文/梧桐兄弟 浙江海圣医疗器械股份有限公司申报北交所IPO于2025年5月29日获得受理，完成二轮问询及回复后于2025年11月7日上会审议通过，2025年12月9日提交注册。公 司主营麻醉、监护类医疗器械产品的研发、生产和销售。公司注册地浙江省绍兴市，前身有限公司成立于2000年10月10日，2021年1月整体变更为股份有限公司， 后续于2024年9月18日在全国股转系统创新层挂牌。黄海生直接持有公司47.11%的股份，为公司控股股东。黄海生及吴晓晔夫妇两人合计控制公司54.92%的股份， 系公司实际控制人。 审议会议提出问询的主要问题： 1.关于财务信息的真实性、准确性。 请中介机构说明对 经销收入、销售费用 核查的充分性和有效性。 2.关于行业政策影响。 请发行人说明 带量集采、"两票制"等政策 对公司经营业绩稳定性的影响及应对措施。请保荐机构核查并发表明确意见。 3.关于有源设备研发与产业化。 请发行人说明设备类产品研发及进展情况，相关业务拓展的优劣势及风险揭示情况。请保荐机构核查并发表明确意见。 一、主营麻醉、监护类医疗器械，毛利率逾50% 公司是面向全球的麻醉、监护类医疗器械综合产品提供商，主营业 ...

Core Viewpoint - Haiseng Medical's IPO journey faces significant challenges despite a 26.70% year-on-year profit increase to 58.78 million yuan in the first three quarters of 2025, with concerns over its weak position in the supply chain and unstable performance [1] Supply Chain Vulnerabilities - Raw material costs account for over 60% of production costs, with a dependency on Israeli supplier Elcam Medical reaching 19.26% [2] - As of the first half of 2025, 10.44% of key components were still imported, indicating potential risks to production continuity [2] - The self-manufacturing ratio for infusion valves was only 7.24%, with no disclosed capacity assurance agreements from alternative suppliers [2] Research and Development Challenges - R&D investment has been insufficient, with expenses rising from 13.54 million yuan in 2022 to 16.16 million yuan in 2024, maintaining a revenue ratio of 5%-6% [2] - Compared to peers like Weili Medical, which spent 111 million yuan on R&D in 2024, Haiseng's investment is significantly lower [2] - Of the 63 patents held, only 13 are invention patents, and none of the nine ongoing projects have reached advanced clinical stages [2] Sales Channel Instability - The sales channel is heavily reliant on domestic distributors, with distributor revenue accounting for 83.16%-90.43% during the reporting period [3] - A high turnover rate of distributors was noted, with over 50% changes in the last two years [3] - The gross margin of exiting distributors was 58.95%, higher than the overall company level, indicating issues with distributor management [3] Impact of Procurement Policies - Revenue from centralized procurement products increased from 30.30 million yuan to 46.88 million yuan, rising from 11.34% to 15.45% of total revenue [3] - Price pressures from procurement policies have led to a decline in gross margins, with the gross margin for centralized procurement products dropping from 48.71% in 2022 to 46.49% in 2024 [3] Financial Performance Fluctuations - In 2024, revenue decreased by 0.7% to 304 million yuan, with a 9.41% drop in net profit attributable to the parent company [5] - Despite maintaining a gross margin around 52%, structural risks are evident, particularly with domestic distributor margins declining [5] - Sales expenses rose from 9.48% to 10.76%, significantly exceeding R&D expenses, indicating a reliance on high marketing costs [5] Capacity Expansion Concerns - The 370 million yuan fundraising plan has raised doubts, with 174 million yuan allocated for expanding production capacity by 60% [6] - Core product capacity utilization rates have declined, raising questions about the rationale behind expanding capacity [6] - The company faces challenges in channel absorption, with 5.63% of revenue coming from exited distributors [6] Systemic Risks and Regulatory Challenges - The inclusion of low-value consumables in centralized procurement could further pressure profit margins, potentially lowering the gross margin below 52% [7] - The expiration of CE certification poses risks for EU market access, with a deadline for compliance with new MDR regulations by 2028 [7] - The uncertainty surrounding high-tech enterprise qualifications and R&D expense rates adds to the challenges faced by the company [7]