二、关于公司历史沿革，请说明:（1）公司搭建、拆除红筹架构过程中，履行外汇登记、境外投资、外 商投资、税务等监管程序合法合规的结论性意见；（2）公司设立及历次股权变动均合法合规的结论性 意见。 三、关于公司员工持股计划，请说明其实施合法合规的结论性意见。 智通财经APP获悉，8月1日，中国证监会发布《境外发行上市备案补充材料要求(2025年7月25日—2025 年7月31日)》，证监会国际司共对9家企业出具补充材料要求。在公示中，证监会要求和美药业补充说 明前期进行A股上市辅导备案的详细情况，是否计划继续推进A股上市及具体安排，是否存在对本次发 行上市产生重大影响的情形等事项。据港交所5月29日披露，赣州和美药业股份有限公司向港交所主板 递交上市申请。 证监会请和美药业补充说明以下事项，请律师核查并出具明确的法律意见： 一、请说明公司前期进行A股上市辅导备案的详细情况，是否计划继续推进A股上市及具体安排，是否 存在对本次发行上市产生重大影响的情形。 招股书显示，和美药业于2002年成立，是一家创新驱动的生物制药公司，致力于发现和开发针对自身免 疫性疾病和肿瘤的小分子药物，并在银屑病、白塞病和炎症性肠病和创新化 ...

Summary of the Conference Call for Dize Pharmaceutical Company Overview - Dize Pharmaceutical was established in 2017 by Guotou Innovation and a subsidiary of AstraZeneca, and it went public on the STAR Market in 2021. The company focuses on the research and development of small molecule drugs, with a core team that has extensive international experience from AstraZeneca China [9][3]. Key Products and Market Performance Shuwotini - Shuwotini is the world's first small molecule drug targeting EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC), already launched in China and included in medical insurance. Expected sales in China are close to 400 million RMB in 2024, projected to reach 700-800 million RMB in 2025. In the US, it is expected to be priced around $200,000 [2][4]. - The drug has rapidly become the top recommended product in treatment guidelines for second-line therapy, with an anticipated penetration rate of over 30% in second-line and around 30% in first-line treatments in China. The US market penetration is expected to reach 40% [16][17]. - The peak sales potential for Shuwotini in China is estimated at 2 billion RMB, while in the overseas market, it could reach $900 million, contributing approximately $500 million from the US market [17][22]. Gresitini - Gresitini is approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) and has entered the Chinese medical insurance system. The phase III clinical trial for first-line PTCL is expected to complete enrollment in 2025, with a potential US launch in the first half of 2026 [6][18]. - The peak sales potential for Gresitini in China is estimated at 1 billion RMB, with overseas sales potential reaching $600 million [22]. 8,586 - 8,586 is a dual-target BTK inhibitor with strong blood-brain barrier penetration, currently undergoing registration clinical trials for relapsed/refractory mantle cell lymphoma (MCL) and has potential applications in DLBCL. It aims to address resistance issues associated with BTK inhibitors [7][19]. - The domestic peak sales potential for 8,586 is estimated at 2 billion RMB, while overseas it could reach $1.5 billion [20][22]. 6,008 - 6,008 is a next-generation EGFR TKI effective against C797S mutations and has blood-brain barrier penetration capabilities. It is expected to be presented at the 2025 ASCO conference, with preliminary data anticipated by the end of the year [7][21]. - The domestic peak sales potential for 6,008 is estimated at 2 billion RMB, with overseas potential reaching $1.5 billion [21][22]. Financial Projections - The total peak sales potential for the four main products in the domestic market is projected to reach 6 billion RMB, corresponding to a market valuation of 180 billion to 200 billion RMB. In the overseas market, the combined sales potential is estimated at $3.5 billion, leading to a total target market valuation of approximately 40 billion RMB [8][22]. Competitive Landscape - Shuwotini's competitive advantages include its high safety profile and significant efficacy compared to traditional therapies, which have lower objective response rates (ORR) and progression-free survival (PFS) [13][15]. - Current competitors include companies like Ailis and Ravent, with their respective drugs showing varying efficacy and safety profiles [14]. Additional Insights - The core team of Dize Pharmaceutical has established a robust small molecule drug development platform, particularly excelling in central nervous system research, which accelerates drug development processes [9][4]. - The company aims to achieve profitability by 2027 following a recent financing round of 1.85 billion RMB, which has alleviated some negative impacts from previous share reductions [3].