Harbio BioMed Public Relations
August 31, 2021
CAMBRIDGE, Mass.; Suzhou, China; Rotterdam, Netherlands - August 31, 2021
Harbour BioMed (“HBM”, or the "Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported its interim results for the six months ended June 30, 2021, and provided key business updates.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "Harbour BioMed remains committed to developing innovative therapeutics for patients worldwide, becoming the leader in next generation antibody therapeutics with a strategic focus on immunology and oncology. In the first half of 2021, we further accelerated our product pipeline, advancing multiple clinical trials of the core products: Batoclimab and Tanfanercept are in preparation of expected commercial launches. We will continue to invest in HBM4003, and other numerous candidates generated from our discovery engine, while exploring innovative molecules with new targets as well as known targets. The remarkable business progress and growth momentum achieved in the first half of 2021 give us full confidence in securing the Company’s future. As such, the Company will continue to successfully navigate the complex market environment and provide innovative treatments for patients around the world.”
Core clinical assets are advancing, further developing HBM’s product portfolio and pipeline
Since 2021, China's healthcare reform has been further deepened, and reform of the pharmaceutical industry has gradually matured amidst policy and market changes. Adjustments made to the medical insurance catalog, price negotiation of medical insurance and a new round of volume procurement bring continuous challenges to drug pricing, especially pricing of products with weak differentiators. At the same time, the exploration of medical insurance reform has pushed the industry to pay more attention to drug pricing. The Company is committed to bringing benefits and value to patients, and value-based healthcare approach is adopted in its unique and differentiated portfolio planning as well as the clinical assets’ development.
A fully human monoclonal antibodies that can selectively bind to and inhibit the neonatal crystal fragment receptor (FcRn) and have the potential to treat a variety of autoimmune diseases. During the reporting period, the Company announced the positive results of its phase II clinical trial for Chinese patients with generalized myasthenia gravis (gMG), which is also the first clinical evidence of anti-FcRn therapy in Chinese patients. Batoclimab has entered full clinical stage development in:
Myasthenia Gravis (MG)
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Immune Thrombocytopenia (ITP)
Graves Ophthalmopathy (GO)
Tanfanercept is the Company's lead candidate product for the treatment of moderate to severe dry eye disease (DED), which is expected to meet the huge clinical needs of the Chinese patients.
HBM4003 is a next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from HBM’s HCAb platform. It is also the world’s first fully human heavy chain only antibody to enter clinical development. In 2021, we have implemented the global development plan of multiple types of solid tumors utilizing HBM4003.
Multiple potential preclinical assets approach clinical stage
In addition to the above-mentioned clinical assets, multiple potential products are also in full-speed preclinical development including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1007, HBM1029, etc. – which are all approaching clinical stages. In the near future, the Company will continuously submit more IND applications through its efficient drug discovery engine.
HBM7008 is a bispecific antibody targeting Tumor Associated Antigen (B7H4)x4-1BB. It is discovered from Company's heavy-chain antibody immune cell engager HBICE® and is currently the only bispecific antibody against these two targets worldwide. It is expected to file a CTA/IRB submission in the second half of 2021.
HBM9378 is a fully human monoclonal antibody generated from HBM’s H2L2 platform, which has less immunogenicity risk and better bioavailability comparing to the other TSLP target competitors. The long half-life optimization and outstanding biophysical properties support its favorable dosing and formulation advantages. It is expected that an IND application will be submitted in the second half of 2021.
HBM1022 is a CCR8 antibody developed by HBM, which cross-reacts with the CCR8 target of cynomolgus monkeys, and has demonstrated its significant tumor growth inhibitory effect in mouse tumor models. As an innovative target, CCR8-targeted drugs have not yet entered the clinical development stage globally. It is expected that an IND application will be submitted in 2022.
HBM1020 is a fully human monoclonal antibody generated from HBM’s H2L2 platform. The antibody is directed against a brand-new target in the B7 family and can enhance the anti-tumor immunity by blocking the immune checkpoint target. Preclinical data has demonstrated its immune activation and anti-tumor functional activities. It is expected to file an IND in 2022.
HBM1007 is a fully human monoclonal antibody against CD73 generated from HBM’s H2L2 platform. It is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. HBM1007 is being studied in preclinical setting and an IND application is expected to be submitted in 2022.
HBM7020, HBM1029 and HBM7015
HBM7020 is a BCMAxCD3 bispecific antibody equipped with HBM's HBICE® technology. HBM1029 is a fully human monoclonal antibody developed from the Company's H2L2 platform with higher CLDN18.2 binding affinity and stronger ADCC and CDC anti-tumor activities. HBM7015 is a bifunctional fusion protein generated from the H2L2 platform that demonstrated better PD-L1 binding activity than competitor drugs.
In 2020, the Company licensed-out the Greater China rights and interests of three preclinical products (HBM7020, HBM1029 and HBM7015) developed from its own technology platform to Hualan Genetic, a Chinese biopharmaceutical corporation. After completing the technology transfer, the two companies have jointly worked on the development of these three innovative products. It is expected that IND applications for these products will be submitted in 2022.
Build a global innovation hub with strong R&D capabilities and expertise
HBM focuses on a new generation of innovative therapies in the field of immunology and oncology. The drug discovery and preclinical research team has conducted drug discovery, formulation development, process development and preclinical research on new drug candidates. At the same time, the Company has a professional team of scientists to optimize, upgrade and re-develop our technology platform.
During the reporting period, the Company's main progress in drug discovery, technology platform and patents are as follows:
HBM has established a robust antibody discovery platform and GPCR drug development platform. Based on these technology platforms, the Company is expected to move towards more novel and challenging drug targets worldwide.
Strengthened R&D collaborations worldwide
During the reporting period, HBM continued to expand collaborations with leading global academic institutions and selected industry partners focused on innovation and efficiency. HBM’s flexible business models built around our proprietary technologies and our strong internal discovery capabilities can and will maximize our platform value by leveraging complementary advantages from the Company and our collaborators.
Build internal manufacturing and commercialization capability to support clinical development and product launches
With the maturity of our pre-clinical products, we planned to build internal manufacturing and commercialization capability in due course.
Financial Summary of First Half of 2021
For the half-year ended June 30, 2021, the Company recorded a revenue of US$2.2 million, mainly from molecule license fee.
For the half-year ended June 30, 2021, the Company's other income and gains were US$2.7 million, mainly attributable to the increase of bank deposit interest, as well as increase of government subsidy and grants.
For the half-year ended June 30, 2021, the Company's R&D expenses were US$41.2 million, increased investment in key clinical programs, discovery and pre-clinical programs; increased employee costs, mainly research scientists and development clinician headcounts, as well as share-based compensation expenses.
HBM4003 is the next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice®. It is the first molecule generated through our in-house efforts and has entered clinical trial since first being discovered as a drug candidate only 3 years ago. HBM4003 is the world’s first fully human heavy chain only anti CTLA-4 antibody entered into clinical development. It shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.
About Tanfanercept (HBM9036)
Tanfanercept (HBM9036) is at the forefront of the Company’s R&D pipeline, it is a modified 19 kDa TNF receptor 1 fragment and is for the treatment of moderate to severe Dry Eye Disease. Tanfanercept has the potential to seize a majority market share in a fast-growing DED drug market.
About Batoclimab (HBM9161)
Batoclimab (HBM9161) is a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). As the first in class FcRn inhibitor being developed in Greater China, it is expected to become a breakthrough therapy to patients with autoimmune disease conditions.
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.
Harbio BioMed Public Relations