Lupeng Pharmaceuticals Limited has submitted its listing application to the main board of the Hong Kong Stock Exchange (HKEX), with CITIC Securities acting as the sole sponsor. According to the prospectus, Lupeng is a globally leading biopharmaceutical company with its self-developed BeyondX oral drug chemistry platform. The company focuses on designing, discovering, clinically developing, and commercializing high-bioavailability oral drugs that go beyond the traditional "Rule of Five" in molecular chemistry space, addressing unmet medical needs for cancer and autoimmune disease patients worldwide.
The company's core product, LP-168, is a BTK inhibitor currently in the NDA stage. LP-168 is the world's first and only dual "covalent and non-covalent" BTK inhibitor, demonstrating best-in-class potential in both oncology and autoimmune disease fields. This dual-binding mechanism enables LP-168 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 their single-action mode (either covalent or non-covalent only).
LP-168 has shown significant clinical benefits across multiple oncology and autoimmune disease indications, with superior safety profiles and lower incidence of treatment-related adverse events compared to previous BTK inhibitors. Beyond oncology indications, LP-168 has been strategically extended to autoimmune indications, positioning the asset beyond anti-tumor applications to capture significant value in the fast-growing autoimmune treatment market. Clinical studies for LP-168 in chronic spontaneous urticaria (CSU) have commenced, with plans to expand to major autoimmune indications including immune thrombocytopenia (ITP), primary membranous nephropathy (pMN), multiple sclerosis (MS), and generalized myasthenia gravis (gMG).
In Phase I clinical trials with healthy subjects, LP-168 demonstrated excellent safety at doses ranging from 12.5mg to 75mg QD, with no Grade 2 or higher TRAEs observed. A single 12.5mg dose achieved near-complete BTK target occupancy (~100%) within 2 hours, maintaining this level for over 24 hours.
According to Frost & Sullivan data, as BTK inhibitors are increasingly included in global treatment guidelines, the global BTK inhibitor market is projected to grow from $12 billion in 2024 to $25.1 billion by 2035, representing a 6.8% CAGR from 2025 to 2035. LP-168 addresses broad hematologic malignancy and autoimmune disease markets with long-term treatment needs. Its differentiated profile of strong efficacy, high safety, and excellent pharmacokinetics positions it 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 responses supports premium pricing potential and long-term revenue generation in chronic disease settings requiring years of continuous treatment.
Financially, the company reported losses of RMB 159.4 million in 2023 and RMB 3.4 million in 2024. 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.