Securities code: 688166 Securities abbreviation: Borui Pharmaceutical Announcement No.: 2023-012.
Borui Biopharmaceutical (Suzhou) Co., Ltd.
VOLUNTARY DISCLOSURE ABOUT SUBSIDARY OBLIGATING ALICYLIN MESULFonate INJECTION
Announcement of Certificate of Registration
the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.
Recently, Borui Pharmaceutical (Suzhou) Co., Ltd., a wholly-owned subsidiary of Borui Biopharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as the "Company"), received the "Elibulin Mesylate Injection" issued by the State Medical Products Administration. "Drug Registration Certificate".
According to the website of the State Drug Administration, the company's eribulin mesylate injection is the first drug in China to apply for marketing license and be approved according to the four categories of chemical drugs.
The relevant information is hereby announced as follows:
1. Drug Registration Certificate Basic Information
Drug Name: eribulin mesylate injection
Dosage form: injection
Specifications: 2ml:1mg
Application: Drug Registration (Domestic Production)
Registration classification: chemical drugs 4
Marketing Authorization Holder: Borui Pharmaceutical (Suzhou) Co., Ltd.
Manufacturer: Wuxi Yew Pharmaceutical Co., Ltd
Drug Approval No.: H20233223
Drug approval number valid until February 27, 2028
Approval conclusion: According to the "the People's Republic of China and Drug Administration Law" and relevant regulations, after review, this product meets the relevant requirements of drug registration, approved registration, and issued a drug registration certificate.
Other information related to 2. drugs
Eribulin Mesylate Injection is indicated for patients with locally advanced or metastatic breast cancer who have received at least two previous chemotherapy regimens. Previous chemotherapy regimens should include an anthracycline and a taxane.
Eribulin mesylate injection, developed by Eisai Corporation of Japan, is the first single-agent chemotherapy drug to be used in patients with metastatic breast cancer and to achieve improved overall survival. The company's eribulin mesylate injection is the first drug in China to apply for marketing license and be approved according to category 4 of chemical drugs, which is regarded as passing the consistency evaluation.
According to statistics, global sales of eribulin mesylate injection from October 2020 to September 2021 were
$0.37 billion, October 2021-September 2022 global sales of $0.353 billion (data from
Cortellis database).
The impact of 3. on the company and related risk tips.
The approval of the listing of the mesylate Eribulin injection further enriches the company's anti-tumor preparation product pipeline. The company attaches great importance to drug research and development, and strictly control the quality and safety of drug research and development, manufacturing and sales. Due to the influence of uncertain factors such as industry policies and market environment, the impact of the approval of the drug on the company's operating performance is still uncertain. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.
It is hereby announced.
Board of Directors of Borui Biopharmaceutical (Suzhou) Co., Ltd.
March 4, 2023
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