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Chronological Events

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2011

1.21 The 'Outstanding Achievement Enterprises in Shenzhen Special Economic
Zone and their Leadership in 30 years' was awarded to the CEO of Sibiono along
with 5 other top multi-national enterprise CEO from Shenzhen.
5.29 The 10t h 'Pinnacle Forum for Business Start-up' The CEO of Sibiono Wei
Hsu was selected ‘New Enterprise Leader’
6.3-7 Participated the 47th ASCO annual oncology meeting in the USA , 6
abstracts were selected for presentation
7.24 Gendicine® was chosen the ‘Guangdong Superior Brand Name’
11.12-14 The CEO of Sibiono was invited to APEC at 'informal meeting for leaders'
at Honolulu, USA
11.21 The recipient of the 5th 'Shenzhen Enterprise Culture-Innovative Cultural
Construction Enterprise' award
11.22 Collaborative agreement was signed between Sibiono and the Chinese
Univ. of Hong Kong (CUHK) on the development of a new generation of gene
therapy drugs. It was mediated by Lantong Co., Ltd. of HK and Sibiono and led
by Prof. FS Kong (Acad memb) of CUHK.
11.27 Successfully held the 'International Gene Therapy Symposium' at Kuala
Lumpur. The introduction and registration for Gendicine® use in Malaysia was
agreed and document signed.

2010
3.13-15 The first ‘International Symposium on Clinical Gene Therapy’ was held at
Sibiono.
4.29 Successfully passed the GMP accreditation for the second time.
9.13 Award 10,000,000Y from the ‘City Development Committee Scientific
Support Fund’.
12.29 ’Production Permit' renewed.


2009
6.4 Signed collaboration agreement with N. America Gene Diagnostics &
Therapeutics Ltd ,Canada at Sibiono. Both parties agreed to develop a gene
therapy treatment center and business development in N America, Europe, the
Philippines and more for gene therapy and diagnosis market. It symbolized the
emergence of Sibiono in the Euro-American market.
5.29 Sibiono initiated and organized ‘rAd-p53,Inj’ Gendicine® for use by itself or
in combination with surgery, chemo- radiotherapy and other modalities for the
treatment of Stage IV head & neck cancer in open-end, randomized, positively
controlled clinical studies with 3 sub-titled studies. A totat of 2940 head & neck
cancer patients are going to be recruited. They have been filed and accepted for
clinical studies monitored by a series of medical journals, includig ‘New England
Jounnal of Medicine, NEJM’.


2008

12.15 Inauguation of the ‘Science & Technology Expert Committee’, invited
national authority on gene therapy panel: Dr. YiXan Zeng (Acad memb),
ZuZe Wu (Acad memb), Yan Sun, ( Acad memb), YuQuan Wei( Acad memb),
Prof. Wenlin Huang for the first term of the Committee, with Dr. Zeng as the
Chairman. Dr ZuZe Wu expressed the wish that Sibiono should build a ‘S & T
strategic platform for the structuring of gene therapy specialty’.
12.15 Recognized as a ‘ National HighTech Enterprise’


2006
10.- Restructuring of the Co.. Sibiono was.acquired by Tong Ji Benda
Pharmaceutical Co. Ltd., Hubei, a daughter co. of Brenda Pharmaceutical
Co.. Wei Hsu served as the company’s CEO and legal representative.
Funding approved to the construction of the Company’s gene therapy R&D
Center


2005
‘rAd-p53 Inj’, Gendicine® was awared ‘National Key New Product
Certificate’, issued jointly by the ‘Ministry of Science & Technology’ , the
‘Ministry of Commerce, the 'General Administration of Quality Supervision,
Inspection & Quarantine' and the ‘Bureau of Environmental Protection ’.

2004
10.22 The topic: ‘The correlation of p53 mutation & the clinical efficacy of
Gendicine®’ was officially approved for the ‘National Major Basic Research
Development Plan' ( '973 Plan' ).
10.13 Sibiono gene therapy drug manufacturing base was inauguated at
the HiTech Industrial Park at Shenzhen, with the Mayor & the 'National
Development Improvement Committee' presented
9.- The first place winner of ‘Shenzhen Scientific Progress Award, 2004’
gladly went to Sibiono, presented by the Shenzhen City Government.
3.11 ‘rAd-p53,Inj’ production plant was given ‘Drug GMP Certificate’
1.20 ‘rAd-p53,Inj’ was awarded the ’Production Permit’ by the SFDA
Gained support in the form of ’National major science project’ in the same
year.

2003
10.16 ’rAd-p53, Inj’ was awarded by the SFDA the ‘Biological type I New
Drug Certificate’

2002
11.22 ‘Drug Production Permit’ was issued by Guangdong FDA 。
11.- ‘rAd-p53, Inj’ was designated ‘Tenth 5 Year Plan’ by the 'Ministry of
Science & Technology'

2001
12.- Ministry of Science & Technology listed ‘rAd-p53, Inj’ as ‘National S&T
Cross Hurdle Project’
12.- Completion of production plant for gene therapy at HighTech Center
completed.

1999
11.- ‘rAd-p53, Inj’ project was included in ‘Shenzhen Major Enterprise
Project’
1.- The Ministry of S& listed ‘rAd-p53, Inj’ as ‘863 Plan: Biotechnology Field
Trial Development Project’

1998
12.28 ‘rAd-p53, Inj’ was allowed to enter Phase I clinical trial by SFDA
3.09 The inauguration of Sibiono GeneTech Co., Ltd, Shenzhen


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