Harbour BioMed Reports Full Year 2021 Financial Results: Empower Value Creation with Global Innovation Capabilities

CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, March 24, 2022 /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 oncology and immunology, today reported full year 2021 annual results. During the reporting period, the Company's product development continued to make outstanding breakthroughs, unleashing the power of innovative technology platforms and globalization advantages.

"2021 was a year of strong momentum for Harbour BioMed. The company has been making significant progress with respect to our highly differentiated pipeline products and business operations," said Jingsong Wang, Founder, Chairman and Chief Executive Officer. "Our 10 clinical trials are ongoing while two of them, Batoclimab and Tanfanercept, are in pivotal phase III trials and are progressing towards BLA (Biologics License Application) submission. We've seen encouraging data of the global clinical trials of HBM4003 and solid progress of multiple assets through pre-clinical development. The value of our platforms has been further validated with more than 50 leading partners around world.

Moving forward in 2022, we will continue to explore more differentiated novel therapeutics on a global basis, leveraging in-house technology platforms and strong research and development capabilities. I believe that each of our innovative products empowered by our unique platforms has the potential to benefit the patients globally, accelerating our mission to lead a healthy life with breakthrough medicines globally."

Recent Highlights:

Continued advancement across broad pipeline of core assets —

• 10 clinical trials are ongoing.
• 2 products, Batoclimab (HBM9161 for patients with myasthenia gravis) and Tanfanercept (HBM9036 for patients with dry eye disease), are in pivotal phase III trials and are progressing towards BLA submission.
• Global clinical trials of HBM4003 in both monotherapy and combination therapy are also rapidly advancing at full pace, with encouraging data and promising results to date.

Multiple assets are progressing through pre-clinical development —

• 6 innovative and differentiated products are nearing clinical stages of development.
• HBM7008 was approved for phase I clinical trial in Australia and HBM9378 was approved for phase I clinical trial in China.
• HBM1020, HBM1022, HBM1007, and HBM7020 are all advancing towards clinical applications.
• Another 7 INDs are approved. This portfolio of innovative and differentiated products entering the clinical stage demonstrates the value of the Company's technology platforms.

The Company is actively exploring new scientific discoveries in novel therapeutic areas to address unmet medical needs —

• Leveraging in-house technology platforms, the Company is incubating NK cell therapy, bispecific NK cell engager and developing innovative antibody drug conjugate (ADC) products.

The Company's scientific research team strives to scale new heights in science with its strong research and development capabilities —

• In the period, 65 patents were filed.
• The Company also participated in multiple academic conferences, presenting scientific achievements while highlighting its strong innovation capabilities.

Further advanced its global strategy through multiple collaborations —

• Entered into a research collaboration agreement with the Dana-Farber Cancer Institute of the Affiliated Hospital of Harvard Medical School.
• Reached a strategic collaboration on artificial intelligence with BioMap, integrating the Company's AI technology advantages into the Harbour Mice^® platform.
• Further expanded an academic collaboration with the Icahn School of Medicine at Mount Sinai.
• Advanced the strategic collaboration with Hualan Bio, and several assets are expected to enter the clinical stage this year.
• The value of the Company's platforms is further validated with more than 50 leading partners around the world.

Driving antibody drug development through innovation

The Company remains committed to the discovery and development of differentiated antibody therapeutics focusing on oncology and immunology. Powered by Harbour BioMed's unique technology platforms, it has developed a differentiated portfolio and innovation engine for sustained long-term expansion and growth of its self-developed pipeline.

Harbour BioMed is at the forefront of developing next generation immuno-oncology therapeutics, including innovative immune cell engager bispecific antibodies, unique Treg depletion mechanism, and novel immune escape pathway. Cancer treatment market unfolds vast opportunities, and the Company seeks to develop oncology therapeutics that address situations where 70%-80% of patients do not respond to or are resistant to PD1/PD-L1, in its pursuit of next-generation immuno-oncology therapeutics which tap the potential value of this $100 billion market.

With the R&D advantages of HBM's unique and highly efficient antibody discovery platforms under one organizational umbrella, the Company developed a number of first-in-class clinical and preclinical products. Among them, the bispecific antibody HBM7008 (B7H4/4-1BB) and the monoclonal antibody HBM1020 (B7H7) which represents the next generation of immune checkpoint inhibitors with significant differentiated advantages. In addition, the monoclonal antibody HBM1022 targets the Treg cell protein CCR8. CCR8 is recognized globally as a challenging target but one which is garnering increased attention in immuno-oncology. The Company's use of mRNA immunization technology combined with its proprietary antibody platforms allow for a suite of solutions of G protein-coupled receptor (GPCR) antibody discovery. These noted products were all developed by the Company and indicative of the encouraging progress HBM has made in overcoming the challenges faced across the competitive landscape.  The Company looks forward to continuing this success with promising clinical results as these and other programs move forward in their development lifecycles.

The rapid advancement of HBM's clinical pipeline has continued into 2022, with multiple milestones reported in the first quarter. In February, the fully human monoclonal antibody HBM9378 (or SKB378) generated from the Company's H2L2 platform was approved for an investigational new drug ("IND") clinical trial application for the treatment of moderate to severe asthma; in the same month, HBM7008 (B7H4/4-1BB), the world's first-in-class product from the HBICE^® bispecific antibody platform, was officially approved by the Independent Review Board (IRB) in Australia and could potentially provide improved efficacy with better safety as compared to traditional monoclonal antibody therapies. The Company expects 4-6 products to enter the clinical stage this year and to rapidly push forward innovative products with blockbuster potential, laying a solid foundation for building a global competitive advantage.

HBM's cutting-edge fully human antibody platforms enable unique innovation and differentiation

HBM's antibody discovery platforms are the engine of its portfolio innovation: HBICE^® - a fully human bispecific antibody platform for immune cell engagers, a fully human heavy-chain-only antibody HCAb platform for monoclonal antibodies, and a fully human heavy and light chain antibody H2L2 platform with global patent protection. These robust technology platforms drive the Company to continuously advance antibody drug development while move towards more novel and challenging targets to address unmet medical needs, providing the momentum for sustained therapeutics innovation worldwide.

It is worth noting that, in the field of bispecific antibodies development, the Company's fully human HBICE^® bispecific platform for immune cell engagers, the highly differentiated bispecific antibody technology platform globally, is built upon the fully human HCAb based formats for immune cell engagers, which is also a patented achievement independently developed by the Company. The HBICE^® platform focuses on immune cell engagers, which can flexibly generate multiple molecular structures adapting to different biological mechanisms of action and effectively solving the problem of heavy and light chain mismatch in antibody engineering. The technology platform connects tumor cells with immune cells, activates immune cells, and kills tumor cells specifically, which can improve the effectiveness of treatment and reduce the risk of cytokine storm, avoiding the toxicity risk of systemic activation. Thus, safety is significantly improved, which is conducive to creating more innovative, differentiated, and safe products.

HBM is actively strengthening globalization presence to empowering its long-term development goals

As innovation and development across the biopharmaceutical industry continues to become more global, the Company is thriving on its three global innovation research centers and four major clinical sites, which reflects the Company's global ambition and continued investment into its R&D capabilities. By integrating R&D centers established in the US, the Netherlands and China, the Company is capable to consolidate leading global scientific and technological innovation resources. By maximizing regional innovation success, resource utilization is improved and translational clinical research results are advanced, accelerating bringing about differentiated innovative therapeutics, facilitating cooperation within the industry for the benefit of patients. At the same time, following the strategy of international research and development, HBM set up with four clinical sites in China, the US, Australia, and Europe to speed up the global development of its self-developed products.

Importantly, innovative solutions shape the global biopharmaceutical industry. The Company is jointly developing the next generation of innovative therapeutics through its proprietary technology platforms and global innovation network; an approach that has been validated by over 50 industry and academia partners with more than 10 products having entered the clinical stage. External collaborations include those with Eli Lilly, AbbVie, Pfizer, BeiGene, Innovent, Dana-Farber Hospital of Harvard Medical School, and Icahn School of Medicine of Mount Sinai Medical System in New York. Our global footprint enables the value proposition the Company's antibody technology platforms, which can be continuously tapped into and increasing the commercial income generating potential of its R&D capabilities.

In addition, the Company previously announced that it will initiate exploration of NK cell and ADC therapeutics. The Company hopes to leverage its novel technology across these frontier therapeutic areas, expand the application of its technology platforms, and lead next drug development programs to address areas of significant unmet clinical needs.

Accelerating clinical development to unlock potential value

As of now, the Company has independently developed more than ten highly differentiated products, two of which are in pivotal clinical phase III trials and are moving towards Biologics License Application (BLA) submission – namely Batoclimab (HBM9161), which has obtained the national Breakthrough Therapeutics Designation for myasthenia gravis, and Tanfanercept (HBM9036), the first globally innovative biological drug for dry eye disease in China.

Specifically, Batoclimab is a next generation fully human monoclonal antibody that selectively binds to and inhibits the neonatal crystal fragment receptor (FcRn) and has the potential for breakthrough treatment of various autoimmune diseases. Tanfanercept is the most advanced product candidate currently being developed by the Company for the treatment of moderate-to-severe dry eye disease, which has a bright market potential in the emerging dry eye drug market in China. These two products are highly differentiated and have large potential market opportunities.

As people begin to emerge from the global pandemic, good health is even more in focus now. In the increasingly competitive biopharmaceutical market, innovation is no doubt the core commodity. Harbour BioMed has built a broad moat with its innovation engine and differentiated pipeline, leveraging its unique and robust antibody technology platforms, regional global innovation ecosystem, and accelerated clinical operations of its core products.

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 Company's proprietary antibody technology platforms Harbour Mice^® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.

SOURCE Harbour BioMed