Zhejiang Shimai Pharmaceutical Co. Ltd., a developer of T-cell engager (TCE) therapies, has been cleared by the China Securities Regulatory Commission (CSRC) for its overseas listing, marking an important step forward for its planned Hong Kong IPO.

According to the filing on the CSRC website, the company plans to issue up to 56.05 million Hong Kong-traded H shares and convert another 184 million domestic shares into H-shares for the listing. Shimai Pharma recently submitted its listing application, the company’s second such application, to the Hong Kong Stock Exchange, with Huatai International as its sole sponsor.

Founded in 2017, Shimai Pharma is a clinical-stage biotech company focused on next-generation cancer immunotherapies based on T-cell engager technology. Its pipeline includes four clinical-stage drug candidates, led by DNV3 and SMET12, targeting solid tumors, lymphoma and EGFR-positive advanced cancers. The company also has two trispecific antibody candidates in preclinical development.

As a pre-commercial biotech company, Shimai Pharmaceutical has yet to generate revenue from its core business. The company reported a net loss of 81 million yuan ($11.96 million) in 2025.

By Lee Shih Ta

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