Harbour BioMed Announces 2023 Interim Results

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Aug. 28, 2023 /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 announced its interim results for the six months ended June 30, 2023.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "In the first half of 2023, Harbour BioMed recorded a significant increase in its revenue, turning losses into profits. The outstanding performance demonstrated the Company's excellent global business development capabilities and remarkable achievements in cost reduction and efficiency improvement. Our strategy on global innovation ensures we maintain a competitive edge in multiple fields of drug discovery, further creating favorable advantages for differentiated pipeline development and expansive international collaborations, thus unleashing a wider range of value. Despite the numerous challenges ahead, we will steadfastly promote the Company's global strategy to drive sustainable growth on the base of innovation, thereby accelerating the advancement of our business."

With strong R&D capabilities, the Company has continued to optimize and upgrade its industry leading and globally patented antibody platforms to further implement its "Antibody+" business strategy. During the reporting period, the Company filed 268 patents, 12 of which had been granted invention patents by the China National Intellectual Property Administration with 174 in progress. Robust patent clusters provide effective protection for the Company's products and new technology innovations, enabling the company to maintain an advantageous position in global biotech industry. Leveraging the unique antibody discovery technology, Harbour Therapeutics currently has over 10 innovative global programs in immuno-oncology and immunology, while Nona Biosciences further create value through global collaborations based on technology innovations.

The Company has achieved positive half-yearly revenue growth rates exceeding 40% for two consecutive years benefiting from its robust technology platform and cutting edge innovations in the field of Immuno-oncology and Immunology. The Company recorded revenues of over $40 million in the first half of 2023 and achieved its first interim profit of approximately $3 million. Turning to a profit verifies Harbour BioMed's sustained and outstanding value creation ability. The out-licensing and collaboration of innovative products from Harbour Therapeutics' portfolio, including HBM7008 and batoclimab (HBM9161), have significantly contributed to this growth. At the same time, the Company has also seen the positive contribution from Nona Biosciences to the earnings growth and profits during the period.

Harbour Therapeutics: Advanced pipeline with exciting advancements

Batoclimab (HBM9161) 's positive results on its phase III clinical trial for the treatment of generalized myasthenia gravis (gMG) were announced during 1H2023. Batoclimab resulted in a higher rate of sustained MG-ADL improvement in adult patients with gMG than placebo, and sustained improvement were observed in the second cycle. As the most advanced asset in the portfolio, this marks a major milestone for Harbour BioMed as it is the first positive readout of a registrational trial since its establishment. Also, as the first anti-FcRn product with a complete data set in Greater China, this result of batoclimab has significant positive impact on the development of effective therapeutics for patients with gMG in China.

Porustobart (HBM4003) is a next-generation fully human heavy chain only anti-CTLA-4 antibody generated from the Harbour Mice^® HCAb platform. It has showcased promising efficacy and safety profile in multiple clinical trials in patients with melanoma, neuroendocrine neoplasms and hepatocellular carcinoma, demonstrating the potential to be developed as a cornerstone therapy in immuno-oncology. Data released in 1H2023 showed that the overall objective response rate (ORR) was 36.8% in its phase Ib clinical trial of porustobart in combination with toripalimab in patients with advanced high-grade neuroendocrine neoplasms, and in its phase Ib clinical trial of porustobart in combination with toripalimab in patients with hepatocellular carcinoma, the ORR hit 46.7%. The Company is poised for the first pivotal trial of porustobart in the next 6 months and plans to expand in multiple new indications including colorectal cancer.

HBM1020 is a first-in-class therapeutic monoclonal antibody against B7H7/HHLA2 entering clinical development globally. It obtained U.S. FDA clearance for phase I trial in January 2023 and completed the first patient dosing in June 2023. As a newly discovered member of the B7 family, B7H7/HHLA2 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which indicates an alternative immune evasion pathway besides PD-(L)1. Preclinical data demonstrated its immune activation and anti-tumor functional activities, showing great potential to address huge unmet medical needs in patients with advanced malignancies.

HBM9033 is an antibody-drug conjugate-based (ADC) drug that specifically targets human mesothelin (MSLN), a TAA that is upregulated in various solid tumors, including mesothelioma, ovary cancer, lung cancer, breast cancer, and pancreatic cancers. HBM9033 is the first ADC product of the Company, which is generated from the Company's patented ADC platform and has obtained the IND Clearance by U.S. FDA for phase I trial in August 2023.

The collaboration with industry partners on product development has provided more diversified avenues and enriched resources for Harbour Therapeutics' portfolio advancement, which is an integral part of the strategy that the Company will continue to implement and optimize. Regional and global business collaborations are accelerating the development of numerous programs including HBM7022, HBM7008 and HBM9378. These efforts have verified our innovation ability and recognized the value of the product portfolio of the Company.

Nona Biosciences: Unleashing platform value to shape the second growth curve

As a pioneer in innovative antibody platform technology, the Company continues to advance the "Antibody+" strategy based on its unique advantages of Harbour Mice^® technology and develop its strengths in cutting-edge research areas such as bispecific antibody, ADC, mRNA, CAR-T, artificial intelligence and protein engineering, providing strong momentum for breakthroughs in innovative technologies. Nona Biosciences, a wholly-owned subsidiary of the Company, as a pivot of value realization and business expansion, is committed to providing global partners with innovative antibody solutions, continuously developing the global cooperation network, and constantly exploring diverse business areas to promote sustainable business growth. With its world-leading technology innovation, the Company's second growth curve is steadily gaining momentum.

In the field of ADC development, the Company disclosed its ADC technology platform patent as early as 2021 to invest strong R&D efforts ahead of the curve. Not only is Harbour Therapeutics advancing its ADC program HBM9033 generated from the ADC platform from Nona Biosciences, it has successively entered into strategic cooperation with global ADC leaders with rich technology expertise and has generated substantial financial returns through technology licensing and product partnerships.

During the period, there were more than 30 projects ongoing with over 20 new projects initiated by Nona Biosciences. The ongoing platform upgrade driven by Nona is broadening the frontiers of applications in challenging fields including immune cell engager, G protein-coupled receptor (GPCR), mRNA, etc. and more platform-based global bio-innovation is expected to continue to emerge.

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^® 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 visit www.harbourbiomed.com  

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