FOSUN PHARMA - Announcement on the registration 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 on the Registration Approval of the Drug Controlled Subsidiary" is for reference only.
By order of the board of directors Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Chairman
Chen Yuqing
China, Shanghai
May 29, 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 2026-077
Shanghai Shanghai Fufu Xingxing Medical and Pharmaceutical ((Group)) Co., Ltd.
Announcement on the approval of registration for the pharmaceutical products of the controlling 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") have The main research and development of Pertuzumab Injection (the first trade name in China: Hanbeiyou®, hereinafter referred to as "the drug")
The marketing registration application was approved by the State Food and Drug Administration (hereinafter referred to as "this approval"). This approval applies to
The disease covers all indications approved for the original research Pertuzumab Injection in China, specifically including:
- Early breast cancer: combined with trastuzumab and chemotherapy for: (1) HER2-positive, locally advanced,
Neoadjuvant therapy for patients with inflammatory or early-stage breast cancer (>2cm in diameter or positive lymph nodes), as early-stage breast cancer Part of the overall treatment plan; (2) Adjuvant treatment for patients with HER2-positive early breast cancer with high risk of recurrence
treatment.
- Metastatic breast cancer: combined with trastuzumab and docetaxel, suitable for patients who have not received treatment for metastatic disease in the past.
Anti-HER2 therapy or chemotherapy for metastatic breast cancer HER2-positive, metastatic, or unresectable local recurrence
Treatment of breast cancer patients.
- Registration information of the drug
Generic name of the drug: Pertuzumab injection
Dosage form: injection
Specifications: 420mg (14ml)/bottle Registration Classification: Biological Products for Therapeutic Use Class 3.3
Marketing authorization holder/manufacturer: Shanghai Fuhong Hanlin Biopharmaceutical Co., Ltd.
Drug approval number: National Drug Approval Number S20260034
1 Excluding Hong Kong, Macao and Taiwan, the same below.
- The registration progress of the drug and the market situation of similar drugs
This drug is Pertuzumab independently developed by the Group (i.e. the Company and its holding subsidiaries/units, the same below). Biosimilars.
In addition to this approval, as of the date of this announcement (i.e. May 29, 2026), the drug has been approved by the U.S.
Marketing approval from the China Food and Drug Administration (FDA) and the European Commission (European Commission)
approved, and the marketing application has been accepted by Health Canada.
As of April 2026, the Group's current cumulative R&D investment in this drug is approximately RMB 2.32 billion (unaudited).
According to the latest data from IQVIA CHPA2, in 2025, the sales of pertuzumab products in China will be approximately
was RMB 2.728 billion.
- Impact and risk warnings on listed companies The approval of this drug for marketing will bring more treatment options to breast cancer patients in China and further
This further enriches the Group's marketed pipeline in this therapeutic field in China.
Due to the industry characteristics of pharmaceutical products, the specific sales situation of drugs after they are launched may be affected by (including but not limited to
Affected by market demand, competitive environment, sales channels and other factors, there is great uncertainty. Please invest
Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
board of directors
May 29, 2026
2 Provided by IQVIA, a professional information and strategic consulting service provider for the global pharmaceutical and health industry; IQVIACHPA data represents China’s In the domestic drug sales market of hospitals with more than 100 beds, different drugs have different sales channel layouts, and the actual sales situation may be different from that of IQVIA There are varying degrees of variability in CHPA data.