Securities code: 002422 securities abbreviation: Sichuan Kelun Pharmaceutical Co.Ltd(002422) Announcement No.: 2022-012 Sichuan Kelun Pharmaceutical Co.Ltd(002422)
Announcement on the company's compound amino acid (15) dipeptide (2) injection passing the conformity evaluation of generic drugs
The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete without false records, misleading statements or major omissions.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) (hereinafter referred to as the "company" or " Sichuan Kelun Pharmaceutical Co.Ltd(002422) ") has recently obtained the notice of approval for drug supplementary application of chemical drug "compound amino acid (15) dipeptide (2) injection" approved and issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Basic information of drugs
1. Drug name: compound amino acid (15) dipeptide (2) injection
Dosage form: injection
Specification: 500ml: 67g (amino acid / dipeptide)
Application content: consistency evaluation application
Registration category: Chemicals
Acceptance No.: cyhb2050046
Drug approval No.: gyzz h20066058
Listing Permit Holder: Sichuan Kelun Pharmaceutical Co.Ltd(002422)
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.
2. Other relevant information of drugs
Recently, our company's compound amino acid (15) dipeptide (2) injection passed the consistency evaluation and obtained the notice of approval for drug supplement application. This product is an parenteral nutrition preparation, which is used for patients who can't take oral or enteral nutrition and whose nutrition can't meet their needs, especially for patients with moderate to severe catabolic status. Such as severe catabolic diseases, intestinal function damage, immune deficiency syndrome, patients with advanced malignant tumors, etc. At present, the parenteral nutrition products approved by the company are packaged in single bag (bottle), double chamber bag and three chamber bag. The differentiated product formula can meet the nutritional treatment of patients with different types (liver function impairment, perioperative period, critical illness, etc.) and different energy needs.
This product is especially suitable for severe patients with major diseases or stress states, such as large-scale surgery, burns or severe trauma, severe infection, middle and late stage tumor, radiotherapy, chemotherapy, severe diarrhea, fasting, parenteral nutrition, etc. when glutamine is rapidly depleted, glutamine storage in the body drops sharply, and a large amount of glutamine is urgently needed. Gu angung, originally researched as "Gu angung" of fisenyuskabi, is registered and listed in China, Germany, Switzerland, Finland, Denmark and the United Kingdom, and imported from China is sub packaged by Huarui.
In 2020, the sales of terminal compound amino acid (15) dipeptide (2) injection in urban public hospitals, county-level public hospitals, urban community centers and township health centers in China (hereinafter referred to as "Chinese public medical institutions") were nearly 500 million yuan, with a year-on-year increase of more than 10% in the first half of 2021.
This time, our company is the second one in China to pass the consistency evaluation, which will further enhance the market competitiveness of this variety. With the continuous approval of this product and subsequent series, the company will become a leading professional supplier of parenteral nutrition in China.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) new parenteral nutrition products approved for marketing
Serial number packaging form product name clinical applicable population
1 fat emulsion amino acid (17) glucose (11%) injection
Fat emulsion (10%) / amino acid (15) / glucose (20%) most patients with low energy needs and basic energy needs 2 injection
Three chamber bag
3 (4) fat emulsion amino acids (17) glucose (19%) injection for severe patients with high energy needs
4 medium and long chain fat emulsion / amino acid (16) / glucose (16%) is especially suitable for patients with impaired liver function and tumor
5 alanyl glutamine amino acid (18) injection severe burn / trauma, acute pancreatitis, surgical severe swelling, double ventricular pocket tumor and ICU patients
6 (4) amino acid glucose injection in patients with severe hyperlipidemia or dyslipidemia
Compound amino acid (16AA - Ⅱ) / glucose (48%) is especially suitable for patients with severe hyperlipidemia or dyslipidemia, especially electrolyte injection for patients with limited infusion volume and high nutritional needs
8 compound amino acid (15aa - Ⅱ) / glucose (10%) can be used in patients with severe hyperlipidemia, dyslipidemia or short-term parenteral nutrition electrolyte injection at the same time for adults and children
9 medium / long chain fat emulsion injection (C8 ~ 24ve) is the most widely used fat emulsion outside China, especially for patients with liver function impairment and tumor
ten ω- 3 fish oil medium / long chain fat emulsion injection formula contains ω- 3 fish oil fat emulsion is especially suitable for patients with perioperative single bag / bottle, critical illness and tumor
11 (4) fat emulsion injection (C14 ~ 24ve) for patients who need to supplement energy and essential fatty acids, 30% high concentration preparation is more suitable for patients with limited liquid intake
Compound amino acid (15) dipeptide (2) injection is suitable for parenteral nutrition of patients who need glutamine supplement, including patients in catabolic and hypermetabolic conditions
2、 Risk tips
The future production and sales of this product may be affected by some uncertain factors.
The company will timely fulfill the obligation of information disclosure according to the follow-up progress. Please make careful decisions and pay attention to preventing investment risks. It is hereby announced.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) board of directors February 23, 2022
