Securities code: 002019 securities abbreviation: Yifan Pharmaceutical Co.Ltd(002019) Announcement No.: 2022-012 Yifan Pharmaceutical Co.Ltd(002019)
Announcement on consistency evaluation of quality and efficacy of drugs through generic drugs
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Yifan youshengmeite Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yifan youshengmeite”), a holding subsidiary of Yifan Pharmaceutical Co.Ltd(002019) (hereinafter referred to as “the company”), recently received a notice from the shareholder and entrusted drug manufacturer Zhejiang Jutai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jutai pharmaceutical”) that Yifan youshengmeite has all the rights and interests of cefuroxime sodium for injection, Reviewed by the National Drug Evaluation Center, it passed the consistency evaluation of generic drug quality and efficacy. The relevant information is hereby announced as follows:
1、 Main information of approval notice of cefuroxime sodium for injection
1. Drug name: cefuroxime sodium for injection
2. Dosage form: injection
3. Specification: 0.25g; 0.75g
4. Registration category: Chemicals
5. Holder of drug marketing license: Zhejiang Jutai Pharmaceutical Co., Ltd
6. Pharmaceutical manufacturer: Zhejiang Jutai Pharmaceutical Co., Ltd
7. Approval conclusion: after review, this product has passed the consistency evaluation of generic drug quality and efficacy. At the same time, it is agreed to change the drug production process and drug quality standards, change the packaging materials and containers in direct contact with drugs, change the source of API and revise the drug instructions.
2、 Other relevant information of drugs
In April 2018, the company signed the product investment cooperation agreement with Zhejiang pradeson Pharmaceutical Co., Ltd. (hereinafter referred to as “Debon pharmaceutical”), a wholly-owned subsidiary of Apeloa Pharmaceutical Co.Ltd(000739) and Jutai pharmaceutical, and jointly invested to establish a joint venture Yifan youshengmeite. The company invested 53.6 million yuan in currency and held 51% shares of Yifan youshengmeite, It is the holding subsidiary within the consolidation scope of the company. Debang pharmaceutical invested with its 12 sterile cephalosporin APIs and Jutai pharmaceutical with its 23 patented technologies and proprietary technologies of cephalosporin preparations for injection, holding a total of 49% shares of Yifan Yousheng Meite. According to the product investment cooperation agreement, Yifan youshengmeite owns all the rights and interests of the above cephalosporin products, APIs and preparations.
In 2020, the research and development of raw materials and injection powder preparation of cefuroxime sodium, a product under development by Yifan Yousheng Meite, will be completed. In order to accelerate the supplementary application, conformity evaluation, declaration and review of products under development, Yifan youshengmeite submitted the supplementary application data of the API cefuroxime sodium to the National Drug Evaluation Center in the name of Debang pharmaceutical, and passed the review in January 2022. In the name of Jutai pharmaceutical, it submitted the application for consistency evaluation and registration of cefuroxime sodium for injection (specifications 0.25g, 0.75g and 1.5g) to the National Drug Evaluation Center. Cefuroxime sodium for injection (specifications 0.25g and 0.75g) was approved this time.
Cefuroxime sodium for injection is the second generation of cephalosporin antibiotics. It is mainly used for infections caused by sensitive bacteria, including respiratory tract infection, ear, nose and throat infection, urinary tract infection, skin and soft tissue infection, sepsis, meningitis, gonorrhea, bone and joint infection, puerperal and gynecological infection, etc.
According to the data of Intranet, the sales of cefuroxime sodium for injection in China in 2019 and 2020 were 5.227 billion yuan and 4.375 billion yuan respectively.
As of the disclosure date of this report, the product has invested about 22.2498 million yuan in R & D expenses.
3、 Impact on the company and risk tips
As of the disclosure date of this report, Yifan youshengmeite has all the rights and interests of the evaluated product cefuroxime sodium for injection, and will timely improve the relevant qualifications of drug listing holders. Meanwhile, Debang pharmaceutical and Jutai pharmaceutical will be entrusted to produce raw materials and preparations respectively, and the company will be entrusted to sell them in China.
The approval of cefuroxime sodium for injection (specification: 0.25g, 0.75g) will further enrich the company’s antibacterial product line, improve the company’s market competitiveness and have a positive impact on the company’s future business performance. However, the specific operation of products is affected by national policies, market competition environment and other factors, which is uncertain. Please make careful decisions and pay attention to investment risks.
4、 Filing documents
Notification of approval of supplementary drug application
It is hereby announced.
Yifan Pharmaceutical Co.Ltd(002019) board of directors February 15, 2022
