New stock news | Lu Peng Pharmaceuticals submitted an application to the Hong Kong Stock Exchange. Its core product LP-168 is the world's first and only "covalent non-covalent" dual BTK inhibitor.

According to the disclosure by the Hong Kong Stock Exchange on October 31st, Lupeng Pharmaceuticals Co., Ltd. has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC as the exclusive sponsor. The prospectus shows that Lupeng Pharmaceuticals is a leading global biopharmaceutical company with its proprietary BeyondX oral drug chemistry platform, focusing on designing, discovering, clinically developing, and commercializing high bioavailability oral drugs that surpass the traditional "Five Rules" molecular chemistry spatial definitions to meet the unmet medical needs of patients with cancer and autoimmune diseases worldwide. LP-168- The company's core product, an NDA-stage BTK inhibitor. The company's core product LP-168 is the world's first and only "covalent and non-covalent" dual BTK inhibitor, with the best potential in the fields of oncology and autoimmune diseases. The dual binding mechanism of LP-168 allows it to simultaneously eliminate tumor cells carrying wild-type and resistant mutant BTK, overcoming the resistance limitations of traditional first, second, and third generation BTK inhibitors due to single action mode (either covalent or non-covalent). LP-168 has shown significant clinical benefits in multiple oncology and autoimmune disease indications, demonstrating outstanding safety with a lower rate of treatment-related adverse events than previous BTK inhibitors. In addition to oncology indications, LP-168 has strategically expanded into autoimmune indications, positioning the asset beyond anti-cancer to capture significant value in the rapidly growing autoimmune treatment market. Clinical studies of LP-168 for CSU have been initiated and plans to expand to major autoimmune indications, including ITP, pMN, MS, and gMG. In Phase I clinical trials in healthy subjects, LP-168 showed excellent safety at doses of 12.5mg-75mg QD, with no observed Grade 2 or higher TRAE, while achieving nearly complete BTK occupancy (~100%) within 2 hours after a single dose of 12.5mg and maintained for over 24 hours. According to data from Crusoe Consultancy, as more BTK inhibitors are included in global treatment guidelines, the global BTK inhibitor drug market is expected to increase from $12 billion in 2024 to $25.1 billion in 2035, with an annual compound growth rate of 6.8% from 2025 to 2035. LP-168 covers a broad market for hematologic tumors and autoimmune diseases, with patients requiring long-term treatment. The differentiated characteristics of LP-168 in efficacy, safety, and pharmacokinetics make it poised to capture significant market share in both existing oncology indications and emerging autoimmune applications. The asset's ability to address resistance mechanisms and provide sustained relief supports its potential for premium pricing and long-term revenue generation in the chronic disease environment where patients require continuous treatment for many years. In terms of performance, the company incurred losses of RMB 159.4 million and RMB 3.4 million in 2023 and 2024, respectively. For the six months ended June 30, 2024, and 2025, the company recorded profits of RMB 32.9 million and RMB 35.9 million, respectively.