Securities code: Betta Pharmaceuticals Co.Ltd(300558) securities abbreviation: Betta Pharmaceuticals Co.Ltd(300558) Announcement No.: 2022015 Betta Pharmaceuticals Co.Ltd(300558)
About bevacizumab injection (betaine) ®） New indications
Announcement of approval of supplementary application
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.
Today, Betta Pharmaceuticals Co.Ltd(300558) (hereinafter referred to as ” Betta Pharmaceuticals Co.Ltd(300558) ” or “the company”) received the notice of approval of supplementary drug application (Notice No.: 2022b00904, 2022b00905, 2022b00906) issued by the State Drug Administration (hereinafter referred to as “nmpa”), and the company applied for bevacizumab injection (trade name: Betaine) ®， Hereinafter referred to as “the drug”) is intended to add new indications for the treatment of patients with recurrent glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, cervical cancer and other patients (hereinafter referred to as “new indications”) and has been approved by nmpa. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Product Name: bevacizumab injection
Registration classification: therapeutic biological products
Applicant: Betta Pharmaceuticals Co.Ltd(300558)
Application items: supplementary application for adding new indications
Acceptance No.: cysb2101294, cysb2101295 and cysb2101296
Notice No.: 2022b00904, 2022b00905, 2022b00906
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, the application matters of this product meet the relevant requirements of drug registration, and the supplementary application for the revised manual of this product is approved. The revised instructions and packaging labels shall be implemented as attached.
2、 Basic information of drugs and market conditions of similar drugs
The drug is a recombinant humanized monoclonal antibody against human vascular endothelial growth factor, which can selectively bind to human vascular endothelial growth factor (VE GF) and block its biological activity. It includes the frame region of human antibody and the antigen binding region of humanized mouse antibody that can bind VEGF, which can inhibit the binding of VEGF to its receptors flt-1 and KDR on endothelial cells, By making VEGF lose its biological activity and reduce tumor angiogenesis, it inhibits tumor growth. The drug belongs to Aventin ® Following the rigorous research and development approach of biological analogues, it has not only passed the comprehensive quality Similarity Study and non clinical similarity study, but also showed the same effect with Aventin in the clinical comparison test ® Highly similar in PK characteristics, clinical efficacy, safety and immunogenicity.
On November 24, 2021, the drug was approved by nmpa for marketing. The approved indications are: it is suitable for the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. For details, please refer to the announcement on obtaining the drug registration certificate for bevacizumab injection (mil60) (Announcement No.: 2021118) disclosed on cninfo.com on November 29, 2021. The supplementary application for new indications submitted this time was accepted by nmpa in December 2021. For details, see the “about bevacizumab injection (betaine)” disclosed by the company on cninfo.com on December 23, 2021 ®） Announcement on acceptance of supplementary application for new indications (Announcement No.: 2021123). As of the disclosure date of this announcement, in addition to the drug, there were 8 bevacizumab injections approved for listing in China.
3、 Impact on the company and risk tips
After obtaining the notice of approval of supplementary drug application, the company can use it on the new indications applied for. This approval has a positive effect on the company’s operating revenue. Considering that the specific sales situation may be affected by factors such as changes in the market environment and sales channels, and has a certain degree of uncertainty, please pay attention to prevent investment risks and make prudent decisions.
It is hereby announced.
Betta Pharmaceuticals Co.Ltd(300558) board of directors March 4, 2022
