Drug­mak­ers ap­plaud ac­cel­er­ated ap­provals

Pa­tients to ben­e­fit as break­throughs take less time to come to mar­ket, while in­creased com­pe­ti­tion helps to lower costs

China Daily - - BUSINESS - By LIU ZHIHUA li­uzhi­hua@chi­nadaily.com.cn

China is ap­prov­ing for­eign drugs at a record speed, which in­dus­try sources said shows the coun­try’s com­mit­ment to fur­ther open­ing up its health­care sec­tor and sup­port­ing in­no­va­tion.

Since 2016, the coun­try has adopted a se­ries of pol­icy amend­ments to speed up new drug ap­provals, as part of its widespread re­forms in health­care, open­ing-up, and im­prov­ing mar­ket ac­cess.

A state­ment is­sued af­ter the an­nual Cen­tral Eco­nomic Work Con­fer­ence in De­cem­ber said China will work to pro­mote tech­no­log­i­cal in­no­va­tion and foster new in­dus­trial clus­ters, and build a uni­fied and open mar­ket sys­tem with orderly com­pe­ti­tion.

It also said that mi­cro mar­ket en­ti­ties will be fur­ther mo­ti­vated and en­er­gized, with the es­tab­lish­ment of fair, open and trans­par­ent mar­ket rules and a law-based busi­ness en­vi­ron­ment.

“China is open­ing up its lu­cra­tive phar­ma­ceu­ti­cal mar­ket to the out­side world with a de­ter­mi­na­tion never seen be­fore,” said Liu Guoen, an econ­o­mist and health­care re­form spe­cial­ist with the Na­tional School of Devel­op­ment, Pek­ing Univer­sity.

“The ac­cel­er­ated ap­proval and a more open mar­ket are good for ev­ery­one,” he added.

Widely ac­claimed re­forms in the drug reg­u­la­tion sys­tem in re­cent years in­clude fast-track ap­proval for treat­ments ad­dress­ing se­vere or rare dis­eases, ac­cep­tance of global clin­i­cal trial data, and fast and easy ac­cess to clin­i­cal trial regis­tra­tion.

More than 100 for­eign-de­vel­oped drugs were ap­proved for the Chi­nese mar­ket in 2018, ac­cord­ing to a re­port re­leased in De­cem­ber by global man­age­ment con­sult­ing firm McK­in­sey and Co.

In an­other re­port re­leased in May 2018, the con­sult­ing gi­ant de­scribed the re­forms as be­ing “in full stride” and said there would be “a tsunami of new-prod­uct launches ex­pected”.

It ob­served a record num­ber of ap­provals and new prod­uct launches in 2017: a to­tal of 37 new prod­ucts ver­sus a mere five or six be­tween 2014 and 2016.

By the end of 2017, it found that some 180 can­di­dates had been granted pri­or­ity re­view sta­tus, each of which would be gear­ing up for launch in the com­ing years.

McK­in­sey at­trib­uted the in­creases mainly to China’s re­forms in drug reg­u­la­tion, and in­creased mar­ke­tac­cess.

China was the world’s sec­ond­largest na­tional phar­ma­ceu­ti­cal mar­ket in 2017 — worth $122.6 bil­lion, af­ter the United States, and also the big­gest emerg­ing mar­ket for phar­ma­ceu­ti­cals with growth tipped to reach $145 bil­lion to $175 bil­lion by 2022, ac­cord­ing to health­care in­for­ma­tion com­pany IQVIA.

Quick­ened ap­proval for new drugs and the fur­ther open­ing-up of the Chi­nese mar­ket prom­ises a faster and bet­ter sup­ply of cut­ting-edge medicines to Chi­nese pa­tients, who in the past of­ten waited for years for new drugs de­vel­oped by for­eign com­pa­nies, af­ter they first launched in other mar­kets, ac­cord­ing to Liu, who is also mem­ber of the State Coun­cil’s health­care re­form ad­vi­sory com­mit­tee.

Such changes pro­vide great growth op­por­tu­ni­ties to both do­mes­tic and multi­na­tional phar­ma­ceu­ti­cal com­pa­nies, with fore­see­able hikes in rev­enues, as new drugs are launched into China, said Liu.

In his opin­ion, multi­na­tional phar­ma­ceu­ti­cals would get greater ben­e­fits than do­mes­tic ones, be­cause of their lead­ing po­si­tion in in­no­va­tion and new treat­ment re­search and devel­op­ment.

Mean­while Chi­nese lo­cal firms, es­pe­cially tra­di­tional drug mak­ers, of­ten rely on gener­ics for a large share of sales and rev­enues, and lag be­hind in de­vel­op­ing new drugs, he noted.

Shi Lichen, an in­dus­try an­a­lyst and founder of Bei­jing Dingchen Med­i­cal Con­sul­tancy, said such a sit­u­a­tion is good for the do­mes­tic phar­ma­ceu­ti­cal in­dus­try in the long run.

Chi­nese com­pa­nies will have to in­vest gen­er­ously into in­no­va­tion to forge their R&D abil­i­ties, now that they have to com­pete in a fair mar­ket that is com­pe­ti­tion-driven and in­no­va­tion-fo­cused, where fast ap­proval will bring an in­creas­ing num­ber of drugs ap­proved, he ex­plained.

A va­ri­ety of the world’s big pharma firms have ap­plauded the eas­ing mar­ket ac­cess.

No­var­tis AG said in the past two decades it has re­ceived ap­provals for 44 in­no­va­tive drugs from the Na­tional Med­i­cal Prod­ucts Ad­min­is­tra­tion (for­merly the China Food and Drug Ad­min­is­tra­tion).

Num­bers then spiked to 12 in 2017, and 10 in 2018, due to the speed up of ap­provals.

In 2017, 10 of the com­pany’s drugs were in­cluded on the na­tional med­i­cal in­sur­ance list. In 2018, four of its can­cer treat­ments were added to the na­tional can­cer ther­apy in­sur­ance pro­gram.

United King­dom-based As­traZeneca PLC has been an­other drug­maker to ben­e­fit from faster ap­proval times, via the pri­or­ity re­view path­way. In March 2017, China green­lit the firm’s lung can­cer pill Ta­grisso, just 15 months af­ter it was ap­proved in the US — a record for re­cent years.

Last month, China be­came the first coun­try to ap­prove Roxadu­s­tat, a first-in-class treat­ment for ane­mia caused by chronic kid­ney dis­ease in pa­tients who are dial­y­sis-de­pen­dent, co-de­vel­oped by As­traZeneca China and Fi­broGen China.

Novo Nordisk A/S, a global di­a­betes medicine pro­ducer, also ben­e­fited from the fast-track pri­or­ity re­view path­way, af­ter get­ting Tre­siba, an ul­tra-long du­ra­tion basal in­sulin, ap­proved in Septem­ber 2017 by the Chi­nese drug reg­u­la­tor.

Chris­tine Zhou, se­nior deputy pres­i­dent at Novo Nordisk, spoke highly of the Chi­nese govern­ment’s de­ter­mi­na­tion to fur­ther open up the mar­ket, and ease mar­ket ac­cess.

Fast ap­proval helps pa­tients gain eas­ier ac­cess to high-qual­ity health­care, and also sig­ni­fies China’s pledge to fur­ther open up its mar­ket to for­eign com­pa­nies, she said, adding the Chi­nese mar­ket is now one of the most at­trac­tive mar­kets in the world.

China is al­ready the com­pany’s sec­ond-largest mar­ket, she said, ob­serv­ing the Chi­nese health­care in­dus­try to­day en­cour­ages in­no­va­tion, and fo­cuses on qual­ity and ef­fi­ciency.

The com­pany plans to bring 10 in­no­va­tive medicines to China in the next seven to eight years.

It also aims to get ap­proval in China si­mul­ta­ne­ously to other coun­tries and re­gions, so that Chi­nese pa­tients will have timely ac­cess to its medicines.

Miao Zhon­grong, a top ex­pert in cere­brovas­cu­lar dis­ease at Tiantan Hospi­tal in Bei­jing, said the fast ap­proval and eas­ing of Chi­nese mar­ket ac­cess is def­i­nitely good for pa­tients, who can have ac­cess to more new drugs at rel­a­tively lower prices, es­pe­cially for can­cer treat­ment.

How­ever, he said a speed up re­view and ap­proval of new drugs should not be at the cost of a drop in drug qual­ity.

The econ­o­mist Liu said Chi­nese drug reg­u­la­tors should ex­pand their staff num­bers, to meet the ex­pected de­mand for new drug ap­provals.

China is open­ing up its lu­cra­tive phar­ma­ceu­ti­cal mar­ket to the out­side world with a de­ter­mi­na­tion never seen be­fore ...”

Liu Guoen, an econ­o­mist and health­care re­form spe­cial­ist with the Na­tional School of Devel­op­ment, Pek­ing Univer­sity

XIN­HUA

A re­searcher tests a new vac­cine prod­uct at a re­search lab­o­ra­tory in Kun­ming, Yun­nan prov­ince.

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