Portfolio News

The year 2025 has witnessed a rising risk appetite in China’s capital markets toward the biopharmaceutical sector. Investor sentiment has shifted from caution over the past few years to enthusiastic optimism today, with the Hang Seng Healthcare Index surging more than 90% year-to-date. Recently, Dr. Shui On LEUNG, founder and CEO of the first Hong Kong–based biopharmaceutical company listed on the Hong Kong Stock Exchange, was interviewed on Bloomberg’s live program The China Show.

Dr. Leung described SinoMab’s commercial vision as “Biotech Innovation 3.0.” Unlike earlier waves of innovation, “Innovation 3.0” emphasizes breakthroughs in  target discovery—identifying targets that have never been discovered or developed before. By contrast, “Innovation 2.0” primarily involved applying existing known targets in different combinations to address disease indications. Dr. Leung explained: “The reason we pursue this ‘Innovation 3.0’ is that we aim to develop first-in-class products that can ultimately become best-in-class, thereby addressing unmet medical needs and delivering differentiated clinical outcomes.”

In SinoMab’s R&D landscape, SM03 (Suciralimab) and SM17 are not only core products but also key vehicles for implementing the “Biotech Innovation 3.0” strategy. These two first-in-class drugs demonstrate significant clinical advantages and commercial potential in the fields of autoimmune and allergic inflammatory diseases.

SM17 is a highly anticipated global first-in-class product from SinoMab, with topline trial results released in April this year. The drug targets the IL-25 receptor and is being developed for the treatment of atopic dermatitis (AD), asthma, and idiopathic pulmonary fibrosis (IPF). According to data from institutional Reseach, the global market size of AD drugs was approximately 14 billion USD in 2024. This demonstrated a huge demo and for AD treatment around the world. Against this backdrop, with its triple advantages of rapid and deep itch relief, effective skin clearance, and well tolerated safety profile, SM17 has the potential to become a first-in-class and best-in-class therapy.

In addition, SM03 is the world’s first monoclonal antibody targeting CD22 to demonstrate clinical efficacy in the treatment of rheumatoid arthritis. Its unique mechanism of “immunomodulation without B cell depletion” avoids the infection risks typically associated with traditional B-cell depletion therapies, offering a superior safety profile.

In the first half of 2025, the Company strategically adjusted its commercialization approach for SM03 by voluntarily withdrawing its Biologics License Application (BLA) for rheumatoid arthritis (RA). This decision was made after careful analysis of preclinical data, regulatory feedback—including communications with the CDE—and a thorough cost-benefit assessment. As a result, the company has redirected its resources toward advancing the clinical development of SM03 for SLE and Alzheimer’s disease.

Unlike the well-established RA market, SLE and Alzheimer’s disease present significant unmet medical needs and broader opportunities for innovation. For SLE, preclinical studies have shown that SM03 provides notable renal protection: it reduces proteinuria, alleviates renal histopathological damage, and lowers autoantibody levels. These promising results support the continued clinical development of SM03.

Furthermore, emerging research suggests that SM03 may regulate microglial activity, enhancing Aβ clearance and reducing neuroinflammation—key mechanisms implicated in Alzheimer’s disease. The Company is planning for a Phase 2 clinical program for Suciraslimab in the treatment of SLE and begun preparations for an IND submission in Alzheimer’s disease, with the goal of advancing to clinical trials in the near future.

SinoMab’s R&D pipeline continues to deliver significant breakthroughs, complemented by a commercialization strategy focused on an “asset-light + global licensing” approach. This enables the Company to address the common challenge in the biotech sector of excelling in research and development while lacking robust commercialization capabilities. By adopting this strategy, SinoMab creates an effective pathway to bring products from clinical development to the market.

On the manufacturing front, SinoMab has implemented a flexible model that combines its own production base with strategic CDMO partnerships. This approach allows the Company to avoid the financial strain associated with fixed asset investments, while harnessing the mature production capacity and quality systems of CDMO partners to accelerate production timelines and reduce costs.

In advancing our innovative drug toward commercialization, SinoMab has implemented a dual-pronged strategy targeting both domestic and international markets. For China, SinoMab will retain full product development rights, completing all clinical trials in-house and independently submitting the Biologics License Application (BLA) to secure marketing authorization. Production will be managed through a contract development and manufacturing organization (CDMO), and commercialization will be executed in partnership with local pharmaceutical companies equipped with established sales forces.

For international markets, our strategy is to pursue a license-out approach, granting product rights to multinational pharmaceutical companies. By doing so, we can jointly accelerate late-stage clinical development and commercialization. This approach enables SinoMab to leverage the extensive global sales networks and brand recognition of our partners, while also capturing the enhanced valuations that first-in-class drugs typically command in the international arena.

Dr. Leung highlighted that, in addition to its status as a leading global financial center, Hong Kong possesses distinctive and irreplaceable strengths in biotechnology research. As a biotech enterprise headquartered in Hong Kong, SinoMab capitalizes fully on the city's accessible financing channels, supportive government policies, international connectivity, and robust talent pool.

From a financing perspective, Hong Kong offers a well-established environment for biotech fundraising. Notably, in the first half of 2025, SinoMab secured nearly HK$500 million through two share placements, providing ample resources to support ongoing R&D initiatives. On the policy front, the Hong Kong government has identified biotechnology as a strategic industry, offering comprehensive R&D support through platforms such as Hong Kong Science Park and the Hong Kong Genome Institute. The “1+1 mechanism”—which allows products approved in mainland China to be expedited for approval in Hong Kong following completion of local clinical trials—further accelerates commercialization within the region.

In summary, SinoMab stands at a pivotal point as it transitions from R&D-led growth toward full-scale commercialization. Anchored by its core “Biotech 3.0” strategy, the Company’s product portfolio is showing notable clinical differentiation. Moreover, its asset-light model mitigates operational risks and bolsters profitability, while healthy cash reserves and a streamlined financial structure underpin its outlook for long-term, sustainable growth.