FOSUN PHARMA - Announcement on the clinical trial approval of the controlled subsidiary’s drugs
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (a joint stock limited company incorporated in the People's Republic of China)
(Stock code: 02196)
Overseas regulatory announcement
This announcement is made in accordance with Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.
This is to set forth the "About
Announcement of the Drug Controlled Subsidiary’s Clinical Trial Approval” is for reference only.
By order of the board of directors Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Chairman
Chen Yuqing
China, Shanghai
May 21, 2026
As at the date of this announcement, the executive directors of the Company are Mr. Chen Yuqing, Ms. Guan Xiaohui, Mr. Wen Deyong, Mr. Wang Kexin and Mr. Liu Yi; the Company The non-executive directors of the company are Mr. Chen Qiyu and Mr. Pan Donghui; the independent non-executive directors of the company are Mr. Yu Zishan, Mr. Wang Quandi, and Mr. Chen Mr. Penghui and Mr. Yang Yucheng; and the employee director of the Company is Ms. Yan Jia.
*For identification only
Securities code: 600196 Stock abbreviation: Fosun Pharma Number: Lin 2026-071
Shanghai Shanghai Fufu Xingxing Medical and Pharmaceutical ((Group)) Co., Ltd.
Announcement on the approval of clinical trials for pharmaceutical products of Yukou Holdings’ subsidiaries
The Board of Directors of the Company and all directors hereby certify that the contents of this announcement do not contain any false records, misleading statements or
The author makes any serious omissions and assumes legal responsibility for the authenticity, accuracy and completeness of the content. .
- Overview
Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as the "Company") holding subsidiary
Shanghai Henlius Biotechnology Co., Ltd. and its holding subsidiaries (hereinafter collectively referred to as "Fuhong Henlius") Go to the National Medical Products Administration to approve the injection of HLX48 (i.e., an antibody conjugate drug targeting EGFR and c-MET).
(hereinafter referred to as "HLX48") was approved to conduct Phase I clinical trials for the treatment of advanced/metastatic solid tumors. complex
Honghanlin plans to carry out relevant clinical research on this drug in China1 when conditions are met.
- Basic information and research status of HHLLXX4488 HLX48 is an EGFR-targeted and
A bispecific antibody-drug conjugate to c-MET is intended for the treatment of advanced/metastatic solid tumors. May 2026,
The Phase I clinical trial protocol of HLX48 for the treatment of advanced/metastatic solid tumors has obtained relevant human research ethics committee approval
approved by the Australian Therapeutic Goods Administration
Clinical trial filing. As of April 2026, the Group’s current cumulative R&D investment in HLX48 is approximately RMB 0.66
billion (unaudited).
As of the date of this announcement (i.e., May 21, 2026), there are no drugs targeting EGFR and c-MET globally.
The bispecific antibody conjugate drug was approved for marketing.
1 Excluding Hong Kong, Macao and Taiwan, the same below.
- Risk reminders
According to relevant regulatory requirements, HLX48 still needs to conduct a series of clinical studies in China and be approved by the National Drug Administration.
It can be put on the market only after it has been approved by the review department. According to R&D experience, there are certain risks in drug R&D, such as clinical Clinical trials may be terminated due to issues such as safety and/or efficacy. Drug research and development to launch is a long-term
There are many uncertainties in the work, so investors are advised to pay attention to investment risks.
Announcement is hereby made.
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
board of directors
May 21, 2026