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Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Announcement Regarding the Approval of Clinical Trials for Drugs of Its Controlling Subsidiary
Stock Code: 600196 Stock Name: Fosun Pharma Announcement No.: Lin2026-036
Fosun Pharmaceutical (Group) Co., Ltd.
Announcement Regarding Clinical Trial Approval of Subsidiary’s Drug
The Company’s Board of Directors and all directors guarantee that this announcement contains no false records, misleading statements, or major omissions, and assume legal responsibility for the truthfulness, accuracy, and completeness of its content.
Recently, Shanghai Fosun Pharma (Group) Co., Ltd. (hereinafter referred to as “the Company”)’s controlling subsidiary, Shanghai Junji Health Technology Co., Ltd. (hereinafter referred to as “Junji Health”), received approval from the National Medical Products Administration (NMPA) to conduct clinical trials of LBP-ShC4. Junji Health plans to initiate Phase I clinical research of LBP-ShC4 within China (excluding Hong Kong, Macao, and Taiwan) once conditions are met.
LBP-ShC4 is an independently developed live biological therapy product by the Group (i.e., the Company and its controlling subsidiaries/units), intended for the treatment of androgenetic alopecia (AGA). In May 2025, clinical trials of LBP-ShC4 for this indication received approval from the U.S. Food and Drug Administration (FDA).
As of February 2026, the Group’s total R&D investment in LBP-ShC4 was approximately RMB 20 million (unaudited).
As of the date of this announcement (March 16, 2026), no live biological therapy products (including monotherapy or combination therapy) for the treatment of androgenetic alopecia (AGA) have been approved for market release worldwide.
According to Chinese regulations, LBP-ShC4 still requires a series of clinical studies within China and approval from the national drug review authorities before it can be marketed. Based on R&D experience, drug development involves certain risks, such as potential termination of clinical trials due to safety or efficacy issues.
Drug development and market approval is a long-term process with many uncertainties. Investors are advised to exercise caution and be aware of investment risks.
This announcement is hereby made.
Fosun Pharmaceutical (Group) Co., Ltd.
Board of Directors
March 16, 2026
Stock Code: 600196 Stock Name: Fosun Pharma Announcement No.: Lin2026-037
Fosun Pharmaceutical (Group) Co., Ltd.
Announcement Regarding Clinical Trial Approval of Subsidiary’s Drug
The Company’s Board of Directors and all directors guarantee that this announcement contains no false records, misleading statements, or major omissions, and assume legal responsibility for the truthfulness, accuracy, and completeness of its content.
Recently, Shanghai Fosun Pharma (Group) Co., Ltd. (hereinafter referred to as “the Company”)’s controlling subsidiaries, Shanghai Fosun Hanlin Biotech Co., Ltd. and its controlling subsidiaries (collectively referred to as “Fosun Hanlin”), received approval from the National Medical Products Administration (NMPA) to conduct clinical trials of HLX07 (a recombinant anti-EGFR humanized monoclonal antibody injection) combined with Shulili monoclonal antibody injection (brand name: Hanshuang■ in China, excluding Hong Kong, Macao, and Taiwan) and chemotherapy (hereinafter referred to as “the treatment regimen”) for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC). Fosun Hanlin plans to initiate relevant clinical research within China once conditions are met.
As of the date of this announcement (March 16, 2026), no similar combination therapy has been approved for market release worldwide.
As of February 2025, the Group (the Company and its controlling subsidiaries/units)’s total R&D investment in this treatment regimen was approximately RMB 93 million (unaudited, excluding R&D investments for individual drugs).
The treatment regimen involves HLX07, an innovative biologic targeting the EGFR receptor developed independently by Fosun Hanlin, and Shulili monoclonal antibody injection, an innovative anti-PD-1 monoclonal antibody also developed independently by Fosun Hanlin. The main clinical or registration progress of these drugs is as follows:
HLX07 is intended for the treatment of advanced solid tumors. As of this announcement, multiple clinical studies are underway in China, including Phase II trials of HLX07 monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and other solid tumors, and Phase II trials of HLX07 combined with Shulili monoclonal antibody injection for squamous non-small cell lung cancer (sqNSCLC) and other solid tumors.
As of this announcement, Shulili monoclonal antibody injection has been approved for market in China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India. Approved indications in China include first-line combined chemotherapy for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC). The drug has been granted orphan drug designation by regulatory agencies in the U.S., EU, Switzerland, and South Korea. Its registration application for neoadjuvant/adjuvant therapy of gastric cancer combined with chemotherapy was accepted by the NMPA in December 2025 and included in priority review. Additionally, multiple clinical trials of the drug as monotherapy and in combination are progressing globally, covering indications such as lung cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer.
Risk Warning
According to Chinese regulations, the investigational drugs HLX07 involved in this treatment regimen still require a series of clinical studies within China and approval from the national drug review authorities before they can be marketed. Based on R&D experience, drug development involves certain risks, such as potential termination of clinical trials due to safety or efficacy issues.
Drug development and market approval is a long-term process with many uncertainties. Investors are advised to exercise caution and be aware of investment risks.
This announcement is hereby made.
Fosun Pharmaceutical (Group) Co., Ltd.
Board of Directors
March 16, 2026