Announcement on the Acceptance of the Marketing Application for Enwevituximab Injection of a Controlled Subsidiary

CSPC Innovation Pharmaceutical Co., Ltd.·July 17, 2026·2 pages

✨ AI Summary

This announcement details the acceptance of the marketing application for Enwevituximab Injection, a HER2-targeted ADC drug developed by a subsidiary. The application is for treating unresectable or metastatic HER2-positive breast cancer. The drug has shown significant efficacy and good safety in clinical trials, potentially offering a superior option to existing treatments.

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Securities Code: 300765

Securities Abbreviation: CStone Innovations

Announcement No.: 2026-066

CStone Innovations Pharmaceutical Co., Ltd.

Announcement on the Acceptance of the Marketing Application for Enwevituximab Injection of a Controlled Subsidiary

The Company and all members of the Board of Directors guarantee that the content of this information disclosure is true, accurate, and complete, and that there are no false records, misleading statements, or major omissions.

I. Overview

CStone Innovations Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company")'s controlled subsidiary, Stone Biologics Co., Ltd. (hereinafter referred to as "Stone Biologics"), recently received an "Acceptance Notice" issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"), accepting the marketing application for Enwevituximab Injection. The relevant situation is hereby announced as follows:

II. Basic Information of the Drug

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