HUTCHMED (HCM) 1 Aug 222022 Q2 Earnings call transcript

Dr. Marek Kania, our Managing Director and Chief Medical Officer of HUTCHMED International. Dr. Karen Atkin, Chief Operating Officer and Mr. Hong Chen, our Chief Commercial Officer of China. hand Dr. will I that over to With Su.

Thanks, everyone. Mark. Hello

goals know biotech you to going our through As stay objectives. is on trying some the is industry all HUTCHMED significant focus and changes.

XX% deliver disruptions. Staviga half third-line XXXX, CRC. share the Commercial grow fulfilling, delivered During a the reduction. continue improved second NRDL growth SULANDA this [ph] to grew to aided strong Yet the compared XXXX. was the gain HUTCHMED XX%, with particularly COVID first widen. results, sales from for of into patient continues continued The included China year access. to strong to price lead by much and of ORPATHYS half ELUNATE impact also prescription considering in sequential

while U.S. were surufatinib withdrawn. we now MMA the by FDA and pipeline, of disappointed On CRL the

pipeline Our to deep and broad progress. continues

global Our followed begin filings will registration read first out the NDA starting towards the for end year, MRCT in positive, Japan. will And EU the and from multinational if fruquintinib August. shortly by of U.S.

Registration approval. continuing XXXX. An of For are for including all expected disclosed XXXX for The enroll global SAFFRON for and and with NDA cancer PRCC lung is are cell during non-small study, filings for studies in submissions sovleplenib and potential for accelerated multiple shortly, our wave enrolling. amdizalisib, also second studies products, tazemetostat WCLC data to SAVANNAH in registration China as MRCT be SAMETA savolitinib, to enrolling.

has setback COVID cash difficult in in we commercial challenges stronger. cap China. team we very with operation is generative and cash Finally, confident, as challenges, dealing managing HUTCHMED to market management over The disruption changes balance our solid unfavorable experienced history. through these a overall the and are or from gone right able Surufatinib stretches in And challenges. China, now. has be emerge in will many HUTCHMED such the a

half first to Officer, Mr. on an Chen? performance. Chen, give Chief update China ask Hong oncology Commercial I'll China commercial Next,

you, in see in-house through had HUTCHMED of Hello HUTCHMED renewal slide, the a successful and approved platform. its market and after Weiguo. only SULANDA China price is ELUNATE with decrease, for commercialization X% everyone. can continued ELUNATE half own also three this this Thank From and commercialize year grow we already year. NRDL XXXX to strongly innovative to products second first

sales The patients, the was it as than RMBX May, billion. last ELUNATE more million XX% market more XX% US$XX patients ELUNATE CRC and away. of launches in achieved XX,XXX sales expand a first continued cumulative leading with months six latest to third-line growth already CRC during position By than benefited in already the than more end in-market year. versus to of the post share

slide Next please.

created price sales XXX% sales see the first of XX% For over We already SULANDA SULANDA. of numbers access much cuts, year by new which for SULANDA. still of was wider NRDL was can in XX% patient growth half by US$XX.X this XXXX. the the to despite value increased of terms whole allows inclusion up The the to million patient in year,

it This savolitinib please. slide was for Next first is June anniversary year in year. since last the approved

of XX% versus of by market million increased the The first US$XX.X year. second year half this to last sales half in

non MET in small standard lung recommended new the already guidelines. lung inhibitor for MET cell As late the exon stage And non-small is with of treatment first-in-class care diagnostic for cancer five selective in patients is [Indiscernible] cell testing cancer. savolitinib now skipping recommended treatment with China, of XX as

of commercial is at Our working the negotiation on proactively coming end this AstraZeneca preparation now partner, the NRDL for year. the

XXX HCPs More staff, digital especially summary capabilities. new online can promotional X more highly team be size more in year X the Tier the mitigate of events first hospitals effective as a a of increasing This slide We can is and communication cities. were high XXX to More please. and challenges. Tier than through to with Next level covered say covered than half hospitals commercial HUTCHMED and well. and and slide especially COVID in half executed this the in first more

example, events XX,XXX we first held with can HCPs also we more events of growth SULANDA last by For year. versus more half we more more XXX% than see than XXX% than And growth. than ELUNATE X,XXX with the covered

progress very team we the continues continue challenges, of confident continue over in commercialize to in So of year. build this to this to market stress- year. Thanks. the overall, half momentum despite go good from as to-stress this I'm three our to to balance the China COVID make first products commercial of our

and Okay. please. Weiguo Marek,

Hong Thanks, Chen.

Moving on the progress. pipeline to

pipeline grow. Our continued clinical development to

HMPL-AXX anti-CDXX in-license into And for study. Our antibody bridging product X initiated entered our Phase tazemetostat first China the study registration. the

COVID impact studies some has XX Next. delay the China registration outbreak and Generally are estimated China. This filings. half NDA possible ongoing on most and slide we anticipating the first some both lists timeline for with in in speaking, for enrollment studies globally,

savolitinib China. the are Three studies globally all enrolling. and Again, and for slide. registration Next seven they four in

the of definition. is slide. IHC-X PFS. and interim GCN you now XXX SAFFRON's These presented can gene identify patients, MET XX% to including The In activation, SAVANNAH patients MET additional, XX% data a tumor between difference And the were activation, TAGRISSO at less This this subgroups with supported all global data, highlight and data MET be than greater copy for study, greater these information in an five efficacy XX. and with OLR, two than activation MET And see, which most or inform both patients, DLR there high. cells, other is The copies. moderate is with high than study, XX% registration a XX% the clear plus and is XX moderately the namely plus high things, number underway. Next the of or ICH-X is among of important progressed WCLC. to on biomarker from

slide. Next

mutations, driver as amplification. such net addition exon alterations, In or skipping XX, targeting to genetic

Currently, strong in driven partner, study and savolitinib, to small published durvalumab which preparing of HGF cancer. lung registration sub is benefit year. Last is AstraZeneca target patients clinical are ongoing MRCT of global MET start study appeared the area same We to immunosuppressive the cell pathway. year, the non combination. study. of explore our in Another the derive from to treatment now the SAMETA driven is signaling later CALYPSO role the to enroll interest the MET this robust combination MET The expected we PRCC

Next slide.

of you an and me outside Moving on to update. to let fruquintinib ask colleague, Kania, the Dr. HMI China, give CMO surufatinib clinical development Marek for my Managing and Director

Hello, latest Thank you Thanks. developments I give update everyone. quick you, will a Weiguo. on globally. our

and on you high fruquintinib was our that. main really see patients As driving high can burden on and colorectal housing focus HUTCHMED to medical in continues cancer with and unmet focus needs to this this find therefore slide solutions

second the common two see, the and for can quickly in second patients you third-line of therapy are As is options. of most approved type use in Only line standards running options the cancer patients. total XX% out are less

next this means being And strong developed and in setting. highlight that's rationale for please. strong slide frequently So

driving few six our months multinational through slide the Last the times on our past. line. the focus MRCT and strong was seen study second in finish go pivotal FRESCO-X, you which is As

We are predictions narrowing our actually here.

your line medical in conference will August, results hence very presenting We results be upcoming seven of for top in soon. position

PMDA regulatory all Europe, started discussed FRESCO-X for both Japan protocol therefore it MAA finalizing and reminder, the NDA, Just And has [Indiscernible] discussion. in efforts will as was is a participation with the contract. study. before FRESCO-X if major Japan strong in agencies positive, be U.S., and

it will from So position with a view effort, this our to be global start our truly point global of regulatory -- strong mission.

will U.S. starting in stress us rolling Therefore, very this late FDA U.S. reminder, we'll FRESCO-X positive. talking fast -- a track more this year grant submission soon. designation. is As Again, granted about be afford it and

update. please. slide Next Surufatinib, quick

conducting U.S. reasons this in similar to earlier April/May with Main to regulatory not the to European and to limitations withdraw conducting the going inspections, discussions on to Europe. in summarized response both NDA next which both are in decision bring we our Today, complete objections slide, TCP similar to MRCT. of perspective, discussed addition really and passing have about and MAA and focusing limitations in GMP, this. in development, of concerns more and phase announced withdrawal fast-forwards from regulatory highlight our influences We highlights in I'm

study PMDA of that name this For different in conducting for And bridging a term. discussion on the below are be pivotal the at study Japan, a in part we we conclusion for PMDA study. are would Japanese regulatory two approaching

I Next Back you. think will you to slide. this Weiguo, slide, covering be please.

Thanks, Yes. Marek.

a is designation oc to in covering therapy valuable several in in Amdizalisib, move of on second development. pretty space, discovery. spectrum. clinical HUTCHMED our stage in An onc both entire with Now, late All heme compounds programs in onc heme more breakthrough wave with believe Sovleplenib, much has China. We six this assets hem development pipeline let's highly

slide. Delta studies. profile Next our in continued Phase inhibitor Amdizalisib, differentiated with good X PIXK to enroll registration two has safety

of subtypes compounds. The evaluated lymphoma. MCL third-line FDA April and Outside possible light will above lymphoma on Delta it the the for other and ODAC follicular plus of maturing or studies. for are and additional of marginal Data including in second-line PTCL zone China class still PIXK registration be

expanding in patient the enrollment post are or in BTKiMCL demonstrate differentiation and to priority We a the confirm subtypes with several PTCL.

is data, upon promising in be profile, intention not population ASH was Delta more when existing remind The improve only this safety in population. year discovered inhibitors which of we much efficacy patient Let patient you now also to the our at larger center obviously U.S. last that further published also me amdizalisib but question. showed needs the and confirmed was safety favorable data profile, PXXK to

as also the addition, In combinations tazemetostat. such inhibitor EZHX considering

ITP strong Next inhibitor X little suggesting this study medical impact enrolling China, slide. registration patient well unmet in the from Phase population. a COVID, the a with in very Savolitinib, need second in is

two data space, anemia, an preparing population. autoimmune COVID-XX We have complete expansion in to medical designation. study in in Phase we China, Outside death where potential. indication end the and a INDs breakthrough continues therapy encouraging strong ITP and this by for IND activity of enrollment priority Behind with another severe year. X China post unmet POC in ITP, explore for submit patient and lymphoma to the this to been explore cleared Another Hodgkins to to dose of the from rate China, in indications study to hemolytic in the its reduce the are one based have we to critical needs hope BTKCLL anti-inflammatory on addition, enroll

Next slide.

Taz Our comparing a together RX Safety in-licensed second-line At taz indications sarcoma SYMPHONY-XX encouraging be the RX. just EZHX taz plus were global support our monotherapy. for Run-in parallel, as MRCT will versus China Multiple a initial follicular combination and epithelial registration. follicular in RX China study, special approval. kicked in partner as to will XXXX based X province Data approved bridging been Hainan has very in of is a study proof-of-concept in studies being lymphoma. monotherapy. tazemetostat, present with approved follicular the the global in off combination Epizyme, registration planned. tazemetostat with in inhibitor in registration U.S. ASCO, the to been initiated it and on we the China pathway support through part In also U.S. The China safety a of the second-line, efficacy has are Phase the

update this the on assets. So last-stage

to us give the I'll on an financials, Cheng, Johnny? CFO Next, update Johnny

Su. Weiguo you, Thank

page, moving So the on next please. to

So, maintains sheet. balance company June of a strong as

million. banking and of facilities short term utilize and cash $XXX over million $XXX investments have We of over a [ph]

addition, In Shanghai have our another fund. cash with joint $XX we million in venture

So the commercial million, of increased to of double teams resulting which run $XX to cash XX% to than million. performance more over target the Move page. by revenue rate to group over our year business to on three oncology than is revenue years. strong more The $XXX extend our of overall, last our next by up

to increase in to continue $XXX well R&D U.S. million we in as the China So as over our in and Europe. investment

increased of to So equity investees million. $XX XX% the over popularity our by

Moving on to the next page please.

assets non-core continue well. to Our do

it billion to can net group. has than all more $X.X income as the So see, contributed you

to to assets additional support we provide unlock explore value our to ways R&D So cash the these continue investment. to resources of

next Moving page. the to on

earlier, heard immunology I all earlier, $XXX Chen gave have now our pass million we our from Weiguo. is oncology you on our $XXX commercial that the performance, we for As and will to to with will our strong Hong business. million maintain performance, guidance market

and while the on Johnny. HUTCHMED to continues commercial to strives recap, operations stay Thanks To change macro focused Okay. progression. environment all pipeline

strong China continue We the expect momentum in that second half. in to commercial

a the deep August, and registration from EU the of the PLC the lifecycle second and pipeline starting engaged wave on at continue expand products; the China, same On robust data, amdizalisib, a in three will have which FDA a We in starting a both generating NDA we Amdizalisib in out China, it registration savolitinib if U.S., and approved candidates, and the and disappointment. case significant fruquintinib, sovleplenib sovleplenib Outside is and our we to tazemetostat a and a Fruquintinib, Surufatinib positive Japan do to end have surely be are define pathway indications moving registration. MRCT the the with XX the unique of of time the to will in the behind multinational believe drug has impact strategy it on pipeline next and will surufatinib for a towards to six months. year. and from And read discuss while been and pipeline. rest filings

are though long unfavorable that to a equity solid we we would balance, like have even through manage I out potentially cash market. to prepared Finally, point lasting

our spend clinical operations to carefully we cash programs that reviewing make are prudently. and sure We

look will collaboration finally, income. further generate We we licensing China And activities. to in our also to business to and efforts grow all more up plan

environment current is challenged. Our

have team This is our We difficult able we well from experienced management the first period are through stronger. to we conditions. confident the and not will difficult time that market even emerge be leverage that managed

any The to So questions. this team be answer presentation. management happy our wraps up will

Ladies and and now question session. gentlemen, we start our [Operator answer Instructions]. will

come Jeffries. ahead. comes Shi The go Please from Kelly first one from from

thank Congrats taking on the for the and my progress you questions.

from in a for issues Phase X global again, China comprehensive do on you an X a the trial, which and pathway regulatory U.S. a Phase trial trial, the potential the regarding clinical FRESCO FRESCO that of provide should with a information. So CRC? population, fruquintinib the But to to U.S.-based see suru, have any experience topic data patient U.S. also the in applicability and a there's package Thank of And S. FDA up. U.S. like a approval U potential previous while the you. follow the support discussion regarding to medical current also meetings? U.S. And practice,

matter, Thanks, Kelly. obviously, the U.S. representative in FRESCO-X which and strategy will centered is Well, the MRCT and be obviously, patient that obviously in for Okay. population. fruquintinib for registration on the study elsewhere

also China and think, will supports. all I study as the FRESCO FRESCO, studies early the original serve in study, other clinical stage

So expect kicked we don't with before off the and the FRESCO-X. previous we actually we certainly agency discussion issues had any as well

case. issues, if should have are different Marek you actually you else completely add. that want we So, this confident now quite to anything -- MRCT cover most surufatinib from Maybe

Yes, you. Weiguo. Thank

FRESCO Now just and were of I would do nothing just add and my voice to surufatinib confidence as you unique. said well, with

designed of We have discussions idea considered U.S. transparent totality FRESCO-X as very is and how in FDA and in we pivotal very meeting the with in main collaborative which be FRESCO-X the FRESCO-X study. well. in were numerous was this will the study, way package we formal and

three if based So regulatory we on FRESCO-X continental be that are confident very would discussion. positive, is

the provided FRESCO-X with to comments As already have before, who design. also we advisor scientific reported we EMA,

study. Europe with pivotal have PMDA. we the the discussion time, same same So FRESCO-X primary will At be

remained here. in we strategy confident have very our So

Thank also about to much. up how have in the Great Ts hear. China competitive How should China given indications a the those lymphoma I there U.S. CAR opportunity are few PIX we very Thanks. in entered the entering follow a kinase landscape have the also inhibitor. in of lymphoma regarding market you market anti-CDXX versus and and think CDXX market market. indications? different bispecific the in antibodies a for the And

Yes.

be We also or should safe it's competitive biologics oral. all strong and believe it used So edge, can after treatment a to have PIXK because safety these tolerability before how if and and it down the proven Delta, obviously, comes efficacious. very

diseases As for will these patients relatively treatment have on indolent you to and a very stay long are time. know,

tolerability and safety So important. is extremely

ultimately Some But of recurrence. benefit single not still confirmed. have these progress they for the patients patients, be bispecifics all Car again, to and data. has even can T studies are all or for shown some works and remain strong arm some but

So, need new --patients indolent long to repeatedly. for they time. patient live to they and all-in-all live a up population, we rotate therapies believe And lymphoma

PIXK inhibitor. believe has safe and So tolerable Delta We a for that patients. its place good these efficacious

Very helpful. Thank you.

the Operator? to Move Thanks. next.

from Goldman Sachs. Paul Hello. Choi

Your is open. microphone

thank questions. Good and you. Thank you evening, taking our for

ones couple start of to question. then financial one a quick and Just pipeline

that any on built then regard And the to maintained, would First, to with and question there and included to year your what the end the pushes some current maybe full that view pulls the newer a NRDL? the end? at inventory higher then of be drive being the was were results end with up. pipeline I environment you respect to guidance the products can macro you of to follow lower had And might how versus sort the speak

Yes, we some -- the lock the downs, that some believe June, of Paul. depletion and With of inventory anything, moment level kind regard to from If it's the April, a May inventories. at level. during inventory, into depletion was normal of there

push and or the at pull. think of second have we are confident the momentum quite continue. the we the to disruptive are else inventory. we you whether And moment, regard concerned can somewhere, it quite COVID-XX, another will a a think be about I level outbreak can somewhere think bit half, basically. and with Again, normal we now at it's So, the And

a bit predict So the situation. uncertain. that remains can Nobody

and Although and doctors online putting our team place distribution visit, multiple we and including have the inventory been once conferences, gone online through also is measures, the in management.

are depending nevertheless, COVID lock be obviously. scale, to better outbreak in issue, now But can deal downs positioned So, an potential China the any believe it on with we with we potential.

higher we can hopefully we within that do guidelines. able better we'll optimistic cautiously be are deliver the towards And end. the So to

would COVID. of think the uncertainty headwind the the have I only So be

is, for pipeline you'll of half taking detail the a our second in to know in imminently we results have for more at XXXX? questions. Thank you here August. medical And in meeting Is up the follow the have plan to question that. as will until FRESCO-X a there Thank XXXX? my I you wait data present Okay. here a Or

Marek, Yes. want. if you

Yes, I take can it.

conference. disclosure principal a of is as level our possible in obviously, important Paul, in full quickly So set a both data, major also, as as data announcements but expeditiously,

So soon exact being I'm but and as that. we short always year. confirmed. conference, for to it confirm as position when location and conference, not We'll be this can of here timing speculate, you go in our definitely separate but have have is and aim possible But announcement which accepted as obviously will major the

year. This

you very Thank Okay. much.

Yes.

We have Panmure another Please ahead. question from Gordon. from Mitchell Mike go

Good in everyone. oncology wondered have afternoon, the you're Thanks. continuing commercial couple. my Many for team. just terms questions. current a add thanks taking of significantly the just I to I organization, to

I say physicians but is XXX have now, starting of off covered people you think oncology somewhat. the number flatten over you to

terms also So question structure? business. terms the process looking then just data way important for optimal and looks of on organization out, global the paving clearly, if in But in we then potential Savolitinib, how the wondered of strategy of for the of at the towards you're which global widely then probably outside story, more little fruquintinib and just hope, that sort NDA. way are of out SAFFRON the a global the as global doesn't think SAMETA I play is terms And now and China commercial strategy FRESCO-X regulatory a in the

recap you So, could terms please? context, just if I that TAZVERIK Thanks. global wondered in

in optimal commercial now portfolio the China, products. we to are current the regard this organization, around is for With believe the staff. of Mike. We scale XXX Thanks Okay.

grow don't we intent to So further.

staff. the we'll productivity focus of driving from efficiency driving we and on However, instead current

registration. So, global second with regard your on fruquintinib to question

you FRESCO-X have And anxiously to things a wait can know, out. first, to a all don't kinds you think And of add? anything the this all wealth at data need just FRESCO-X for I of scenarios, I read there data accumulated the want out. first waiting think, I MRCT have personally fruquintinib you else serve until if as amount -- read we Marek global be to like pivotal. we but

outcomes, are data, and including You the of view other given outcome, given in thinking said of number we a like addition of it our study the about wealth one well. obviously, positive Obviously, studies. to negative proximity positive

Our approximately of given use different lines cohorts study confident normal study make about in will And reason. concerned the prior pivotal lines is positive results course. demonstrated. with of our study, studies study, to we probability are this from therapy a the consistence anticipation, There success but of and for we in circumstance we are benefits first do of let's nothing clinical a XX% across already doing any one again, but U.S.

planning will science. we we finish cross negative success in outcome for case adjust are the for now. well surprise Let's and And according line. if But a

was Okay. want That's angle off to the fair. maybe related address? Do global one I next think SAVO you And to question. that

post the FDA you and Are surufatinibr? obviously, of Well, CRL talking about MRCT. recommendation considering also

No.

to think surufatinib, development question both programs case was Savolitinib from that global in negative will important?. focus our I are of entirely mean, I shift perspective?

I we it major drugs be will four is to is are these right? Obviously, surufatinib, CLL. It's think, about setback that to the years years, basically going but the three, Savolitinib significantly setback, and obviously, approval. first patients, can that a back talking valuable we the for help are just I push confident a timeline. negative remain if similar mean,

what we and but back. be NPVs the to we'll doing negative. similar surufatinib carefully change very greatly can evaluate if pushed Again, fruquintinib, be continues are to for doing same we'll timeline So the for the

that's an need we very area So very, careful. to be

have. I all Thank That's you. Understood.

Credit ahead. from go question Please Suisse. from Huang Next Yang comes

Yes. Huang This for questions. Thanks Suisse. me Credit to is ask Yang for opportunity from the

actually trial I I second know The XXXX. half think just up have But of first some peers today, I our one started study to want FRESCO-X. about given think asked already in, I I this a a on study. follow have

know, certainly into drugs changed all from their XXXX. in we reviewing position FDA However, China

I kind So if what FRESCO-X of noticed can we colors a helpful talking after we what events? before had more change will with FDA? get too. FDA's follow of kind be any communication Thanks. about it with XXXX potential view we we're about trial. some So FDA have on started we financial study before the the in very Have the company up started it FRESCO-X

Yes.

we also think to on for designed No, enter I had And for we'll we FRESCO-X. note discussion indication likely. particular positive, you regard that know chime with end have aligned this we FDA U.S. fast the on I'll and destination, of with ask already with study obviously, to maybe have this. And touched X He we X obviously, and FDA. With FDA, him Pre-Phase the to if as anytime. agency pre-NDA or discussions opportunity track got Phase Marek in. obviously the position discussion kind another discuss can on more involvement in Marek?

Yes. surufatinib Thank to broader application I That's case. was agency where to if is bring any is very That's to in bringing Overall populations. one specific country Fruquintinib some the related sponsors the concern system situation China in Yes, simply clarify, the FRESCO-X is of different to case. you, X concern. with NDA now Weiguo. country their this here. other necessarily to challenges one just or their trials. applicable were Phase made even X is The trial, confusion very was different country you just hear core or/and concern, to one China, and related Phase U.S. not of core

plus another line top meeting. Type we preparing said, we're pre-Phase Weiguo of results. Phase very had had of meeting And this As pre-NDA, meeting very year. We shortly X B for similar Type C pre-end meeting X

conducted consistent. is XX study in are agency and we global countries, very in study, this a study is far, been running important global fact And way. U.S. again, has XXX to therefore, contributing significant So sites,

play agency part other the a package more So than supporting than role study. Every more expecting. multinational well. as it It cannot exactly be of is regional to studies want what is important

overplay forward, Thank that. all Overall, everything don't the Weiguo you. yes, in else moving with into Fruquintinib it's So not concerns because thing.

Yes. second And question then financials. is Thank my you.

growth. for slower half, the the growth total our as we So total the what or XX%. about revenue think half grew notice, has I of growth, revenue low you cost year? revenue first trend good cause only pretty But in kind continue cost is the these XX%. this much going a think as of revenue, first Do our the to growth and

Johnny Okay. the to the Thanks provide I'll answer. question. for ask

Weiguo. you, Thank Okay.

I think it's a composition of products. our

half, to last we you did If Savolitinib now year. compare have first have not the which in of Savolitinib this first half we in the period, the

royalty. As you market we all actually we the XX% sales, Savolitinib in know, of recognize recognized for

So improve margin. we invested into the terms cost in part sales capture other on our we which And of the actually of sales. have hand, of in profit gross our which that force, of course, are

I I that the think combining going But So answer will your question? difference time, At do hopefully, together, you the well, all that time. over forward, the actually makes in just of hope analysis and to. to sales referred mix a to to think we I targeting product are continue the same continue, think ELUNATE I proportion surufatinib. we savolitinib have increase

Thanks. helpful. very That's Okay.

from comes ahead. Cantor. Chen Louise Please from go question Next

our for [Indiscernible] Louise, is and for questions. you This Hi. thank taking

So our fruquintinib. question on is

that studies of indicates representative EU. practicing EMA were these So medical and patients

and you of in just Japan? still do you. So EU complication forward trials? local think And wouldn't global why a path Thank to U.S. need fruquintinib the for potential to in while you be light this clarify, pursue

particular almost I the CLL, is U.S. patient Well, understandable is which that it's patient argument think from population. representative identical

different. I think Japan is quite

First registration they a us off, requested different to secondly, obviously study. on Asians, They are right. bridging path. And it's do a

discuss it's are understandable on add, very Caucasians of different population continue clearly, Japan, they is And to in PMDA I patient obviously they Marek? registration a and Asia but in Anything also study terms that difference. ongoing. Asians, else Japan. between to path. think we'll with So And

I unique needs. NDA actually medical No, Japan I case unique studies in case be. personally submit would will coming I two from from only am -- unmet in add for the as as sorry, Japan it a Phase can case. a high highlight. fruquintinib China We Japan And with be submission of recall attempts to intent kind for call as X with don't

As discussion. Weiguo Phase XXXX this in X a said discuss in we of post path with which conduct study bridging forward expect study pre-NDA will and engage

So we see. will

the in U.S. Japan know, you NDA bias that may in context. always There As persistent some be also at approvals look

So we'll bridge later. we have that when

Thank you. it. Got

comes CLSA. Yan question ahead. from go from Next Please Matthew

management. your question in Hi, material, FRUTIGA. congratulate got I noticed question I taking based presentation results. and SAFFRON two for XXXX. Thanks on on NDA you regarding my savolitinib you on the that filed and the mentioned

that So an second Those the of versus support how in SAVANNAH like questions. capmatinib. in NDA terms data Thanks. filing proved peers, near savolitinib does readout, mean they do my term? differentiate regarding is not tepotinib see question my this And clinical and you of SAVANNAH profile already are the two

the timeline Well, XXXX SAFFRON estimate. Matthew. NDA Thanks, is an Okay. obviously

just think started. it got I we

FDA So it approval we on and which in more for study can be AstraZeneca, to enrollment SAVANNAH an obviously speed can that support both the think But the can our follow sometimes SAFFRON with months U.S. assessment we than approval. timeline all So, savolitinib depends is clarity, to now on PFS the the SAVANNAH, be, SAVANNAH the potential accelerated But at aligned XX we'd of what ahead also to need U.S. think the least I right? probably and get the expect. have HUTCHMED XX be longer we it up,

differentiation with question, second tepotinib regarding and your the others. Now

are patients. have not we exposed a not China Chinese capmatinib, They've of Now limited -- approved to compounds yet. and tepotinib think, they been obviously, in number these I two

Just looking think and at the inhibitors. c selective they're I potent profile, all MET

However, chemical of terms they significantly structures. in vary

and AstraZeneca exposure its very outside tepotinib study compare difference. hard studies, or in Chinese the safety I or it from compound to the expect think tell other Chinese would patients base have patients, versus they I differences China. Because well. profiles. can to has And So With regard in they in [Indiscernible] pharmacokinetics studies you clearly know limited capmatinib the

out. figured the we biomarkers Now have

are as a in of, studies, in exploring a TKI have think Else in population. bigger the two pretty only the we products only well. the have the So now competitive also gastric good, other terms other we compound combination edge in we of PRCC. we are we EGFR, the -- only we And patient refractory think competitive, I

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Thanks, very Dr. That's Okay. clear. Su.

from Bank Stranahan We question another go America.Please from of have ahead. Alec

good Kind question taking guys, This Alec. Thanks of on Hey, us. for question. John is a my morning. for from two part

quarter So just Are trial? they build or they international comparison far going your to the into will of to the of do view market? comparison look Or to landscape an of it in the the of budget U.S. first first the trial, kind FRESCO-X more that be So data? on the kind to in your grander be that to question. going in conversations with you treat that's Chinese population going less current How the a factoring That's landscape And U.S. you. they factor with If Chinese harder also into experience. at in are a that. off do my Thank through play? the fact U.S. think potentially trial, and be initial the MRCT so regulatory agency think with with they the FRESCO-X the look will do you viewing there part.

Yes.

think a that's question. I really good

in. yes, these different are a think, studies, therapies. prior obviously, have response. The brief Marek I versus patient different FRESCO-X, right, different chime very population, FRESCO and can then I And

support have other. can they and but both they each So, merits

my this. that's initial think on read I

FRESCO other in the or FRESCO-X both without subset versus or think different the VGFR prior terms Chinese to form studies I will basis and of or patient population, support efficacy with in treatment, different Caucasians. VGF Chinese the in settings,

think each they complement So I will basically. other

So can your further add on that, maybe Marek comments this. you

this, powered, in obviously highly I But to risky, endpoints. will others, are to questions is XX% is is know. and designed question. this and John, very independently comparisons one is FRESCO-X designed study the address make good power Study built scientific, detect as study. because not everyone although statement, primary doing uniquely you Yes. study

data. FRESCO. in if obviously, or this always alone So study of the But look totality, without could with FRESCO positive, stand we totality into

discrepancies So of far, prior in any lines haven't therapy. big seen we

As exactly U.S. was we benefits. heavily one our pretreated consistency of mimicking see And mimicking I the more before, which cohort in number pretreated. populations in we mentioned, clinical a Actually like cohorts was one conducted that heavily for study. FRESCO like, exactly FRESCO-X

he FRESCO-X design not and but answer more here, going had studied studies. FDA, precise We for asking those I'm is pivotal speculate and mean, here. discussions to I for So

Obviously, do during the So limitation. thought investigators to the that's And study strongly really study. XX, of are and way XX almost is very to in use in the COVID supportive convincing And they'll most time, that's totality job. the accrues the most in data field record the reason leaders positive, and clinical why the packets. why is the months and also

So I stop here. will

Thank Okay. you. the Thank you for color.

John. Thanks,

last our It question. was

speakers, questions. So I'll ladies your give and for dear gentlemen, you floor the written back

It’s [Indiscernible] questions.

read them out. So will I

have several the we system, questions. On online

The holding pointed update management the U.S. arm issue. first is And authority auditors an have Amdizalisib, any companies regarding dose the based that have Weiguo? regarding concerns single regulatory design. several China on the And companies also current has has selection share this company strategy. raise regarding capital,

Yes. ongoing China with are At modification. had without multiple we've registered and studies two the interactions and regulatory CDE there single arm moment

be flat QD XX QD you But without as basically flat amdizalisib as zandelisib, compounds, can the throughout basically, So dose these milligram I mean, with I study, similar, regimen and parsaclisib China modifications taken and regard XX the milligram know, in to dose it's study. their modify continuous. any dosing dose guess,

the past direct Okay. what for fund In I the Johnny. question is, is Thanks, funding question or the Maybe the the Weiguo. factory? can mechanism factory, this at

Mark. you, Thank

factory in the also. for reading So terms I'm of the the, question

is total is the in factory terms total the XXX cost about factory China question earlier, and the in the million. so mentioned So of forth. of fund for project new how the factory we We the

about so spent XX-odd have far We million.

So, this in this fixed payback of year the XX with asset arrangement we bank loan. withdraw target years to China, spend stretched XX million, of local which but the drawdown a for and we for has loan infrastructure the have

the out provided And be factory entire the by this million. the local So, XXX bank. of total amount loan will infrastructure fixed is drawn

year, end of project we the year. So to target next by complete next

will year, be drawing within the for slowly CapEx. down, amount next So this this year, drawing required we

Okay. Thanks. Johnny perhaps I could ask you to answer as the question on HSCA well.

Okay.

have related some the to the our companies of question circumstances, to other some U.S. was it these sorry, base companies, companies. different of before, auditor. To auditor, changed their is So other

operation, assets, us, based generated are For pictures in China. of all our revenue majority

license in changing So based as meet supporting not qualified even the be have the therefore, by [ph]. PCAOB and we will not a they documents China the auditor requirements will U.S. provide those able not to they to auditors, to audit auditor, U.S. the to are to

to of the But Thank development everybody in in you, continue U.S. progress this are meantime, I Hong UK listing knows the monitor and the Kong the the We of two countries. think with shares between Mark. authorities fungible ABS. our

Okay. Thank you Johnny.

Okay. question. anything change takeover the tazemetostat? for of Does There's licensing of Epizyme another development

think No, don't so. so. think don't We we

Okay.

running we're now. I out time think of

any a draw line to need to remarks? we maybe So closing do have Weiguo, here.

a important continue No. FRESCO-X. to to and I hopefully execution I half good is think focus most we the from, to forward the look second on the we starting want just say,

We will in touch. be

everybody, the Thank Weiguo. joining Okay. you, for Thanks call.

Ladies participating. this for all today's Thank you and call. conference gentlemen, concludes

You may now disconnect.