Technology transfer of three products such as epirubicin hydrochloride freeze-dried powder for injec

Release date:2016-12-26

Epirubicin hydrochloride freeze-dried powder for injection

I. Brief introduction

1. Common name: epirubicin hydrochloride for injection; English name: Epirubicin Hydrochloride for Injection

2, the main component chemical name:

(8S,10S)-10-[(3-Amino-2,3,6-trit-deoxy-α-L-arabinopyranosyl)-oxy]-6,8,11-trihydroxy-8-(Hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride.

3. The chemical composition of the main components:


Molecular formula: C27H29NO11·HCl

Molecular weight: 579.98

4, indications

Treatment of malignant lymphoma, breast cancer, lung cancer, soft tissue sarcoma, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, melanoma, colorectal cancer, ovarian cancer, multiple myeloma, leukemia. Intravesical administration contributes to the treatment of superficial bladder cancer, carcinoma in situ and prevention of recurrence after transurethral resection.

5, registration classification

This application for injection of the Coriolis sulphate is a product of Pfizer Pharmaceutical Co., Ltd., registered as 4 categories, generic drugs.

Second, the research and production status of epirubicin hydrochloride for injection and production

Epirubicin is an anthracycline antitumor antibiotic synthesized by the Italian scholar Arcamone et al. in 1975 through a semi-synthetic pathway. The original manufacturer is Pfizer, and the specifications are 10 mg and 50 mg.

Epirubicin hydrochloride for injection is suitable for the treatment of malignant lymphoma, breast cancer, lung cancer, soft tissue sarcoma, esophageal cancer, stomach cancer, liver cancer, pancreatic cancer, melanoma, colorectal cancer, ovarian cancer, multiple myeloma, leukemia. And intravesical administration is helpful for the treatment of superficial bladder cancer, plain cancer and prevention of recurrence after transurethral resection. It is a commonly used anti-tumor drug in clinic.

Third, the status of intellectual property

The formulation process and related experimental data of epirubicin hydrochloride for injection are obtained by the research unit independently. After patent search, the intellectual property rights of Pfizer Pharmaceutical Co., Ltd. and other related patent inventions are not infringed.

Fourth, dosage form specifications and domestic production and sales

There are four approved domestic manufacturers of epirubicin for injection, 10mg and 50mg.

At present, there are few domestic manufacturers and there are approved raw materials. In 2013, Zhejiang Haizheng Pharmaceutical's sales of epirubicin hydrochloride for injection was 716 million.

The product has few domestic manufacturers and has a large market demand.

The technology transfer dosage form is a freeze-dried powder needle with a specification of 10mg, which is valid for up to 3 years and is stored at room temperature without the need for refrigerated truck transportation. .

V. Other product technology transfer

In addition to the injection of epirubicin freeze-dried powder needles, we also transfer the technical processes of the following two products:

1. Gemcitabine hydrochloride freeze-dried powder injection for injection

[Indications] Locally advanced or metastatic non-small cell lung cancer; locally advanced or metastatic pancreatic cancer.

[Specifications] 0.2g, 1.0g (calculated as gemcitabine).

[Storage] sealed and kept in a dry place.

[Validity period] 24 months.

2. Pemetrexed disodium 0.5g for injection

[Indications] This product is suitable for the treatment of malignant pleural mesothelioma that cannot be operated with cisplatin.

[Specification] 0.5g

[Storage] Store at room temperature.

[Validity period] 24 months.


Interested companies are welcome to contact us.

Tel: 010-59648213, 010-59648216, 17, 18 to the sales department