InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading
biopharmaceutical company focusing on cancer and autoimmune
diseases, today announced the 2024 interim results and corporate
update as of 30 June 2024.
- Revenue of orelabrutinib increased by 30.0% year-on-year
(YoY) to RMB417.0 million in the first half of 2024, with a YoY
growth of 48.8% in the second quarter. This is attributed to the
rapid growth of marginal zone lymphoma (MZL) as well as effective
sales execution.
- The Loss decreased by 37.6% YoY to RMB268.0 million in
the first half of 2024.
- Cash and Related Accounts Balance stood at about RMB7.99
billion as of 30 June 2024. This robust cash position provides the
Company with flexibility to expedite clinical development and
invest in a competitive pipeline.
- Gross Profit increased by 19.3% to RMB359.6 million in
the first half of 2024. Gross profit margin was 85.7%, representing
an increase of 5.8 percentage points, which was primarily due to
the sales combination change of drugs and service.
- Research and Development Expenses increased by 17.5%1 to
RMB420.8 million in the first half of 2024 primarily due to mainly
due to more resources to increased investment in advanced
technology platform innovation and Phase III clinical trials aimed
at accelerating the Group’s transformation.
Total Revenue reached RMB419.7 million in the first half of
2024, which was primarily attributable to rapid ramp-up of
orelabrutinib sales volume. All three approved indications of
orelabrutinib, including relapsed and refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL),
relapsed and refractory mantle cell lymphoma (r/r MCL) and relapsed
and/or refractory marginal zone lymphoma (r/r MZL) have been
covered under the updated National Reimbursement Drug List (NRDL)
2023. Orelabrutinib has been approved as the first and only BTK
inhibitor for r/r MZL in China. Orelabrutinib was officially
included as a class I recommended regimen for the treatment of r/r
MZL patients in the 2024 Chinese Society of Clinical Oncology
(CSCO) Guidelines. The Company’s commercial capabilities have
undergone significant enhancements, including an optimized and
upgraded commercial team, which has developed more executable
strategies. The dedicated team has been optimized to operate with
heightened efficiency and strategic focus, ensuring effective
execution of market initiatives. This optimization has bolstered
the team’s ability to penetrate markets swiftly and effectively.
These advancements underscore InnoCare’s commitment to delivering
value and driving sustainable growth in the Company’s commercial
endeavors.
Benefiting Patients Worldwide
Entering InnoCare version 2.0, the Company is continuing to
strengthen the entire value chain and rapidly advance the clinical
trials of its pipeline. Over the next three to five years, five to
six innovative drugs are expected to be approved for marketing,
addressing unmet treatment needs and benefiting patients
worldwide.
Becoming a Leading Player in Hemato-Oncology
Hemato-oncology, including lymphoma, leukemia, and myeloma, is
known for its high mortality rates. InnoCare is dedicated to
developing therapeutics with diverse mechanisms of action (MoA) to
achieve comprehensive coverage of blood tumor indications, with the
aspiration of becoming a leader in this field.
Beyond the approved indications, InnoCare is advancing the
first line registrational clinical trials and new drug application
(NDA) for orelabrutinib. Tafasitamab (CD19 monoclonal antibody),
another key product, is expected to be approved for marketing in
the first half of next year, further strengthening the Company's
market presence. InnoCare is also accelerating the development of
BCL2 inhibitor ICP-248, which has significant combination synergy
with orelabrutinib. Notably, BCL2 inhibitors are the preferred
therapeutic option following resistance to BTK inhibitors, creating
an optimal sequential treatment strategy. With these assets in
the pipeline, along with the molecule glue ICP-490, monoclonal
antibody ICP-B05 and bispecific antibody ICP-B02, and potential
future developments from internal and external sources, the Company
is aimed at becoming a leading player in hemato-oncology both in
China and worldwide.
Orelabrutinib
- The clinical trial of orelabrutinib in combination with
ICP-248, a BCL2 inhibitor developed by InnoCare, for first-line
treatment of CLL/SLL was initiated in May of this year, and
patient enrollment of the Phase II trial has been completed as
of this announcement.
- The Company is accelerating the registrational trials and NDA
of the first line indications of orelabrutinib, including CLL/SLL,
SCL and diffuse large B-cell lymphoma (DLBCL).
- Orelabrutinib continues to gain attention from top
international academic conferences. Five studies of orelabrutnib
were selected for the European Society for Medical Oncology (ESMO)
Congress 2024, with a prospective study of orelabrutinib regimen in
treatment-naive MZL as an oral presentation at the conference. 10
studies on orelabrutinib have been selected for the European
Hematology Association (EHA) 2024 Hybrid Congress.
Tafasitamab
- The biologics license application (BLA) for tafasitamab in
combination with lenalidomide for adult patients with r/r DLBCL who
are not eligible for Autologous Stem Cell Transplant (ASCT) was
accepted and granted priority review in China in June 2024.
DLBCL is the most common type of non-Hodgkin’s lymphoma (NHL),
accounting for 31%~34% of NHL patients globally. In China, DLBCL
accounts for 45.8% of all NHLs2.
- Tafasitamab regimen 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
- ICP-248 is a novel, orally bioavailable BCL2 selective
inhibitor. The clinical trial of ICP-248 in combination with
orelabrutinib for first line (1L) CLL/SLL was initiated, and
patient enrollment for the Phase II trial has been completed.
- So far, 47 patients have been dosed, and among 28 evaluable
patients with BTK inhibitor failure r/r MCL, the overall response
rate (ORR) was 71.4%.
- The investigational new drug (IND) filing for ICP-248
for Acute Myeloid Leukemia (AML) has been accepted by the
CDE.
ICP-490
- Developed from InnoCare's molecular glue platform, ICP-490
shows strong potential to revolutionize the treatment of MM, NHL,
and other hemato-oncology indications, whether as a monotherapy or
in combination with other therapies.
- The Phase I dose escalation study is ongoing in China with
multiple myeloma (MM) and NHL patients, demonstrating a good
tolerability and safety profile. This safety profile has supported
the decision to continue dose escalation to the next dosage
level.
ICP-B02 (CM355)
- ICP-B02 is a CD20xCD3 bispecific antibody co-developed with
Keymed. Data from 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 15
patients who were treated with ICP-B02 at doses ≥6mg achieved
response, resulting in an ORR of 100%. All patients who
achieved CR maintained the remission as of the cutoff date.
- Based on the encouraging results of ICP-B02 as a single agent,
the Company is planning for a dose expansion study of ICP-B02 in
combination with other immunochemotherapies targeting earlier lines
of treatment in NHL patients. The IND application for the
combination therapies was approved in China in June 2024.
ICP-B05 (CM369)
- ICP-B05 (CM369) is a potential first-in-class anti-CC chemokine
receptor 8 (CCR8) monoclonal antibody, co-developed by InnoCare and
Keymed as a monotherapy or in combination with other therapies for
the treatment of various cancers.
- The Phase I trial is ongoing, aiming to evaluate the safety,
tolerability, pharmacokinetic characteristics, and efficacy of
ICP-B05 in subjects with advanced solid tumors and r/r NHL.
- Preliminary efficacy was observed in NHL patient.
ICP-B05 was well tolerated with no dose-limiting toxicities
(DLTs).
Advancing Research and Development in Solid Tumors
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-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)
- The fusion mutation of NTRK gene is a carcinogenic factor for
many cancers, including lung cancer, colorectal cancer, breast
cancer, pancreatic cancer and melanoma. Zurletrectinib is a
second generation TRK inhibitor developed by InnoCare. The Company
is accelerating the registrational trial of zurletrectinib in
China, which has entered the pre-NDA stage.
- Zurletrectinib has demonstrated good efficacy and safety
profile. It was shown to overcome acquired resistance to the
first generation TRK inhibitors, bringing hope for patients who
failed prior TRKi therapy.
- The clinical study with zurletrectinib has covered neurotrophic
tyrosine receptor kinase (NTRK) gene fusion adult patients,
adolescent patients (12 to 18 years old) and pediatric patients (2
to 12 years old). The efficacy has been observed in both adolescent
and pediatric patients. The dose escalation trial for pediatric
patients has been completed.
ICP-189
- 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. The clinical
trial of the combination of InnoCare’s lCP-189 with ArriVent’s
third generation EGFR inhibitor furmonertinib in patients with
advanced non-small cell lung cancer (NSCLC) is ongoing, with the
preliminary efficacy observed. NSCLC is the predominant subtype of
lung cancer, accounting for approximately 85% of all
cases3.
- Preliminary efficacy was observed in ICP-189
monotherapy. 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 Epidermal Growth Factor Receptor (EGFR)
over-expression. The SHP2 combination therapy provides a
promising treatment option for NSCLC patients who are resistant to
the third generation EGFR inhibitors.
- As of this announcement, the study of the 120mg QD group has
been completed, 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.
InnoCare is also actively exploring preclinical development in
solid tumors, and developing small molecule and large molecule
innovative drugs by building a differentiated platform for the
treatment of solid tumors such as lung cancer and gastric cancer,
so as to meet huge unmet medical needs.
Comprehensive Coverage 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 20294. 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) for
orelabrutinib in the treatment of primary immune thrombocytopenia
purpura (ITP), and has completed enrollment of over 50% of patients
in the Phase III registrational trial. The annual incidence rate
of adult ITP is about 2-10 per 100,000 people5. Only about
70% of patients respond to first-line treatment. Orelabrutinib has
potential to provide a better treatment option for ITP patients6.
From blood tumor to autoimmune diseases in the hematological field,
orelabrutinib will demonstrate its huge commercial potential.
The ITP Phase II result was published by the American Journal of
Hematology in April 2024. For details, please refer to
https://onlinelibrary.wiley.com/doi/10.1002/ajh.27303.
- 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. Orelabrutinib is global first and only BTK
inhibitor ever shown efficacy in Phase II SLE trials. A Phase
IIb trial is ongoing, and the patients enrollment has been
nearly completed as of this announcement.
SLE is a systemic disease that often leads to damage to organs,
especially the kidneys and nervous system, skin, blood system,
respiratory system, and almost all systems may be affected.
According to Frost Sullivan analysis, it is expected that there
will be 8.18 million SLE patients worldwide by 2025. The Chinese
Systemic Lupus Erythematosus Development Report 2020 points out
that there are about one million SLE patients in China, ranking
first in the world in number of patients and second in incidence
rate.
ICP-332
- ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is
being developed for the treatment of various T-cell related
autoimmune disorders, including atopic dermatitis (AD),
vitiligo, inflammatory bowel disease, etc., with broad market
prospects.
- The latest data of ICP-332 for the treatment of patients with
moderate-to-severe AD has been released at the 2024 American
Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral
presentation.
- ICP-332 achieved multiple efficacy endpoints in the China Phase
II study for the treatment of patients with moderate-to-severe AD,
demonstrating an outstanding efficacy and safety profile. ICP-332
showed better efficacy profile across different classes/MoAs of
therapies for the treatment of AD patients (not a head-to-head
comparison).
- In the ICP-332 80 mg once-daily (QD) and 120 mg QD groups for
four weeks, the response rates of EASI 90 (improvement of at
least 90% in EASI score from baseline) and NRS (Pruritus
Numerical Rating Scale) score from baseline ≥4
points demonstrated a 40% and 56% improvement respectively
compared with the placebo group, both of which were superior to
competitors.
- ICP-332 was safe and well tolerated in AD patients. The overall
incidence rates of adverse events (AEs) 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 in the fourth quarter of 2024, and
to submit IND for the Phase II/III trial for a second indication of
vitiligo. The US trials have been initiated.
ICP-488
- Data shows that 100 million people worldwide are affected by
various types of psoriasis7. 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. The Phase II study of ICP-488 in psoriasis has
completed patient enrollment in May 2024. The Company
expects the data readout by the end of 2024.
- A total of 129 patients were enrolled in this study. Patients
were randomly assigned to two treatment groups and placebo group,
for 12 consecutive weeks of treatment.
- ICP-488 demonstrated good efficacy and safety in the Phase I
study of ICP-488 in psoriasis patients.
Novel Small Molecule Inhibitor of
IL-17
- 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.
Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of
InnoCare, said, "In the first half of 2024, our commercial team
exceeded pre-set goals, with a significant increase in revenue. We
have developed innovative drugs with huge unmet medical needs, with
three NDAs submitted in the first half of this year. We have also
been actively exploring preclinical innovation, laying a solid
foundation for future development. Looking ahead to the second half
of the year, we will continue to make concerted efforts in the
fields of new drug R&D, clinical development, commercialization
and globalization, focusing on key goals to achieve high-quality
development.”
To know more about the detailed financial data and business
updates of InnoCare 2024 annual results, please log in to
https://www.innocarepharma.com/en/investor/home .
Conference Call Information
InnoCare will host a conference call at 9:30 a.m. Beijing time
on August 21 in Chinese and at 8:30 p.m. Beijing time in English on
August 21, 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://ubs-innocare-h124-earnings-call.open-exchange.net/
For Chinese conference call, please register through the below
link: https://s.comein.cn/AHJAP
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 Based on HKFRS (Hongkong
Financial Reporting Standards) 2 Hematology Branch of Chinese
Medical Association 3 Journal of Clinical Oncology,IF: 50.717 4
iHealthcareAnalyst, Inc., Oct. 3, 2023 5 Adult ITP Guidelines (2020
Edition) 6 Poster at the 63rd ASH Annual Meeting (Abstract Number:
3172) 7 Progress in Epidemiological Investigation of Psoriasis,
Journal of Diagnostics Concepts & Practice. 2021.
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Media Chunhua Lu 86-10-66609879
chunhua.lu@innocarepharma.com Investor Relations
86-10-66609999 ir@innocarepharma.com