The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest grow­ing re­gion glob­al­ly for cell & gene ther­a­py tri­als rep­re­sent­ing more than a third of all cell & gene stud­ies glob­al­ly, with Chi­na lead­ing in the re­gion. 

APAC is the lead­ing lo­ca­tion glob­al­ly for CAR-T tri­als with Chi­na at­tract­ing ~60% of all CAR-T tri­als glob­al­ly be­tween 2015-2022. The num­ber of CAR-T tri­als ini­ti­at­ed by West­ern com­pa­nies has rapid­ly in­creased in re­cent years (cur­rent CA­GR of about 60%), with mul­ti­ple tar­gets be­ing ex­plored in­clud­ing CD19, CD20, CD22, BC­MA, CD30, CD123, CD33, CD38, and CD138.

Novotech, the lead­ing Asia Pa­cif­ic biotech spe­cial­ist clin­i­cal re­search or­ga­ni­za­tion with op­er­a­tions in APAC and the US, has ex­ten­sive ex­pe­ri­ence in cell & gene stud­ies.

Chi­na has a sup­port­ive pol­i­cy en­vi­ron­ment pro­mot­ing a fa­vor­able cell and gene ther­a­py ecosys­tem that in­cludes:

• World-class sci­en­tif­ic ex­cel­lence
• FDA-ac­cept­ed clin­i­cal tri­al da­ta
• The world’s largest pa­tient pop­u­la­tion – which fa­cil­i­tates re­cruit­ment
• Gov­ern­ment sup­port for cell ther­a­py tri­als with ex­pe­dit­ed ap­proval process­es – short­ened the ap­proval time­line to 60 work­ing days
• De­vel­op­ment of re­gion­al in­fra­struc­tures such as cell stor­age and lo­cal man­u­fac­tur­ing fa­cil­i­ties
• In­ves­ti­ga­tor-ini­ti­at­ed cell ther­a­py tri­als, which are wide­ly con­duct­ed in Chi­na, ac­cu­mu­late valu­able da­ta across the dif­fer­ent in­di­ca­tions
• Top on­col­o­gy dis­ease treat­ment fa­cil­i­ties in Chi­na de­liv­er a prac­ti­cal ex­pe­ri­ence in cell and gene ther­a­py re­search
• While CAR-T re­search can be ex­pen­sive, APAC costs are on­ly about 40-50% of West­ern coun­tries
• Chi­na has the world’s sec­ond-largest phar­ma­ceu­ti­cal mar­ket
• Adop­tion of in­ter­na­tion­al reg­u­la­to­ry guide­lines (ICH)

Pa­tient Re­cruit­ment Dri­vers

The APAC re­gion and specif­i­cal­ly Chi­na show strong me­di­an pa­tient re­cruit­ment rates and short­er en­rol­ment pe­ri­ods com­pared to the US and Eu­rope.

The com­pelling da­ta around re­cruit­ment in­clude:

• Chi­na shows en­roll­ment pe­ri­ods 25% short­er than the US and 20% short­er than Eu­rope.
• The APAC re­gion shows en­roll­ment pe­ri­ods al­most 40% short­er than the US and 35% short­er than Eu­rope
• Chi­na and APAC show 4 times faster me­di­an pa­tient re­cruit­ment rates than the US and Eu­rope.
• The APAC re­gion shows en­roll­ment pe­ri­ods al­most 40% short­er than the US and 35% short­er than Eu­rope

On­col­o­gy Cas­es

Chi­na ac­counts for 24% of the new­ly di­ag­nosed cas­es glob­al­ly.  In 2020 Chi­na had about 4.5 mil­lion new can­cer cas­es, as well as 30% of can­cer-re­lat­ed deaths world­wide.  Among all glob­al CAR-T stud­ies, about 60% have Chi­na in­volve­ment. Over the past 5 years, the growth of on­col­o­gy tri­als (CA­GR of 25%) in Chi­na out­paced all oth­er coun­tries.

“The num­ber of clin­i­cal tri­als in Chi­na in­creased by 20% in 2021 and on­col­o­gy rep­re­sent­ed around 40% of all clin­i­cal tri­als, with the ma­jor­i­ty of these be­ing Phase 1 stud­ies.”

Cell & Gene Ther­a­py Land­scape in APAC

On­col­o­gy tri­als oc­cu­py the ma­jor­i­ty of cell & gene ther­a­py tri­als fol­lowed by in­fec­tious dis­eases, CNS, and car­dio­vas­cu­lar dis­eases. Blood can­cers, vi­ral in­fec­tions, and sol­id tu­mors are the ma­jor on­col­o­gy in­di­ca­tion types in cell and gene ther­a­py tri­als in the Asia Pa­cif­ic.

APAC shows near­ly 50% faster growth rate in cell & gene ther­a­py tri­als than the ROW be­tween 2016 and 2021. Chi­na shows a 15% faster growth rate than the ROW.

Re­gion­al­ly, Chi­na, Aus­tralia, Japan, South Ko­rea, and Tai­wan are the lead­ing lo­ca­tions par­tic­i­pat­ing in cell & gene ther­a­py tri­als in APAC.

Chi­na Reg­u­la­to­ry and IP Spot­light

Chi­na con­tin­ues to align with the In­ter­na­tion­al Coun­cil for Har­mo­niza­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), with more than 70% of ICH guide­lines now im­ple­ment­ed. Im­por­tant­ly al­so the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) was re-elect­ed as a mem­ber of the ICH Man­age­ment Com­mit­tee in June 2021.

In ad­di­tion, The Cen­ter of Drug Eval­u­a­tion (CDE) guide­lines on the clin­i­cal de­vel­op­ment of on­col­o­gy and rare dis­ease drugs re-em­pha­size pa­tient-cen­tric, and clin­i­cal-val­ue-ori­ent­ed de­vel­op­ment on par with ICH.

Chi­na al­so har­mo­nized IP pro­tec­tion with glob­al, with the new patent law ef­fec­tive from June 2021 re­search or­ga­ni­za­tions.

How to in­clude Chi­na in your clin­i­cal de­vel­op­ment strat­e­gy

Novotech has just re­ceived the Asi­a­Pa­cif­ic Cell & Gene Ex­cel­lence Award 2022: Clin­i­cal Tri­als