麓鹏制药IPO：研发取得阶段性成果估值不增反降 赛道竞争激烈商业化价值兑现难

Core Viewpoint - Lupu Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor. The company focuses on drug design, discovery, clinical development, and commercialization for cancer and autoimmune diseases, with a product pipeline that includes six major candidates. The core product, LP-168, is the first covalent and non-covalent dual mechanism BTK inhibitor in clinical trials for treating relapsed/refractory mantle cell lymphoma (R/R MCL) and is currently at the NDA stage. However, the company faces multiple challenges in value realization due to intense competition and the presence of strong competitors with established advantages [1][10]. Financial Performance - The company has no main business revenue as its products have not yet been commercialized. From 2023 to the first half of 2025, the company generated other income of CNY 25.536 million, CNY 12.072 million, and CNY 6.774 million, with over half coming from government subsidies, totaling CNY 30.697 million over three and a half years. Net profits for the same periods were -CNY 159 million, -CNY 3.385 million, and CNY 35.9 million. The company achieved book profits in 2024 and the first half of 2025 mainly due to a significant increase in "fair value change of preferred shares" in its financial statements, which resulted from a decrease in overall company valuation [2][11][12]. - The post-investment valuation of the company peaked at USD 420 million during the 2023 Pre-B round financing but fell to USD 311.25 million in the 2025 B round, with the per-share cost dropping from USD 23.19 to USD 10.69 [12]. Research and Development - The company has seen a decline in R&D spending, with expenditures of CNY 168 million and CNY 150 million in 2023 and 2024, respectively. In the first halves of 2024 and 2025, R&D spending was CNY 69.6 million and CNY 53.2 million, showing a year-on-year decrease in the last two reporting periods [3][13]. - The company’s core operations continue to incur cash burn, with net cash outflows of CNY 134.2 million, CNY 113.4 million, and CNY 47.4 million in 2023, 2024, and the first half of 2025, respectively [3][12]. Competitive Landscape - The market for BTK inhibitors is highly competitive, with six approved or NDA-submitted BTK inhibitors already in the market. Established products like ibrutinib and zanubrutinib have been included in China's national medical insurance directory, solidifying their standard treatment status and creating significant pricing barriers [7][17]. - LP-168, as a latecomer, must demonstrate its efficacy and safety in head-to-head or real-world studies to capture market share. It also faces potential price reductions due to medical insurance negotiations, which could severely impact its pricing power and profit margins [9][20]. Product Pipeline - Lupu Pharmaceutical has established a product pipeline that includes six major candidates, with three core assets in the new drug application and clinical stages: LP-168, LP-108, and LP-118. LP-168 is currently the only covalent and non-covalent dual mechanism BTK inhibitor in clinical trials for R/R MCL, with its NDA stage indicating significant development progress [4][14].