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About Beilu Pharma

BEILU PHARMA

A Leading High-tech Innovation Company
29 Years Since 1992

About Beilu Pharma

Founded in 1992, Beilu is mainly engaged in the research & development, production and sales of pharmaceutical products. It is high-tech innovation company with core competence in the Contrast Media domestic. It has around 650 employees with 0.82 Bn/¥ revenue in 2019. Beilu provides complete Contrast Media products suitable for X-Ray and Magnetic Resonance Imaging (MRI), and it is the leading manufacturer in the Contrast Media field in China. It is one of the 1st batches of listed enterprises in GEM of SZSE (Ticker: 300016.SZ) in China.


Beilu's main products are Contrast Media, Anti-anxiety traditional Chinese medicine, and Anti-diabetic drugs to benefit people and improve their quality of life. Contrast Media are widely used to improve pictures of the inside of the body produced by X-rays, computed tomography (CT), magnetic resonance (MR) imaging, etc. Anti-anxiety traditional Chinese medicine is the original product with Chinese patent to contribute to improving the physical and mental status. And Anti-diabetic drugs are hypoglycemic drugs for the treatment of type 2 diabetes.


Beilu

Beilu History

Beijing Beilu Pharmaceutical Chemical Ltd. was established, and the first domestic MRI contrast agent Gadopentetate Dimeglumine Injection went on the market, breaking the foreign monopoly and filling the domestic gap.

1992

Beijing Beilu Pharmaceutical Chemical Ltd. was restructured into a joint-stock cooperative enterprise, and its name was changed to Beijing Beilu Pharmaceutical Chemical Group.



1996

The company's first iodine contrast agent, Iohexol Injection, went on the market.



1998

The company was restructured into Beijing Beilu Pharmaceutical Co., Ltd., and the registered capital was changed to RMB 35.25 million.

1999

Beijing Beilu Pharmaceutical Company was legally changed as a whole into Beijing Beilu Pharmaceutical Co., Ltd, and the changed share capital of the company was 38.388491 million shares.

2001

The company established the Miyun Pharmaceutical Factory in Beijing Miyun Economic Development Zone to build a modern pharmaceutical production base.

2003

The company's exclusive oral gastrointestinal nuclear magnetic contrast agent, Ferric Ammonium Citrate Effervescent Granules, went on the market.



2004

The company was officially listed in the Shenzhen Stock Exchange's agency share transfer system. [stock code 430006]

2006

Jiuweizhenxin Granules, the NMPA approved anti-anxiety proprietary Chinese traditional medicine independently developed by the company, was successfully listed.

2008

The company was listed on the GEM of Shenzhen Stock Exchange in the first batch and issued 17 million A-shares. The issued share capital was 67.888491 million shares. [stock code: 300016.SZ]

2009

The company was selected as the first batch of large-scale enterprises in the Beijing Biomedical Industry Leap-forward Development Project (G20 Project).

2010

The company was approved by the Beijing Municipal Commission of Development and Reform to build Beijing Engineering Laboratory for Biomedical Imaging Medicine.

2011

The injection workshop built by the company according to EU standards has successfully passed the national new GMP certification.

2013

The company participated in joint stocks with Geneseeq Technology Inc., and gradually realized the strategic layout of the company in the field of precision medicine.



2014

The company set up Cangzhou Branch in Cangzhou Lingang Economic and Technological Development Zone, Hebei Province, to build a base for extracting traditional Chinese medicine and producing raw materials.


The company's contrast agent, Iopamidol Injection, was first developed and listed in China.



2015

The company participated in joint stocks with Wuhan YZY Medical and gradually improved the strategic layout in the field of precision medicine.



2016

Jiuweizhenxin Granules, the company's original product, was included in the national medical insurance catalog.

2017

The company participated in Zhejiang Hichi Pharmaceutical Corporation Limited to improve the strategic layout of industry consolidation.

2018

The company participated in joint stocks with Dr. Brain and gradually improved the strategic goal of dual platforms coordinated development of personalized diagnosis and treatment.

2019

The company completed the acquisition of Zhejiang Hichi Pharmaceutical Corporation Limited and Hichi Pharmaceutical became the holding subsidiary of the company.



2020

Company Structure

Company Structure
Company Structure

Factory Show

Beijing Beilu Pharmaceutical Co., Ltd. (hereinafter referred to as “Beilu”) mainly produces Contrast Media, oral anti-diabetic drugs, and anti-anxiety traditional Chinese medicine, with its production base located in No. 3 Shuiyuan Road, Industrial Development Zone, Miyun District, Beijing and covering an area of 40,000 m2. Building 1 is a comprehensive preparation building with four floors and a building area of 10,745 m2. The Quality Center (QC) located on the second floor of Building 1 is used for physical, chemical, and microbiological inspection. The warehouse located on the first floor of Building 1 is responsible for the storage of raw materials, excipients, and packaging materials. Building 2, workshop 201 (injection workshop), which is located in the north of Building 1, is a two-floor workshop to cover an area of 2000-2500 m2. Building 3, the finished products warehouse, which is located in the north of Building 2, is a one-floor workshop to cover an area of 2000 m2.


Workshop 201 is an independent two-floor building with a building area of 5000 m2 including an 850 m2 clean area. Its main production equipment includes the automatic batching system of Morimatsu, the automatic filling line of Bosch Packaging Technology (Hangzhou) Co., Ltd. FEDEGARI sterilization cabinet, Brevetti light inspection machine, and so on. Such equipment and facilities were built and put in service in 2013. All production equipment has been subject to periodic preventive maintenance and reconfirmation based on relevant documents and has been kept in a good stable state. The workshop of Beilu Pharma is designed and constructed according to the“Good Manufacturing Practice (Rev 2010)” of the State Food and Drug Administration and EU GMP standard.


Workshop 201 is an injection production workshop of big and small capacities with an existing production line. Its main products comprise Gadopentetate dimeglumine injection for enhanced magnetic resonance imaging, Iohexol injection (Shuangbei) for CT enhancement and interventional (including cardiovascular intervention) examination and therapy, Iodixanol injection for angiography, urography, phlebography, and CT enhancement scanning examination, Iopamidol injection for neuroradiology, angiography, urography, enhanced scanning in CT examination, arthrography, epistolography, and digital subtraction angiography, and gadobenate dimeglumine injection (paramagnetic contrast agent) for diagnostic magnetic resonance imaging (MRI) for the liver and central nervous system. All these products are the final sterilized product.


Overall View of Beilu Factory
Overall View of Beilu Factory
Part of Grade C clean area
Part of Grade C clean area
Bosch automatic Filling line
Bosch automatic Filling line
Morimatsu batching system
Morimatsu batching system
Italy BREVETTI light inspection machine
Italy BREVETTI light inspection machine
Korea Hoonga High-speed Aluminum Plastic Packaging Machine
Korea Hoonga High-speed Aluminum Plastic Packaging Machine

Quality Control

The quality establishment is the core content of Beijing Beilu Pharmaceutical enterprise culture. Beilu always puts quality in the first place.

The quality establishment is the core content of Beijing Beilu Pharmaceutical enterprise culture. The company always puts the quality in the first place, so the complete quality control system was built, the materials, media, intermediate products, products to be packaged and finished products under well control each level and the whole production process, storage process, transportation process and sales process under whole monitored synchronously.

All personnel involved in quality control have passed rigorous training and assessment, and inspectors will be regularly evaluated and promoted to ensure that quality control personnel can always comply with the requirements of the quality control system. All equipment participating in the inspection has been measured or confirmed to meet the requirements of data integrity.

All methods used for inspection and control have been repeatedly verified and re-verified, and the standards for quality control are based on legal standards. In addition, data review and statistical analysis are conducted on the generated data every year to ensure that the company's product quality is consistently qualified and stable.