Transcript PowerPoint Template

Beijing Biote Pharma
Expert in Microspheres
www.biotepharma.com
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Company Profile
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Product
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History & Future
Beijing Biote Pharmaceutical Co., ltd.
Company Profile
 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
2013: 18 million USD
2014: 26 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.
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
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.
Key Product
Indications
 Endometriosis
 Uterine Leiomyoma (Fibroids)
 Breast Cancer
 Prostate Cancer
 Central precocious puberty
 Ovary protection
Marketing Centre
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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.
 Agent recruiting division
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Responsible for recruiting sale agents in Beijing, Shanghai, Tianjin,
Chongqing, Jiangsu, Zhejiang, Anhui, Jiangxi, Fujian, Shandong, Guangdong,
Guangxi, Hainan, Hebei, Shanxi, Sichuan, Yunnan, Guizhou.
 Hospital sales division
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10 offices responsible for hospital sales in Beijing, Tianjin, Jilin, Shenyang,
Shanxi, Shandong, Henan, Jiangsu, Guangdong, Sichuan.
 Academic promotion division
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Responsible for the training, education of the doctors nationwide.
 Sale services
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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.
 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.
 The Biote Academic Salon sponsored by the
company has become a well-known brand in the
industry, attracting more experts to participate.
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.
History and future
 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.
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.
The end
The End
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