Recently, Hebo Pharmaceuticals released a positive earnings forecast: it expects profits of US$68 million (approximately HK$532 million) to US$74 million (approximately HK$579 million) in the first half of 2025. This figure represents a more than 47-fold increase from approximately US$1.4 million in the same period of 2024, and easily exceeds its projected full-year profit of US$2.778 million in 2024.

Its profit growth mainly comes from BD cooperation income, of which the initial payment, milestone payment and option payment from AstraZeneca accounted for US$175 million.

Since Harbour BioMed successfully turned a profit in 2023 through licensing revenue, the market has questioned the sustainability of this model. However, Harbour BioMed's continued strong performance has proven that BD revenue can be converted into a stable and regular revenue stream, exploring a new path for innovative pharmaceutical companies to survive.

Billions of BD orders ignited the performance explosion point

As early as 2020, Hebo Pharmaceuticals embarked on the overseas BD journey.

In 2022, after concentrating resources and implementing strategic adjustments, Harbour BioMed's BD development has accelerated even faster than before, placing it in the top tier of Chinese pharmaceutical companies in both quantity and value. To date, Harbour BioMed has secured over 40 collaborations with a potential total value exceeding US$10 billion. In the first half of this year alone, Harbour BioMed secured six collaborations, earning its title as the "King of China's BD."
Currently, Harbour Biopharma's business segments are primarily divided into Harbour Medical and Nona Biopharma. The former focuses on pipeline development, product collaboration, and commercialization, while the latter engages in CRO business, providing global partners with solutions from idea to IND filing, generating recurring revenue for the company.

Harbour BioMed is rapidly developing a pipeline of innovative R&D products, leveraging its fully human transgenic mouse platform, Harbour Mice®, its immune cell engager, HBICE®, its bispecific immune cell antagonist, HBICA™, and its single B cell clone screening platform. This is the foundation for its continued pipeline of project licenses.

Currently, Hebo Pharmaceutical’s partners include many well-known pharmaceutical companies, including MNCs such as AstraZeneca and Pfizer, and leading Chinese pharmaceutical companies such as Shijiazhuang Pharmaceutical Group and Kelun Pharmaceutical.

Among them, AstraZeneca played an important role in the development of Harbour BioMed. It reached cooperation with Harbour BioMed three times and introduced 4+ projects with a potential cooperation amount of more than US$5 billion, accounting for half of all BD transaction amounts of Harbour BioMed.

In the first half of this year, Hebo Biopharma expects to generate profits of US$68 million to US$74 million, a significant portion of which will come from upfront and milestone payments from AstraZeneca. Meanwhile, AstraZeneca also subscribed to a 9.15% stake in Hebo Biopharma's additional offering, representing an investment exceeding US$100 million.

In the first half of this year, Harbour BioMed also completed a NewCo transaction. In January, Harbour BioMed and Kelun Biotech entered into a collaboration with Windward Bio. Under the agreement, Windward Bio obtained exclusive global rights to the TSLP monoclonal antibody HBM9378 (excluding Greater China and certain Southeast Asian and West Asian countries). Harbour BioMed and Kelun Biotech are entitled to receive up to US$970 million in upfront and milestone payments, as well as royalties. The upfront payment and near-term milestone payments total US$45 million, consisting of cash and equity in Windward Bio's parent company.

The first product is about to be launched

The concept of "treating technology as a product" has helped Hebo Pharmaceuticals overcome the challenges of the long R&D cycle of innovative drugs. Continuous licensing transactions have enabled it to achieve continued profitability in 2023, 2024 and H1 2025.

Harbour Biopharma calls itself "China's Regeneron," but it's still one blockbuster drug away from reaching that level. While Regeneron initially relied on technology exports to generate revenue, it's the two billion-dollar drugs dupilumab and aflibercept that truly propelled it to prominence.

Looking at Harbour Biopharm's current pipeline, the company focuses on two key areas: inflammatory diseases and oncology, encompassing cutting-edge and hot research areas such as TCE, bispecific antibodies, and XDC. Many of these pipeline products have potential for FIC and BIC, including Batolimumab, which filed for marketing approval last year and is nearing commercialization. However, it's worth noting that this product isn't derived from Harbour Biopharm's technology platform, but rather was acquired from Immunovant. It may be some time before products from Harbour Biopharm's proprietary technology platform reach commercialization.
Batolimumab (HBM9161): A novel FcRn-targeting drug, designed to treat autoimmune diseases by reducing pathogenic IgG levels. In March 2023, Harbour BioMed announced that its Phase III clinical trial of the FcRn antibody Batolimumab for the treatment of generalized myasthenia gravis (gMG) met its primary and key secondary endpoints. In July 2024, the drug's BLA application was accepted by the National Medical Products Administration (NMPA), with approval expected in the second half of 2025.

FcRn has been a hot target in the autoimmune field in recent years. Currently, only Zai Lab's agamodulin alfa is available in China , with its first annual reimbursement revenue reaching nearly $100 million. Recent data on batolizumab demonstrate sustained efficacy and safety in long-term disease management. Harbour BioMed has licensed the drug to CSPC Pharmaceuticals, a well-established pharmaceutical company with commercial resources, and is expected to capture a significant share of the Chinese gMG treatment market.

In addition, Batolimab is being explored for multiple indications, including thyroid eye disease (TED), neuromyelitis optica spectrum disorder (NMOSD), and primary immune thrombocytopenia (ITP), and its long-term market prospects are promising.

HBM9378: The world's second fully human anti-TSLP antibody, jointly developed and equally owned by Harbour BioMed and Kelun Biotech. Tezepelumab, the world's first TSLP antibody, received US FDA approval in 2021, and its sales are expected to exceed $1 billion in 2024, reaching $1.219 billion. HBM9378's half-life in monkeys and humans is approximately 2-3 times longer than tezepelumab, effectively reducing injection frequency and significantly improving dosing convenience. Furthermore, it exhibits strong stability at high concentrations and good drugability, making subcutaneous administration more convenient for patients, demonstrating best-in-class potential.

In January of this year, Harbour BioMed signed a licensing agreement with Windward Bio for HBM9378, with an initial payment and near-term milestone payments totaling US$45 million. The drug has now initiated the global Phase II POLARIS clinical trial for the treatment of asthma.

Targeting the TSLP target, Hebo Pharmaceuticals has also developed an ultra-long-acting bispecific antibody molecule HBM7575, which is expected to obtain IND within 2025.

HBM7020 is a BCMAxCD3 bispecific antibody. Utilizing HBICE technology, this drug features an asymmetric structure, effectively addressing light chain mispairing challenges. This approach minimizes the risk of cytokine release through a CD3 monoclonal antibody with low binding affinity and a silent Fc. Previously, HBM7020 was approved for clinical trials targeting cancers, but in 2024, Hebo BioMed adjusted its strategy to focus on immunological diseases and is currently preparing to submit an IND application.

In June of this year, Harbour BioMed entered into a global strategic collaboration with Otsuka Pharmaceutical, which granted the latter exclusive rights to develop, manufacture, and commercialize HBM7020 worldwide (excluding Greater China). Harbour BioMed will receive a total of US$47 million in upfront payments and near-term milestone payments, as well as up to US$623 million in additional payments.

In addition, Hebo BioMed has potential candidate molecules such as CLDN18.2xCD3 bispecific antibody HBM7022 (licensed to AstraZeneca), MSLN ADC drug HBM9033 (licensed to Pfizer), and CRH-targeting neutralizing antibody HBM9013.

Conclusion

With three consecutive years of profitability, Harbour BioMed has demonstrated the sustainability of its technology platform licensing model. To date, the company has secured dozens of licensing deals with a potential total value exceeding $10 billion, securing endorsements from pharmaceutical giants such as AstraZeneca, Pfizer, and Otsuka Pharmaceutical. Driven by continuous innovation, Harbour BioMed is expected to continue to achieve robust profitability through this model. Of course, if it can successfully develop its own blockbuster products, as Regeneron has, the company's growth will reach new heights.