Leaders never stop reaching new heights. Following Kolonbo Tai’s continuous business development (with a total transaction volume exceeding $10 billion), the industry has gradually witnessed the "counterattack" of innovative drugs: it turns out that China has numerous outstanding products. From the approval of sac-TMT as the first TROP2 ADC for both breast cancer and lung cancer, a major oncolytic drug rooted in China and aimed at the global market is emerging. As the "barometer of tumor treatment" — the 2025 ESMO conference shines its spotlight, Kolonbo Tai (06990) showcases its ADC products with three new breakthrough abstracts (LBA) and six cutting-edge poster presentations, demonstrating to the industry that China has birthed a company with both star ADC commercialized products and a "mature + innovative" ADC matrix capable of high output and high translation in the broad field of solid tumors.

01 ESMO Moment: ADCs Dance to the Fore If the ASCO annual meeting in June raised awareness of the potential of Kolonbo Tai’s self-developed TROP2 ADC — sac-TMT becoming a global star product, then the October ESMO conference, featuring the collective appearance of TROP2 ADC, HER2 ADC, and CLDN18.2 ADC, represents a deep release of Kolonbo Tai’s proprietary ADC and new DC technology platform OptiDC™ strength and research efficiency. At this ESMO conference, the TROP2 ADC sac-TMT saw two Phase III clinical studies selected for LBA and presented orally, both of which provided key clinical data supporting new indication approvals. Notably, one study supporting second-line treatment for EGFR-mutant non-small cell lung cancer (NSCLC) (OptiTROP-Lung04) was showcased during a prestigious Presidential Symposium, underscoring the high recognition from the international academic community. OptiTROP-Lung04 aims to evaluate the efficacy and safety of sac-TMT compared with pemetrexed plus platinum for EGFR-mutant NSCLC patients who have progressed after EGFR-TKI treatment. The study shows that compared to the current standard chemotherapy regimen, sac-TMT monotherapy significantly improved PFS and OS, providing tangible benefits to patients' overall survival. This positive result makes it the first ADC drug worldwide to achieve dual benefits in PFS and OS for the second-line EGFR-mutant NSCLC patient population, filling a long-standing critical gap in this treatment area. Currently, the core focus in the development of cancer treatment drugs has shifted — not only seeking PFS benefits but also long-term OS benefits. From a regulatory standpoint, the FDA’s demands for OS data are becoming increasingly stringent. However, existing treatment drugs for second-line EGFR-mutant NSCLC have varying OS performance, none achieving a significant OS benefit compared to standard chemotherapy. Against this backdrop, the advancements of sac-TMT undoubtedly signify a historic breakthrough in a new stage of cancer therapy. Previously, sac-TMT had been approved for third-line treatment of EGFR-mutant NSCLC, and the second-line approval further fills the treatment gap after EGFR-TKI resistance.

Besides the lung cancer realm, sac-TMT has also seen success in breast cancer. Its Phase III randomized, multi-center study (OptiTROP-Breast 02) for HR+/HER2- breast cancer treatment in the second-line and above was also selected for LBA and presented orally. Since sac-TMT's first approved indication is triple-negative breast cancer, gaining approval for HR+/HER2- breast cancer would allow this product to cover two major subtypes of breast cancer treatment, positioning it to become a "cornerstone drug" in this field. Additionally, a Phase III study (KL166-III-06) supporting the market launch of HER2 ADC A166 was included in LBA and presented orally, aimed at evaluating the efficacy and safety of A166 compared with T-DM1 for treating HER2-positive breast cancer in the second line and above. Data indicated that A166 has significant statistical and clinical significance in improving PFS compared to T-DM1, and OS also displayed a trend of benefit—this result supports A166’s potential to become the first comprehensive domestic HER2 ADC for the second line and above HER2-positive breast cancer population. In addition to the LBA submissions, Kolonbo Tai had six additional studies showcased via posters. Among them, the CLDN18.2 ADC product SKB315 made its debut at ESMO, targeting another major indication aside from lung and breast cancers — stomach cancer. Gastric cancer is the fifth most prevalent and the fourth deadliest malignancy globally, and China is among the countries with a high incidence rate. At this ESMO conference, Kolonbo Tai disclosed the clinical data for SKB315 for the first time (concerning advanced solid tumor patients who failed standard treatment), with preliminary results being stunning. The data indicates that SKB315's overall efficacy is among the best in its class. In terms of safety, SKB315 employs a novel TOPO1 inhibitor and a high drug-to-antibody ratio (DAR) design, whereby the linker-payload system is more stable in the bloodstream, reducing toxicity to normal gastric tissues. Therefore, SKB315 is expected to hold a differentiated advantage amidst fierce competition in the CLDN18.2 ADC space, owing to its excellent efficacy-safety balance, cross-cancer coverage, and the potential for combination therapies. Additionally, five other posters presented research outcomes, including indications for cancers that K-drugs previously encountered setbacks in — prostate cancer, where the combination of sac-TMT is gradually becoming a key variable in resolving this issue. The Phase II study displayed at ESMO shows that the sac-TMT + K-drug combination has demonstrated good anti-tumor activity and manageable safety within the corresponding population, with notable improvements in median rPFS and DCR over current second-line recommended therapies for mCRPC.

02 Transition Logic from ADC to Novel DC Currently, the ADC field faces three realities. First, breakthroughs on mature targets remain the key to generating heavyweight products, yet homogenous competition has intensified. To realize global commercial value further, only true leaders can seize opportunities. Second, the value of ADC technology platforms outweighs that of single products, as the value of individual products declines with target homogenization. To break through, one must either rank among the global top three in the same field or have a technological foundation to create scarce, leading-edge products based on clinical needs. Third, the R&D strategy of ADCs hinges on constructing systematic capabilities in biotechnology, clinical, manufacturing quality management, and commercialization. One interviewee noted that “Kolonbo Tai is one of the few innovative pharmaceutical companies in the industry with strong execution and high connectivity in R&D, production, and commercialization.” In the ADC field, starting from the accumulation of small molecule pharmaceutical technology and biotechnology, solidifying differentiated project advantages step by step, to the rapid commercialization of products and a robust, sustainable pipeline matrix, Kolonbo Tai has firmly established itself in the domestic first tier. Dissecting its layout in the ADC and new DC domains reveals three core levels: Level One, platform empowerment, creating a "better solution" from the source. Kolonbo Tai ADC's development starts not from simple imitation, but from their independently developed OptiDC™ technology platform. The benefits of this platform allow for comprehensive optimization of drug structure and molecular design — including antibody selection, linker stability, and precise control of payload release, thereby expanding the "therapeutic window" from the outset. Relying on this platform, Kolonbo Tai has led the introduction of ADC products on mature targets like TROP2, HER2, and CLDN18.2, and exhibited exceptional clinical data across multiple solid tumors—not just validating the reliability of the technology platform but also laying a solid foundation for future indication expansions. Level Two, achieving "big products" within "major cancers". If the platform is the "starting point," then the ability to create big products within large indications directly determines a company's market height. Kolonbo Tai’s layouts in TROP2 ADC, HER2 ADC, and CLDN18.2 ADC exemplify this, especially TROP2 ADC, which nearly covers all major solid tumor tracks, with a clear strategy: mono-therapy/combination therapy in parallel—breaking through both in lung and breast cancers while actively exploring combination strategies with immunotherapy and targeted small molecules. Full disease-course coverage includes progressing from backline to frontline treatments. Global clinical trials are being quickly penetrated into the international frontline market through collaborations with Merck for global clinical trials. Level Three, targeting novel targets and next-generation DC technologies to unlock future potential. If the first two levels signify "visible value", then the third level signifies "potential future." Kolonbo Tai's explorations in frontier innovations have expanded from single ADCs to a dual-engine of “new targets + new mechanisms.” Especially in next-generation DC therapies, systematic advancements are made in twin antibody ADCs, iADCs, DACs, and RDCs among other novel technological pathways. By employing "multi-pathway strikes," the goal is to achieve diversification in tumor-killing mechanisms to tackle issues of tumor resistance and heterogeneity. Notably, Kolonbo Tai has signed an exclusive licensing agreement for RDC drug SKB107 with Southwest Medical University affiliated hospital, with the product smoothly entering clinical trials for treating advanced solid tumor bone metastasis. Additionally, the company has successfully licensed its first dual antibody ADC, SKB571, to Merck, accelerating its clinical development process. It can be said that these three levels—from the underlying logic of technology platforms, to the construction of competitive advantages for big products, and to the exploration of diversified DC innovative products—endow the company with the potential to redefine the tumor treatment landscape in the DC era.

03 Triple Capability Advancement from the Inside Out Currently, most companies within the biopharma arena have weathered the previous cycle's trials and established their fundamental models, albeit via differing pathways and facing unique challenges. Kolonbo Tai has valued its innovative capacity substantiated by its market valuation exceeding 100 billion, yet this has also created sustained evolutionary pressure tests: Can it consistently expand its diverse pipeline reserves and accelerate the product iteration process? Furthermore, can it secure a significant position on the international stage? Addressing these questions, Kolonbo Tai is responding through action: First, according to the updates on disease maps, while ensuring the competitiveness of existing flagship products, Kolonbo Tai is enhancing the diversity and resistance of its product portfolio to cycles, aiming to create more innovative assets with “global voice rights.” In terms of R&D vision, Kolonbo Tai has achieved the “three news” in anti-tumor drugs — new targets, new technologies, and new combinations, while also venturing into the vast territories outside of oncology, tapping into diseases that, although carrying similarly large bases, have longer ecological cultivation cycles and more dispersed markets, such as developing targeted drugs for non-cancer diseases, including monoclonal antibodies that have entered clinical stages and ADCs with non-cytotoxic payloads currently in development. In terms of product layout, the company not only reinforces its advantageous position in the DC field but also maintains a steady pace in non-DC products—anti-PD-L1 monoclonal antibody Tagrisso (A166), and domestic biosimilar cetuximab N01 injection (A140) have achieved commercialization; recently, the new-generation RET inhibitor A400 has also received NDA acceptance. Second, establishing a sustainable profit ecosystem driven by innovation, providing long-term stable funding security and strategic support for R&D pipelines. This year’s semi-annual report indicates that Kolonbo Tai will no longer rely solely on single BD creatorship, but rather enhance profitability through a dual-track approach of "BD + self-commercialization". The impressive upward trajectory in sales during the first half is a reflection of the systematic allocation of its commercialization team, combined with efficient collaboration of funds and channels. This capability establishment signifies that Kolonbo Tai has met the basic conditions for converting innovative achievements into stable cash flows, and cash flows in turn provide "hard support" for more substantial R&D investment and international expansion. Third, accelerating the move towards globalization. Kolonbo Tai is laying a solid path towards the global market through BD and its self-built commercialization system. Currently, Merck is intensively advancing 15 global Phase III clinical trials for sac-TMT, while Kolonbo Tai simultaneously leads nearly 10 registration clinical trials, creating interactions with the progress of the former’s global clinical developments, and jointly launching several global basket studies. This deep collaboration in multinational clinical trial networks clearly outlines the evolutionary path of a globally significant medication. Looking further into the future, Kolonbo Tai’s globalization objectives extend beyond mere product export, remaining determined to shape the global competitiveness of its products. Through continuous innovative iterations and deepening international pathways, it seeks to dismantle long-standing ceilings. Today, Kolonbo Tai stands at the brink of achieving a robust logic of operation seen in matured global biopharma through “diversified product pipelines, sustainable profit models, and global market layouts.” This “inside-out” systematic upgrade not only stabilizes its footing in the current adjustment cycle of the innovative drug industry but also seizes the initiative for future global competition — when product power, profitability, and globalization work in concert, Kolonbo Tai will surely achieve a substantial leap from "Chinese Innovation Pioneer" to "Global Biopharma."