Chi­na's Foun­tain Med­ical scores $62M as de­mand for CRO ser­vices surges

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, Eu­ropeJapanIn­dia, 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.

Exelixis CEO Michael Morrissey (file photo)

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Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

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Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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