港股IPO招股书披露先例 · 9 家公司，10 项
医药医疗类上市申请人涉及的此类事项，一般指药品及医疗器械注册、生产及经营质量管理规范合规、临床试验、人类遗传资源管理及医疗机构执业许可等监管事宜。招股书通常于风险因素、业务、概要及财务资料章节披露药监部门现场检查发现的质量体系缺陷、责令停产停售或集采资格受限等情况，并按时间顺序说明整改、复检及恢复生产经营的进展，同时解释相关措施是否构成行政处罚或对业务运营及财务表现造成重大不利影响。
合规类事项自 2026 年 8 月 24 日起递交的文件开始收录。
As advised by our PRC Legal Advisor, our medical equipment products do not fall within the definition of ‘‘medical devices’’ under applicable PRC laws and regulations.
Business · 第 118 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看Accordingly, they are not subject to medical device product registration or filing requirements in the PRC and do not require product approval from the NMPA.
Business · 第 118 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看As advised by our PRC Legal Adviser, under the applicable PRC laws and regulations, the production and sale of batteries used in medical devices do not require any special licence or mandatory product testing specifically by reason of their intended use in medical devices.
Business · 第 138 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看Based on these confirmations, as well as compliance certificates issued by the relevant competent authorities, and publicly available information from local legal and regulatory databases, our PRC Legal Advisor is of the view that we had complied in all material respects with the laws and regulations on Two-Invoice System during the Track Record Period and up to the Latest Practicable Date.
Business · 第 192 页
In July 2024, our subsidiary Mabsky was subject to administrative measures imposed by the Guangdong Medical Products Administration following an on-site inspection, which identified certain deficiencies in its production quality management system.
Business · 第 189 页
In November 2024, we completed the required rectification, submitted a rectification report, passed the follow-up inspection, and resumed production.
Business · 第 189 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看Historically, certain deficiencies in our production quality control system were identified during on-site inspections conducted by regulatory authorities.
Risk Factors · 第 42 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看As advised by our PRC Legal Advisors, we have complied with applicable laws and regulations relating to the Two-Invoice System in all material aspects in applicable provinces during the Track Record Period and up to the Latest Practicable Date.
Business · 第 198 页
In addition to the above, on April 2, 2026, Hunan Vedkang Science and Technology Co., Ltd. (“Hunan Vedkang”), an indirect wholly-owned subsidiary of our Company, was ordered to suspend production and sales by the Hunan Medical Products Administration (the “Hunan MPA”) following an on-site inspection, which identified certain deficiencies in its production quality control system.
Business · 第 190 页
Following this, on June 3, 2026, the National Healthcare Security Administration announced the cancelation of Hunan Vedkang’s selected status for relevant products under the sixth national VBP program, together with a suspension of its eligibility to participate in VBP bidding until December 2, 2027.
Business · 第 190 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看The comprehensive rectification process was completed on April 9, 2026, and Hunan Vedkang fully resumed its normal production and commercial operations on April 20, 2026, upon confirmation from the Hunan MPA.
Business · 第 190 页
Based on the above and FT-002 clinical trial protocols submitted to the CDE, our PRC Legal Advisor is of the view that we are not required to obtain additional regulatory approval from the NMPA for commencing the dose expansion Phase II clinical trial in China.
Business · 第 170 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看Based on the provisions set forth in the Announcement for Drug Approval and FT-003 clinical trial protocols submitted to the CDE, our PRC Legal Advisor is of the view that we are not required to obtain additional regulatory approval from the NMPA for commencing the dose expansion Phase II clinical trials for both nAMD and DME in China.
Business · 第 186 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看Based on the above and on the confirmations obtained from us and from our medical consumables distributors in these places as of the Latest Practicable Date, and based on the advice of our PRC Legal Adviser, our Directors are of the view, and the Sponsor concurs, that during the Track Record Period and up to the Latest Practicable Date, we and such distributors had complied with the applicable requirements of the Two Invoice System in these places in all material respects.
Business · 第 173 页
As advised by the PRC Legal Adviser, during the Track Record Period and up to the Latest Practicable Date, we have not been subject to any material non-compliance or administrative penalties in relation to the Two-Invoice System, and we remain in compliance with the applicable PRC laws and regulations in all material aspects.
Business · 第 185 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看During the Track Record Period, we complied with the two-invoice system for our pharmaceutical products sold to public hospitals and other public medical institutions in Chinese Mainland.
Risk Factors · 第 39 页
As advised by our PRC Legal Advisors, we have complied with the Two-Invoice System during the Track Record Period and, excluding exempt intra-group distribution arrangements, we have not engaged any sub-distributors for the sales of our Core Product, sebaloxavir marboxil tablets, through public hospital channels.
Business · 第 180 页
公司的解释、律师意见及原文页码定位：在 Matters 中查看As advised by our PRC Legal Advisors, during the Track Record Period and up to the Latest Practicable Date, we were not subject to any administrative penalties due to issues related to the two-invoice system.
Business · 第 180 页