Zhejiang ShiMai Pharmaceutical Co., Ltd. (ShiMai Pharma) has resubmitted its application for a main board listing on the Hong Kong Stock Exchange, with Huatai International acting as its sole sponsor.

The company is a clinical-stage biotech firm focused on developing T-cell engager (TCE) therapies. Its pipeline includes four clinical-stage candidates, featuring two core products: DNV3 for advanced/metastatic solid tumors and lymphoma, and SMET12 for EGFR-positive advanced solid tumors.

TCEs are bispecific or multispecific antibodies designed to simultaneously bind tumor-associated antigens on cancer cells and receptors on T cells, directing immune cells to tumors and activating them to induce targeted cytotoxicity. ShiMai Pharma recognized the differentiated potential of TCEs early on as a next-generation immunotherapy harnessing the body's immune system against cancer. The company has developed shielded TCEs designed for selective activation within tumors for treating solid tumors.

As of May 11, 2026, ShiMai Pharma's four self-developed clinical-stage candidates are: (i) DNV3, an advanced T-cell modulator targeting LAG-3; (ii) SMET12, an innovative intravenous EGFR×CD3 TCE; (iii) CMD011, an advanced GPC3×CD3 TCE; and (iv) CMDE005, an innovative shielded EGFR×CD3 TCE. The company also has two preclinical-stage multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, which are trispecific shielded TCEs targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively.

The company acknowledges the risk that it may ultimately fail to successfully develop and commercialize its pipeline products, including the core candidates DNV3 and SMET12.

Core product DNV3 is an advanced T-cell modulator targeting Lymphocyte Activation Gene-3 (LAG-3), an inhibitory receptor highly expressed by exhausted T cells in the tumor microenvironment. It was developed using the company's proprietary high-capacity fully human IgM phage display antibody library. DNV3 has demonstrated a favorable safety profile and broad combination therapy potential in clinical trials, with no Grade 3 or higher Cytokine Release Syndrome (CRS) reported. As of May 11, 2026, a Phase II trial is ongoing for DNV3 in combination with an anti-PD-1 antibody (toripalimab) and chemotherapy (nab-paclitaxel, cisplatin, or carboplatin) targeting locally advanced unresectable or metastatic melanoma. A Phase I monotherapy trial for DNV3 targeting advanced/metastatic solid tumors and lymphoma was completed in March 2022. According to Frost & Sullivan data, as of May 11, 2026, DNV3 ranks second globally and in China by clinical development stage among anti-LAG-3 antibody candidates for melanoma treatment.

Core product SMET12 is an innovative intravenous EGFR×CD3 TCE. It validates the company's TCE structural design capabilities and sets a benchmark for its broader TCE pipeline. As of May 11, 2026, SMET12 is in a Phase IIa trial in China targeting EGFR-positive advanced solid tumors, including esophageal cancer. It received IND approval from the U.S. FDA in November 2021. The company completed a Phase I trial in China for SMET12 targeting EGFR-positive advanced solid tumors in February 2023. According to Frost & Sullivan, as of May 11, 2026, SMET12 ranks first globally and in China by clinical development stage among EGFR×CD3 TCE candidates.

Financial Information: * Revenue (Other Income & Gains): RMB 6.618 million in 2024 and RMB 9.372 million in 2025. * Loss: Total comprehensive loss of RMB 59.899 million in 2024 and RMB 80.960 million in 2025. * R&D Expenses: RMB 53.382 million in 2024 and RMB 46.589 million in 2025.

Industry Overview: The global therapeutic antibody market reached $254.3 billion in 2024, with a 9.5% CAGR from 2020-2024. Monospecific antibodies are the largest segment. While multispecific antibodies (msAbs) and antibody-drug conjugates (ADCs) are in earlier stages, their markets are expected to grow rapidly. In China, the therapeutic antibody market was $18.2 billion in 2024, with a 32.1% CAGR from 2020-2024. Key future trends in China include more diversified reimbursement systems, increased biosimilar accessibility, and the launch of innovative antibody drugs.

The number of approved antibody drugs and their indications continues to grow globally and in China, with increasing treatment penetration in oncology, autoimmune, and metabolic diseases. This is particularly notable in oncology, where global incidence is projected to rise from 21.91 million cases in 2025 to 27.02 million by 2035. In China, incidence is projected to rise from 5.13 million cases in 2025 to 6.29 million by 2035.

Pipeline expansion continues: globally, there are 1,096 monospecific antibody, 420 ADC, and 523 msAb candidates in active development; in China, there are 469, 264, and 295 candidates in these categories, respectively. Over the next 5-10 years, multiple ADC and msAb products targeting HER2, TROP2, EGFR, BCMA, and CD20 are expected to gain regulatory approval. Advances in linker, payload, and bispecific platform technology are expected to further improve efficacy, safety, and clinical applications.

The global TCE drug market grew from $0.4 billion in 2020 to $3.0 billion in 2024, a 67.6% CAGR. The China TCE drug market reached $0.1 billion in 2024, with a 104.0% CAGR from 2021-2024.

Board & Shareholding: The Board comprises 9 directors: 3 executive, 3 non-executive, and 3 independent non-executive directors. Hangzhou Shimai, established in China on October 29, 2020, holds 11,409,650 shares (post-share subdivision adjustment), representing approximately 5.85% of the issued shares as of the document date. It is controlled by its sole general partner, Dr. Xiao.

Intermediary Team: * Sole Sponsor: Huatai Financial Holdings (Hong Kong) Limited * Company's Legal Advisors: Davis Polk & Wardwell (Hong Kong & U.S. law); Commerce & Finance Law Offices (PRC law) * Sole Sponsor's Legal Advisors: Jingtian & Gongcheng (Hong Kong law); Jingtian & Gongcheng (PRC law) * Reporting Accountant & Independent Auditor: Ernst & Young * Industry Consultant: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch * Compliance Advisor: Glowing Capital (Asia Pacific) Limited