Milestones
2005
- Oct.
- Company established
2006
- Feb.
- Set up R&D Lab in Taipei Medical University Incubation Center
2007
- Jun.
- Received government-sponsored SBIR grant to develop Gemcitabine oral dosage form
- Aug.
- Received ANDA approval for anti-bacteria drug "Bestnem®"and MRI contrast agent "Gadomni®" from Taiwan FDA
2008
- Mar.
- Licensed and-in and co-developed for Bendamustine with SymBio Pharmaceuticals
- Sep.
- Received "New Drug Development" endorsement from government MOEA
2009
- May
- Received ANDA approval for immuno-suppression drug "Immurin®"and MRI contrast agent "Gadoscan®" from Taiwan FDA
- Jun.
- Received ITDP Grant for Gemcitabine Oral Development
2011
- Sep.
- Received US FDA IND approval for Gemcitabine Hydrochloride Oral Formulation (D07001-F4)
- Oct.
- Received NDA approval for Bendamustine (Innomustine®) from Taiwan FDA
2012
- Aug.
- Signed distribution contract for MRI products with Akorn(NASDAQ listed company) for US market
- Sep.
- Listed on Emerging Stock Market in Taiwan Stock Exchange, the ticker symbol is 4172
2014
- Apr.
- Completed the PK clinical study of Gemcitabine Oral in USA
- May
- Gadopentetate filed US ANDA through Akorn
2015
- Jul.
- Selected as a company of “BIO Taiwan Highlights 2015”by IBMI
- Aug.
- US FDA agreed the company’s Carvedilol CR Tablet will be eligible for NDA submission after BE study completion
- Nov.
- Completed Clinical Phase I Trial for Gemcitabine HCI Formulation
2016
- Jan.
- Received FDA Orphan Drug Designation for Gemcitabine in the Treatment of Cholangiocarcinoma
- Apr.
- Signed contract of distribution to Canada market defined Middle East countries for Gadomni®, Gadoscan®, Immurin® and other 2 MRI products with Avir Pharma
2017
- Mar.
- Signed product supply and distribution contract for Gadoscan® with Shenzhen Rosso Pharmaceutical Co. Ltd in China
- Jul.
- Signed distribution contract for Inpheno Tablets with BL&H Co. Ltd. for Korea Market
- Aug.
- InnoPharmax Received IND Approval from US FDA to Proceed with Clinical Development in Efficacy, Pharmacokinetics and Safety of Gemcitabine Oral Formulation in Biliary Tract Cancer
2018
- Mar.
- Signed license-out & supply contract for Inpheno with China New Age Pharmaceutical Co., Ltd. For China & Spain market
- Apr.
- Signed license-out contract for Oral Insulin with HEC(1558.HK) for China market
- Jul.
- Filed Gadopentetate Dimeglumine injection ANDS to Health Canada through Avir Pharma
2019
- Feb.
- Filed US DMF of sapropterin dihydrochlorid (#033553, date of submission: Feb. 19, 2019)
- Jul.
- The signed global license-out contract for C08001 with China New Age Pharmaceutical Co., Ltd.
Awards
2009
- Nov.
- Won a Bronze award in the "Taiwan Healthcare Industry Innovation and Excellence Awards 2009"
2012
- Sep.
- Awarded "2012 Taipei Biotech Research and Development Innovation Golden Award"
- Dec.
- 「Gemcitabine OralPAS®」 was awarded the 9th National Innovation Award in the Innovative Technology Category
2013
- Aug.
- Awarded "2013 Excellence Award for Research and Development Results in the Technology Development Program of DoIT of MOEA"
2014
- Jul.
- Received "2014 Taiwan Bio Industry Organization Award"
2015
- Dec.
- Rank as 7th place in Taiwan on the selecting list of "Technology Fast 500™ Asia Pacific 2015" by Deloitte
