‘‘CRO in­dus­try will de­velop vig­or­ously in China’’

BioSpectrum (Asia) - - BIO CONTENT - Wendy Wang, Man­ag­ing Di­rec­tor, Lini­cal Ac­celo­vance Group, China

Clin­i­cal trial ac­tiv­ity in China has been on the rise since 2007, and the num­ber of Phase I–IV tri­als re­vealed a clear up­ward climb year-on-year, from 487 tri­als in 2007 to over 1,300 tri­als in 2016. De­spite the bumps and reg­u­la­tory hur­dles that it faced this past decade, China is rec­og­niz­ably the sec­ond­largest pharma mar­ket in the world, and its mar­ket value is fore­casted to reach $200 bil­lion by 2020. The cur­rent land­scape of clin­i­cal tri­als reg­is­tered in the coun­try paints a well-bal­anced, healthy pipeline of drug in­no­va­tions. Speak­ing to Aish­warya Venkatesh of BioSpec­trum Asia, Wendy Wang, Man­ag­ing Di­rec­tor, Lini­cal Ac­celo­vance Group, elab­o­rates on op­por­tu­ni­ties and chal­lenges of China’s CRO in­dus­try. China-based Lini­cal Ac­celo­vance is an award­win­ning, niche Con­tract Re­search Or­ga­ni­za­tion (CRO) fo­cused pri­mar­ily on on­col­ogy, vac­cines, and gen­eral medicine. With a pres­ence in the US and China, Lini­cal Ac­celo­vance has been hon­ored as a Best CRO ViE Award nom­i­nee by in­dus­try lead­ers for the past 11 con­sec­u­tive years, af­ter be­ing eval­u­ated against global CROs for qual­ity of ser­vices and per­for­mance. Edited

ex­cerpts;

What is the cur­rent mar­ket size and trends in China’s CRO space?

The CRO mar­ket in China started to de­velop in 1990s, later than those in Europe and Amer­ica. CRO com­pa­nies can be di­vided into 3 cat­e­gories in China: pre­clin­i­cal CRO, clin­i­cal CRO, and drug regis­tra­tion and ap­proval agent CRO. The first two com­pa­nies usu­ally in­clude the third one, a smaller share, in their “one-stop ser­vice”. In 2017, the size of China’s CRO mar­ket was over 55 bil­lion RMB (~9 bil­lion USD), with a 19 per cent year-on-year growth com­pared with 2016, ac­cord­ing to the re­port pub­lished by Prospec­tive In­dus­try Re­search In­sti­tute. Ac­cord­ing to the data of WuXi Ap­pTec, Tigermed, JOINN Lab, and Boji Phar., in 2017, the busi­ness in­come of the four en­ter­prises in the con­tract R&D ser­vice to­taled more than 7 bil­lion RMB (ex­clud­ing non CRO busi­ness), which ac­counted for 10.04 per cent, 3.02 per cent, 0.52 per cent and 0.22 per cent of the to­tal Chi­nese CRO mar­ket, re­spec­tively.

What are the key driv­ers and res­traints af­fect­ing CRO busi­ness in China?

The clin­i­cal tri­als in China in­clude global mul­ti­cen­ter clin­i­cal tri­als, im­port regis­tra­tion clin­i­cal tri­als, and the reg­is­tered clin­i­cal tri­als of do­mes­tic generic phar­ma­ceu­ti­cal en­ter­prises, in which clin­i­cal tri­als in do­mes­tic phar­ma­ceu­ti­cal en­ter­prises mainly based on generic drugs are the main­stream. Only in the first half of 2018, there are 291 Bio Equiv­a­lence (BE) no­ti­fi­ca­tion sub­mit­ted to China Food and Drug Ad­min­is­tra­tion (CFDA), which is the re­sult of re­form of drug regis­tra­tion. Ap­prox­i­mately 2793 clin­i­cal tri­als have been reg­is­tered in Chi­nese Clin­i­cal Trial Reg­is­ter (ChiCTR) in the first half of this year, an in­crease of 81.63 per cent over the same pe­riod of last year. There are ap­prox­i­mately 880 reg­is­tered in CDE Drug Clin­i­cal Trial Reg­is­ter (CTR) in the first half of 2018, an in­crease of 45.45 per cent com­pared with those in the same pe­riod of 2017. These reg­is­tered clin­i­cal tri­als con­sist of post-mar­ket­ing drugs, clin­i­cal tri­als on new ther­apy, and oth­ers. All this in­di­cates that clin­i­cal tri­als have had a huge burst in China. At the same time, there will be more global mul­ti­cen­ter clin­i­cal tri­als be­cause of rel­a­tively cheaper Chi­nese man­power and huge pa­tients’ pool since China joined ICH in 2017. This means more op­por­tu­ni­ties for CRO com­pa­nies in China.

There are many fac­tors af­fect­ing the de­vel­op­ment of the CRO in­dus­try in China. First, the do­mes­tic phar­ma­ceu­ti­cal mar­ket is grad­u­ally in­te­grat­ing with the in­ter­na­tional mar­ket, and the in­vest­ment of multi­na­tional phar­ma­ceu­ti­cal en­ter­prises in China has been in­creas­ing. Multi­na­tional phar­ma­ceu­ti­cal com­pa­nies such as Bayer, Merck, Pfizer and Novo Nordisk have in­vested more than 10 bil­lion RMB in China, and dozens of re­search cen­ters have been set up

since 2000. Se­cond, do­mes­tic pol­icy re­form, generic drug con­sis­tency eval­u­a­tion and other pol­icy fac­tors make the clin­i­cal trial out­sourc­ing mar­ket ex­pand rapidly. The do­mes­tic drug mar­ket is trans­form­ing from “generic drugs” to “in­no­va­tive drugs”, and gov­ern­ment poli­cies en­cour­age in­no­va­tion. This brings more CROs in­volved in drug re­search to re­duce un­cer­tainty risks as­so­ci­ated with these huge in­vest­ments and im­prove re­search and de­vel­op­ment ef­fi­ciency. Fur­ther­more, the large treat­ment naïve pa­tient pool and lower costs also pro­vide abun­dant op­por­tu­ni­ties. On the con­trary, there are many con­straints af­fect­ing the de­vel­op­ment of CROs. The level of cog­ni­tion and ac­cep­tance is lim­ited. Only about 50 per cent po­ten­tial sub­jects are will­ing to take part in a clin­i­cal trial. The de­vel­op­ment and op­er­a­tion of CROs are not ma­ture. Com­pared with the for­eign CRO com­pa­nies, the lo­cal CRO ser­vices are less com­pre­hen­sive, and the qual­ity of ser­vice can be poor. There is a big gap be­tween the au­then­tic­ity and re­li­a­bil­ity of clin­i­cal trial data. The gov­ern­ment su­per­vi­sion sys­tem is im­per­fect. In re­cent years, many reg­u­la­tions are be­ing re­vised to make up for de­fects. There are also com­mon prob­lems, such as the qual­ity of in­dus­try per­son­nel, the poor ex­e­cu­tion of clin­i­cal projects, fre­quent turnover of per­son­nel and low price com­pe­ti­tion.

Where do you see China’s CRO in­dus­try in the next five years?

The CRO in­dus­try will de­velop vig­or­ously in China, with the im­prove­ment of the rel­e­vant reg­u­la­tions and poli­cies of new drug re­search and de­vel­op­ment, the com­pre­hen­sive re­form of the med­i­cal and health sys­tem, and the de­vel­op­ment of over­seas re­search and de­vel­op­ment cen­ters. The growth is ex­pected to be in dou­ble dig­its over the next five years.

Can we ex­pect a CRO in­dus­try boom in China in the com­ing years?

There are many op­por­tu­ni­ties as well as chal­lenges for China CROs. These in­clude the patent ex­pi­ra­tion of in­no­va­tive drugs, boom­ing Tra­di­tional Chi­nese Medicine (TCM) re­search, CFDA im­proved su­per­vi­sion and re­quire­ments on clin­i­cal trial qual­ity, and the gov­ern­ment’s pol­icy on the en­cour­age­ment of in­no­va­tive drug de­vel­op­ment.

In 2019, patents of 11 NCE drugs are to ex­pire in China. Patent cliff will make phar­ma­ceu­ti­cal com­pa­nies face fierce com­pe­ti­tion in generic drugs. CROs can help phar­ma­ceu­ti­cal en­ter­prises achieve ac­cel­er­ated progress in the lim­ited patent pe­riod, shorten the R&D cy­cle, and help bring new drugs on mar­ket sooner, which trans­lates into in­creased de­mands for CROs. The re­search and de­vel­op­ment of TCM is also boom­ing. A few of fa­mous do­mes­tic TCM com­pa­nies have al­ready be­gun to ex­plore pro­mot­ing TCM to global mar­kets, which pro­vide op­por­tu­ni­ties for CROs not only within China but also over­seas.

Since July 22, 2016, then CFDA (now Na­tional Drug Ad­min­is­tra­tion- NDA) has car­ried out a self­ex­am­i­na­tion and ver­i­fi­ca­tion of clin­i­cal trial data of drugs, ex­pos­ing some prob­lems in the field of clin­i­cal re­search in China, such as poor qual­ity of re­search, lack of re­search ca­pac­ity, and non­stan­dard re­search be­hav­ior to fal­si­fi­ca­tion. These find­ings are help­ing pave the way for im­prove­ments to the qual­ity of clin­i­cal re­search and a stricter reg­u­la­tory sys­tem, which have brought both chal­lenges and op­por­tu­ni­ties to the CRO in­dus­try.

The CRO mar­ket in China is closely re­lated to the growth trend of in­no­va­tive drug de­vel­op­ment. The generic drug con­sis­tency eval­u­a­tion and the ac­cel­er­a­tion of drug re­view has pro­moted many large phar­ma­ceu­ti­cal com­pa­nies to trans­form ac­tively from generic medicines to new drug re­search since 2010, which brings huge op­por­tu­ni­ties for the CRO mar­ket. More CRO com­pa­nies are get­ting in­volved in pro­duc­tion and sales. The model of new drug re­search is emerg­ing, that is, VC plus IP plus CRO plus OS. This mode com­bines ven­ture cap­i­tal (VC), in­tel­lec­tual prop­erty (IP), R&D out­sourc­ing and op­er­a­tion sup­port (OS), which bring lots of pres­sure to small and medium sized phar­ma­ceu­ti­cal com­pa­nies.

In ad­di­tion, the re­form of drug reg­u­la­tory pol­icy has helped shape the Chi­nese phar­ma­ceu­ti­cal in­dus­try. The self-ex­am­i­na­tion and ver­i­fi­ca­tion of clin­i­cal tri­als im­posed by CFDA, and the new reg­u­la­tion rec­om­men­da­tion of GCP clin­i­cal trial in­sti­tu­tion no­ti­fi­ca­tion in­stead of cer­ti­fi­ca­tion by CFDA will en­able more hos­pi­tals to un­der­take clin­i­cal tri­als. All these fac­tors con­trib­ute to growth op­por­tu­ni­ties for CROs in China.

Wendy Wang,Man­ag­ing Di­rec­tor, Lini­cal Ac­celo­vance Group, China

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