Securities code: Shandong Lukang Pharmaceutical Co.Ltd(600789) securities abbreviation: Shandong Lukang Pharmaceutical Co.Ltd(600789) Announcement No.: 2022018 Shandong Lukang Pharmaceutical Co.Ltd(600789)
Announcement on conformity evaluation of ceftriaxone sodium for injection through 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 liabilities for the authenticity, accuracy and completeness of its contents.
Recently, Shandong Lukang Pharmaceutical Co.Ltd(600789) (hereinafter referred to as “the company”) received the notice on approval of supplementary application for drug of ceftriaxone sodium for injection (hereinafter referred to as “the drug”) issued by the State Drug Administration (Notice No.: 2022b01456, 2022b01455, 2022b01454). The drug passed the consistency evaluation of quality and efficacy of generic drugs. The relevant information is hereby announced as follows:
1、 Drug information
Ceftriaxone sodium for injection
Dosage form: injection
Specification: 0.5g, 1.0g, 2.0g
Original drug approval No.: gyzz h20 Hefei Lifeon Pharmaceutical Co.Ltd(003020) , gyzz h2 Jiangsu Eastern Shenghong Co.Ltd(000301) 9, gyzz h2 Anhui Shenjian New Materials Co.Ltd(002361) 4
Drug standard: ybh03802022
Registration category: Chemicals
Drug manufacturer: Shandong Lukang Pharmaceutical Co.Ltd(600789)
Approval conclusion: it passed the consistency evaluation of quality and efficacy of generic drugs.
2、 Drug R & D and market
Ceftriaxone sodium for injection is suitable for infection caused by pathogenic bacteria sensitive to this product, such as sepsis; Meningitis; Disseminated Lyme disease (early and late); Abdominal infection (peritonitis, biliary tract and gastrointestinal tract infection); Bone, joint, soft tissue, skin and wound infection; Infection in immunocompromised patients; Kidney and urinary tract infection; Respiratory tract infection, especially pneumonia, ear, nose and throat infection; Reproductive system infections, including gonorrhea; Prevent infection before operation.
After inquiry, there are 300 document numbers of ceftriaxone sodium for injection in China. Iqvia database shows that in 2020, the purchase amount of ceftriaxone sodium for injection hospital was 249334 million yuan. The sales volume of ceftriaxone sodium for injection in the first three quarters of 2021 was 50.67 million yuan.
At present, 22 manufacturers in China have passed the consistency evaluation and approval of the State Drug Administration, and the company is the 22nd one approved.
Since the consistency evaluation of the drug was carried out, the company has invested about 108731 million yuan in R & D (Unaudited).
3、 Impact on the company and risk tips
The company’s ceftriaxone sodium for injection (0.5g, 1.0g, 2.0g) passed the consistency evaluation, which is conducive to expanding the market share of the drug and improving the market competitiveness. As drug sales are affected by national policies, market environment and other factors, there is uncertainty. Please make prudent decisions and pay attention to investment risks.
It is hereby announced.
Shandong Lukang Pharmaceutical Co.Ltd(600789) board of directors April 13, 2022
