Announcement from Jianyou Co., Ltd. that Nadroparin Calcium Injection passed the quality and efficacy consistency evaluation of generic drugs
Securities code: 603707 Securities abbreviation: Jianyou Shares Announcement number: 2025-082 Bond code: 113579 Bond abbreviation: Jianyou Convertible Bonds
Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
About Nadroparin Calcium Injection Passed
Announcement on consistency evaluation of quality and efficacy of generic drugs
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 bear individual and joint liability for the authenticity, accuracy and completeness of its contents.
Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianyou" or the "Company") recently received the Nadroparin Calcium Injection issued by the National Medical Products Administration (hereinafter referred to as "NMPA") 0.3ml: 3075AⅩaIU (Drug Approval Number: National Drug Approval Number: H20194077) and 0.6ml: 6150AⅩaIU (Drug Approval Number: National Drug Approval Number: H20191005) Drug Supplementary Application Approval Notice. The product was approved to pass the generic drug quality and efficacy consistency evaluation. The relevant information is now announced as follows:
1. Basic information about drugs
(1) Drug name: Nadroparin Calcium Injection
(2) Indications:
In surgery, it is used to prevent venous thromboembolic disease in patients with moderate or high risk of venous thrombosis. Treat deep vein thrombosis that has developed. Combined with aspirin for the treatment of unstable angina pectoris and the acute phase of non-Q-wave myocardial infarction. Prevention of blood clot formation in extracorporeal circulation during hemodialysis.
(3) Dosage form: injection (prefilled syringe product)
(4) Specifications: 0.3ml: 3075AⅩaIU, 0.6ml: 6150AⅩaIU
(5) Original drug approval number: National Drug Approval Number H20194077, National Drug Approval Number H20191005
(6) Applicant: Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
2. Other related information about drugs
The company recently received notice from the NMPA that the supplementary application submitted by the company to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for nadroparin calcium injection, 0.3ml: 3075AⅩaIU and 0.6ml: 6150AⅩaIU, was approved and passed the generic drug quality and efficacy consistency evaluation.
Nadroparin calcium injection, 0.3ml: 3075AⅩaIU and 0.6ml: 6150AⅩaIU reference preparation, trade name: FRAXIPARINE, 0.3ml: 3075AⅩaIU, WHO unit (i.e. 0.3ml: 2850AXaIU, European Pharmacopoeia unit) and 0.6ml: 6150AXaIU, WHO unit (i.e. 0.6ml: 5700AXaIU, European Pharmacopoeia unit), is owned by Aspen PharmaTrading Limited (referred to as Aspen) and was approved for import on April 8, 1994. The registration certificate numbers are National Drug Approval No. HJ20181135 and National Drug Approval No. HJ20181137.
After inquiry, there are currently 8 generic drugs of Nadroparin Calcium Injection on the market in China, including Changzhou Qianhong Biochemical, Shenzhen Saibaoer Biochemical, Tianjin Biochemical, Hebei Changshan Biochemical, Tianjin Hongri Pharmaceutical, Zhaoke Pharmaceutical (Hefei), Yantai Dongcheng North and Jianyou Co., Ltd. Up to now, the company has invested approximately RMB 23.5594 million in research and development expenses in projects related to consistency evaluation.
3. Impact on the company
According to relevant national policies and regulations, drug varieties that pass consistency evaluation will receive greater support in areas such as medical insurance payment and medical institution procurement; at the same time, products that pass consistency evaluation will be eligible to participate in national centralized drug procurement. The company's Nadroparin Calcium Injection passed the consistency evaluation, which is conducive to expanding the market sales of this product and improving market competitiveness.
4. Risk warning
The company attaches great importance to drug research and development and strictly controls the quality and safety of drug research and development, production and sales. However, the production and sales of products are easily affected by uncertain factors such as national policies and market environment, and sales may not meet expectations. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
November 07, 2025