23年仅一款产品获批，八成股权激励内循环，和美药业IPO闯关前景承压

Core Viewpoint - The biopharmaceutical company Harmony Pharmaceuticals has submitted its prospectus to the Hong Kong Stock Exchange, aiming to address its financial pressures and advance its commercialization efforts for its drug pipeline, particularly Mufemilast, which is set to be approved in September 2025 [3][4]. Company Overview - Harmony Pharmaceuticals focuses on developing small molecule drugs for autoimmune diseases and tumors, with a pipeline that includes seven candidate drugs. However, only Mufemilast, aimed at treating moderate to severe plaque psoriasis, is expected to be approved by September 2025, while the others are still in clinical trials [4][12]. - The company has accumulated losses of 350 million yuan from 2023 to mid-2025 and has not yet achieved profitability due to the lack of product sales [4][18]. - Harmony Pharmaceuticals has raised a total of 950 million yuan through financing, with a post-E round valuation of 3.9 billion yuan [4][20]. Financial Situation - As of June 2025, the company has only 140 million yuan in cash and cash equivalents, with 77.94 million yuan in short-term debt, indicating a tight liquidity situation [20][22]. - The company has incurred significant R&D expenses, totaling 270 million yuan from 2023 to mid-2025, with 167 million yuan allocated to Mufemilast [18][19]. Ownership Structure - The majority of shares are held by founder Zhang Hesheng and his family, controlling approximately 46.51% of the voting rights. This includes Zhang's direct and indirect holdings through various entities [6][7]. - The company has established an employee stock ownership plan, but the majority of shares are concentrated among family members, raising concerns about talent retention and employee motivation [10][11]. Product Pipeline and Market Strategy - Mufemilast is positioned as a dual-action drug with a unique mechanism, but it faces competition from 17 other approved psoriasis treatments in China, including both small molecules and biologics [12][16]. - The company plans to set the annual treatment cost for Mufemilast between 52,700 and 119,900 yuan, which is higher than some competitors but lower than others, indicating a differentiated pricing strategy [16][22]. - Hemay022, another core product for treating advanced breast cancer, is currently in Phase III clinical trials, but patient recruitment has been slower than expected due to competition in the oncology space [17][22]. IPO and Future Prospects - The upcoming IPO is seen as a critical step for Harmony Pharmaceuticals to alleviate its financial constraints and support the commercialization of Mufemilast and the advancement of its pipeline [22][23]. - The company faces challenges in attracting talent and maintaining team stability due to its family-centric ownership and incentive structure, which may impact its long-term innovation capabilities [22][23].