CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU,
China, March 28,
2024 /PRNewswire/ -- Harbour BioMed ("HBM" or the
"Company"; HKEX: 02142), a global biopharmaceutical company
committed to the discovery, development and commercialization of
novel antibody therapeutics focusing on immune-oncology and
immunology, released annual financial results of full year
2023.
"We made progress in two significant undertakings in 2023, the
third financial year since listing on the Main Board of the Stock
Exchange of Hong Kong: preparing
Harbour Therapeutics to operate as a faster, more focused
clinical-stage next-generation therapeutics company and initiating
Nona Biosciences to leverage our unique global patent-protected
technology platforms to empower global therapeutic innovation. We
recorded a significant increase in our revenue, demonstrating the
Company's excellent global business development capabilities," said
Dr. Jingsong Wang, Founder, Chairman
and CEO of Harbour BioMed. "We are navigating a fiercely
competitive world that is going through rapid changes, facing human
being's fundamental quest for longevity and quality of life, and
having a greater demand for biotechnological breakthroughs and
innovative therapeutics. We've been well-positioned in the new era
to achieve results that will propel the Company to new heights and
create robust business value."
FULL YEAR 2023 FINANCIAL HIGHLIGHTS
Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023. This is the first time that the
Company has recorded a net profit on its annual financial
statements. Other financial highlights include:
- Revenue: The revenue for the full year 2023 is
US$89.5 million, which increased
significantly by US$48.8 million, or
119.9%, compared with US$40.7 million
for the year ended 31 December 2022.
Our revenue primarily consists of molecule license fee, research
service fee and technology license fee. The increase is primarily
attributed to license out and collaboration agreement with Pfizer,
Cullinan Oncology and Kelun-Biotech.
- Research and development costs: The research and
development expenses decreased by 66.6%, from US$135.1 million in 2022 to US$45.1 million in 2023. This decrease was
primarily attributable to the combined impact of (i) optimized
investments in our clinical programs and our molecule assets in
discovery and pre-clinical stages; and (ii) the efficient
implementation of cost control measures.
- Administrative expenses: The administrative expenses
decreased by 28.6%, from US$27.3
million in 2022 to US$19.5
million in 2023.
ROBUST PORTFOLIO AND DIFFERENTIATED PIPELINE
Harbour Therapeutics, a sub-brand parallel to Nona Biosciences,
is individually responsible for the development of the Company's
product pipeline. Focused on oncology and immunology, Harbour
Therapeutics has a robust and diversified pipeline of more than ten
potentially differentiated drug candidates, four of which are in
clinical development stage. Batoclimab (HBM9161), porustobart
(HBM4003), HBM7008 and HBM1020 are the main products.
- Batoclimab, as the clinically most advanced FcRn
inhibitor being developed in Greater
China, has the potential to be a breakthrough treatment for
a wide spectrum of autoimmune diseases in Greater China. Harbour Therapeutics completed
the treatment of patients in early 2023 and announced the positive
topline results of the phase III clinical trial of batoclimab for
the treatment of generalized myasthenia gravis (gMG) in March,
which is also the first positive pivotal trial outcome for
batoclimab worldwide. This marks a major milestone as it is the
Company's first product to complete phase III clinical trial and be
poised for commercialization to benefit the gMG patients. The
Company also initiated open-label extension clinical trial in 2022
and completed enrolment in March
2023. As the cut-off of open-label extension clinical trial
for gMG in November 2023, the data
showed sustainable efficacy and safety of batoclimab in long-term
disease management.
- Porustobart (HBM4003) is the next-generation, fully
human heavy chain only anti-CTLA-4 antibody generated from the HCAb
platform. It is also the first fully human heavy chain only
antibody which has entered into clinical development around the
world. In 2023, Harbour Therapeutics conducted the global clinical
development program of porustobart for multiple types of solid
tumors, and positive data of efficacy and safety profile have been
read out in the ongoing trials of neuroendocrine neoplasms and
hepatocellular carcinoma.
- Another example demonstrating Harbour Therapeutics' strong
research capabilities is the discovery of HBM7008, a novel
product targeting B7H4 and 4-1BB. Developed from the immune cell
engager platform HBICE®, HBM7008 is the only bispecific
antibody against these two targets globally. Leveraging and
integrating the expertise in biology and antibody engineering and
the unique characteristics of HBICE® platform, HBM7008
showed exciting performance both in efficacy and safety profile at
pre-clinical stage. In 2022, the Company conducted the phase I
trials in the U.S. and Australia.
In February 2023, to maintain a
leading position in the development of this first-in-class asset,
the Company entered into a co-development collaboration with
Cullinan Oncology, to expand its study process in the U.S.,
Europe and Australia.
- HBM1020 is a first-in-class fully human monoclonal
antibody generated from Harbour Mice® platform targeting
B7H7. As a newly discovered member of the B7 family, B7H7
expression is found non-overlapping with PD-L1 expression in
multiple tumor types, which potentially plays a more important role
for tumor cells to escape immune surveillance. HBM1020 is the first
product against B7H7 in clinical stage globally. With its excellent
product design and target features, HBM1020 presents great
potential to address huge unmet medical needs on solid tumors.
- Driven by the Company's leading drug innovation and discovery
engine, new assets are continually being developed, of which
HBM1020, HBM1022, HBM1007 and HBM9033 obtained the IND
clearance from the U.S. FDA to initiate clinical study in the U.S.
in 2023, and HBM9027 obtained the IND clearance from U.S.
FDA in the first quarter of 2024.
- In addition, we have a number of pre-clinical stage products in
the pipeline, including HBM7004, HBM1047 and HBM9014, which
have shown great potential for development.
PLATFORM-VALUE-MAXIMIZED BUSINESS COLLABORATIONS
In 2023, the Company continued to expand its business
collaborations with leading academic institutions and select
industrial partners focusing on innovation and efficiency across
the world. The business collaboration model is not only limited to
out-licensing, but also to engage with academic institutions or
other leading innovative pioneers in the industry for
co-development and incubation of joint ventures on next-generation
innovative therapy. With flexible business models built around
proprietary technologies and platforms, the Company can and will
maximize its platform value to address global unmet medical
needs.
Assets Collaboration of Harbour Therapeutics
Harbour Therapeutics has entered into several external
collaborations in terms of pipeline licensing and collaborations.
In 2023, Harbour Therapeutics has granted the regional
out-licensing of HBM7008 in the U.S. to Cullinan Oncology, and
HBM7022/AZD5863, which was licensed to AstraZeneca in 2022, has
entered into clinical stage. Meanwhile, the three assets which have
been licensed the Greater China Rights to Hualan Genetic obtained
IND approvals from NMPA to initiate clinical study in China. In addition, HBM9378, which was
developed in collaboration with Kelun-Biotech, completed its phase
I clinical trial.
With these multiple collaborations based on the assets generated
from HBICE®, Harbour Therapeutics has shown its strength
and unique advantages in building a comprehensive portfolio in
immune cell engagers. And the co-development and collaboration of
the pipeline is not only the recognition of the industry partners
for the Company's products and technology platforms, but will also
help the Company to improve the efficiency of portfolio
advancement, spread the costs and risks, and make the development
of the Company more robust.
Multiple Collaborations of Nona Biosciences
In addition to collaboration through the molecules and pipeline
generated from the platforms, the Company is also focusing the
vision on more original and innovative collaborations on early
stages. By integrating the industry leading Harbour
Mice® and HCAb PlusTM platforms with an
experienced therapeutic antibody discovery team, Nona Biosciences
provides a one-stop solution for therapeutic antibody discovery,
engineering and development from I to ITM (Idea to IND)
with flexible business models.
From the end of 2022, Nona Biosciences achieved big success in
its launch as it has landed several international collaborations in
multiple innovative formats. It is worth mentioning that Nona
Biosciences has granted the global out-licensing of HBM9033, a
potential best-in-class MSLN-targeted ADC, to Pfizer. Until now,
Harbour Mice® platforms have been validated by over 50
industry and academic partners.
Nona Biosciences has established four leading technology units
based on HCAb, including protein engineering, conjugation
technology, delivery technology and cell therapy to empower the
next-generation therapies. With the multiple collaborations based
on the assets generated from HCAb PlusTM, Nona
Biosciences has demonstrated its robust capabilities in antibody
discovery and development, exploring a new path to expand the
collaboration network and maximize the value of the platforms.
Incubation on Cutting-Edge Collaborations
To give full play to the value of the unique platform
technologies, the Company has continued to explore the
expandability of platform technology application scenarios which
generate impactful values and bring us new value growth points with
minimal marginal investment. Representative projects include HBM
Alpha Therapeutics, in partnership with Boston Children's Hospital,
and Shanghai NK Cell Technology Limited.
2024 OUTLOOK: EXTENSIVE GLOBALIZATION AND BREAKTHROUGH
INNOVATION
Looking to the future, Harbour BioMed will keep driving business
growth and accomplishing its mission through two key pillars,
Harbour Therapeutics and Nona Biosciences. The former will advance
multiple clinical trials of the internal pipeline to fully advance
the global clinical development project, and the latter will keep
providing integrated discovery solutions for biotechnology and
pharmaceutical companies and ultimately create an innovation
ecosystem to promote biological advancement.
A range of products based on the technology platform and
generated from the concept of T-cell engager and NK cell engager,
will be pushed forward to clinical stage in the following years.
With a combination of in-house development and business
collaborations, the Company will continuously form a portfolio of
products with a differentiated competitive advantage in
immuno-oncology.
The platform-valued-maximized business collaborations, driven by
Nona Biosciences, will further walk the Company down the path of
global development. Positive outcomes have been attained through
platform-based collaborations with top institutions around the
world and more extensive global collaborations are expected in 2024
as our preclinical products become increasingly mature.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical
company committed to the discovery, development, and
commercialization of novel antibody therapeutics focusing on
immunology and oncology. The Company is building its robust
portfolio and differentiated pipeline through internal R&D
capability, collaborations with co-discovery and co-development
partners, and select acquisitions.
The proprietary antibody technology platforms Harbour
Mice® generates fully human monoclonal antibodies in two
heavy and two light chains (H2L2) format, as well as heavy chain
only (HCAb) format. Building upon the HCAb antibodies, the
HCAb-based immune cell engagers (HBICE®) bispecific
antibody technology is capable of delivering tumor-killing effects
unachievable by traditional combination therapies. Integrating
Harbour Mice®, and HBICE® with a single B
cell cloning platform, our antibody discovery engine is highly
unique and efficient for the development of next-generation
therapeutic antibodies. For further information, please refer to
www.harbourbiomed.com.
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SOURCE Harbour BioMed