InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading
biopharmaceutical company focusing on cancer and autoimmune
diseases, today announced the 2023 annual results as of 31 December
2023.
Financial Highlights
- Revenue increased by 18.1% to RMB738.5 million in 2023,
including RMB670.7 million from orelabrutinib, an increase of
18.5%, mainly due to the continuous and rapid ramp-up of
orelabrutinib sales.
- Gross Profit increased by 26.6% to RMB610.1 million in
2023, with a gross profit margin of 82.6%, representing an increase
of 5.5%, mainly due to the increase of orelabrutinib sales and the
reduction in the unit cost of sales.
- Research and Development Expenses increased by 17.5% to
751.2 million in 2023, primarily due to heightened spending on
global clinical trials that have made significant progress and
strategic investments in early-stage candidates poised to become
key future assets.
- The Loss decreased by 27.8% to RMB645.6 million.
- Cash and Bank Balance stood at approximately RMB8.2
billion. With this robust cash position, the Company is
well-positioned to expedite the clinical development of key
projects and invest in a competitive pipeline.
Accelerating Pipeline Development for the Benefit of
Patients
In 2023, InnoCare has continued to advance its robust pipeline
across various clinical stages, continuously unleashing the power
of innovation to meet unmet medical needs. Orelabrutinib has become
the first and only BTK inhibitor approved for the treatment of
relapsed or refractory Marginal Zone Lymphoma (r/r MZL) in China,
an indication which has been included in the updated 2023 National
Reimbursement Drug List (NRDL) without a price cut. The Company has
continuously forged ahead on the road to improving public health.
Additionally, the Phase II study results of our novel TYK2
inhibitor, ICP-332, met the primary endpoints in patients with
moderate-to-severe atomic dermatitis. From research, clinical
development, manufacturing, commercialization, to global
collaboration, InnoCare not only established an integrated
platform, but also formulated a clear growth strategy aimed at
benefiting patients worldwide as we embark on the Company 2.0
phase.
Building A Leading Franchise in Hemato-Oncology
With orelabrutinib (BTK inhibitor) serving as the backbone
therapy and a key component of InnoCare’s extensive pipeline in
hemato-oncology – including tafasitamab (anti-CD19 antibody),
ICP-248 (BCL2 inhibitor), ICP-B02 (CD20xCD3 bispecific antibody),
ICP-490 (CRBN E3 Ligase modulator), and potential future
developments from internal and external sources - InnoCare strives
to become a leading player in hemato-oncology both in China and
worldwide. Orelabrutinib's exceptional safety and efficacy profiles
promise synergistic benefits when combined with other pipeline
drugs, such as ICP-248 (BCL2 inhibitor). InnoCare intends to
address various segments, such as non-Hodgkin lymphoma (NHL),
multiple myeloma (MM), and leukemia, utilizing both single and
combination therapies.
Orelabrutinib
- Orelabrutinib was approved for the treatment of
relapsed/refractory marginal zone lymphoma (r/r MZL) in April 2023
and included in the NRDL. Orelabrutinib has thus become the
first and only BTK inhibitor for r/r MZL in China, which also
marks orelabrutinib’s third indication approved in China.
- Patient enrollment of the Phase III registrational trial
of orelabrutinib for the first-line treatment of chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was
completed in China in the first half of 2023. The Company
expects to submit the NDA in the third quarter of 2024.
- In the U.S., patient enrollment of the Phase II registrational
trial for relapsed/refractory mantle cell lymphoma (r/r MCL) was
completed. The Company expects to submit the NDA to the U.S.
Food and Drug Administration (US FDA) in the third quarter of
2024.
- The Company is initiating a global Phase III study of
orelabrutinib for the first-line treatment of MCL.
- Orelabrutinib was approved by the Health Sciences Authority
(HSA) of Singapore for the treatment of adult patients with r/r
MCL, which marks InnoCare’s entrance onto international commercial
markets. The Company expects to submit r/r MZL NDA in Singapore
in 2024.
- The Company is initiating a Phase III MZL confirmatory study
with orelabrutinib.
- The strategic combination of orelabrutinib with BCL2 inhibitor,
ICP-248, for the first line treatment of CLL/SLL.
- A Phase III registrational study of orelabrutinib for the
first-line treatment of MCD subtype diffuse large B-cell lymphoma
(DLBCL) is ongoing in 45 sites in China.
Tafasitamab
- Patient enrollment of the registrational trial of tafasitamab
in combination with lenalidomide for the treatment of r/r DLBCL was
completed in China. The Company expects to submit the biologics
license application (BLA) in the second quarter of 2024 and
anticipates BLA approval in the first half of 2025.
- Tafasitamab in combination with lenalidomide was approved by
the Department of Health, the Hong Kong Special Administrative
Region, China, and approved for use in Bo’ao and Greater Bay
Area with first prescription issued respectively.
ICP-248
- The preliminary results demonstrated good safety profile and
achieved favorable pharmacokinetic (PK), demonstrating
differentiation from other BCL2 inhibitors. So far, seventeen
patients were dosed, and among six evaluated patients, the ORR
was 100%, with three complete responses (CR) in which two
achieved undetectable minimal residual disease (uMRD).
- The clinical trial approval of ICP-248 in combination with
orelabrutinib as a first-line therapy for CLL/SLL in March 2024. In
the U.S., the IND was cleared in January 2024. ICP-248 will
become an important asset for the Company’s
globalization.
- ICP-248 is a novel, orally bioavailable BCL2 selective
inhibitor, developed as monotherapy or in combination with
orelabrutinib for the treatment of CLL/SLL, MCL, AML, and
other NHLs.
ICP-B02 (CM355)
- The preliminary data of both the intravenous infusion (IV) and
the subcutaneous (SC) formulations have shown good efficacy of
ICP-B02 in patients with follicular lymphoma (FL) and DLBCL. All 13
patients who were treated with ICP-B02 at doses ≥6mg achieved
response, resulting in an ORR of 100%. Among the nine
patients who were evaluable in the SC group, seven achieved a
complete response (CR), including two with DLBCL.
- Based on the encouraging results of ICP-B02 single agent, the
Company is planning for dose expansion study of ICP-B02 in
combination with other immunochemotherapies for earlier lines of
treatment in NHL patients. An IND for the combination therapies has
been submitted.
- ICP-B02 is a CD20xCD3 bispecific antibody co-developed with
Keymed.
ICP-490
- The Phase I dose escalation study is ongoing in China with
multiple myeloma (MM) patients, demonstrating a good tolerability
and safety profile. Pharmacodynamic (PD) analysis showed deeper
degradation of primary pharmacological targets Aiolos (IKZF3) and
Ikaro (IKZF1).
- In September 2023, the IND was approved to conduct a clinical
trial of ICP-490 in combination with dexamethasone. ICP-490 shows
strong potential in hemato-oncology therapeutics as a monotherapy
or in combination with others.
- ICP-490 was developed from InnoCare’s molecular glue platform
for the treatment of MM and other hematological malignancies.
ICP-B05 (CM369)
- The Phase I trial is ongoing, showing good tolerability with no
DLT observed. The preliminary results demonstrate favorable PK
profile and PD biomarker, Treg depletion, was observed.
- Dose escalation in solid tumors has been escalated up to 150
mg, which is also the initial dose designated for NHL.
Preliminary efficacy was observed in NHL.
- ICP-B05 is an anti-CC chemokine receptor 8 (CCR8) monoclonal
antibody, a potential first-in-class drug co-developed with KeyMed
as a monotherapy or in combination with other therapies for the
treatment of various cancers.
Developing B-cell and T-cell Pathways in Autoimmune
Diseases
Autoimmune diseases can affect almost every organ in the body
and can occur at any age. The global market for autoimmune disease
therapeutics anticipated to reach $185 billion by 20291. The
Company has fortified its powerful discovery engine focusing on
global frontier targets for the development of differentiated
autoimmune therapeutics through B-cell and T-cell pathways, aiming
to offer first-in-class or best-in-class treatments to the massive
unmet medical needs with promising market potential worldwide
and/or regionally.
Orelabrutinib
- ITP: The Company has achieved proof of concept (PoC) of
orelabrutinib for the treatment of primary immune thrombocytopenia
purpura (ITP), with a Phase III registrational trial underway in
China. The last patient is expected to be enrolled by the end
of 2024. In June 2023, the ITP Phase II result was orally presented
at the European Hematology Association (EHA) 2023 Hybrid Congress.
The results showed that 40% of patients met primary endpoint at
50mg. 83.3% achieved durable response among patients met the
primary endpoint. A subgroup analysis of patients who previously
responded to glucocorticoids (GC) or intravenous immunoglobulin
(IVIG) showed that 75.0% of patients at the 50mg dose
achieved the primary endpoint.
- SLE: The Phase IIa trial for systemic lupus
erythematosus (SLE) demonstrated positive results, with remarkable
SLE Responder Index (SRI)-4 response rates observed in a dose
dependent manner, along with trends indicating a reduction in
proteinuria levels. A Phase IIb trial is ongoing, and the
Company expects to complete patient enrollment by
mid-2024.
- MS: The 24-week data of orelabrutinib from the multiple
sclerosis (MS) global Phase II trial is consistent with the
previous reported 12-week data in terms of both efficacy and
safety.
- The primary endpoint was achieved dose-dependently (Cmax
driven) in all three active orelabrutinib treatment groups.
Notably, a 92.3% relative reduction was achieved in
cumulative number of new gadolinium (Gd) + T1 lesions at week 24 at
80mg QD compared to placebo arm (which switched to orelabrutinib
50mg QD after Week 12). This reduction stands out as a leading
indicator of efficacy when compared to other MS therapies that are
approved or in developmental stages.
- All orelabrutinib groups achieved T1 new lesion control after 4
weeks of treatment, with effects sustained through 24 weeks.
The 80 mg QD cohort showed the highest reduction rate of cumulative
number of new lesions Gd+T1 lesions and the best for lesion control
throughout 24 weeks, with the best safety profile, indicating
orelabrutinib’s potential as a leading MS treatment.
- NMOSD: The Phase II clinical trial for the treatment of
neuromyelitis optica spectrum disorder (NMOSD) is ongoing in
China.
ICP-332
- The latest data of ICP-332 for the treatment of patients with
moderate-to-severe atopic dermatitis (AD) has been released at the
2024 American Academy of Dermatology (AAD) Annual Meeting as a
late-breaking oral presentation.
- ICP-332 demonstrated an outstanding efficacy and safety
profile. ICP-332 achieved multiple efficacy endpoints in the 80 mg
QD and 120 mg QD dosing groups respectively, including the
percentage change in Eczema Area and Severity Index (EASI) score
from baseline, EASI 50, EASI 75, EASI 90 (improvement of at least
50%, 75% and 90% in EASI score from baseline), Investigator’s
Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost
clear’) with >= 2 points improvement, and Pruritus Numerical
Rating Scale (NRS) score from baseline, etc.
- The mean percentage change from baseline of the EASI score
reached 78.2% and 72.5% at the 80 mg QD and 120 mg QD groups
respectively, both with a highly significant P value (p<0.0001),
compared to 16.7% for the patients receiving placebo. The
percentages of patients achieving at least 75% improvement in EASI
75 were significantly higher in the ICP-332 80 mg QD (64.0%,
p<0.0001) and 120 mg QD (64.0%, p<0.0001) groups than that of
placebo (8.0%), which are better than the reported efficacies of
multiple approved innovative drugs treated for 12 weeks or 16 weeks
(not a head-to-head comparison).
- In the ICP-332 80 mg QD group, the response rates of EASI 90
and IGA 0/1 with >=2 points from baseline demonstrated a 40.0%
(P=0.0009) and 32.0% (P=0.0047) improvement respectively compared
with the placebo group.
- ICP-332 was safe and well tolerated in AD patients. The overall
incidence rates of adverse events (AEs) and AEs related to
infections and infestations in the two treatment groups were
comparable to that of the placebo group.
- The Company expects to start the patient enrollment of the
Phase III trial for AD in China, initiate US trials, and initiate a
Phase II trial for a second indication of vitiligo in 2024.
- ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is
being developed for the treatment of various T-cell related
autoimmune disorders.
ICP-488
- The Phase I trial has been completed, with preliminary efficacy
assessed in psoriasis patients. The least-squares mean percentage
change from baseline in the Psoriasis Area and Severity Index
(PASI) score indicated preliminary significantly difference between
the ICP-488 6 mg once-daily dosing group and placebo group at week
4 (38% vs 14%, p=0.0870). PASI 50 assessments demonstrated a 42%
improvement with treatment of ICP-488 at 6 mg QD.
- Following single ascending doses (1mg to 36mg) and multiple
ascending doses (3mg -12mg) once daily, ICP-488 plasma exposures
were dose proportional. No significant food effect was observed
following co-administration with standard high-fat, high-calorie
meals.
- ICP-488 demonstrated good tolerability and safety. The TRAE
rate was the same between the ICP-488 arm and placebo arm.
- The Phase II study of psoriasis is ongoing, InnoCare targets to
finish the patient enrollment in the first half of 2024.
- ICP-488 is a potent and selective TYK2 allosteric inhibitor
that binds to the pseudo kinase JH2 domain of TYK2 and blocks
IL-23, IL12, type 1 IFN, and other cytokine receptors.
ICP-B02 (CM355)
- ICP-B02 (SC & IV) induced a profound and sustained
depletion of peripheral B- cells after first infusion in Phase I/II
clinical trial in r/r NHL patients. Given the critical role of
B-cells in a variety of severe autoimmune diseases, ICP-B02 may
have wider applications in severe autoimmune diseases.
ICP-923 (New Target)
- IL-17 is a pro-inflammatory cytokine that plays an important
role in immune functional responses. Orally administered small
molecules targeting IL-17 may represent a convenient alternative to
IL-17-targeting monoclonal antibodies for patients. This novel
orally available small molecule can potently block the binding of
both IL-17AA and IL-17AF to IL-17R.
Building Innovative Solid Tumor Assets
InnoCare strives to expand the breadth of its pipeline to cover
solid tumor diseases areas through a combination of targeted
therapy and immune-oncology approaches. The Company believes that
potential best-in-class molecule, zurletrectinib (ICP-723), will
enable InnoCare to establish a solid footprint in the field of
solid tumor treatment. To benefit a broader range of patients,
InnoCare’s rapidly maturing early-stage pipeline, including the
cornerstone therapy ICP-192, ICP-189 and ICP-B05 immune-oncology
treatment, aims to offer competitive treatment solutions for a
large array of solid tumors, both in China and worldwide.
Zurletrectinib (ICP-723)
- InnoCare is accelerating the registrational trial of
zurletrectinib in China. The NDA is expected to be
submitted by the end of 2024.
- An outstanding efficacy of 80-90% ORR was observed in
adult patients with various cancers carrying NTRK gene fusion who
received ≥8 mg dosages.
- Zurletrectinib was shown to overcome acquired resistance to
the first generation TRK inhibitors, bringing hope for patients
who failed prior TRKi therapy.
- The Company is conducting a clinical trial of zurletrectinib
for pediatric (2 to 12 years old) and adolescent patients (12 to 18
years old). Patient enrollment of pediatric patients is ongoing,
with PR observed.
ICP-189
- InnoCare and ArriVent reached a clinical development
collaboration to evaluate the anti-tumor activity and safety of the
combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189,
with ArriVent’s third generation EGFR inhibitor furmonertinib in
patients with advanced non-small cell lung cancer (NSCLC).
Currently, the combo study is underway. NSCLC is the predominant
subtype of lung cancer, accounting for approximately 85% of all
cases2.
- The novel SHP2 allosteric inhibitor, ICP-189, is being
developed for the treatment of solid tumors as a single agent
and/or in combination with other antitumor agents. Preliminary
efficacy was observed in ICP-189 monotherapy. As of this
announcement, the dosage has been escalated up to 120 mg with no
DLT observed, and it has shown a favorable PK profile with a long
half-life. The patient enrollment at 160mg QD is ongoing.
- As a potential first-in-class SHP2 inhibitor, ICP-189 is an
ideal partner for combination with multiple targeted and
immune-oncology therapies in solid tumors. ICP-189 has demonstrated
significant anti-tumor effect in tumor models driven by KRASG12C
mutation and EGFR over-expression.
Gunagratinib (ICP-192)
- The latest data of gunagratinib in patients with
cholangiocarcinoma (CCA) was presented at 2023 ASCO-GI3.
Gunagratinib showed good efficacy and safety in previously treated
patients with locally advanced or metastatic CCA harboring FGR2
gene fusions or rearrangements.
Other Corporate Development
- InnoCare appointed Xin Fu and Jeff Chen as Chief Financial
Officer and Chief Commercial Officer respectively.
- InnoCare was approved by the Hong Kong Stock Exchange to remove
"B" from the stock code from May 12, 2023. This is another
important milestone in the Company's development.
- Following the approval for commercial production, InnoCare
Guangzhou quickly launched the manufacturing of orelabrutinib,
which is now available to patients in China. This achievement
allows InnoCare to cover the entire industry chain from in-house
research and development to production.
Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare,
said, "We must maintain the entrepreneurial spirit and persist in
continuous innovation, focusing on key objectives with high quality
growth, so as to make our contributions to patients, partners, and
the broader biopharmaceutical industry. We’re committed to
deepening our focus on original innovation, pushing forward
multiple innovative molecules to further strengthen our pipeline;
we will accelerate the registrational trials both in China and
worldwide, aiming to submit multiple NDAs; we will increase market
penetration to achieve our long-term strategy and realize
significant sales increases; we will amplify our global presence
and push more projects to reach international markets.”
To know more about the detailed financial data and business
updates of InnoCare 2023 annual results, please log in to
https://www.innocarepharma.com/en/investor/home.
Conference Call Information
InnoCare will host a conference call at 8:30 p.m. Beijing time
on March 28 in English and at 9:30 p.m. Beijing time in Chinese on
March 29, 2024. Participants must register in advance of the
conference call. Details are as follows:
For English conference call, please register through the below
link:
https://goldmansachs.zoom.us/webinar/register/WN_DYQFyxtGQiC_WaqnlGAMvw#/registration
For Chinese conference call, please register through the below
link: https://net.comein.cn/roadshow/home/199181?institute=zjgs
Forward-looking Statement
This report contains the disclosure of some forward-looking
statements. Except for statements of facts, all other statements
can be regarded as forward-looking statements, that is, about our
or our management's intentions, plans, beliefs, or expectations
that will or may occur in the future. Such statements are
assumptions and estimates made by our management based on its
experience and knowledge of historical trends, current conditions,
expected future development and other related factors. This
forward-looking statement does not guarantee future performance,
and actual results, development and business decisions may not
match the expectations of the forward-looking statement. Our
forward-looking statements are also subject to a large number of
risks and uncertainties, which may affect our short-term and
long-term performance.
About InnoCare
InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage
biopharmaceutical company committed to discovering, developing, and
commercializing first-in-class and/or best-in-class drugs for the
treatment of cancer and autoimmune diseases with unmet medical
needs in China and worldwide. InnoCare has branches in Beijing,
Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
___________________________________ 1 iHealthcareAnalyst, Inc.,
Oct. 3, 2023 2 Cancer-free 3 2023 ASCO GI Abstract
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Media Chunhua Lu 86-10-66609879
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Investor Relations 86-10-66609999
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