Securities code: 600196 Stock abbreviation: Fosun Pharma Number: Lin 2026-022
Announcement of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. on the clinical trial approval of drugs of its controlled subsidiaries
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 a Phase I clinical trial of HLX15-SC (recombinant anti-CD38 fully human monoclonal antibody injection – subcutaneous injection) for the treatment of multiple myeloma. Henlius plans to carry out relevant clinical research on this drug in China (excluding Hong Kong, Macao and Taiwan, the same below) when conditions are met.
2. Basic information and research status of HLX15
HLX15 (i.e., recombinant anti-CD38 fully human monoclonal antibody) is a daratumumab biosimilar independently developed by the Group (i.e., the company and its holding subsidiaries/units, the same below), including subcutaneous injection HLX15-SC and intravenous injection HLX15-IV. It is intended to be used for the treatment of multiple myeloma (MM) and other diseases. In June 2024, the phase I clinical study of HLX15-IV in Chinese male healthy subjects was completed.
As of January 2026, the Group's current cumulative R&D investment in HLX15 is approximately RMB 191.53 million (unaudited).
As of the date of this announcement (i.e. February 12, 2026), the daratumumab preparations that have been marketed globally include DARZALEX? and DARZALEX FASPRO?. According to the latest data from IQVIA MIDAS (provided by IQVIA, a professional information and strategic consulting service provider for the global pharmaceutical and health industry.), in 2024, global sales of daratumumab preparations will be approximately US$12.882 billion.
3. Risk warning
According to relevant Chinese regulatory requirements, HLX15 still needs to conduct a series of clinical studies in China and obtain approval from the national drug review department before it can be marketed. 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.
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Board of Directors
February 12, 2026
