Securities code: 600252 securities abbreviation: Guangxi Wuzhou Zhongheng Group Co.Ltd(600252) No.: pro 2022-11 Guangxi Wuzhou Zhongheng Group Co.Ltd(600252)
With regard to the announcement that the drugs of the holding subsidiary passed the conformity evaluation of generic drugs, 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 individual and joint responsibilities for the authenticity, accuracy and completeness of its contents. The holding subsidiary Chongqing Lummy Pharmaceutical Co.Ltd(300006) (hereinafter referred to as ” Chongqing Lummy Pharmaceutical Co.Ltd(300006) “) of Guangxi Wuzhou Zhongheng Group Co.Ltd(600252) (hereinafter referred to as “the company” or ” Guangxi Wuzhou Zhongheng Group Co.Ltd(600252) “) recently received the notice of approval for supplementary drug application of methylprednisolone sodium succinate for injection (specification: 40mg) (hereinafter referred to as “the drug”) approved and issued by the State Drug Administration, The relevant information is hereby announced as follows: I. Basic information of drugs
Generic name of drug: methylprednisolone sodium succinate for injection
English name / Latin name: methylprednisolone sodium succeed for injection
Dosage form: injection
Registration category: Chemicals
Specification: 40mg (calculated as c22h30o5)
Original drug approval No.: gyzz h20203329
Package specification: 10 bottles / box
Drug registration Standard No.: ybh01402022
Application content: To evaluate the quality and efficacy consistency of injection generic drugs.
Approval conclusion: according to the drug administration law of the people’s Republic of China and the opinions of the State Council on reforming the evaluation and approval system of drugs and medical devices (GF [2015] No. 44) According to the provisions of the announcement on matters related to the evaluation of the quality and efficacy consistency of generic drugs (No. 100 in 2017) and the announcement of the State Food and Drug Administration on the evaluation of the quality and efficacy consistency of generic drugs for chemical drug injection (No. 62 in 2020), the product has passed the evaluation of the quality and efficacy consistency of generic drugs. The production process, quality standards and instructions shall be implemented according to the attached, and the relevant contents of the label shall be consistent with the instructions. The validity period is 12 months.
Listing Permit Holder: Chongqing Lummy Pharmaceutical Co.Ltd(300006)
Manufacturer: Chongqing Lummy Pharmaceutical Co.Ltd(300006)
Production address: No. 99, Yuma Road, Nan’an District, Chongqing
2、 Other relevant information of drugs
Methylprednisolone sodium succinate for injection is a synthetic glucocorticoid, which is mainly used for anti-inflammatory treatment (such as rheumatic diseases, collagen diseases, skin diseases, etc.), immunosuppressive treatment (organ transplantation), blood diseases (acquired hemolytic anemia, adult spontaneous thrombocytopenic purpura, adult subsequent thrombocytopenia, etc.) Tumor (palliative treatment of adult leukemia and lymphoma and children’s acute leukemia), shock treatment, endocrine disorders. Methylprednisolone sodium succinate is very soluble in water. It is used for intravenous or intramuscular injection. It hydrolyzes rapidly in plasma and plays a pharmacological role in the form of free methylprednisolone. * compared with prednisolone, besides the pharmacological action of glucocorticoid, it has stronger anti-inflammatory effect and weaker water and sodium retention.
Chongqing Lummy Pharmaceutical Co.Ltd(300006) submitted the registration application of methylprednisolone sodium succinate for injection to the State Food and Drug Administration in August 2013 and was accepted. Chongqing Lummy Pharmaceutical Co.Ltd(300006) the existing specifications of methylprednisolone sodium succinate for injection are 125mg and 40mg. It obtained the drug registration certificate approved and issued by the State Drug Administration in June 2020 and July 2020 respectively. Methylprednisolone sodium succinate for injection was included in the medical insurance catalogue in December 2020, Chongqing Lummy Pharmaceutical Co.Ltd(300006) submitted the application for consistency evaluation of methylprednisolone sodium succinate for injection (specification: 40mg) to the drug evaluation center of the State Drug Administration in November 2020 and was accepted. Recently, the drug passed the consistency evaluation of quality and efficacy of generic drugs.
Up to now, Chongqing Lummy Pharmaceutical Co.Ltd(300006) has invested 8.9948 million yuan in the research and development of this product (the data has not been audited).
3、 Market situation of similar drugs
Methylprednisolone sodium succinate for injection was developed by pharmaciaand Upjohn, which is now subordinate to Pfizer pharmaceutical in the United States. It was first listed in the United States in 1959. The commodity name is Solu-Medrol, and then it was listed and sold in Europe, Japan, China and other countries. According to the hospital data in the national enlarged version of intranet (urban public hospitals), the sales of methylprednisolone sodium succinate for injection in 2019, 2020 and the first half of 2021 were about 1.222 billion yuan, 1.031 billion yuan and 538 million yuan respectively, including 20mg, 40mg, 125mg, 250mg and 500mg, of which 40mg was the dominant specification in the market, The sales of methylprednisolone sodium succinate for injection (specification: 40mg) in 2019, 2020 and the first half of 2021 were about 969 million yuan, 799 million yuan and 409 million yuan respectively. 4、 Impact on the company and risk tips
The conformity evaluation of Chongqing Lummy Pharmaceutical Co.Ltd(300006) methylprednisolone sodium succinate for injection is conducive to improving the market competitiveness of the product and the future market expansion of the product. At the same time, it has accumulated experience for the conformity evaluation of Chongqing Lummy Pharmaceutical Co.Ltd(300006) subsequent products. Due to the influence of national policies, changes in market environment and other factors, drug sales have great uncertainty. Please make careful decisions and pay attention to preventing investment risks.
5、 Documents for future reference
Notice of approval of supplementary drug application issued by the State Drug Administration.
It is hereby announced.
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Guangxi Wuzhou Zhongheng Group Co.Ltd(600252) board of directors February 23, 2022
