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Product introduction:

As the third generation aromatase inhibitor, anastrozole is used in postmenopausal advanced breast cancer. It has strong specificity, less adverse reactions, high efficacy and convenient administration.

市场价:

  • Product information
  • 产品描述
  • 参数配置

1、 Product introduction

Chinese Name

English Name

Declaration Type

Department

Reportable Dosage Form

Declaration Progress

Patent Term

CAS
阿那曲唑Anastrozole5+4Oncology DepartmentTablet

Already accepted

No core patent120511-73-1

Indication】

1. It is suitable for postmenopausal women with advanced breast cancer who can not be controlled by tamoxifen and other anti estrogen therapy.

2. Adjuvant treatment of estrogen positive early breast cancer in postmenopausal women.

3. For patients with negative estrogen receptor, if they have positive clinical reaction to tamoxifen, they can consider using this product.

Reportable Dosage Form &Strength

        Tablet:1mg

Usage and Dosage

        Take one tablet once a day(1mg)。

Mechanism of Action

     This product is a highly effective, highly selective non steroidal aromatase inhibitor. The main source of estradiol in postmenopausal women is: androstenedione is converted to estrone by aromatase complex in peripheral tissues, and then to estradiol. Reducing circulating estradiol levels has proven beneficial for women with breast cancer. A highly sensitive analytical test showed that daily administration of 1 mg of anastrozole in postmenopausal women reduced estradiol levels by more than 80%. This product has no progesterone like, androgen like and estrogen like activity.      

Development Progress】

        Our company has obtained the material registration application acceptance number(JXHS1200104)。

Research and production at home and abroad】

Anastrozole 阿那曲唑 CAS号:120511-73-1   
     The original manufacturer, aliscom, was approved to market in 1995, making it a leader in breast cancer. In 2007, the number of prescriptions of brand drugs in the United States ranked 149 in the top 200, with 1.825 million tablets. In 2005, the global sales volume of Arimidex (anastrozole) of AstraZeneca was 1.181 billion US dollars, a substantial increase over the previous year.

    The first one in China is Zhejiang Wanma Pharmaceutical Co., Ltd., which obtained SFDA approval in 2001. At present, there are three domestic preparations, and Chongqing Huabang Pharmaceutical Co., Ltd. is the best domestic manufacturer. However, at present, the largest market share is still the original research manufacturer aliskang, accounting for 95.6% of the market share.


2、 Product Character

1. Anastrozole is the first choice in the treatment of breast cancer;

2. National medical insurance, widely used;

3. The price of the preparation is expensive and market potential is large.

3、 Clinical Application

        Aromatase inhibition is the gold standard for the treatment of early and late stage breast cancer in postmenopausal women with estrogen receptor positive. Currently, two reversible aromatase inhibitors (anastrozole and letrozole) and an irreversible aromatase inactivator, exemestane, have been established. Although exemestane is the only widely used aromatase inactivator at this stage, doctors often choose anastrozole or letrozole in general treatment. These third-generation aromatase inhibitors (letrozole / flor (Novartis, Basel, Switzerland) and anastrozole / riningde (AstraZeneca pharmaceutical company, mclesfield, Cheshire, UK)) have recently shown excellent efficacy and improved disease-free survival compared with tamoxifen as initial treatment for early breast cancer.       

4、 Patent information

      25 patents were found, among which aliscom applied for the patent of anastrozole sustained-release agent without authorization, applied for the use indication patent of postmenopausal women with early breast cancer, authorized (02824544. X), and Lunan applied for the patent of anastrozole dispersible tablets, authorized (200410090726.5).

5、 Quality comparison
       Our raw materials meet the European pharmacopoeia standard. Compared with the domestic standard, the impurity control standard is higher than the new drug normalization standard.

6、 Original manufacturer and time of listing
       AstraZeneca. It was approved for listing in the United States in 1995.

7Domestic Declaration



Declaration Type

Reportable Dosage Form

Number of Declared Preparations

Number of Existing Preparation Enterprises 

5+4
tablet
6 imported, 6 domestic1 imported,4 domestic


 


 Anastrozole 阿那曲唑 CAS号:120511-73-1

Guangzhou Tosun Pharmaceutical Ltd

FL 4-5,No.3, 2nd Kehui street, Science Park, Guangzhou High-tech Industrial Development Zone, Guangzhou, China. 510663

Tel: +86-20-66392521; Fax: +86-20-66392525

As the third generation aromatase inhibitor, anastrozole is used in postmenopausal advanced breast cancer. It has strong specificity, less adverse reactions, high efficacy and convenient administration.

national medical insurance,first choice of breast cancer drug 

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