CAMBRIDGE, Mass., SUZHOU, China and ROTTERDAM, Netherlands, April 3, 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 immune-oncology and immunology, released annual results of full year 2022.

"2022 has been our second financial year since listing on the Main Board of the Stock Exchange of Hong Kong in December 2020. With greater opportunities, the Company integrated enriched resources and significant additional efforts to drive the advancement of our portfolio and expand our collaboration worldwide, leveraging our unique global proprietary technology platforms and sustained discovery engine." said Jingsong Wang, Founder, Chairman and Chief Executive Officer.

"2022 was a year of high efficiency on portfolio development for HBM. The Phase III clinical study of batoclimab, through the joint efforts of the sponsor, investigators and patients, overcame all difficulties during the pandemic and completed enrollment of 132 subjects in 10 months, with the positive outcome achieved. This is the first successful pivotal Phase III study of myasthenia gravis clinical trials in China."

"2022 was a year of expansion in collaboration network for HBM. With innovative and agile business model as well as robust portfolio and proprietary technology , we have successfully partnered with top pharmaceutical companies such as AstraZeneca and CSPC Pharmaceutical Group for pipeline products in Harbour Therapeutics, and cooperated with innovative industry leaders such as Moderna and Dragonfly Therapeutics for cutting edge technology innovation with transformational business model of Nona sciences. Based on the continuous collaborations on Immune Cell Engagers globally, the Company has established itself as the leader in HBICE^®  based bispecific antibody innovations. Leveraging on the cash income brought by varieties of global collaborations, the Company's revenue increased by 846.5% year on year, and our capability to monetize technology and innovation has been strongly validated."

"2022 was a year of breakthrough in technology innovation for HBM. We have established a wholly-owned subsidiary, Nona Biosciences. It is the technology platform arm for HBM, and it's mission is to focus on cutting-edge technology innovations and providing discovery solutions from 'Idea to IND' to partners around the world. The key value drivers for the company are industry leading technology platforms including Harbour Mice^®, HBICE^® and Antibody Plus in various therapies, with deep expertise and rich experience. Since its inception, Nona Biosciences has been endorsed by renowned partners, demonstrated its innovation engine power in next generation therapeutics. ."

"Moving forward, we will build upon these significant achievements and continue our mission to be the global leader in driving innovation in the next generation of antibody therapeutics, benefiting the patients around the world." Dr. Wang concluded.

Continued advancement of robust portfolio and differentiated pipeline

The Company is committed to discovering and developing innovative antibody therapeutics for oncology and immunology diseases and has a differentiated product pipeline that includes more than ten drug candidates, six of which are in clinical stages.

In 2022, the Company moved forward the global clinical development program of porustobart (HBM4003) in multiple indications. Porustobart, the next-generation anti-CTLA-4 antibody, is the first fully human heavy chain only antibody in the world that has entered into clinical development. This flagship program has advanced rapidly from candidate selection to Phase II with unprecedented clinical data released in 2022. The results showed an excellent safety profile with a strong positive signal on efficacy, with the potential to become the best-in-class treatment option for melanoma patients in China. In parallel, further clinical data of this combination therapy with PD-1 for patients with Neuroendocrine Neoplasms (NEN) will be released in 2023, which also show best-in-class potential for patients with high grade NEN. With more data collected and strong efficacy demonstrated in clinical trials, we are enabling the pivotal trial of porustobart.

Another flagship program is the exciting development for HBM7008, a novel product targeting B7H4 and 4-1BB,and generated from our immune cell engager platform HBICE^®. HBM7008 is also the only bispecific antibody against these two targets globally. This product entered into Phase I trials in the U.S. and Australia in 2022 with great potential on solid tumors. To maintain the leading position in the development of this first-in-class asset, the Company has entered into a co-development collaboration with Cullinan Oncology, to accelerate its development in the U.S., Europe and Australia.

The Company co-developed HBM9378 with Kelun-Biotech and drove this program into clinical stage in 2022. HBM9378 is a fully human monoclonal antibody against TSLP (thymic stromal lymphopoietin) generated from H2L2 platform. The long half-life optimization and outstanding biophysical properties solidify its favorable dosing and formulation advantages.

In the first quarter of 2023, HBM1020 (B7H7), HBM1022 (CCR8) and HBM1007 (CD73) obtained the IND clearance from the U.S. FDA to initiate clinical study. HBM1020 is a first-in-class fully human monoclonal antibody targeting B7H7 (HHLA2) generated from Harbour Mice^® platform and also the only product in IND stage globally. B7H7 is widely expressed in solid tumors and has low overlapping with PD-L1, especially stronger expression than PD-L1 in NSCLS. With excellent molecular  design and target features, HBM1020 demonstrates  the potential to address broad unmet medical needs on solid tumors.

In addition, HBM7022 (CLDN18.2xCD3), HBM7004 (B7H4x4-1BB), HBM9027 (PD-L1xCD40), HBM9033 (MSLN ADC), HBM1047 (CD200R1) and HBM9014 (LIFR) are all preclinical stage products in the company's pipeline. With the efficient output of the technology platforms as well as the rich expertise of our R&D team, the Company aims to file at least one IND each year moving forward.

Platform-driven business model to maximize value creation

Out-licensing and co-development, as important business models of HBM, ascended  great achievements. In 2022, the Company granted the global out-licensed of HBM7022 to AstraZaneca, and achieved a co-development partnership on HBM7008 with Cullinan Oncology. In addition, HBM9378 developed in collaboration with Kelun-Biotech, has entered the clinical stage. These achievements validate our platform value through multiple milestones on business development and will accelerate the development of our portfolio.

To maximize the value creation of our platform and enhance our influence in the industry through technology collaborations, the Company established Nona Biosciences to better empower the innovators and enable its collaborators from idea to IND (I to I^TM). At the end of 2022, Nona Biosciences achieved significant success in its launch as it has landed numerous major deals, such as the collaboration with Moderna, a global biotechnology company well recognized for its capabilities in mRNA technology, and with Dragonfly Therapeutics, a cutting-edge developer on multiple therapies in relation to NK cells. As an original discovery engine, our platform allows Nona Bioscience to be a reliable partner for collaborations for diverse R&D needs in various therapeutic areas and modalities. Nona Biosciences is on a new path to expand the Company's collaboration network and bring strong value growth in the future.

To give full play to the value of the unique platform technologies, the Company continues to explore the application of its platform in broader application scenarios with deep biology expertise, incubating several joint ventures focusing on next-generation innovation. HBM Alpha Therapeutics (HBMAT), an innovative biotechnology company incubated together with Boston Children's Hospital, completed seed financing to advance its novel antibody therapies to treat congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS). Another incubation program, Shanghai NK Cell Technology Limited, completed its A round financing and raised a fund over RMB100 million to deepen its efforts in cutting-edge NK cell therapeutics.

Looking ahead to 2023, HBM will continue to focus on global innovation and cooperation, taking its core technology platform as the innovation fulcrum, accelerating the clinical development of the innovative pipeline products focusing on immune-oncology therapeutics, and actively embracing the first commercialization of our portfolio. Furthermore, through expansive business collaborations, we will accelerate the advancement of our portfolio and enable our partners to generate more cutting-edge target molecules through collaborations with Nona Biosciences. HBM aims to lead next-gen biotherapeutics innovation on a global basis, leveraging in-house unique technology platforms and strong research and development capabilities, and accelerate our mission to lead a healthy life with breakthrough medicines globally.

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.