This year, Hong Kong's innovative pharmaceutical sector has continued its remarkable rally. Wind data shows that southbound capital has recorded net inflows exceeding 120 billion yuan into the healthcare and biotechnology industry, driving funds toward high-quality targets with greater certainty. SINOMAB BIO-B (03681) has emerged as one of the market's core targets for institutional accumulation. The company's share price began its ascent in late May, surging steadily higher and reaching an intraday high for the year on July 31st, with cumulative gains reaching as much as 193.33% during this period, making it a standout performer in Hong Kong's innovative drug sector. This performance reflects institutional consensus on the company's "differentiated innovation plus high-potential pipeline" capabilities.

On August 29th, SINOMAB BIO-B released its interim results for 2025. During the period, the company's operational quality continued to improve, with losses narrowing significantly by 40.8% year-over-year, benefiting from precise R&D cost optimization and fully demonstrating the company's "clinical value-oriented" cost management capabilities. Meanwhile, the company's core products achieved better-than-expected clinical progress while continuing to consolidate differentiated competitive advantages in autoimmune disease treatment, laying a solid foundation for subsequent global expansion.

**Orderly Pipeline Advancement with SM03 Focusing on High Clinical Value Indications**

Unlike the previous innovative drug bull market driven by policy factors, the current Hong Kong innovative drug rally is more fundamentally driven by companies themselves, with "hardcore innovation—global monetization—performance validation" becoming the key logic for judging investment certainty in innovative drug companies. Therefore, innovative drug companies with highly promising R&D pipelines have become investors' primary focus.

SINOMAB BIO-B has consistently focused on innovative drug development in the autoimmune disease space, targeting "global first-in-class" and "best-in-class" as R&D objectives. To date, the company has established a product pipeline of biologics and new chemical entities (NCEs) based on monoclonal antibodies that can treat multiple immune diseases, with significant progress in core products and pipeline development.

Notably, in the first half of 2025, the company's flagship drug Suciraslimab (SM03) achieved breakthrough R&D progress. As one of SINOMAB BIO-B's core products, Suciraslimab is a global first-in-class monoclonal antibody targeting CD22. CD22 is a sialic acid-binding transmembrane protein primarily expressed on B cells, with significant expression in the nervous system (including microglia), associated with MCI, Alzheimer's disease, and other autoimmune diseases.

During the period, Suciraslimab leveraged its unique mechanism to achieve multi-indication breakthroughs, demonstrating enormous market potential. Recently, SINOMAB BIO-B achieved breakthrough preclinical results in systemic lupus erythematosus (SLE) treatment research. Suciraslimab's novel mechanism of action demonstrated three key competitive advantages in SLE treatment: "non-depleting B cell modulation," "dual mechanism with bidirectional regulation," and "organ protection." It not only significantly reduces anti-double-stranded DNA (anti-dsDNA) antibody levels but also shows superior advantages over existing drugs in improving lupus nephritis (LN) proteinuria and renal pathological damage.

SLE is a chronic autoimmune disease that often affects multiple systems and organs throughout the body and is prone to relapse after treatment. Currently, there are over 5 million patients globally, with approximately 1 million patients in China, of whom about 50% may progress to lupus nephritis (LN), which is the leading cause of end-stage renal disease and death in patients. However, existing treatment regimens either cannot improve renal damage or have limited efficacy for LN, with long-term use carrying infection risks.

This breakthrough by Suciraslimab in SLE treatment is expected to fill the unmet needs of "long-term medication safety risks" and "lack of actual organ damage protective benefits" in SLE treatment, providing a safer and more effective new treatment option for patients worldwide.

Based on communications with national drug regulatory authorities and clinical value assessments, the company strategically withdrew Suciraslimab's BLA application for RA and is accelerating planning for SLE Phase II clinical trials. Notably, Suciraslimab's Phase III data for RA treatment has previously validated its long-term efficacy and safety.

Beyond systemic lupus erythematosus, Suciraslimab has also shown promising potential in Alzheimer's disease (AD) treatment. The drug can regulate microglial function by targeting CD22, promoting β-amyloid (Aβ) clearance and exerting anti-inflammatory effects, potentially becoming the world's first Alzheimer's immunotherapy combining both efficacy and safety. The company is currently advancing IND application preparations for this indication.

**SM17 Leading Atopic Dermatitis Treatment Track with Accelerated Global Development**

The heightened secondary market sentiment this year is closely related to SINOMAB BIO-B's innovative clinical results and growth expectations for its blockbuster product SM17. In April this year, SINOMAB BIO-B's core product SM17, a global first-in-class humanized monoclonal antibody targeting the IL-25 receptor, achieved positive topline results in a Phase 1b study for moderate-to-severe atopic dermatitis (AD) patients that significantly exceeded market expectations, demonstrating "best-in-class" potential.

Epidemiological studies show that there are at least 230 million AD patients globally, with China having a large AD patient population exceeding 70 million, of which moderate-to-severe AD accounts for approximately 28%. In comparison, the U.S. is estimated to have 16.5 million adult AD patients, with moderate-to-severe AD accounting for about 40%. This large patient population indicates enormous potential in the AD market, driving pharmaceutical companies to accelerate development of differentiated therapies.

From a mechanism perspective, SM17 not only inhibits downstream signaling pathways IL-4, IL-5, and IL-13 by preventing IL-25 binding to receptors (IL-17RB) on ILC2 and Th2 cells, but can also directly inhibit the autocrine cycle of the IL-25 pathway at the keratinocyte level, directly treating non-histamine-dependent skin itching and skin inflammation. This upstream regulatory mechanism is expected to suppress inflammatory cascade reactions at the source while directly acting on the stratum corneum, showing significant differentiation from existing drugs.

Clinical data shows that in the Phase 1b study for moderate-to-severe AD patients, 91.7% of patients in the high-dose group achieved itch relief (NRS-4 standard), 75% achieved skin lesion recovery (EASI75 standard), and 41.7% achieved complete/near-complete symptom clearance (IGA0/1 standard). Compared to existing therapies, SM17 provides faster itch relief, superior skin lesion recovery, and significantly better safety than JAK inhibitors, becoming the first AD treatment drug to simultaneously satisfy "rapid itch relief, potent skin lesion recovery, and high safety." This fully demonstrates that SM17 has the potential to become a first-in-class and best-in-class therapy for AD indication.

To date, clinical bridging studies for SM17 formulation conversion have been initiated and are expected to complete in Q1 2026. The company is also preparing next-phase clinical development plans to pave the way for global multi-center clinical trials and international cooperation, while simultaneously advancing development for asthma, idiopathic pulmonary fibrosis (IPF), and other indications.

Beyond core products SM03 and SM17, the company's pipeline continues to diversify. The anti-CGC antibody is an internally developed global first-in-class humanized anti-γc (common gamma chain) antibody that regulates immune cell proliferation, autoreactivity, and tissue infiltration, potentially treating alopecia areata, vitiligo, and other autoimmune diseases. IND submission for alopecia areata treatment is expected in 2026.

The bispecific antibody candidate targets RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand) and sclerostin for treating osteoporosis and other bone-related indications. This drug has a differentiated mechanism of action, with internal in vitro and in vivo studies showing superior efficacy compared to marketed antibodies (such as denosumab and romosozumab), also expected for IND submission in 2026.

Additionally, SINOMAB BIO-B's pipeline includes SM06, a second-generation anti-CD22 antibody that is a humanized variant of Suciraslimab with similar mechanism but potentially stronger efficacy and longer half-life. SN1011 is a third-generation reversible covalent BTK inhibitor for treating SLE, pemphigus, multiple sclerosis (MS), and neuromyelitis optica spectrum disorders (NMOSD).

**Capitalizing on Policy and Market Synergies, Core Product Innovation Value Awaits Release**

In the first half of 2025, improvements in China's innovative drug industry fundamentals were not limited to companies' own value realization, but were driven more fundamentally by synergies between supportive policy measures and the "going global" trend.

Specifically, in the first half of 2025, relevant departments formed a systematic "combination punch" of supportive policies for innovative drugs. The "Comprehensive Measures to Support High-Quality Development of Innovative Drugs" was officially promulgated, proposing comprehensive support for innovative drugs across the entire chain including regulatory review and approval, clinical trial medications, and capacity expansion. This means that every stage from R&D, approval to commercialization now has clearer policy support.

Accordingly, the company has built five core R&D platforms (B-cell therapy, sentinel pathways, selective T-cell therapy, nervous system diseases, and antibody framework humanization) to support innovative target discovery, provide technical support for existing products, and lay a solid foundation for future innovation.

Based on strong scientific research capabilities, as of June 30, 2025, the company holds multiple authorized patents in China, the U.S., and other regions, covering major drug candidates, with multiple PCT applications and pending patents. This comprehensive intellectual property protection system provides solid guarantee for the company's future development and international cooperation.

Against this backdrop, the company will prioritize two core tasks: first, continuing to use innovation as core competitiveness to drive commercialization of existing drug pipelines and development of new drug pipelines. Suciraslimab and SM17 are expected to further validate their best-in-class characteristics in subsequent clinical trials, addressing unmet medical needs for global patients. Second, accelerating IND preparations for anti-CGC antibodies and bispecific antibody candidates to consolidate pipeline advantages in the autoimmune field.

Meanwhile, the international competitiveness of domestic innovative drugs is rapidly rising. Data shows that in the first half of 2025, China's innovative drug licensing "going global" total amount reached a new high, securing over $60 billion in half a year, setting a historical record. Whether through large license-out transactions by Chinese innovative drug companies or direct commercialization breakthroughs in European and American markets, this confirms increased recognition of Chinese early-stage innovative drugs by international pharmaceutical companies, with "best-in-class" receiving greater recognition in terms of bidding and valuation.

From this perspective, the company's core pipeline products are well-positioned to leverage this momentum to accelerate international licensing and future commercialization of core pipelines.

SINOMAB BIO-B has made adequate preparations for this. Regarding commercialization implementation, the Haikou production facility has successfully completed GMP inspection and can fully meet clinical and commercial production requirements. Construction of the Suzhou production facility was completed at the end of 2024, expected to pass acceptance and obtain property certificates by the end of 2025, providing solid guarantee for commercial-scale production of its products.

On the other hand, SINOMAB BIO-B will support R&D work with sufficient funding reserves: as of the end of June 2025, the company's available funds totaled RMB 125.7 million. Combined with two share subscription fundraisings in May and August 2025 (raising approximately HK$124 million and HK$369.5 million respectively, totaling approximately HK$493 million), the company's financial strength continues to strengthen, providing sufficient funding guarantee for core pipeline clinical advancement, new target R&D, and future commercialization.

From the current standpoint, SINOMAB BIO-B has demonstrated strong innovation execution and strategic determination. Its differentiated positioning in autoimmune indications, combined with global cooperation and production capacity building, not only fills multiple unmet clinical needs but also lays a solid foundation for long-term growth. As core pipelines enter critical clinical stages, the company is positioned to achieve global breakthroughs in autoimmune disease treatment, providing better therapies for patients while its innovation value realization pathway becomes increasingly visible to the market.