Beijing Biote Pharma�Expert in Microspheres

www.biotepharma.com

Beijing Biote Pharmaceutical Co., ltd.

Company Profile

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• Beijing Biote Pharmaceutical Co., ltd was founded in 2004, certified as high-tech enterprise by Beijing Science and Technology Commission.
• The company holds China CFDA GMP certification, microsphere drug research and manufacture certification issued by Beijing Drug Administration.
• Unparalleled experience in microsphere drug research, manufacture and marketing. It is the first domestic company which is approved to make microsphere product for injection.

Beijing Biote Pharmaceutical Co., ltd.

Sales achievement

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• 2013: 18 million USD
• 2014: 26 million USD
• 2016: 50 million USD
• 2017: 60 million USD
• 2018: 80 million USD
• 2019: 98 million USD
• Sale force and distributing agents covers:
• 28 provinces
• 200 cities
• 800 hospitals

Manufacturing facility

Brand new 4-level facility

7150m² clear ground currently unused for future product portfolio.

Manufacturing facility

• Ground floor:
• Water system, compressed gas, trial workshop. 1600 m² reserved for future expansion.

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Manufacturing facility

• First floor:
• Lyophilized powder injection workshop, small-volume injection workshop, packaging room, raw material warehouse.

Manufacturing facility

• Second floor:
• Finished product warehouse, packaging material warehouse, QA sample retention.

Manufacturing facility

• Third floor:
• QC,R&D, and office for administrative work.

Key Product

In 2009 Beijing Biote Pharma’s key product “leuprorelin acetate sterile lyophilized microspheres sustained release for injection" was granted by CFDA.

It was the first generic marketed in China. The successful launch of this product terminated the monopoly of microsphere drugs by US, EU, Japanese companies in China.

The dream of Chinese made microspheres for injection became reality on that day.

Key Product

Leuprorelin Acetate sterile lyophilized microspheres sustained release for injection, 3.75mg with 2ml solution

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Features

1. Essential excipients are imported from US, fully compliant with US FDA standard.

2. Encapsulation efficiency reaches 95%, product dry weight 45mg, drug loading 8.3%.

3. Stable 28 days sustained release.

4. Monograph of Leuprorelin Acetate microspheres in China Pharmacopeia was drafted by the company.

5. The first approved Leuprorelin Acetate microspheres for injection by China FDA.

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Key Product

Indications

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• Endometriosis
• Uterine Leiomyoma (Fibroids)
• Breast Cancer
• Prostate Cancer
• Central precocious puberty
• Ovary protection

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Marketing Centre

• The marketing centre was established in 2010, consisting of:
• 1. Agent recruiting division
• 2. Hospital sales division
• 3. Academic promotion division
• 4. Sale services

Marketing Centre

• The Marketing Director is responsible for the entire operation of marketing centre.

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• Agent recruiting division
• Responsible for recruiting sale agents in Beijing, Shanghai, Tianjin, Chongqing, Jiangsu, Zhejiang, Anhui, Jiangxi, Fujian, Shandong, Guangdong, Guangxi, Hainan, Hebei, Shanxi, Sichuan, Yunnan, Guizhou.

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• Hospital sales division
• 10 offices responsible for hospital sales in Beijing, Tianjin, Jilin, Shenyang, Shanxi, Shandong, Henan, Jiangsu, Guangdong, Sichuan.

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• Academic promotion division
• Responsible for the training, education of the doctors nationwide.

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• Sale services
• Provide data processing and statistics service to the sale team.

Marketing Centre

• Growing constantly for the past 4 years Biote sales network now covers 90% of the provinces in China, nearly 800 hospitals.

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• Biote has built favourable relationship with top doctors and experts in gynecology, pediatrics, urinary surgery departments. The company actively organize and participate various academic conferences.

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• The Biote Academic Salon sponsored by the company has become a well-known brand in the industry, attracting more experts to participate.

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History and future

• History - the past days
• 2004.09 Beijing Biote Pharmaceutical Co., ltd was incorporated.
• 2005.11 Clinical trial completed for Leuprorelin Acetate microspheres sustained release for injection.
• 2009.07 Leuprorelin Acetate microspheres sustained release for injection was approved by China FDA, licence number: H20093809, which was the first microsphere product granted in China.
• 2009.12 Facility dedicated for lyophilized powder and small volume solution completed and passed China FDA inspection. Annual capacity 200k unit. GMP certificate number: K5134.
• 2010.06 Launch of Leuprorelin Acetate microspheres sustained release for injection in China.
• 2011.08 National Development and Reform Commission set the price limit for leuprorelin acetate microspheres sustained release at 1899 RMB (311 USD).
• 2011.11 The company was certified as High-Tech enterprise by Beijing Science and Technology Bureau, Finance Bureau and Inland Revenue.
• 2014.01 The new site received CFDA GMP certificate.

• 2012.01 Purchased 26500 square metres ground from Beijing Miyun Industrial Park for new facility. 
• 2012.07 Foundation of the new facility.
• 2013.05 Validation of equipments in new facility.
• 2013.07 The entire company migrated from Changping to Miyun new site.
• 2013.11 China FDA GMP inspection of the new site.
• 2016.01 Start marketing endoscopic instruments imported from Germany
• 2018.12 Start developing a Swedish pollen based herbal medicine to reduce symptoms caused by reduced sex hormone level in women
• 2020.01 Licensing in Dienogest 2m tables from Netherlands

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History and future

• Future - the sunshine days
• Being the leader of Chinese companies in microspheres for injection sector we have unparalleled expertise in developing, manufacturing and marketing of microsphere injectables.
• Using our proprietary microsphere technology as the foundation, trying to apply microsphere delivery to various APIs, we invest in our own R&D to achieve product commercialization as the final goal.
• At the same time we are expanding the product portfolio, trying to bring into China the most advanced technologies and world-class products in the sector we know well - Gynecology. By utilizing the relationship we have built with the doctors in gynecology/ obstetrics departments throughout China during the past years while marketing our drug product we are now making an entry to the medical device business.
• The project selection is heavily biased towards market demand. Benefiting from our current sales team and the integration of external resources we make sure our products keep their frontline position in the sector.

History and future

The end

by Lee Xiao

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Thank you for viewing!

Lee@biotepharma.com