At the crossroads of innovation, the global autoimmune drug market is undergoing a critical cycle of structural reshaping and value realization. On one hand, the scale of BD transactions in the autoimmune field continued to break records in 2025. On the other hand, multinational pharmaceutical companies are facing insufficient innovation pipeline supply and mounting patent cliff pressures, making the pursuit of high-quality innovative assets a definitive trend for overseas drugmakers. Amid this backdrop, Chinese biotechs with First-in-Class (FIC) and Best-in-Class (BIC) attributes are transforming into core sources of global innovation. Among the autoimmune pipeline targets introduced by multinationals in 2025, the proportion of Chinese innovative assets is steadily rising, positioning the autoimmune sector as the most promising BD track in the biomedical field. Wisdom Finance APP observed that this industry shift presents a crucial opportunity for innovative drug companies like SINOMAB BIO-B (03681), which has been deeply entrenched in the autoimmune field for years. Based on the company's series of actions over the past year, its strategic focus and pipeline progress demonstrate clear positioning awareness and tangible growth potential.

The autoimmune sector is experiencing a value explosion, with early data for SM17 showing immense potential.

In recent years, the global innovative drug market has gradually recovered after a period of adjustment, with BD transaction activity continuing to rise. Notably, the immunology field is emerging as the most explosive super-sector after oncology. The current global autoimmune market has long been dominated by three major companies: Sanofi, AbbVie, and Johnson & Johnson. However, traditional blockbuster products are facing patent expirations and the impact of biosimilars. The industry's competitive logic is shifting from sales of existing products to innovation in upstream targets. Catalyzed by industry trends, top multinationals are continuously confirming the long-term value of specific sub-sectors through substantial investments. In late June, AbbVie announced a $10.9 billion all-cash acquisition of the clinical-stage biotech Apogee Therapeutics, at a price of $135.11 per share, representing a nearly 60% premium over the closing price before the announcement. This is AbbVie's largest deal since its $63 billion acquisition of Allergan in 2019 and the highest-value merger in the global innovative drug sector in the first half of 2026. According to public information, the primary core asset of this acquisition is Zumilokibart, a subcutaneous, long-acting IL-13 monoclonal antibody modified with an Fc-region YTE amino acid mutation. It is intended for the treatment of atopic dermatitis. Its half-life in the body reaches 77 days, enabling a long-acting maintenance dosing regimen of every three months, or up to every six months. From a market demand perspective, the number of patients with atopic dermatitis is enormous, with significant unmet needs and vast growth potential in the sub-sector. According to Frost & Sullivan data, there are approximately 600-700 million patients globally and about 67 million patients in China. It is projected that the number of AD patients will further increase to 755 million by 2030. Existing clinical drugs either have a slow onset of itch relief, incomplete skin lesion clearance, or safety shortcomings. Therefore, a product that can simultaneously achieve rapid itch relief, strong skin lesion repair, and good drug safety will possess a significant competitive advantage.

Who will become the autoimmune drug king in the post-Dupixent era?

OX40/OX40L was previously a very promising direction. However, on January 30, 2026, Amgen terminated the development and commercialization collaboration with Kyowa Kirin for the OX40 monoclonal antibody rocatinlimab, citing "product portfolio strategy priorities," and returned the global rights for Kyowa Kirin to advance independently. The industry generally believes that the core reason for Amgen's exit was that rocatinlimab did not show superiority in cross-trial comparisons with Dupixent, and its commercial prospects were considered only "moderate." On July 24, Sanofi also announced the termination of clinical development for the OX40L monoclonal antibody amlitelimab in moderate-to-severe atopic dermatitis, stating that "the overall efficacy and safety evidence generated to date does not support further development." It clearly determined that the drug cannot bring meaningful clinical improvement to the current standard of care for AD. Notably, amlitelimab met its primary endpoints in three Phase 3 trials as assessed by US regulatory standards, and the long-term extension study ESTUARY showed durable efficacy without relapse. Yet, it was still voluntarily abandoned due to a lack of "clinical differentiation advantage." The cumulative report of two cases of Kaposi's sarcoma further compounded the issue. The consecutive setbacks of two major multinational pharmaceutical companies on the OX40/OX40L "upstream T-cell regulation" pathway precisely highlight the difficulty of developing an autoimmune drug that combines rapid itch relief, strong skin lesion repair, and good drug safety.

As the world's first humanized monoclonal antibody targeting the IL-17RB receptor, SM17 demonstrates a fundamental mechanistic difference from mainstream autoimmune drugs. The mainstream products on the market typically act on downstream inflammatory cytokines like IL-4/IL-13 and IL-17A/F. In contrast, IL-25 is an alarmin at the apex of the Type 2 inflammatory pathway. By blocking its receptor, SM17 can simultaneously inhibit the Th2, Th17, and core autocrine pathways of the skin tissue, blocking the inflammatory cascade at its source. This provides core advantages in onset speed and dosing concentration. Clinical data further confirms the product's differentiated efficacy. In the field of atopic dermatitis, SM17's completed Phase 1b proof-of-concept clinical trial achieved breakthrough results: among patients treated with a high dose of SM17 (600mg), over 90% achieved an NRS-4 response, over 70% achieved an EASI75 response, and over 40% achieved an IGA 0/1 response. Furthermore, throughout the trial, there were no serious adverse events, demonstrating SM17's good safety profile. These data suggest that SM17 has the potential to become a best-in-class therapy in the AD field, combining excellent efficacy with good safety. In terms of clinical development pace, the Phase 2 clinical trial for the atopic dermatitis indication in China completed the first patient dosing in April 2026. The trial is progressing smoothly, with enrollment expected to be completed in the second half of 2026 and key topline data readout expected in the first half of 2027. Notably, the Phase 2 trial protocol has been accepted by the FDA, allowing for the direct initiation of an international multi-center Phase 3 trial in the future. Additionally, the company is simultaneously advancing a small Phase 2 clinical trial in white subjects in Australia and New Zealand. The combined data from China and overseas will significantly enhance the BD value of the SM17 pipeline. The value of SM17 extends far beyond atopic dermatitis. Its upstream target mechanism provides it with the ability to expand into indications far beyond conventional single-pathway drugs. In the first quarter of 2026, the IND for the inflammatory bowel disease (IBD) indication, encompassing Crohn's disease and ulcerative colitis, was approved by China's NMPA. This marks a key expansion of SM17's core indications from skin diseases to the gastrointestinal autoimmune field, which has significant unmet medical needs, substantially broadening SM17's market potential. SINOMAB BIO-B is currently preparing for domestic and overseas clinical studies for IBD. If the Phase 2 data for SM17 can replicate the impressive results of the Phase 1b study, coupled with the concurrent advancement of the IBD clinical trial, the drug's attractiveness for collaboration with multinational pharmaceutical companies is expected to increase significantly.

The R&D pipeline is showing strength in multiple areas, solidifying the foundation for long-term growth.

From the perspective of its R&D pipeline, SINOMAB BIO-B has constructed a portfolio of early-stage drug candidates with global first-in-class or best-in-class potential. Besides SM17, the company has also made differentiated investments in areas such as skin autoimmune diseases and osteoporosis. Recently, the immunotherapy pipeline for vitiligo and alopecia areata has seen three landmark events, providing strong reference points for the "anti-common gamma chain (CGC) antibody," a more upstream immune regulatory mechanism: On July 7, 2026, Teva reported Phase 1b data for its IL-15 monoclonal antibody TEV-408 in vitiligo, showing a F-VASI50 of 42% and a F-VASI75 of 21%, with a dosing regimen of once every three months subcutaneously. Based on the positive data, it will advance to a Phase 2b trial in Q4 2026 and received up to $500 million in funding from Royalty Pharma. This indicates that the clinical value of the IL-15 pathway in vitiligo has been validated by both data and capital. Shortly after, on July 27, argenx announced the acquisition of Forte Biosciences for approximately $2.2 per share. The core asset acquired, FB102, is a first-in-class anti-CD122 (IL-2Rβ/IL-15Rβ) antibody. Its Phase 1b data in vitiligo showed a F-VASI50 of 58.8% in the severe subgroup. The market is willing to pay a high premium for the "IL-15 pathway targeting T cells/NK cells." Concurrently, Q32 Bio's anti-IL-7Rα monoclonal antibody, bempikibart, achieved a mean SALT improvement of 35.3% in a Phase 2a trial for alopecia areata, with 40% of patients achieving SALT-20, and no Grade 3 or higher adverse events. This further confirms the logic that "modulating adaptive immunity (IL-7/TSLP) can achieve both efficacy and safety." These three events collectively point to a trend: the treatment paradigm for skin autoimmune diseases is shifting from broad-spectrum JAK inhibition towards precision biologics targeting the γc family of cytokine pathways (such as IL-2, IL-7, IL-15). SINOMAB BIO-B's self-developed hC2 (anti-common gamma chain antibody) stands at the very apex of this paradigm. The γc chain is a shared subunit of the receptors for several key cytokines, including IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21. hC2 selectively blocks γc-dependent cytokine signaling, thereby simultaneously modulating multiple pathways relevant to autoimmune diseases, unlike TEV-408, FB102, or bempikibart, which only target a single node. This "one arrow, multiple targets" mechanism gives it differentiated potential in both vitiligo and alopecia areata. Data from humanized animal models presented at the 2026 SID Annual Meeting in May showed that hC2 significantly reduced hair loss in the alopecia areata model (p<0.001) and significantly reduced skin depigmentation in the vitiligo model (p<0.05), accompanied by reduced helper/cytotoxic T cell skin infiltration (p<0.01). Preliminary toxicology studies in non-human primates also showed good tolerability. Related preclinical results for alopecia areata were published in the top dermatology journal JID in June 2026. The company plans to accelerate the initiation of human clinical studies. In the osteoporosis field, SINOMAB BIO-B's self-developed bispecific antibody (targeting RANKL/sclerostin SOST) is currently undergoing CMC optimization and has shown differentiated biomarker changes in monkey studies. From a market potential perspective, the global number of osteoporosis patients exceeds 200 million, and the drug market is projected to grow to $14.8 billion by 2034. The market is closely following the development progress of both the anti-CGC antibody and the osteoporosis bispecific antibody. As the rich R&D pipeline enters critical stages in 2027, the company expects to accelerate the progression of significant BD collaborations, providing sustained momentum for its long-term development.

Strategic transformation: Operating lean, focusing on global innovation.

Over the past year, besides the development of core products, the most notable change for SINOMAB BIO-B has been the proactive adjustment of its development strategy. In the second half of 2025, the company clearly shifted from a traditional full-industry-chain model to a lean biotech route, re-anchoring its resources on the development, out-licensing, and global collaboration of First-in-Class and Best-in-Class early-stage pipelines. In the first quarter of 2026, Liang Fang, who has over 20 years of experience in drug development and investment, joined the company as Chief Operating Officer and was promoted to Executive Director in July. Concurrently, the BD team and clinical team have been continuously expanded. The company's pipeline strategy now prioritizes efficiency—optimally selecting the most promising indications and concentrating resources on advancing core programs. This approach of "doing less" is often more strategically valuable for an innovative drug company with multiple innovation pipelines. In July 2026, the company announced the sale of its entire property portfolio and production facilities in Suzhou Industrial Park for 280 million RMB. From a strategic perspective, this is a key step by SINOMAB BIO-B's management to enhance operational efficiency and focus on R&D and BD. In the current highly mature CDMO industry chain, building in-house production capacity is not the optimal solution for a clinical-stage biotech. Monetizing fixed assets to support the clinical advancement of core pipelines, in exchange for greater financial flexibility and agility, is a rational choice consistent with the current industry environment. In summary, SINOMAB BIO-B is in a critical phase of transitioning from an early-stage R&D biotech to an innovation platform with global BD competitiveness. The differentiated mechanisms and excellent clinical data of its core pipeline, originating from upstream targets, already possess clear global competitiveness. The strategic focus and resource optimization have also freed up greater financial and operational space for future development. It is foreseeable that, within the continuously high-spirited autoimmune sector and the environment where overseas pharmaceutical companies are increasingly introducing Chinese innovative assets, SINOMAB BIO-B, relying on its scarce FIC and BIC pipelines, a clear lean asset development strategy, and a seasoned management team, will continue to seize global BD collaboration opportunities. Its innovative value is expected to be continuously unlocked, making it worthy of close investor attention.