Zhitong Finance App learned that on December 26, the China Securities Regulatory Commission announced the “Requirements for Supplementary Materials for Overseas Issuance and Listing Filing (December 22, 2025 to December 26, 2025)”. The International Department of the China Securities Regulatory Commission announced supplementary material requirements for 19 companies. Among them, Haina Pharmaceuticals was requested to provide additional information on matters such as the specific use of funds raised and the proportion of domestic and foreign uses. According to reports, Haina Pharmaceuticals submitted a statement to the Hong Kong Stock Exchange on November 7, 2025, with CICC as the sole sponsor.
The China Securities Regulatory Commission requested Haina Pharmaceutical to further explain the following matters, and ask lawyers to check and issue clear legal opinions:
1. Regarding changes in equity: (1) Please explain the company's capital reduction procedure compliance, relevant tax payment, and price reduction payments, and issue clear concluding opinions on the establishment of the company and the legal compliance of previous equity changes; (2) Please verify the share brokerage situation in the company's history in accordance with the “Guidelines for the Application of Regulatory Rules - Overseas Issuance and Listing Class No. 2” share brokerage requirements.
2. Please explain the specific implementation of overseas investment, foreign exchange registration and other supervisory procedures involving the establishment of overseas subsidiaries by the company, and issue a concluding opinion on compliance.
3. Please indicate that the business scope of the company and its subsidiaries includes the specific situation of “pharmaceutical development, research; medical research and experimental development; testing services”; whether they have actually carried out relevant business and specific operations; whether the necessary qualifications have been obtained; whether the scope of business and actual business involves “development and application of human stem cells, genetic diagnosis and treatment technology” or other restricted or prohibited areas for foreign investment and the basis for relevant judgment; and whether they continue to meet the requirements of the foreign investment access policy before and after the launch.
4. Please explain the specific situation of the company and its subsidiaries through third party payments and failure to fully pay social insurance and housing provident funds; whether the latest developments in uncompleted litigation and arbitration cases constitute a substantial obstacle to the current overseas issuance and listing.
5. Please explain the specific use of funds raised, the proportion of domestic and foreign use, and the implementation of domestic and foreign investment approval, or filing procedures.
6. Please explain whether the shares held by shareholders who intend to participate in the “full circulation” have been pledged, frozen, or have other rights defects.
According to the prospectus, Haina Pharmaceutical is an integrated pharmaceutical R&D and manufacturing company that provides CXO services; at the same time, the company has proprietary product pipelines, which are mainly commercialized through pharmaceutical technology transfer. According to the Frost & Sullivan report, during the track record period and until the last practical date (November 2, 2025), Haina Pharmaceuticals ranked second in terms of the total number of approved clinical trials and marketing licenses among CXO service providers engaged in drug technology transfer in China. According to the same source, Haina Pharmaceuticals also ranked second in terms of the total number of clinical trials and marketing license applications submitted during the same period.
Haina Pharmaceuticals operates one of the most comprehensive CXO platforms in the industry, covering the entire chain of drug discovery, CMC, preclinical and clinical development, registration and verification to commercial production. The company provides end-to-end or modular CRO and CMO solutions covering drug development and CMC, clinical and bioequivalence testing services, registration and contract production. As of December 31, 2022, 2023, 2024, and June 30, 2025, Haina Pharmaceuticals had 242, 331, 383 and 398 ongoing CXO projects, respectively.