High leves of growth in all life science sec­tors in Tai­wan

BioSpectrum (Asia) - - Front Page - Dr Apo Huang Sec­re­tary Gen­eral, Tai­wan Bio In­dus­try Or­ga­ni­za­tion (TBIO)

In Tai­wan, biotech is fi­nally boom­ing, and new com­pa­nies, ser­vice providers and man­u­fac­tur­ing fa­cil­i­ties are emerg­ing to fill rapidly grow­ing in­dus­try needs. Tai­wan Bio In­dus­try Or­ga­ni­za­tion (TBIO), the largest and the most in­flu­en­tial biotech­nol­ogy or­ga­ni­za­tion in Tai­wan. TBIO rep­re­sents over

300 mem­bers rang­ing from pri­vate com­pa­nies and aca­demic in­sti­tutes to gov­ern­ment bod­ies in­volved in the re­search and devel­op­ment of in­no­va­tive health­care, agri­cul­tural, in­dus­trial and en­vi­ron­men­tal biotech­nol­ogy. TBIO’s mis­sion is to pro­vide ad­vo­cacy, busi­ness devel­op­ment, in­ter­na­tional part­ner­ship, train­ing and com­mu­ni­ca­tion ser­vice for its mem­bers. TBIO or­ga­nizes the an­nual BioTai­wan con­fer­ences and ex­hi­bi­tion, the largest gath­er­ing of biotech­nol­ogy in­dus­try in Tai­wan. BioTai­wan 2017, its 15th an­nual event was held be­tween June 28 and July 2 in Taipei, Tai­wan. In this re­gard BioSpec­trum Asia re­cently spoke to Dr Apo Huang, Sec­re­tary Gen­eral, Tai­wan Bio In­dus­try Or­ga­ni­za­tion (TBIO) on the cur­rent growth in the Tai­wanese biotech sec­tor.

Ex­cerpts of the in­ter­view

The Min­istry of Health and Wel­fare (MOHW) plays a key role in pro­mot­ing phar­ma­ceu­ti­cals and biotech­nol­ogy in Tai­wan, which has be­come par­tic­u­larly ev­i­dent with many re­cent ac­tion plans. Any com­ments?

The TFDA (Tai­wan FDA), part of the MOHW, is the agency re­spon­si­ble for phar­ma­ceu­ti­cal, med­i­cal device and bi­o­log­ics ap­proval in Tai­wan, and also cov­ers food safety is­sues. Such is­sues have been in the spot­light in Tai­wan in re­cent years. The MOHW also heads up Tai­wan’s world-renowned na­tional health in­sur­ance pro­gramme, un­der the Na­tional Health In­sur­ance Ad­min­is­tra­tion (NHIA), pro­vid­ing high qual­ity and af­ford­able health care to all. Since 1998, TFDA has des­ig­nated the CDE (Cen­ter of Drug Eval­u­a­tion), a non­profit or­ga­ni­za­tion sup­ported by MOHW for cer­tain as­pects of drug and med­i­cal device ap­proval and the re­lated reg­u­la­tory mat­ters. CDE’s main role is to im­prove the qual­ity and speed of clin­i­cal tri­als and drug ap­proval pro­cesses. It also sets reg­u­la­tions for new ther­a­peu­tic treat­ments such as cell ther­apy and en­sures the trans­parency of re­view pro­cesses. CDE has played a very im­por­tant role in Tai­wan’s biotech in­dus­try devel­op­ment with its ac­com­plish­ment in set­ting pri­or­ity re­view guide­lines and ac­cel­er­at­ing drug and med­i­cal device ap­proval pro­cesses. In the past five years, clin­i­cal trial ap­pli­ca­tions have num­bered around 250-300 (274 for 2016), with most cases be­ing multi­na­tional, mul­ti­cen­ter Phase II and III tri­als.

What are the fun­da­men­tal strengths of the biotech mar­ket in Tai­wan and what chal­lenges does it face?

Strengths in­clude the fol­low­ing:

1. Strong and ac­tive gov­ern­ment pro­mo­tion of the in­dus­try, with high lev­els of di­rect and in­di­rect

in­vest­ment, in­clud­ing sovereign funds such as the Na­tional Devel­op­ment Fund NDF), in­fra­struc­ture devel­op­ment in­clud­ing the con­struc­tion of a large num­ber of science parks and clus­ters, pol­icy devel­op­ment blue­prints, etc.

2. Ex­ist­ing strengths in ICT, and grow­ing ca­pa­bil­i­ties in the newly emerg­ing realms of IoT and AI all of which are trans­fer­able to med­i­cal device devel­op­ment, de­vice­drug com­bi­na­tions, digital health/mobile health/ehealth.

3. Uti­liz­ing Tai­wan’s Na­tional Health In­sur­ance sys­tem which has com­piled a huge med­i­cal data­base since its im­ple­men­ta­tion in 1997, and which can be mined for im­por­tant lon­gi­tu­di­nal stud­ies for drug devel­op­ment.

4. Well placed to take a lead­ing role in ‘pre­ci­sion medicine’, by com­bin­ing ca­pa­bil­i­ties in drug devel­op­ment, di­ag­nos­tics, de­vices and uti­liz­ing Big Data an­a­lyt­ics and method­ol­ogy on the Na­tional Health In­sur­ance Ad­min­is­tra­tion’s mas­sive med­i­cal data­base.

5. Tai­wan has a west­ern busi­ness en­vi­ron­ment, strong IP pro­tec­tion, and en­joys a high de­gree of eco­nomic freedom. These are de­sir­able qual­i­ties to de­vel­op­ing such an in­ter­na­tion­ally con­nected in­dus­try such as biotech.

6. Rel­a­tively easy ac­cess to cap­i­tal, and strong pub­lic cap­i­tal mar­kets. Tai­wan also has a vi­brant and knowl­edge­able ven­ture cap­i­tal in­dus­try with long ex­pe­ri­ence in­vest­ing lo­cally and over­seas in biotech.

7. World-class clin­i­cal tri­als ecosys­tem; large network of med­i­cal cen­ters (19 med­i­cal cen­ters and 124 clin­i­cal trial hos­pi­tals), good rep­u­ta­tion for ad­her­ence to pro­to­cols, and rapid pa­tient re­cruit­ment. Tai­wan has fast drug ap­proval pro­cesses, par­tic­u­larly IND and has been a PIC/s mem­ber since 2013.

8. En­tre­pre­neur­ial busi­ness cul­ture, and fer­tile start up breed­ing ground. The sub­trop­i­cal cli­mate is ideal for de­vel­op­ing ex­per­tise in agri-biotech, tropic dis­ease re­search, etc.

Since the global fi­nan­cial cri­sis, Tai­wan’s biotech cap­i­tal mar­kets grew by 520%. What do you think is the rea­son for this growth?

Yes, there has been huge growth in the value of listed life science com­pa­nies since the fi­nan­cial cri­sis of 2008. The main rea­son be­ing that af­ter around 30 years of gov­ern­ment-led de­vel­op­men­tal at­ten­tion, the pieces have fi­nally fallen into place, and the in­dus­try is be­gin­ning to blos­som. Waves of new reg­u­la­tions are put into ef­fect that al­low bet­ter aca­demic in­volve­ment in the pri­vate sec­tor, and other benefits are now bear­ing fruit. Since the new gov­ern­ment took of­fice in 2016, there has been a ded­i­cated ef­fort to build Tai­wan up to be­come the cen­ter of biomed­i­cal R&D in the Asia-Pa­cific re­gion. Also, the much-needed in­fra­struc­ture has been built; tox­i­col­ogy fa­cil­i­ties, clin­i­cal batch bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ties, then later CMOs and lo­cally-set up CROs.

As Sec­re­tary Gen­eral, can you high­light a few of the suc­cess sto­ries of BioTai­wan over the past years?

BioTai­wan’s growth is a re­flec­tion of the suc­cess of Tai­wan biotech as a whole in re­cent years. Suc­cess sto­ries of com­pa­nies such as TaiGen Biotech­nol­ogy, Phar­maEngine and Pan­ion & BF Biotech who have re­ceived new drug ap­provals in China, Ja­pan or the US. Oth­ers such as Phar­maEngine, TaiMed, Myc­er­nax and SyneuRx In­ter­na­tional have drugs close to ap­proval un­der fast track devel­op­ment or or­phan drug designation. In bi­o­log­ics, Medi­gen Vac­cine Bi­o­log­ics has a brand-new vac­cine and biosim­i­lars fa­cil­ity, while JHL Biotech and EirGenix and United Bio­pharma have new bi­o­log­ics CMO ca­pac­ity and are also in­volved in an in­house bi­o­log­ics devel­op­ment. TaiMed and United Bio­pharma are working on ex­cit­ing new drugs tar­get­ing HIV and are in Phase II or lat­ter tri­als, while OBI Pharma and TheVax Ge­net­ics Vac­cine have im­muno-on­col­ogy drugs un­der devel­op­ment. There’s grow­ing biosim­i­lars ac­tiv­ity with United Bio­pharm, Myce­nax, JHL Biotech, Foun­tain Bio­pharma and Tan­vex Bio­pharma all with biosim­i­lars pipe­lines.

What is your out­look for the growth of Tai­wan’s biotech and pharma sec­tors?

All sec­tors of the life science in­dus­try in Tai­wan, in­clud­ing biotech, pharma, di­ag­nos­tics and med­i­cal de­vices, are cur­rently un­der­go­ing high lev­els of growth which we be­lieve will con­tinue for some time yet. With the gov­ern­ment’s growth goals to fos­ter 20 new drugs and 80 high-value med­i­cal de­vices in global mar­kets, and to cre­ate 10 flag­ship brands in health ser­vices all by 2025, with the tar­get to­tal rev­enue of NT$1 tril­lion (US$33 bil­lion), and with in­dus­try con­fi­dence lev­els at an all-time high, the out­look is ex­tremely pos­i­tive.

Priyanka Ba­j­pai priyanka.ba­j­pai@mmac­tiv.com

Since the new gov­ern­ment took of­fice in 2016, there has been a ded­i­cated ef­fort to build Tai­wan up to be­come the cen­ter of biomed­i­cal R&D in the Asia-Pa­cific re­gion. Also, the much-needed in­fra­struc­ture has been built; tox­i­col­ogy fa­cil­i­ties, clin­i­cal batch bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ties, then later CMOs and lo­cally-set up CROs.

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