On August 17, SKB BIO (06990) released its 2026 interim results, addressing the pivotal question of transitioning from a research-driven Biotech to a fully integrated Biopharma through two landmark achievements.

First, the gap in commercialization expectations has been fully bridged. In the first half of 2026, SKB BIO's commercialization revenue has already surpassed its full-year 2025 total, demonstrating rapid growth momentum. This surge is driven by the accelerated volume uptake of sac-TMT (Jia Tai Lai®) following its inclusion in the National Reimbursement Drug List (NRDL), coupled with a clear and efficient commercialization strategy. Consequently, the company's independent commercialization foundation has been solidified, completing a full value chain spanning R&D, manufacturing, and commercialization. Second, its global clinical research has secured a leading position. sac-TMT has achieved primary endpoints in multiple registrational studies and delivered its first dual-positive global Phase III results, forming a strategic roadmap that spans from monotherapy to combination therapy, from later-line to frontline settings, from China to global markets, and across multiple indication expansions. Amid intensifying competition in the ADC monotherapy/combination space, where dual PFS and OS benefits are exceedingly rare, this TROP2 ADC has firmly established itself in the global first tier, with the potential to reshape global oncology treatment paradigms.

Currently, the narrative for China's innovative drugs has evolved: the market no longer reacts to single licensing announcements but instead shifts toward rigorous scrutiny of independent commercialization quality, clinical advancement efficiency, and global capabilities. Only sustained performance delivery and R&D breakthroughs can underpin long-term corporate value. With its efficient R&D capabilities and full-chain operational resilience, SKB BIO has emerged as a representative model for domestic innovative drug companies advancing toward Biopharma and even global MNC status.

The Key Commercial Leap: An Endogenous Cash-Generation Loop Takes Shape

In the first half of 2026, SKB BIO's initial commercial product portfolio achieved scale volume uptake, driving sustained improvements in operating cash flow. The company reported total revenue of RMB 978 million, with commercialization revenue reaching RMB 657 million, marking a critical step toward endogenous cash generation. Commercialization capability is never built overnight. SKB BIO adopted a "win before launch" strategy, completing core team formation and promotional strategy refinement before the first NDA approval. This forward-looking setup seamlessly facilitated the commercial launch of multiple products, including the global "potential best-in-class" TROP2 ADC sac-TMT, the world's first PD-L1 for first-line NPC tagolimab (Ke Tai Lai®), the EGFR monoclonal antibody cetuximab (Da Tai Lai®) demonstrating clinical equivalence to the originator, and the first domestic HER2 ADC for second-line or later HER2-positive breast cancer, bodo-trastuzumab (Shu Tai Lai®). The company also secured NRDL inclusion for five indications across three products. With the 2026 NRDL window opening, products have entered a full growth cycle. Combined with expert recognition of high-quality clinical data, shifting treatment paradigms, and comprehensive efforts to enhance product accessibility, commercialization revenue has grown strongly, with earlier R&D outcomes rapidly converting into operational results.

More critically, this growth momentum is far from exhausted. Currently, three indications for sac-TMT and bodo-trastuzumab have passed the formal review for the 2026 NRDL, further reinforcing growth potential. Additionally, the NDA for the RET inhibitor lunbortinib (Ning Tai Lai®) has been accepted, positioning this small-molecule targeted therapy as a strong addition to the initial commercial portfolio and continuously bolstering cash reserves. Behind these advances lies a systematic, replicable innovative industry chain that has formally taken shape. The deeper signal is that SKB BIO now possesses integrated drug development capabilities spanning R&D, manufacturing, and commercialization—the most core and hardest-to-replicate competitive advantage in the Biotech-to-Biopharma transition.

Global Leadership in a Single Product, Platform-Driven Long-Term Innovation

If commercialization validates the company's current cash-generation ability, the depth and breadth of its pipeline determine long-term growth prospects. The core anchor, sac-TMT, is becoming a leading blockbuster drug propelling China's innovative drugs onto the global stage. Domestically, sac-TMT has received approval for four monotherapy later-line indications, with five Phase III first-line monotherapy/combination studies progressing in an orderly manner, ensuring high certainty in both clinical and commercial value. Internationally, sac-TMT has moved from early licensing to a delivery phase. Among 17 global Phase III trials led by partner Merck, the TroFuse-005 study for endometrial cancer has already achieved dual-positive PFS and OS results, serving as a benchmark case of a domestically licensed product passing international clinical scrutiny.

The success of sac-TMT is underpinned by a clear and systematic development strategy, advancing along four main tracks: First, expanding from monotherapy to combination therapy to build a rich "ADC+" landscape, leveraging mechanistic synergies with PD-(L)1 inhibitors, PD-1/VEGF bispecific antibodies, and small-molecule TKIs. Second, extending from later-line to frontline settings with forward-looking positioning in adjuvant/neoadjuvant and maintenance treatment scenarios, covering the full continuum of tumor disease management. Third, comprehensively targeting high-incidence solid tumors, expanding from lung cancer/breast cancer to gynecologic tumors, gastrointestinal, and genitourinary cancers, continuously broadening the addressable patient population and market ceiling. Fourth, coordinating domestic and global advancement through dual clinical systems to maximize product commercial value. This layered R&D approach has been validated by successive hard-hitting milestones. As more Phase III data readouts emerge, combined with the first-mover advantage in "ADC+," sac-TMT's medium-to-long-term value flexibility is substantial. Meanwhile, global study data complement and cross-validate domestic clinical data, creating a virtuous cycle of synergistic empowerment across geographies—a key differentiator from typical "licensing-out" blockbusters.

To become a first-class Biopharma, a company cannot rely solely on a single product. Leveraging its OptiDC™ integrated ADC development platform, SKB BIO has established a three-tier pipeline of ADC and novel DC therapies, creating a sustainable innovation landscape of "near-term delivery, mid-term continuity, and long-term breakthroughs," nurturing broader growth space. In the near term, sac-TMT and bodo-trastuzumab are commercialized based on unique molecular designs, rapidly building the foundational base. In the mid-term, innovative assets such as SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bispecific ADC), SKB500 (B7-H3 ADC), and SKB105 (ITGB6 ADC) provide differentiated reinforcement, complementing approved products in indications while potentially improving efficacy and safety. In the long term, SKB BIO will freely combine the three core components—payloads, linkers, and targets—to develop next-generation novel DC therapies, incubating globally competitive next-generation molecules with a forward-looking vision.

Furthermore, in the ADC+IO arena that will shape the industry's future, SKB BIO is building cross-generational barriers through dual approaches of combination therapy and integrated development. On one hand, it has established a multi-dimensional combination therapy matrix, using PD-(L)1 immunotherapy as the foundation for ADC combination trials. The sac-TMT plus Keytruda combination is the most advanced, with two Phase III first-line lung cancer studies achieving primary endpoints, making it the first ADC+IO regimen validated in the first-line lung cancer setting globally. This combination has nine additional global Phase III trials progressing concurrently. Simultaneously, the company is actively exploring the combination potential of novel immunotherapies such as PD-1/VEGF bispecific antibodies with diverse ADC assets to further amplify therapeutic benefits. Notably, SKB118 (PD-1/VEGF bispecific) plus sac-TMT for NSCLC has received clinical trial approval. On the other hand, it is developing "integrated development" ADC products with synergistic mechanisms, such as SKB103 (TAA-IO bispecific ADC) and SKB565 (novel dual-payload ADC), seizing the first-mover advantage in technological iteration. This comprehensive layout, spanning from combination therapy to source innovation, enables SKB BIO to lead clinical applications of "ADC+IO" while also positioning at the forefront of the "2.0" era of integrated ADC development. Overall, from global leadership in core blockbuster products, to orderly iteration of multi-tiered pipelines, and forward-looking positioning in next-generation therapies, SKB BIO has formed a clearly tiered, generationally distinct innovative supply system, laying robust technological foundations for long-term global competition.

Global Ascension: Three Capability Leaps Toward a World-Class Biopharma

From "leading in China" to "global ascension," SKB BIO is implementing a "three-step" strategy: first, building a domestic industrial chain system; second, leveraging international collaborations to accumulate global experience and brand reputation; and ultimately, transitioning from "riding the waves with others" to "independent global expansion." In the domestic market, SKB BIO has fully completed the "R&D-clinical-manufacturing-commercialization" loop: platform-level innovation in R&D, efficient translation and advancement in clinical development, self-owned ADC manufacturing capacity running in parallel with CMO partnerships, and endogenous cash generation through a self-built professional commercial team. With this comprehensive operational system, its global ascension unfolds naturally: first, entering via "riding the waves" by leveraging top-tier MNC global clinical resources and commercial networks to rapidly advance core products' global multi-center trials, realize milestone revenues, and accumulate global project experience for front-loaded preparation. Then, advancing toward "independent sailing" by exploring diversified outbound pathways on the foundation of mature overseas collaborations, progressively conducting international multi-center registrational studies and establishing commercial systems to achieve true independent globalization. This process simultaneously drives comprehensive ascension across performance, operations, and strategy. On performance, commercial products continue to scale, generating ample endogenous cash flow that provides stable financial support for global R&D investment, reducing reliance on financing and BD income. On operations, sac-TMT's clinical value continues to climb, with platform pipeline tiers and ADC combination layouts progressing seamlessly, and product strength sufficient to support global market competition. On strategy, the domestic industrial loop continues to deliver value while overseas expansion advances step by step, with both ends reinforcing each other to jointly propel SKB BIO from a domestic innovative drug company to a global Biopharma. Throughout this journey, SKB BIO has validated its core qualifications to become a global Biopharma through dual support from full-chain value and global layout, and through triple ascension across performance, operations, and strategy, providing a replicable and proven paradigm for Chinese innovative drug companies pursuing global advancement.