities and Futures Ordinance, Dr. Tan, Ms. Jin, Dr. Chen, and Ms. Li are considered to collectively have an interest in the total number of shares they individually hold. Intermediary Team Company Legal Counsel: K & E Law Firm, Jingtian & Gongcheng Law Firm, Harney Westwood & Riegels Reporting Accountants and Auditors: Ernst & Young LLP Industry Consultants: Zhaoshi Industry Consulting Co., Ltd. Compliance Consultant: FIRST SHANGHAI Financing Co., Ltd.