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 · p. 118
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.
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.
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.
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 · p. 189
In November 2024, we completed the required rectification, submitted a rectification report, passed the follow-up inspection, and resumed production.
Business · p. 189
Historically, certain deficiencies in our production quality control system were identified during on-site inspections conducted by regulatory authorities.
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.
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 · p. 190
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 · p. 190
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.
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 · p. 170
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.
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.
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 · p. 185
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.
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 · p. 180
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.