在竞争激烈的仿制药市场，治疗勃起功能障碍（ED）的男科药物他达拉非已悄然成为最炙手可热的大品种。 他达拉非原研药的专利仅过期五年，但这一品种已成为通过仿制药一致性评价数量最多的药品。根据中康开思系统数据，目前中国已有76个厂家的他达拉非 片仿制药过评，批文数达到150个。头豹研究院数据显示，2023年他达拉非在中国的销售额达19.7亿元。 他达拉非的原研药企是意大利最大的制药企业美纳里尼。如今，他达拉非原研药面临激烈竞争，其价格往往高出仿制药一倍，集采又大幅压缩了其在医院的 市场空间，2020年他达拉非进入第二批国家集采，当年他达拉非原研药在医院端的销售额下滑近60%。 不过，在激烈竞争下，他达拉非原研药仍占据了约30%的市场份额，这主要得益于院外市场。米内网数据显示，2024年，他达拉非原研药在医院销售额为 5320万元，在药店和网店的销售额分别达到了4.26亿元和5.09亿元，仍是一款"十亿单品"。 8月21日，美纳里尼中国首席执行官陈家麟告诉经济观察报，原研药的院外市场蕴含着巨大潜力。他也注意到，近几年零售业态逐渐完善，叠加集采等政策 因素影响，跨国药企院内外销售链路渐渐打通了。 经济观察报 见习记者 ...

Core Insights - The company Wangshan Wangshui has received approval for its "domestic Viagra" TPN171, while simultaneously accelerating its IPO process, indicating a critical moment for the company in 2025 [1][2] - Despite the high valuation of 4.4 billion RMB, the company faces significant financial challenges, including a drastic decline in main revenue and ongoing cash flow issues [1][4] Company Overview - Wangshan Wangshui, established in 2013, focuses on discovering, developing, and commercializing small molecule drugs, with a pipeline of nine innovative assets targeting viral infections, neuropsychiatric disorders, and reproductive health [2] - The company’s core products include VV116, LV232, and TPN171, which are considered to have first-in-class or best-in-class potential [2] Financial Performance - VV116, a COVID-19 oral medication, significantly boosted the company's revenue, contributing 92% of total revenue in 2023, leading to the first annual profit of 6.427 million RMB [4][6] - However, in 2024, the company experienced a 97% drop in external licensing revenue, resulting in a revenue decline to 11.83 million RMB and a net loss of 21.76 million RMB [4][6] - By the first four months of 2025, external licensing revenue further decreased to 27,300 RMB, with a monthly average income from VV116 dropping below 70,000 RMB [5][6] Revenue Structure - The company's revenue is derived from external licensing, CRO services, drug sales, and intellectual property transfers, but none of these have become stable core pillars for sustainable operations [7] - Drug sales increased from 67,400 RMB in 2023 to 259,400 RMB in the first four months of 2025, but this growth is primarily driven by generic drugs, not innovative products [7][8] Valuation Concerns - The company's valuation of 4.4 billion RMB implies a price-to-sales ratio of approximately 18 times for 2024, significantly higher than the generic drug sector average of 5-6 times, raising questions about its sustainability [8] - TPN171, while seen as a key product for the IPO, faces intense competition in the erectile dysfunction market, which is dominated by established products [8] Debt and Cash Flow Issues - As of April 2025, the company has 72.83 million RMB in cash against 231 million RMB in current liabilities, indicating a significant liquidity crisis [9][11] - The company's cash flow health is deteriorating, with a net outflow of 10.9 million RMB in 2024, leading to concerns about its operational sustainability [9][10] Production Capacity and Expansion Plans - The company plans to use IPO proceeds for core product development and factory expansion, despite currently having a 98% idle production capacity [12][13] - The new factory in Lianyungang is set to produce 1 billion capsules and 600 million tablets annually, but the actual utilization rate is below 2% [12][13] Client Dependency Risks - The company relies heavily on a few major clients, with the top five clients contributing over 90% of revenue, which poses significant operational risks [8][9]

Core Viewpoint - Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. is preparing for an IPO in Hong Kong, despite facing significant operational challenges, including low production capacity utilization and reliance on a few core products for revenue generation [1][3][4]. Business Model and Operations - The company focuses on three main therapeutic areas: viral infections, neuropsychiatric disorders, and reproductive health, with a pipeline of nine innovative assets, including three core products: VV116, LV232, and TPN171 [2]. - Wangshan Wangshui employs a hybrid model of collaborative and internal research and has established partnerships with institutions like the Shanghai Institute of Materia Medica to enhance its intellectual property [2]. - The company has a GMP production facility in Lianyungang with an annual designed capacity of 100 million capsules and 600 million tablets, but the utilization rates are critically low at 0.2% for tablets and 1.1% for capsules [3]. Revenue and Profitability - In 2023, the company reported revenue of 42.37 million yuan, primarily from sales of VV116 in Uzbekistan and dapoxetine in China, but faced a net loss of 156 million yuan in the first nine months of 2024, indicating a significant reliance on core product sales [3][4]. - The net profit turned into a loss, increasing by 370% year-on-year, attributed to rising R&D and administrative expenses, alongside high initial commercialization costs [4]. Customer and Supplier Concentration - The top five customers accounted for over 90% of the company's revenue in both 2023 and the first nine months of 2024, with the largest customer representing 79.9% of revenue in 2024 [6]. - The top five suppliers contributed to over 40% of procurement costs, indicating a high supplier concentration risk [7]. Shareholder Structure - The company is controlled by founder Dr. Shen and his spouse, who together hold approximately 56.49% of the shares, which may lead to potential decision-making biases and risks for minority shareholders [8][9]. Management Team - The core management team, led by Dr. Tian Guanghui, has extensive experience in the pharmaceutical industry, with Dr. Tian having over 20 years of relevant experience [11].