10月18日，中国证监会公布境外发行上市备案补充材料要求(2025年10月12日至2025年10月17日)，其中 提到，要求甫康生物补充说明重大合同和重大债权债务情况等事项。据港交所8月31日披露，甫康生物 向港交所主板提交上市申请书，农银国际、民银资本、复星国际资本为其联席保荐人。 证监会请甫康生物补充说明以下事项，请律师进行核查并出具明确的法律意见： 六、请你公司对照《境内企业境外发行证券和上市管理试行办法》第八条的规定，补充说明你公司及所 有境内子公司是否存在境外发行上市禁止性情形。 七、请补充说明：(1)你公司股权激励计划的入股价格及公允性;(2)外部人员的入股原因及背景、入股价 格、作价依据、资金来源，如入股价格与员工相同或接近，说明是否存在利益输送;(3)外部顾问入股价 格存在差异的原因;(4)就你公司股权激励计划实施是否合法合规出具明确结论性意见。 招股书显示，甫康生物成立于2015年11月，是一家以开发突破性疗法为愿景、高效率创新为驱动的商业 化阶段生物医药公司。公司专注于开发癌症相关疾病治疗领域的突破性疗法，同时兼顾针对病毒和衰老 疾病领域创新药物的开发及商业化。公司采取商业化与临床开发并重 ...

Core Viewpoint - Fukan Biotech (Shanghai) Co., Ltd. has submitted its main board listing application to the Hong Kong Stock Exchange, with several financial institutions acting as joint sponsors [1] Company Overview - Fukan Biotech was established in 2015, focusing on both commercialization and clinical development in the field of cancer treatment, as well as innovative drugs for viral and age-related diseases [4] - The company's core products include CVL009 and CVL218, with CVL009 currently undergoing Phase II clinical trials for specific cancer patients [4] - As of August 22, 2025, Fukan Biotech has a diversified product portfolio consisting of one commercialized product, two core products, two key products, and twelve other candidates [4] Financial Performance - The company reported revenues of 0, 17.825 million, and 34.675 million CNY for the years 2023, 2024, and the first half of 2025, respectively, with corresponding net losses of 94.655 million, 74.525 million, and 35.934 million CNY [6] - Research and development expenses for the same periods were 75.792 million, 54.425 million, and 24.421 million CNY [7] Customer Dependency - Fukan Biotech's revenue is highly dependent on a single customer, with nearly 99% of sales from its commercialized product, Han Naijia®, attributed to its largest customer, Fuhong Hanlin [8] - Fuhong Hanlin is a leading biopharmaceutical company in China, and the collaboration allows for a synergistic effect in breast cancer treatment [8] Market Potential - The global breast cancer drug market is projected to grow from approximately 29.2 billion USD in 2019 to about 41 billion USD by 2024, with a compound annual growth rate (CAGR) of 7.0% [5] - The Chinese breast cancer drug market is expected to expand from around 450 billion CNY in 2019 to approximately 683 billion CNY by 2024, with a CAGR of about 8.7% [5] Funding and Valuation - Fukan Biotech has completed six rounds of financing prior to its IPO, with post-money valuations increasing significantly from 95 million CNY in 2019 to approximately 3.188 billion CNY in 2025 [10][13] - The company's valuation has grown 32.56 times since its angel round financing [13] Ownership Structure - As of August 22, 2025, the founder and key stakeholders control approximately 55.58% of the company's issued share capital [13]

Core Viewpoint - The company focuses on cancer treatment and has developed a diverse product portfolio, including one commercial product and multiple candidates in various stages of development [1][2]. Business Model - The company's business model is based on the Right-6D principle, enhancing R&D efficiency through partnerships with leading firms and utilizing a "one drug, multiple indications" approach [2]. Financial Performance - Revenue is primarily generated from the commercial product Han Naijia®, with projected revenues of approximately 17.8 million RMB in 2024 and 34.7 million RMB in the first half of 2025, indicating significant growth [3][4]. - The company has faced continuous losses, with losses of about 94.7 million RMB in 2023, 74.5 million RMB in 2024, and 35.9 million RMB in the first half of 2025, primarily due to high R&D and administrative costs [4][5]. - Gross margin is improving, projected at 58.4% in 2024 and 61.1% in the first half of 2025, but net margins remain negative at -418.1% and -103.6% respectively [5][6]. Market and Competitive Landscape - The global innovative drug market, particularly in oncology, is highly competitive, with the company facing challenges from both similar products and traditional cancer treatments [7]. - The company relies heavily on a few key customers, with revenue from the largest customer accounting for 97.6% in 2024 and 98.9% in the first half of 2025, posing a significant risk to revenue stability [9]. Intellectual Property Risks - The company's success is contingent on intellectual property protection, with risks associated with patent approvals and potential infringement lawsuits that could incur high costs [10]. Management and Incentives - The management team possesses extensive industry experience, led by a CEO with over 10 years in the pharmaceutical sector, providing strong support for the company's development [11]. - However, the lack of detailed disclosure regarding management compensation raises concerns about alignment with company performance and industry standards [12].

Group 1 - The company has submitted a listing application to the Hong Kong Stock Exchange, with Agricultural Bank of China International, Minyin Capital, and Fosun International Capital as joint sponsors [1] - The company focuses on developing breakthrough therapies for cancer-related diseases, while also innovating drugs for viral and age-related diseases [1] - The product portfolio includes one commercialized product, Hanai Jia, two core products (CVL009 and CVL218), and a total of 16 drug candidates in development [1] Group 2 - Hanai Jia was commercialized on June 28, 2024, generating approximately RMB 34.7 million in sales during the first half of 2024 [1] - The company has established partnerships with leading pharmaceutical companies and employs a "one drug, multiple indications" research and development model [2]

Core Viewpoint - Fokang Biotech (Shanghai) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Agricultural Bank International, Minyin Capital, and Fosun International Capital as joint sponsors [1] Company Overview - Founded in November 2015, Fokang Biotech is a commercial-stage biopharmaceutical company focused on developing breakthrough therapies, particularly in cancer treatment, while also addressing viral and age-related diseases [4] - The company employs a dual-track strategy that balances commercialization and clinical development, rather than solely focusing on research and development [4] Product Pipeline - Fokang Biotech's core products include: - CVL009, classified as a Class 2.4 modified new drug, currently undergoing Phase II clinical trials for specific cancer patient groups [4] - CVL218, a second-generation highly selective PARP inhibitor for treating advanced solid tumors [4] - The company has a diversified product portfolio consisting of one commercialized product, two core products, two key products, and twelve other candidates in development [4] - Among the sixteen candidates, five are in clinical phases I/II, seven are in preclinical development, and four are generic drug candidates [4] Commercialization Strategy - The company successfully commercialized Han Naijia on June 28, 2024, achieving nationwide coverage within three months, with projected sales of approximately RMB 17.8 million for the year ending December 31, 2024, and RMB 34.7 million for the six months ending June 30, 2025 [5] - Fokang Biotech aims to establish partnerships with leading international and domestic pharmaceutical companies to expand its geographic reach [5] - The company utilizes a "one drug, multiple indications" (PIP) model to integrate its product pipeline into single products, with examples including CVL009 and other candidates [5] Financial Performance - Revenue during the reporting period primarily came from the sales of Han Naijia, with recorded revenues of RMB 0, RMB 17.825 million, and RMB 34.675 million for the years ending December 31, 2023, 2024, and the six months ending June 30, 2025, respectively [6][8] - The company reported operating losses of RMB 94.655 million, RMB 74.525 million, and RMB 35.934 million for the same periods, primarily due to R&D expenses, financial costs, and administrative expenses [6][8]