On May 15, the China Securities Regulatory Commission (CSRC) published a list of companies required to submit supplementary materials for their overseas listing filings. The CSRC's International Department issued requests to 14 companies, including BioRay, which was asked to provide further details on how special shareholder rights arrangements affect its control structure.
According to reports, BioRay submitted its listing application to the Hong Kong Stock Exchange on January 6, 2026, with Huatai International and J.P. Morgan acting as joint sponsors.
The CSRC has requested BioRay to supplement the following information and has asked its legal counsel to verify and provide a clear legal opinion: 1. (1) Provide a definitive conclusion on whether the implementation of the employee equity incentive plan complies with laws and regulations and whether there is any improper transfer of benefits. (2) Clarify the impact of special shareholder rights arrangements on control, and indicate whether there will be any change in control before and after the listing. (3) Further explain the basis for determining the actual controller and beneficial owner in accordance with the "Applicable Regulatory Guidelines for Overseas Listings No. 2." (4) Disclose through a chain of ownership whether any domestic entities (including legal persons, Chinese citizens, or non-legal person organizations) exist among the investors, managing partners, or actual controllers of its overseas private equity fund shareholders.
2. (1) Detail the internal and external decision-making procedures, state-owned asset management procedures, and listed company regulatory procedures, including information disclosure obligations, related to the company's spin-off from Hisun Pharmaceutical, and provide supporting documentation. (2) Report on the status of state-owned shareholders in obtaining state-owned share identification.
3. Clarify whether the shares held by shareholders intending to participate in the "full circulation" plan are subject to any pledges, freezes, or other encumbrances.
According to its prospectus, BioRay is a leading integrated biopharmaceutical company in China, dedicated to providing comprehensive immunotherapy solutions for patients with autoimmune and inflammatory diseases, tumor immunology diseases, and malignancies of the immune system. Data from Frost & Sullivan indicates that BioRay has ranked first among Chinese pharmaceutical companies for two consecutive years since 2023 in terms of revenue generated from biologics for autoimmune diseases.
BioRay's innovative portfolio is led by three cornerstone immunology products: Beijiele® (bimekizumab), a potential first-in-class and best-in-class IL-17A/F inhibitor; Anruixi (zebutuximab), China's first and only Class 1 innovative CD20 monoclonal antibody; and BR2251, a potential first-in-class and best-in-class gout medication with a differentiated mechanism of action. These products not only provide a solid foundation for the company's growth but also position it to reshape treatment paradigms for various autoimmune and oncology indications in China.
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