Securities code: 600789 securities abbreviation: Shandong Lukang Pharmaceutical Co.Ltd(600789) Announcement No.: 2022-007 Shandong Lukang Pharmaceutical Co.Ltd(600789)
Announcement on subsidiaries' drugs passing 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 liabilities for the authenticity, accuracy and completeness of its contents.
Recently, Shandong Shandong Lukang Pharmaceutical Co.Ltd(600789) group Saite Co., Ltd. (hereinafter referred to as "Saite company"), a holding subsidiary of Shandong Lukang Pharmaceutical Co.Ltd(600789) (hereinafter referred to as "the company"), received the approval for drug supplementary application (approval No.: 2022b00358) on tinidazole tablets (hereinafter referred to as "the drug") issued by the State Drug Administration, The drug passed the consistency evaluation of quality and efficacy of generic drugs.
1、 Drug information
Drug name: tinidazole tablets
Dosage form: tablet
Specification: 0.5g
Original drug approval No.: gyzz h20033090
Drug registration Standard No.: ybh00812022
Registration category: Chemicals
Manufacturer: Shandong Shandong Lukang Pharmaceutical Co.Ltd(600789) group Saite Co., Ltd
Approval conclusion: it passed the consistency evaluation of quality and efficacy of generic drugs.
2、 Drug R & D and market
Tinidazole is an antigenic insect drug and antibacterial drug. It is also a nitroimidazole derivative with higher curative effect, shorter course of treatment, better tolerance and wider distribution in the body after metronidazole. It was researched and developed by Pfizer of the United States and first listed in Germany in 1971. Tinidazole tablets are used for various anaerobic bacterial infections, such as sepsis, osteomyelitis, abdominal infection, pelvic infection, pulmonary bronchial infection, pneumonia, sinusitis, skin cellulitis, periodontal infection and postoperative wound infection. Tinidazole tablets are used for preoperative prophylaxis of colorectal surgery, obstetrics and gynecology surgery and oral surgery; It is used for the treatment of intestinal and extraintestinal amebiasis, vaginal trichomoniasis, giardiasis, Gardner's vaginitis, etc; It can also be used as a substitute for metronidazole in the treatment of gastric sinusitis and peptic ulcer caused by Helicobacter pylori.
This product has successively entered the 2018 edition of national basic drugs, 2021 edition of national medical insurance class B drug catalogue, the fifth batch of national procurement list with quantity, etc. According to the data of PDB database of the Ministry of industry and information technology, the amount of tinidazole used in Chinese sample hospitals in the first three quarters of 2021 was about 38.14 million yuan. Saite's sales of this product in the first three quarters of 2021 was about 6.0678 million yuan.
At present, there are 34 production approvals for tinidazole tablets in China. As of the date of this announcement, five manufacturers (Sichuan Sichuan Kelun Pharmaceutical Co.Ltd(002422) Co., Ltd., Livzon Pharmaceutical Group Inc(000513) Lizhu pharmaceutical factory, Hubei Guangji Pharmaceutical Co.Ltd(000952) , Hainan Haili Pharmaceutical Co., Ltd. and Shandong Shandong Lukang Pharmaceutical Co.Ltd(600789) group Saite Co., Ltd.) have passed the consistency evaluation and approval of the State Drug Administration.
As of the disclosure date of this announcement, the R & D investment of Saite company in the drug was about 4.9348 million yuan (Unaudited).
3、 Impact on the company and risk tips
The tinidazole tablet (0.5g) of Sete company passed the consistency evaluation, which is conducive to the future market sales and market competition of the product.
As the 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 February 9, 2022
