Cir­ca 2016, Chi­na se­cured its sta­tus as the sec­ond-biggest mar­ket for pre­scrip­tion drugs. The soar­ing de­mand for med­i­cines has fu­eled the re­turn of key sci­en­tif­ic tal­ent, the ap­petite for spend­ing on drug re­search and de­vel­op­ment, while Chi­na’s cost ad­van­tage has lured multi­na­tion­al phar­ma­ceu­ti­cal mak­ers to set up R&D shops in the re­gion and stim­u­lat­ed the do­mes­tic CRO in­dus­try. In 2007, a for­mer Quin­tiles (now IQVIA) ex­ec­u­tive set up his own CRO in Chi­na — Foun­tain Med­ical De­vel­op­ment Lim­it­ed (FMD) — and on Fri­day, the com­pa­ny un­veiled a $62 mil­lion Se­ries D round of fi­nanc­ing.

Dan Zhang

The com­pa­ny, set up by Dan Zhang, orig­i­nal­ly tar­get­ed a niche mar­ket that has been ne­glect­ed by both glob­al and lo­cal CROs. Glob­al CROs cater large­ly to multi­na­tion­al phar­ma­ceu­ti­cal mak­ers, as lo­cal phar­ma play­ers are of­ten priced out of their ser­vices. Mean­while, do­mes­tic CROs fo­cus on serv­ing lo­cal drug de­vel­op­ers, since they are not usu­al­ly equipped with the re­sources re­quired to con­duct in­ter­na­tion­al mul­ti­cen­ter tri­als.

FMD was cre­at­ed to “an­swer the needs of in­no­v­a­tive, sin­gle com­pound com­pa­nies en­ter­ing the clin­i­cal stage. They are main­ly lo­cal and in­ter­na­tion­al start-ups that are not ful­ly es­tab­lished yet so most of their fi­nanc­ing comes from the gov­ern­ment or grants. Nor­mal­ly, they would be look­ing to start Phase I clin­i­cal tri­als,” Zhang said in an in­ter­view ear­li­er this year with C-suite pub­li­ca­tion PharmaBoard­room.

The CRO in­dus­try in Chi­na — which in­cludes glob­al play­ers such as IQVIA, Lab­Corp and Parex­el and do­mes­tic out­fits in­clud­ing Wuxi AppTec, Phar­maron, and Mei­di­cilon — was worth about $9.7 bil­lion last year, ac­cord­ing to da­ta com­piled by mar­ket re­search com­pa­ny Re­portLink­er, which es­ti­mates that num­ber will climb to rough­ly $34.3 bil­lion by 2025.

In 2017, Chi­na joined the In­ter­na­tion­al Coun­cil for Har­mo­niza­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), an or­ga­ni­za­tion that brings to­geth­er reg­u­la­tors of the bio­phar­ma­ceu­ti­cal in­dus­try glob­al­ly to as­sess the sci­en­tif­ic and tech­ni­cal as­pects of drug de­vel­op­ment.

With the stan­dard­iza­tion of clin­i­cal re­search in Chi­na through ICH, FMD is now fo­cused on at­tract­ing bio­phar­ma play­ers — in­clud­ing the small­er sin­gle-com­pound biotechs from the Unit­ed States and Eu­rope who pre­vi­ous­ly would have out-li­censed their prod­ucts to multi­na­tion­al phar­ma com­pa­nies or to lo­cal Chi­nese com­pa­nies — to Chi­na.

The new in­jec­tion of funds will en­able “Foun­tain Med­ical to ex­pand and im­prove our ser­vice of­fer­ings to ex­ist­ing glob­al clients, and bet­ter cater to the needs of Chi­nese phar­ma­ceu­ti­cal com­pa­nies with glob­al as­pi­ra­tions as well as multi­na­tion­al com­pa­nies with Chi­na as­pi­ra­tions,” Zhang said in a state­ment on Fri­day.

This round of fi­nanc­ing for FMD — which has more than 1,700 em­ploy­ees world­wide cov­er­ing 55 cities in Chi­na, as well as ma­jor de­liv­ery cen­ters across the Unit­ed States, Eu­rope, Japan, In­dia, and the Philip­pines — was led by Gold­man Sachs, with Lil­ly Asia Ven­tures as co-in­vestor.

Be­fore co-found­ing FMD, Zhang worked with Sig­ma-Tau Re­search as well as Quin­tiles. He is a mem­ber of the grant re­view com­mit­tee for the Na­tion­al Drug De­vel­op­ment Fund of Chi­na and serves as a con­sul­tant for the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA). He is al­so a mem­ber of the ICH E19 Ex­pert Work­ing Group.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.