Funding

These studies were funded by Keymed Biosciences (Chengdu) Co., Ltd.

Conflicts of Interest/Competing Interests

Bo Chen is a shareholder of Keymed Biosciences (Chengdu) Co., Ltd. Libo Zhang is an employee of Keymed Biosciences (Chengdu) Co., Ltd. Yanqiu Huang is an employee of Keymed Biosciences (Chengdu) Co., Ltd. Yingmin Jia is an employee of Keymed Biosciences (Chengdu) Co., Ltd. Hongyue Yan is an employee of Keymed Biosciences (Chengdu) Co., Ltd. Li Chen is an employee of Keymed Biosciences (Chengdu) Co., Ltd. Qiaoyun Hou is an employee of Keymed Biosciences (Chengdu) Co., Ltd. All other authors declare no conflict of interests.

Availability Of Data And Material

The data used and analyzed in the current studies are available from the corresponding author upon reasonable request.

Ethics Approval

These trials were conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines issued by National Medical Products Administration, and relative regulations. The protocols and amendments and other study documents, including the informed consent forms, were reviewed and approved by the ethics committee at each trial center. The HV001 trial was approved by the Drug Clinical Trial Ethics Committee of Peking University (PKU) Care, Luzhong Hospital (Beijing, China) on 27 January 2021 (approval number: [2021] No. 04) and on 26 May 2021 (approval number: [2021] No. 13). The HV002 trial was approved by the Ethics Committee on Clinical Trials, West China Hospital of Sichuan University (Chengdu, China) on 29 November 2021 and on 6 April 2022 (approval number: [2021] No. 290). The 100003 trial was approved by the Drug Clinical Trial Ethics Committee of Peking University (PKU) Care, Luzhong Hospital (Beijing, China) on 4 January 2023 (approval number: [2022] No. 50) and on 9 March 2023 (approval number: [2023] No. 08).

Consent to Participate

All subjects provided written informed consent prior to any study procedure.

Consent for Publication

Not applicable.

Code Availability

Not applicable.

Author Contributions

Bo Chen, Zhu Luo, and Jie Hou have full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Yujing Di, Ling Yang, Jianfei Zhou, Libo Zhang, Bo Chen, Zhu Luo, Jie Hou. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: Yujing Di, Ling Yang, Jianfei Zhou, Libo Zhang. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Libo Zhang. Obtained funding: Bo Chen. Administrative, technical, or material support: Bo Chen, Zhu Luo, Jie Hou. Supervision: Bo Chen, Zhu Luo, Jie Hou.