Jiangsu Hengrui Medicine Co., Ltd. Announcement on Approval of Drug Registration

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Stock code: 600276 Stock short name: Hengrui Pharma Announcement No.: Lin 2026-042

Jiangsu Hengrui Medicine Co., Ltd.

Announcement on Obtaining Approval for Drug Registration

This announcement is issued by the board of directors and all directors of the Company. The board and all directors warrant that there are no false records, misleading statements or material omissions in the content of this announcement, and they assume legal responsibility for the truthfulness, accuracy, and completeness of the content.

Recently, Jiangsu Hengrui Medicine Co., Ltd. (hereinafter referred to as the “Company”) has received a notice from the National Medical Products Administration (hereinafter referred to as the “NMPA”) stating that the Company’s subsidiary, Suzhou Shengdia Biomedical Co., Ltd., has been approved for an additional indication for SHR-A1811, a Type 1 innovative drug for injection (injection for Rongkang Trastuzumab) independently developed by the Company. The relevant details are hereby announced as follows:

I. Basic information of the drug

Drug name: Injection for Rongkang Trastuzumab

Dosage form: Injection

Specification: 0.1g/bottle

Registration classification: Category 2.2 for therapeutic biological products

Acceptance number: CXSS2500094

Prescription drug / OTC drug: Prescription drug

Approved indication: This product is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies.

II. Status of the drug’s approved indications

Injection for Rongkang Trastuzumab has been approved for marketing in China in May 2025, for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one line of systemic therapy.

III. Other information about the drug

Breast cancer ranks among the top causes of incidence and mortality among malignant tumors in women worldwide [1], posing a serious threat to women’s health. Meanwhile, HER2-positive breast cancer accounts for about 15-20% of all breast cancers. Before the advent of anti-HER2 drugs, the average survival period of patients with HER2-positive breast cancer was only half that of negative patients. The introduction of anti-HER2 drugs has greatly changed the disease course and treatment outcomes of HER2-positive breast cancer [2]. However, there remains a significant unmet need in HER2-positive advanced breast cancer, including limited drug choices, early emergence of drug resistance, and adverse events restricting drug use, etc. Clinically, there is an urgent need to explore regimens with superior efficacy and good tolerability.

Injection for Rongkang Trastuzumab can bind to tumor cells expressing HER2 and be internalized. Inside tumor cells’ lysosomes, the toxin is released through protease cleavage, inducing cell-cycle arrest and triggering apoptosis of tumor cells. The released toxin has high membrane permeability, enabling a bystander killing effect and further improving anti-tumor efficacy. Currently, similar products approved and marketed in China include Roche’s Enmetrazumab emtansine (Ado-trastuzumab emtansine), the anti-HER2 drug Ductrazumab deruxtecan (Fam-trastuzumab deruxtecan) jointly developed by AstraZeneca and Daiichi Sankyo, Videlisotuzumab developed by Rongchang Bio, and Boduozumab Trastuzumab developed by Kelun-Biotech. After checking the EvaluatePharma database, the total global sales revenue of all similar products for 2025 and beyond is approximately USD 8.157 billion. To date, the cumulative R&D investment related to injection for Rongkang Trastuzumab is approximately RMB 188,8300,000 (unaudited).

IV. Risk warning

The Company attaches great importance to drug R&D and strictly controls the quality and safety of the links involved in drug R&D, manufacturing, and sales. After the drug receives the approval letter, its production and sales may be affected by certain uncertainties. Investors are kindly requested to make prudent decisions and take care to guard against investment risks.

This announcement is hereby given.

Board of Directors of Jiangsu Hengrui Medicine Co., Ltd.

March 20, 2026

[1]. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.

[2]. Martínez-Sáez O, Prat A. Current and Future Management of HER2-Positive Metastatic Breast Cancer. JCO Oncol Pract. 2021;17(10):594-604.

Stock code: 600276 Stock short name: Hengrui Pharma Announcement No.: Lin 2026-043

Jiangsu Hengrui Medicine Co., Ltd.

Announcement on Obtaining a Notification of Approval for a Drug Clinical Trial

This announcement is issued by the board of directors and all directors of the Company. The board and all directors warrant that there are no false records, misleading statements or material omissions in the content of this announcement, and they assume legal responsibility for the truthfulness, accuracy, and completeness of the content.

Recently, Jiangsu Hengrui Medicine Co., Ltd. (hereinafter referred to as the “Company”) has received a notice from the National Medical Products Administration (hereinafter referred to as the “NMPA”) issued regarding the “Notification of Approval for Drug Clinical Trials” for SHR-3836 injection for approval to proceed with a clinical trial. The Company’s subsidiary, Shanghai Hengrui Medicine Co., Ltd., has received the notification. The clinical trials will be carried out recently. The relevant details are hereby announced as follows:

I. Basic information of the drug

Drug name: SHR-3836 injection

Dosage form: Injection

Application matters: Clinical trial

Acceptance number: CXSL2501117, CXSL2501118

Approval conclusion: In accordance with the “Drug Administration Law of the People’s Republic of China” and relevant provisions, after review, the clinical trial application for SHR-3836 injection accepted on December 23, 2025 meets the requirements related to drug registration. It is agreed that this product as monotherapy will conduct clinical trials in multiple myeloma.

II. Other information about the drug

SHR-3836 injection is an innovative anti-tumor drug independently developed by the Company, and is intended for the treatment of multiple myeloma. After checking, currently there are no drugs of the same class上市 (launched and marketed) either domestically or internationally. To date, the cumulative R&D investment related to SHR-3836 injection is approximately RMB 31,700,000 (unaudited).

III. Risk warning

According to the laws and regulations related to drug registration in China, after a drug receives the notification of approval for a drug clinical trial, it still needs to conduct clinical trials and obtain approval through review and approval by the NMPA before it can be produced and marketed. The cycle from research and development, submission of clinical trial applications, to production is long and involves many steps; drug R&D and even subsequent listing may be affected by certain uncertainties. Investors are kindly requested to make prudent decisions, take care to guard against investment risks. The Company will actively advance the above R&D project in accordance with the relevant national regulations and promptly fulfill information disclosure obligations regarding subsequent progress of the project.

This announcement is hereby given.

Board of Directors of Jiangsu Hengrui Medicine Co., Ltd.

March 20, 2026

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