The Zhitong Finance App learned that on September 5, the China Securities Regulatory Commission announced the “Requirements for Supplementary Materials for Overseas Issuance and Listing (August 29, 2025 to September 4, 2025)”, and the International Department of the Securities Regulatory Commission issued supplementary material requirements for 12 companies. Among them, Anmai Biotech is required to provide additional explanations on whether it will continue to meet the requirements of the foreign investment entry policy before and after the current release and listing. According to the Hong Kong Stock Exchange's disclosure on June 17, Anmai Biotechnology Co., Ltd. submitted a listing application to the main board of the Hong Kong Stock Exchange, with CITIC Securities and CMB International as co-sponsors.
The Securities Regulatory Commission requested Anmai Biotech to further explain the following matters, and ask lawyers to check and issue clear legal opinions:
1. Please explain the concluding opinions on the legal compliance of the major domestic operating entities with all equity changes, summarize and explain how issuers and domestic shareholders fulfilled procedures such as foreign exchange registration, overseas investment, and foreign investment during the establishment of the company's equity structure, and explain the concluding opinions on whether they complied with the regulations on foreign exchange management, overseas investment, foreign investment, tax administration, etc. in effect at the time.
2. The issuer is requested to explain the establishment and shareholding changes of Sanaron Inc., the largest shareholder. Please also explain the relationship between the actual controller and the beneficiary of the trust after the above shareholders penetrated upward.
3. Everlasting Wisdom Holdings Limited holds 5.37% of the issuer's shares. Please refer to the “Guidelines for the Application of Regulatory Rules - Overseas Issuance and Listing Class No. 2” to explain the natural person shareholder information after the shareholder penetrates upward. Please also explain the reason, timing, and fairness of the pricing for the two shareholders to take stock in the issuer, taking into account the background information of the natural person shareholder and Yajun Xu, the issuer's main shareholder, and whether there is a relationship with the issuer's directors, executives, or the issuer's business operations.
4. The issuer is requested to explain the scope of business of the issuer and its subsidiary companies, whether the actual business involves “development and application of human stem cells, genetic diagnosis and treatment technology” or other restricted or prohibited fields for foreign investment and the basis for relevant judgment, taking into account information such as drug research and development technology routes, etc., and whether they continue to meet the requirements of the foreign investment access policy before and after the launch.
According to the prospectus, Anmai Biotech is a clinical-stage biotechnology company at the cutting edge of innovation in the field of bispecific antibody therapy, focusing on developing T-cell connectors to treat various types of cancer and autoimmune diseases on a global scale.
Anmai Biotech's oncology business pipeline includes three clinical-stage drug candidates, including (i) the core product EMB-01 (targeted EGFR/cMET) to treat colorectal cancer, and (ii) two key products EMB-06 (targeted BCMA/CD3) based on T-cell connectors to treat multiple myeloma (“MM”) and EMB-07 (targeted ROR1/CD3) for treating lymphatic and solid tumors, and (iii) three preclinical EM10 drug candidates based on T-cell connectors 32 (target ALPP ( G) /CD3), EM1034 (targets LY6G6D/CD3), and EM1031 (targets KLK2/CD3). Anmai Biotech's immunology business pipeline includes a clinical-stage drug candidate, EMB-06, a key product based on T-cell connectors, and two pre-clinical drug candidates EM1039 and EM1042 based on T-cell connectors.