pleasure Thank in take discuss XXXX. the this It's you of asset update to December progress year major development I a to you, all ended our Tyler. for to our key and want core today. call business to opportunity welcome XXst,
and of challenges, company Since the efforts rate the multiple macroeconomic factors, not ADR to In start pipeline. risks, issues including, to the overall XXXX, such several challenges, made geopolitical hikes but its faced company strategic pandemic. business to reposition prioritize and delisting these interest response including COVID-XX limited as the
in as have and five and reduction pipeline streamlined to resulted structure significant value. in and beyond. achieve allowed as leading prioritized milestones a to us These cash for measures efforts workforce our XXXX critical well rate near-term corporate These of burn key focused the deliver in a development assets,
the In list or December unable previous ADR mainland the that firms. on removed the report jurisdiction is terms delisting from public risk, China investigate vacated the to accounting XXth, determination registered Hong Kong of XXXX, and it completely a inspect PCAOB where of issued and
not after company does This XXXX. fiscal as identified removed the a the under issuer be significant it has expect company reason, For a the year HFCAA in on to report the this headwind for XX-F annual the XXXX. identified Form files commission faced
positive of three clinical front above the including achieved in data mentioned for readouts givastomig. and our XXXX, uliledlimab development pipeline key efforts results, milestones, including on assets lemzoparlimab, key positive the With we strategic XX
novel, These assets and assets the Here we frontrunners we and highly are that the prioritized. five highlight globally have China. key all differentiated among clinical in
trial for in enrollment half completed our X eftansomatropin growth all long-acting of of Phase of alfa, a patients First first We the hormone. XXX XXXX.
submission. readout have data by of BLA XXXX, subsequent second to half followed in the expect a We
XXX top XXXX, November pediatric a In we with company a announced specialized partnership space. in the Chinese Jumpcan, pharmaceutical commercial
felzartamab, differentiated Second, CDXX antibody. a
In is second the myeloma line track our Phase study, impact multiple despite X study for addition registration to on X completed of the Phase COVID-XX.
seek Continue to in make progress with partnership. and BLA a submission preparation commercial potential manufacturing local the plan for
assets CDXX I Next, cancer a a have a impressive later. and cell detail differentiated trial. key in X will activity, has reached frontrunner, discuss Uliledlimab, three has in Phase a Lemzoparlimab, antibody CDXX stage. global Phase more a that we antitumor X non-small antibody the differentiated lung demonstrated
with response tumor is CDXX correlated expression. clinical The
in and signal. attention highlighting because be differentiated profile attracted its Next, highly to givastomig, certainly first I approved the CDXX field malignancies. with like immuno-oncology of bispecific which much for favorable leading hematological a drugs X-XBB efficacy our would a start potentially has so ClaudinXX.X antibody CDXX single to among by the safety agent lemzoparlimab, antibody antibody position
and Difficulty]. would [Technical safety lemzoparlimab while across you compelling blood strong includes dose sink required. differentiated binding that design to red to effect Less remind with priming several expected favorable activity profile I to maintaining is by This avoid activity. antitumor RBC-mediated like the antitumor no cells differentiation
has translated I This preclinically and agreement. into September validated. an AbbVie I-Mab license also in that and being into entered to advantages collaboration and molecular amendment are differentiation clinical original XXXX has been add validated should the
result, antibody a continuing of to collaborate development are both on global anti-CDXX therapy. parties As the
patients In various XXX systemic or of either lemzoparlimab Here review to are with I highlight approximately in with safety data. safety want lemzoparlimab differentiation who treated monotherapy a combinations. as clinical data
when We the and profile a priming MTD have safety data regimen. continue not was favourable today. reached be the dose studies dose Overall, China safety from both administered any a regimen. compelling without to in US seen
in combination hematological Phase safety profile the five in TRAE seen MDS grade been and observed have and safety favourable tumor the a Mild on no and have MDS, reported. we NHL. right. in in study In Azacitidine TRAE's And have X we AML shown solid a good with profile
note patients by comparable worse disease clinical is Western Of that to than due this countries the clinical more the China. conducted heavily study with baseline trials enrolled in in conditions underlying practice influenced
the at grade above azacitidine the three azacitidine XX% lemzoparlimab baseline. even overall safety had that was in and anemia, and without the The tolerated had comparable well showed profile In safety grade results thrombocytopenia this that and was group, monotherapy. of with patients XX% priming combination dose of above and patients of with three
Next, six Of who clinical presented the XXXX. I as March XX% were the for rate patients rate months respectively. enrolled treatment overall of and began like to or longer XX patients efficacy analysis, results would XXXX to response complete at highlight response and XX.X% XXst, the ESMO prior the
CRR CRR, ORR no or with from patients signals clinical consistent I'm of four have For those updated longer, XX%. XX the was with data of months safety to who XX.X% share analysis happy identified. a that began demonstrated new results the ORR recent the most and efficacy, including treatment
present data to major in XXXX. planning are at We half the scientific second the updated a meeting in
Here, I progress would on lemzoparlimab. key like to summarize the
favorable in more hematologic solid safety patients tumors and have We and observed than with lemzoparlimab. treated with profiles XXX consistent
and Our including XXXX. since follow in Phase X consistent data up with September ESMO efficacy the MDS ORR time CRR, trial longer trend, demonstrated a presentation
in has a Lemzoparlimab obtained patients trial initiate Phase treatment with CDE registrational the with combination line MDS. newly azacitidine first for the diagnosed X approval for from risk to higher
Importantly, amendment AbbVie into the agreement. licensing original collaboration to and an I-Mab entered
of on are continuing both anti-CDXX result, therapy. global development the collaborate parties a antibody to As
with turn uliledlimab, another we a Next, cancer. to global cell developing I'd lung to focus are that on non-small like frontrunner
the to by differentiated is design uliledlimab reported previously effect. hook avoid As
the hook what So is effect?
doses. a put, molecule drug is effect phenomena hook by higher paradoxically effect Simply at loses the characterized abnormal that the an
achieved enzymatic in without effect. hook side the figure right shown on As complete inhibition the uliledlimab the
to when In achieve potential believe from higher give other at effect the inhibition concentrations. contrast, an be therapeutic uliledlimab differentiation drugs. partial window with with the epitope combined more Uliledlimab antitumor We oleclumab flexibility comes unique could with improved only the hook differentiation and binding with a C-terminals. best-in-class
We on are conducting advanced a data in CDXX biomarker-guided non-small have our observed efforts lung XXXX. in X second efficacy cancer non-small high half cell pivotal trial robust with and expression cell focusing cancer Stage of we the currently lung in
is linear profiles of kg tumor inhibition our on left in or at study. activity per higher, per X saturation. biopsy side mg target observed PK samples. this of and A really It So XX human CDXX weekly saturation demonstrated PK complete the were kg mg indicating slide
related an with shown tolerated no PD-LX one anti-PD-X or and is safe or grade treatment grade Studies have limiting events either in dose of Most adverse treatment two. uliledlimab with observed. toxicities combination well were
determined been solid toripalimab to three highlights US milligram weeks. X Phase in XX every This of with atezolizumab of combination three tumors. every per study kg combination XX slide has in weeks with uliledlimab be RPXD Uliledlimab refractory with mg our patients the to clinical experience in
and About disease the PR overall XX at XX% XX%. rate seen, efficacy control including were evaluable rate patients, three response at with X responses an
with the activity More importantly, This expression of higher were CDXX responders expression of XX, non-responders. correlate shown compared three may all identified initial as to the clinical indication that high to tumor uliledlimab. exhibit the provides CDXX right, on
development update clinical to Here, the uliledlimab. I latest want highlight on
study As combination of lung PD-X had Phase been toripalimab, with cancer December cell of in in non-small XX XXXX, the in uliledlimab antibody enrolled a patients. patients Stage X X
high of a expression DCR summary, As patients. least the cells. the in Remarkably patients ORR in and first XX% of data the XX high at level or the with expression time March was first level XXXX, immune evaluable XX% was cut-off cells for CDXX at defined in XX% tumor
approximately with and XXX%. observed XX DCR than XX% with XX% August patients overall and in XXXX showing of obtained Similar CDXX high December to in trend expression CDXX as higher XX with evaluable those much an to expression A at consistent ORR XX% XXXX CDXX expression. all patients compared a data relation ORR patients efficacy were to a low with was approximately efficacy signal ORR in evaluable an for XX% greater patients XX% and with ORR in
to in data PFS mature for ORR and XXXX. efficacy continued The
clinical in lung advanced therapy Our PD-X uliledlimab high correlated expression patients data cancer. higher tumor and have cell with non-small demonstrated with that of combination response CDXX
on key safety lung this inhibition best-in-class CDXX antibody complete of and of with cancer Uliledlimab the summarize favorable activity cell achieve a expression. anti-tumor with responses Uliledlimab uliledlimab/toripalimab potential. a development demonstrated to has CDXX without It want in combination with can the differentiated hook uliledlimab clinical robust effect. non-small CDXX is the the correlating I profile slide.
therapy study plan of venue is lung the a ORR include first the in non-small half Phase China. PD-X plan in at further finalized XXXX a a in data readout half for to cancer second our and patients data in clinical regard the Stage combination further expected XXXX company and PFS cell development of to half for XXXX scientific in for in With XXXX. being uliledlimab, XX of X present trial our in in plans of major the with for development The X biomarker-guided pivotal uliledlimab second is to
is chemo And is the cancer. companion a therapy diagnostic with track planned a In in and non-small regimen and parallel, developed for in uliledlimab of kit on advanced PD-X combination studies. with Wuxi global a being cell study lung Diagnostics
planned the global With the new a in actively data, the company global study. been with engaging in has partnership potential sync
on targeting bispecific asset touch last our and antibody novel with has also one is Givastomig that novel antibody I'd targeting made The X-XBB ClaudinXX.X ClaudinXX.X like the progress. to other X-XBB is today arm bispecific local a or activation. clinical conditional through givastomig, significant
is key The givastomig of twofold. differentiation
expression Firstly, it range wide including binds to with of levels, tumors a lower ClaudinXX.X
right pre-clinical on in models. expression, the demonstrated as
Secondly,
of the of a givastomig local X-XBB tumor as activation. engagement to arm conditional function is mechanism designed upon
This feature toxicities. givastomig only makes tumor T systemic localized activator cell at unique a the site without
and typically release, toxicity systemic associated with liver example For X-XBB. are that cytokine
like take ClaudinXX.X differentiation a other givastomig's target compared moment to I'd Here. unique to to highlight agents.
molecular differentiated has monoclonal broader a those including agents ClaudinXX.X population, makes ClaudinXX.X including with ADC among target Zolbetuximab, design expression. a to potential the zolbetuximab. target unique and The lower Givastomig antibody. ClaudinXX.X givastomig
patients AGC and with zolbetuximab tumor. with is rather activity antitumor higher to ClaudinXX.X the limited expression the contrast, in In
upon as cell givastomig activator cytokine with Secondly, conditional a and tumor activation. givastomig toxicity the a mechanism This of no release hepatic function syndrome. designed local arm systemic of makes unique to is feature X-XBB including T toxicities, engagement
that commonly In target therapeutics. other expression that exhibits ClaudinXX.X for respectively. ClaudinXX.X that treatment and considered by gastric targeted Together. gastrointestinal toxicity have givastomig clinically addition, positioned pancreatic not givastomig cancers and ADC clotting eligible less ClaudinXX.X are is zolbetuximab is observed lower for to
in potential The clinical gastric ClaudinXX.X high first modalities. with types. chemo combined preliminary expression favorable in to standard offering by of with data has the Zolbetuximab other over differentiation are cancer profile other tumor the givastomig. and PD-X And with therapeutic several also those line be safety XX.X consistent therapy a more
givastomig of tumors. Here, to advanced trial patients metastatic or I solid Phase summarize escalation with want the ongoing dose X in
related per XX By are encountering the exposure interval drug grade kg up a XXXX, completed eight is suggestive a in end increase There or profile X-XBB favorable X. dose of PK/PD serum, have cohorts dependent cell treatment without been and with Most grade a toxicity. T activation. and limiting potentially longer mg of to soluble durable events X dose adverse dose of dosing
reaches Ctrough cell observed. that above at or T data activation kg of target per PD only occurs its concentration patients XX% mg the X A tumor site. in indicate over Meanwhile,
efficacy mg last a PR July at cohorts including since well. we as additional have have and seen disease and per X disclosed we different As in PR mentioned, signal agent single kg stable
share We global Phase the partnership. expect continue the of in discussions half engage in X XXXX to we a second to potential data and for
Finally, expected highlight I the the would like in future. catalysts to near
is area assets. to our first pre-BLA The really deliver
Phase followed submission. of second XXXX a data in subsequent the half expect X We BLA on readout by eftansomatropin
particularly are and and We opportunity with in a partnership. about China. felzartamab exists excited also on commercial Phase the that potential this We're asset market X track for
second area The the clinical on development is of lemzoparlimab.
as line the trial for initiate a Phase X clinical lemzoparlimab treatment. will We first MDS
first-to-market and in China support in a Phase submission the planned being goal China. with BLA will expect of first-in-class We study our X
year, for initiate cancer while the additional antibody. Phase planning study pivotal an of biomarker-guided second non-small a X we non-small half is in This expect cell lung X uliledlimab cell our Next lung exciting readout XXXX. in Stage to uliledlimab, cancer data CDXX trial
to a continue engage We partnership. in discussions potential global for
we development we in to excited the by Finally, givastomig. see continue be
discussion continue are clinical to potential engage in We trial our completing partnership. for Phase currently a X and
to this Lastly, new year. initiate we expect INDs
have I not company even focus in fundamentals we stage strategies. on to reminder, innovative pre-clinical with a touched have the multiple As on development. assets continues The
over happy I'm Richard? turn to to to our who will that, discuss With Richard, financials.
