Fosun Pharma’s announcement on the clinical trial approval of its controlled subsidiary’s drugs
Securities code: 600196 Stock abbreviation: Fosun Pharma Number: Lin 2025-193
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Announcement on the clinical trial approval of the controlled subsidiary’s drugs
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
1. Overview
Recently, Shanghai Henlius Biotechnology Co., Ltd., a holding subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as the "Company"), and its holding subsidiaries (hereinafter collectively referred to as "Fuhong Henlius") received approval from the National Medical Products Administration to conduct the following clinical trial (hereinafter referred to as the "treatment plan") of HLX22 (i.e., recombinant humanized anti-HER2 monoclonal antibody injection) combined with HLX87 (i.e., HER2-targeting antibody conjugate drug) for injection in China 1:
(1) Phase II/III clinical trials for first-line treatment of HER2-positive breast cancer (BC);
(2) Phase II/III clinical trials for neoadjuvant treatment of HER2-positive breast cancer (BC neo).
Henlius plans to carry out the above-mentioned relevant clinical studies in China when conditions are met.
As of October 2025, the Group's current cumulative R&D investment in this treatment plan is approximately RMB 460,000 (unaudited, excluding R&D investment in related single drugs).
As of the date of this announcement (i.e., December 9, 2025, the same below), no similar combination treatment regimen has been approved for marketing globally.
2. Basic information and research status of the drugs involved
- The HLX22 involved in this treatment plan is a new type of HER2-targeting monoclonal antibody licensed to be introduced by Henlius and subsequently independently developed. As of the date of this announcement, multiple clinical studies related to HLX22 are being carried out in multiple regions around the world, including:
1 Excluding Hong Kong, Macao and Taiwan, the same below
Project code/protocol Indications Progress
HLX22+ standard treatment 2 HER2-positive locally advanced or metastatic gastroesophageal junction cancer in China: in phase III clinical trials and gastric cancer in the United States, EU countries, Australia, Japan and other countries/regions: in phase III clinical trials (international multi-center trial)
HLX22+standard therapy2 HER2 low expression HR-positive localized advanced or metastatic breast cancer in China: in phase II clinical trial/HLX22+trastuzumab
HLX22 + slulimab injection for HER2-positive locally advanced/transformed patients in China: Phase II clinical trial approved for injection + standard treatment 2
metastatic gastric cancer
In addition, HLX22 has been granted orphan drug designation by the U.S. FDA (i.e., the U.S. Food and Drug Administration) and the European Commission (EC) in March and May 2025 for the treatment of gastric cancer.
- HLX87 is an innovative antibody drug conjugate (ADC) targeting HER2. It couples a topoisomerase I inhibitor and an anti-HER2 monoclonal antibody through a stable and cleavable ring-opening linker. HLX87 is intended to be used in the treatment of HER2-positive breast cancer; as of the date of this announcement, its use in the second-line treatment of HER2-positive breast cancer is in Phase III clinical trials in China.
3. Impact on listed companies and risk warnings
According to relevant Chinese laws and regulations, this treatment plan and the drugs under development, HLX22 and HLX87, are still in the clinical trial stage, and they need to conduct a series of clinical studies in China and obtain approval from the national drug review department before they can be put on the market. Based on research and development experience, drug research and development involves certain risks. For example, clinical trials may be terminated due to issues such as safety and/or effectiveness.
Drug research and development to launch is a long-term task with many uncertainties. Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
December 9, 2025
2 That is, trastuzumab combined with chemotherapy.