Securities code: 688136 securities abbreviation: Shan Dong Kexing Bioproducts Co.Ltd(688136) Announcement No.: 2022-011 Shan Dong Kexing Bioproducts Co.Ltd(688136)
Announcement on obtaining the approval notice of supplementary application for human erythropoietin injection
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
On February 12, 2022, Shan Dong Kexing Bioproducts Co.Ltd(688136) (hereinafter referred to as "the company") received the notice of approval of supplementary drug application approved and issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration"), and now the relevant information is announced as follows: I. Basic information of the Notice of approval of supplementary drug application
1. Drug name: human erythropoietin injection
2. Dosage form: injection
3. Specification: 36000iu / 1ml / piece
4. Application content: add specification: 36000iu / 1ml / piece (pre filled syringe); Increase indications: treat anemia caused by chemotherapy in patients with non bone marrow malignant tumors.
5. Examination and approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the application of this product meets the relevant requirements of drug registration. The following supplementary applications are approved: 1. Add the approved indications of similar varieties in China "to treat anemia caused by chemotherapy in patients with non bone marrow malignant tumors". 2. The drug specification of 36000iu / 1ml / piece (pre filled syringe) was added. Instructions and labels shall be executed as attached. Except for recombinant human erythropoietin, the other components in the formulation are the same as those in the formulation of marketed specifications. Other aspects implement the existing quality standards.
6. Drug approval No.: gyzz s20227003
7. Listing Permit Holder: Shan Dong Kexing Bioproducts Co.Ltd(688136)
8. Production enterprise: Shan Dong Kexing Bioproducts Co.Ltd(688136) II. Impact on the company
This approval notice is to add the indication of "treating anemia caused by chemotherapy in patients with non bone marrow malignant tumors" and the specification of 36000iu / 1ml / piece on the basis of the original approved indication and specification.
In the treatment of "anemia caused by chemotherapy for non bone marrow malignant tumors", large-scale human erythropoietin products can significantly reduce the frequency of medication and improve the medication compliance of patients on the premise of equal curative effect. The company is the second manufacturer of 36000iu Chinese erythropoietin. The company will actively promote the above new indications and new specifications of the product.
The approval of new indications and new specifications of human erythropoietin injection will help expand the market share of the drug, further enhance the market competitiveness of the product, and play a positive role in the operation and development of the company. 3、 Risk tips
The company has always attached great importance to drug research and development and the safety, environmental protection and quality requirements of drug production. However, the future sales of products may be affected by uncertain factors such as changes in the market environment, which has uncertain impact on the company's future business performance. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Shan Dong Kexing Bioproducts Co.Ltd(688136) board of directors February 14, 2022
