February：TaiGen has completed the enrollment for the phase II trial of TG-1000 in China.
February：Taigexyn IV became eligible for reimbursement in March as it passed the National Health Insurance Administration’s review and assessment on Feb 14.
Influenza Antiviral TG-1000
March：TaiGen successfully completed TG-1000 phase I trial with excellent safety profile.
December：TG-1000 won the National Innovation Award.
January：TaiGen filed the application of NHI’s reimbursement price for Taigexyn IV formulation.
Feburary：The president met with the Chairman & CEO of TaiGen, Kuo-Lung Huang, for the corporate’s outstanding R&D strength.
March：TaiGen entered transfer agreement of Nemonoxacin with Zhejiang Medicine in China, which is worth totaling up to USD 45~50 million.
June：Taigexyn® IV formulation is approved in China market and the milestone payment of transfer agreement, USD 45 million, is also recognized.
November：TaiGen obtained the certificate of on-site inspection of Nemonoxacin IV formulation for NDA approval in Russia.
Influenza Antiviral TG-1000
January：TG-1000 obtained first patent in the U.S.
February：TaiGen submitted TG-1000 IND to China NMPA.
May：TaiGen received TG-1000 clinical trial authorization from China NMPA.
July：TaiGen initiated TG-1000 phase I clinical trial in China.
October：TaiGen filed IND application for TG-1000 to U.S. FDA.
December：TaiGen initiated TG-1000 phase II clinical trial under the IND approval both in the U.S. and China.
January: Nemonoxacin oral formulation included in the reimbursement list in China Medical Insurance.
May：TaiGen reported 239％ April revenue growth upon selling Nemonoxacin API to Russia for the preparation of NDA filling.
September：TaiGen out-licensed Taigexyn to Luminarie Canada for Canada, Australia and New Zealand.
October：TaiGen received marketing approval from TFDA for Taigexyn® IV formulation in Taiwan.
November：TaiGen partnered with GPCR to develop Taigexyn® in South Korea.
December：Taigexyn is granted three nationals prizes, SNQ, National Bio & Medicine Care Quality Award and National Innovation Excelsior Award.
December：Furaprevir won the National Innovation Excelsior Award.
November：TaiGen partnered with GPCR to develop Burixafor worldwide.
January：Kuo-Lung Huang, President of TaiGen Biopharmaceuticals Co. (Beijing) Ltd. took up the post of the Chairman of the Board, President and CEO of TaiGen Biopharmaceuticals Co. Ltd.
Influenza Antiviral TG-1000
October：TaiGen submitted pre-IND meeting application of influenza antiviral TG-1000.
June：Nemonoxacin obtained the process patent of API intermediate in the U.S.
September：Taigexyn IV formulation proceeded to the process of on-site inspection for NDA approval.
October：TaiGen submitted NDA of Taigexyn intravenous formulation in Taiwan
October：There is no critical observation in on-site inspection of Nemonoxacin IV formulation for NDA approval.
November：Taigexyn oral formulation succeeded to get on reimbursement list in China Medical Insurance.
December：Taigexyn IV formulation passed the drug sampling inspection.
Feburary：Patient treatment and 12-week follow-up in China phase II trial of the combination of Furaprevir and Yimitasvir has been completed.
April：HCV combination treatment successfully completed phase II clinical trial in China with 97.4％ SVR 12.
April：TaiGen initiated phase III trial of the combination treatment of HCV and held the PI meeting.
June：TaiGen enrolled the first patient for the phase III trial of the combination treatment of Furaprevir and Yimitasvir.
July：The first milestone of 5 million USD for the joint development of HCV antivirals is recognized as an non-operating revenue.
December：TaiGen has completed the enrollment for the phase III trial of Furaprevir and Yimitasvir combination in China.
July：TaiGen is awarded the “Outstanding Company of the Year” by the Taiwan Bio Industry Organization.
January : Taiwan’s National Health Insurance Administration (NHI)’s reimbursement price for Taigexyn® (Nemonoxacin) oral capsules, each 250 mg Taigexyn® capsule will be reimbursed at NT $180 (~USD$ 5.99) became effective on January 1, 2018.
February 05 : Taigexyn®（Nemonoxacin）was Granted Priority Review by the China Food and Drug Administration (CDE).
April 24 : Taigexyn®（Nemonoxacin）intravenous and oral formulations successfully completed phase 3 clinical trial for community acquired pneumonia in Russia.
June：Taigexyn®（Nemonoxacin） obtained European patent from European Patent Office (EPO), the patent is valid in 34 contract countries such as UK, France, German, Swiss, Netherlands, Luxemburg etc.
September：The sales of Taigexyn oral capsule in China exceeded 10 thousand boxes. In the first three quarters of 2018, cumulative sales increased by 562.7%. The 2018 Q3 grew by 651.1% in the same period last year.
July：Furaprevir granted formulation patent by United States Patent and Trademark Office, providing patent protection to May 2037.
December：Furaprevir phase I trial of dose escalation is awarded “Second Prize” by 2018 Asian Pacific Association for the Society of the Liver (APASL) in Beijing.
November：Burixafor phase I trial of chemo sensitization in China reached the primary indicator of safety
May 30 : Submitted New Drug Application (NDA) for the intravenous formulation of Taigexyn® (Nemonoxacin) to the China Food and Drug Administration (CFDA).
November 6 : Taigexyn® intravenous formulation successfully completed phase 3 clinical trial for community acquired pneumonia in Taiwan
November 27 : Russian partner, R-Pharm JSC, has completed the patient enrollment of the Phase 3 clinical trial (CJ01060044) of Taigexyn® (nemonoxacin) in Russia.
December 7 :Taigexyn received reimbursement price from Taiwan’s National Health Insurance Administration, each 250 mg Taigexyn® capsule will be reimbursed at NT $180, effective from January 1st , 2018.
February 2 : A Phase 2 study of Furaprevir in combination with peg-interferon and ribavirin for GT-1b was completed in Taiwan, 91% of subjects achieved SVR12, demonstrated potency to reduce HCV treatment duration to 12 weeks.
June 7 : TaiGen Beijing Ltd obtained its 49% Stake in Joint Venture and completed the 9% Equity Sales to HEC. RMB 117 million, the value of TaiGen’s equity in the joint venture was recognized as revenue in the 2nd quarter consolidated financial statement. In addition, the payment of RMB 137 million that TGBJ received on March 29th, 2017 for the sale of 9% equity to HEC was recognized as non-operating revenue of RMB 116 million in the 2nd quarter consolidated financial statement of TaiGen.
June 14 : Furaprevir awarded the Innovation of the Year Award from the Taiwan Bio Industry Organization.
December 5 : Furaprevir won the Bronze Award for New Drug R&D fromTFDA & Ministry of Economic Affairs.
June 13 : Received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of Taigexyn® (nemonoxacin) in mainland China.
August 26 : Out-licensed the Latin American Market rights of Taigexyn (Nemonoxacin) to Productos Cientificos in Mexico.
October 23 : Taigexyn® (Nemonoxacin) capsule was launched in mainland China by its partner, Zhejiang Medicine Co.
February 17 : Signed a Memorandum of Understanding with YiChang HEC ChangJiang Pharmaceutical Co. Ltd to collaborate in the research and development of a novel all-oral interferon-free treatment for chronic hepatitis C virus (HCV) infection.
April 18 : Presented clinical data of Furaprevir at the International Liver Congress 2016 in Barcelona, Spain.
June 7 : Signed an agreement with YiChang HEC ChangJiang Pharmaceutical Co., Ltd. to establish a Joint Venture in mainland China for the joint development, manufacturing, and commercialization of direct-acting antiviral agents (DAAs) for chronic hepatitis C virus (HCV) infection in the greater China region.
December 5 : Furaprevir won the Medal of Technology Award from Chinese Chemical Society.
January 20: Received the drug license of Nemonoxacin oral formulation from TFDA.
March 25: Signed a distribution agreement with Holding Disp. Co. Ltd for Nemonoxacin distribution in Taiwan.
February 5: first patient enrolled in the second Phase II Burixafor trial in the US.
March 17: Signed a collaboration agreement with Cellex GmbH and the University Hospital Carl Gustav Carus Dresden in Germany for an investigator-initiated clinical trial using Burixafor in allogenic stem cell mobilization.
April 29: Initiated Phase 1/2 trial of Burixafor in relapsed or refractory acute myeloid leukemia in China
June 4: Signed a collaborative agreement with Johns Hopkins University for a pilot study using Burixafor in metastatic prostate cancer.
January 17: TaiGen Biopharmaceuticals Holdings Ltd., (100% owns TaiGen Biotechnology Co. Ltd.) listed on Taiwan GreTai Securities Market with the ticker of 4157.TWO.
January 13: TaiGen signed an exclusive agreement with R-Pharm, a leading Russian pharmaceutical company, to develop and commercialize Nemonoxacin (Taigexyn®) in Russian Federation, Turkey and other members of the Commonwealth Independent States (CIS).
March 12: Taiwan Food and Drug Administration (TFDA) approved the new drug application (NDA) of Taigexyn® (Nemonoxacin) oral formulation for the treatment of community-acquired bacterial pneumonia (CAP).
May 30: Initiated Nemonoxacin I.V. formulation Phase III trial in China.
Sept 19~20: The external expert committee of China FDA/Center Drug Evaluation held a meeting to review Nemonoxacin NDA
November 18: Submitted reimbursement price application for Nemonoxacin oral formulation with National Health Insurance (NHI) Administration
June 10: Filed CTA with China FDA (CFDA) for Phase II trial of Burixafor in Hematopoietic Stem Cell Transplantation (HSCT).
June: patient enrollment complete for Furaprevir Phase I/IIa trial
January: TaiGen Holdings increases TaiGen Taiwan capital by NT$360 million. Paid in capital now stands at NT$751,513,920.
March: NDA application to the Taiwan's Food and Drug Administration (TFDA) sumbitted for Nemonoxacin in oral formulation.
April: NDA application to the CFDA submitted for Nemonoxacin in oral formulation.
December: Phase II clinical trial in Taiwan and China for Nemonoxacin in injectable form completed. Trial data currently undergoing consolidation and analysis.
December: Nemonoxacin in oral formulation received qualification in two FDA programs: the Qualified Infectious Disease Product (QIDP) program, set up to reward existing and promising drugs in the fight against drug-resistant bacteria and other pathogens; and the 'Fast Track' program. A drug which qualifies under the QIDP program receives five years market exclusivity, with an extra five years added if the drug is a new chemical entity, making a total of 10 years for Nemonoxacin. For the Fast Track program, the approval review processes are sped up for qualifying drugs, and priority is given over others in the pending review queue, which enables faster time to market for drugs qualified under this program. Qualification by Nemonoxacin in both programs is certain to be of great benefit to TaiGen and its partners.
December: TaiGen has received the National Innovation Award from Taiwan's Institute for Biotechnology and Medicine Industry (IBMI), as well as the Taipei Biotech Award for Technology Transfer.
January: Furaprevir patient proof-of-concept study launched, with results published by the American Association for the Study of Liver Diseases (AASLD) in November.
May: Approval received from CFDA to begin Phase I/II clinical trial for Burixafor as a chemotherapy sensitizer for leukemia patients.
July: Phase II clinical trial for Burixafor for autologous hematopoietic stem cell transplantation completed (12 patients enrolled). Results published at the annual meeting of the American Society of Hematology (ASH) in December.
TaiGen Taiwan allocates NT$417,233,135 of company's capital reserve to cover accumulated losses, followed by a reduction of capital by NT$3,071,502,350 after accumulated losses. TaiGen Taiwan paid-in capital now stands at NT$391,513,920.
September: US$10,000,000 raised for TaiGen Holdings from the sale of ordinary shares.
June: Exclusive agreement signed with Shanghai's Zhejiang Medicine Co., Ltd. for the manufacture and commercialization of Nemonoxacin in China (excluding Hong Kong and Macau).
December: Combined China-Taiwan Phase III clinical trial for Nemonoxacin in oral dosage form completed.
December: Phase II clinical trial for Nemonoxacin in injectable form begins in Taiwan and China.
December: Nemonoxacin development and commercialization license agreement for European, US and Japanese territories transferred without compensation by Warner Chilcott to TaiGen, giving the company worldwide rights to the drug.
November: Furaprevir Phase I/II single dose and multi-dose clinical trials under FDA authority completed.
Ministry of Economic Affairs grant received to help fund Phase I clinical trial for Furaprevir.
Phase II clinical trial for Burixafor begins for autologous hematopoietic stem cell transplantation in US-based patients.
TaiGen Beijing, applies for Burixafor IND with China's SFDA.
TaiGen Holdings increases capital of TaiGen Taiwan by NT$280 million, with paid in capital now standing at NT$3,463,016,270.
July: TaiGen enters into an amendment to its Nemonoxacin development and commercialization license agreement for European, US and Japanese territories with Warner Chilcott, which had earlier acquired P&G Pharmaceuticals.
Phase I clinical trials in China for Nemonoxacin in injectable dosage form completed.
Ministry of Economic Affairs grant received to subsidize the cost of Phase III clinical trial on Nemonoxacin.
April: FDA IND filed for Furaprevir, with Phase I/II clinical trials beginning in November.
Series C round funding for TaiGen Holdings, part III completed, with US$7,220,451 raised.
Combined China-Taiwan Phase III clinical trial begins for Nemonoxacin in oral dosage form.
Burixafor Phase II clinical trial under FDA authority begins for autologous hematopoietic stem cell transplantation in Asian patients.
Ministry of Economic Affairs grant received to begin Phase II clinical trials on Burixafor.
Series C round funding for TaiGen Holdings parts I and II completed, with US$32,779,548.92 raised. TaiGen Holdings increasing TaiGen Taiwan capital by NT$900 million, now standing at NT$3,183,016,270.
Phase II trial for Nemonoxacin for DFI under FDA IND authority completed.
Nemonoxacin in oral dosage form begins Phase II clinical trials in China.
Development begins on Furaprevir, a next generation anti-hepatitis C virus NS3/4A protease inhibitor drug.
Ministry of Economic Affairs grant received to undertake further drug screening and development on Furaprevir.
Burixafor Phase I clinical trials under FDA IND authority completed.
TaiGen receives the National Innovation Award, Corporate R&D Class, for Burixafor from Taiwan's Institute for Biotechnology and Medicine Industry (IBMI).
TaiGen Biopharmaceuticals Holdings Ltd formed as 100% equity holder of parent company TaiGen Taiwan. 1,000,000 ordinary shares and 227,301,627 preferred shares issued, at par value of US$0.001.
Approval received from SFDA for Phase I clinical trial in China for Nemonoxacin in injection form. Clinical trial begins.
Phase I clinical trial in China for Nemonoxacin in oral dosage form completed.
Phase I clinical trial for Burixafor under FDA authority begins.
Ministry of Economic Affairs grant received to undertake clinical trials on Burixafor.
TaiGen receives Taipei Biotech Award, R&D Innovation category for Burixafor.
Nemonoxacin Phase II clinical trial for CAP under FDA authority completed.
Nemonoxacin Phase II clinical trial for diabetic foot infection (DFI) under FDA authority begins.
December: Approval received from China SFDA to begin Phase I clinical trial of Nemonoxacin in oral dosage form.
Application sent for FDA IND for Burixafor.
Nemonoxacin Phase II clinical trial for Community-Acquired Pneumonia (CAP) initiated under FDA authority.
September: Proposal presented to Chinese State Food and Drug Administration (SFDA, named changed in March 2013 to the China Food and Drug Administration, CFDA) for Category 1.1 'New Drug' designation for Nemonoxacin in oral and injectable dosage formulations.
Series A and Series B funding rounds completed, raising NT$1,438,550,000 and NT$834,466,270 respectively for the purchase of preferred stock. TaiGen paid-in capital now stands at NT$2,283,016,270.
Nemonoxacin, a drug candidate for drug-resistant bacterial infections, licensed from P&G Pharmaceuticals, with single-dose clinical trial (Phase 1a) already completed by P&G.
Multi-dose clinical trial (Phase Ib) for Nemonoxacin under US Food and Drug Administration (FDA) IND authority completed.
Ministry of Economic Affairs grant received to undertake multinational, multicenter Phase IIb clinical trial on Nemonoxacin under FDA authority.
Ministry of Economic Affairs grant received to undertake further drug screening and development on Burixafor.
TaiGen Biopharmaceuticals Co. (Beijing), Ltd. established, responsible for the implementation in China of the TaiGen's clinical trial program, drug registration and market research activities.
Development begins on stem cell mobilizer Burixafor, discovered in-house and with pre-clinical research undertaken at TaiGen's drug development facilities.
TaiGen Taiwan Co. Ltd. established with paid-in capital of NT$10,000,000.