Securities code: 002755 securities abbreviation: Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Announcement No.: 2022-016 Beijing Aosaikang Pharmaceutical Co.Ltd(002755)
Announcement on the conformity evaluation of the subsidiary levobupivacaine hydrochloride injection through generic drugs
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Jiangsu Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Pharmaceutical Co., Ltd. (hereinafter referred to as Beijing Aosaikang Pharmaceutical Co.Ltd(002755) pharmaceutical), a wholly-owned subsidiary of Beijing Aosaikang Pharmaceutical Co.Ltd(002755) (hereinafter referred to as "the company"), recently received the notice of approval for supplementary application for levobupivacaine hydrochloride injection (Notice No.: 2022b00211) approved and issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration"). The relevant information is hereby announced as follows:
1、 Basic information of drugs
Product Name: levobupivacaine hydrochloride injection
Dosage form: injection
Specification: 10ml: 50mg (calculated by c18h28n2o)
Acceptance No.: cyhb2050682
Notice No.: 2022b00211
Applicant: Jiangsu Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Pharmaceutical Co., Ltd
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
Levobupivacaine is a new long-acting amide local anesthetic developed by Abbott. In March 2000, it was applied by CellTech's marketing partner Purdue pharmaceutical in the United States and approved by FDA. From May 2000 to August 2008, it was approved to be listed by 12 EU countries and Japan. In June 2012, levobupivacaine hydrochloride injection applied for import by Abbott Pharmaceutical Co., Ltd. was approved for listing by China nmpa. At present, a number of Companies in China have approved the listing of generic levobupivacaine hydrochloride injection. The indications are mainly used for surgical epidural block anesthesia. In November 2016, the company was approved to market levobupivacaine hydrochloride injection 10ml: 50mg. In November 2020, it applied for the evaluation of the consistency of quality and efficacy of generic drugs, and was recently approved. It is the second company in China to pass the evaluation of the consistency of quality and efficacy of generic drugs.
Epidural block, also known as epidural space block anesthesia, can be divided into high, middle, low and sacral block according to the puncture site. Epidural block is mainly used for abdominal and lower operations. It is a commonly used anesthesia method in clinic. Levobupivacaine and bupivacaine are commonly used epidural anesthetics. The onset time, maintenance time and muscle relaxation effect of levobupivacaine sensory block are similar to that of bupivacaine. Compared with bupivacaine, levobupivacaine has less direct cardiac toxicity. At the same time, due to its wide distribution in the body and low plasma free concentration, the toxicity of cardiovascular and nervous system is significantly less than that of bupivacaine, With better security. Based on the clinical demand and safety advantages of levobupivacaine injection, it has a certain market potential.
3、 Impact on the company
According to relevant national policies, the varieties, quality and efficacy of drugs that pass the consistency evaluation are equal to the original products, and appropriate support will be given in terms of medical insurance payment and medical institution procurement. In the context of the national policy of encouraging the priority purchase and use of products that have passed the conformity evaluation, the conformity evaluation of levobupivacaine hydrochloride injection through generic drugs is conducive to further enhance the technical advantages of the drug, enhance the market competitiveness and expand the market share. At the same time, it has accumulated valuable experience for the subsequent consistency evaluation, product research and generic drug development of the company and its subsidiaries. 4、 Risk tips
Due to the high-tech and high-risk characteristics of pharmaceutical products, the sales of drugs are affected by national policies, changes in market environment and other factors, with great uncertainty. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Beijing Aosaikang Pharmaceutical Co.Ltd(002755) board of directors January 25, 2022
