The Zhitong Finance App learned that on September 18, the China Securities Regulatory Commission issued the “Requirements for Supplementary Materials for Overseas Issuance and Listing Filing (September 14, 2026 - September 18, 2026)”. The International Division of the China Securities Regulatory Commission issued supplementary material requirements for a total of 6 companies. Among them, Shenzhou Cell (688520.SH) was requested to further explain the specific implementation of overseas investment and foreign exchange management procedures involving the establishment of overseas subsidiaries, and further explain matters such as the necessity and rationality of this listing in Hong Kong in conjunction with capital raised investment. According to the Hong Kong Stock Exchange disclosure on May 22, Beijing Shenzhou Cell Biotechnology Group Co., Ltd. submitted a listing application to the main board of the Hong Kong Stock Exchange, and CITIC Securities was the sole sponsor.
The China Securities Regulatory Commission requested Shenzhou Cell to further explain the following matters, and ask lawyers to check and issue clear legal opinions:
1. Please provide additional information on the specific implementation of overseas investment, foreign exchange management and other regulatory procedures involving the establishment of overseas subsidiaries by your company, and issue a concluding opinion on compliance.
2. Please itemize the specific amount and proportion of the funds raised in this issuance for domestic and foreign investment projects, and explain the implementation of the relevant approval, approval or filing procedures. If so, please issue a commitment to return all of the funds raised to the country during the implementation of the relevant procedures.
3. Please further explain the details of all pending lawsuits and arbitration involving your company, whether the relevant circumstances will have a significant adverse impact on the company's future operations, whether they will constitute a material obstacle to this issuance, and whether the relevant circumstances have been fully disclosed.
4. Please further explain the necessity and rationality of this listing in Hong Kong in conjunction with the fund-raising investment.
5. Please provide additional explanations on whether the issuer's share pledge, loan guarantee, etc. may lead to major ownership disputes or changes in the issuer's controlling shareholder before and after the issuance is completed, taking into account circumstances such as solvency, etc.
6. Please provide additional information on the specific development of your company's property management business.
According to the prospectus, Shenzhou Cell is an innovative biopharmaceutical company focusing on R&D, production and commercialization of therapeutic antibodies, recombinant proteins and vaccines. Since its establishment in 2002, Shenzhou Cell has been committed to independent research and development, and has established an end-to-end development platform to support drug discovery, clinical development and commercialization. In July 2021, Shenzhou Cell launched its first commercial product, Anjiain (recombinant human coagulation factor VIII, or “rhFVIII”), transforming it into a biopharmaceutical company with commercial operations. Since its launch, Anjiayin has contributed to improving the domestic supply of rhFVIII products, and has ranked first among comparable products in China in terms of sales value since 2023, accounting for about 35.5% of the rhFVIII market in 2024.
With an integrated technology platform, Shenzhou Cell has established a product pipeline covering oncology, autoimmunity, ophthalmology, hemophilia and vaccines. As of the last practical date, Shenzhou Cell has five commercial products, three COVID-19 vaccine products authorized for emergency use, and 13 candidate products in ongoing clinical research. All of the company's products and candidate products are independently developed, and it has global intellectual property rights for such products. More than 40 research projects from Shenzhou Cell have been selected and supported by national and municipal research programs.