ESMO explosion! China's top ADC player shines his sword.

Leaders never stop at existing heights. Starting from the consecutive BDs of Kelenbor, the industry gradually saw the "counterattack" of innovative drugs: it turns out that China has so many good products. Starting from the approval of the first TROP2 ADC (sac-TMT) for both breast cancer and lung cancer, a solid tumor blockbuster rooted in China and targeting the global market is on the verge of emerging. And when the "tumor treatment indicator" - the 2025 ESMO conference spotlighted, Kelenbor's ADC products made their appearance with 3 latest breakthrough abstracts (LBA) and a lineup of 6 cutting-edge posters, the whole industry saw that China has created a company with both successful commercialized ADC products and a "mature + innovative" target ADC matrix, which can achieve high output and conversion in the vast field of solid tumors. 01 ESMO Moment: ADC Fully Dances If the ASCO conference in June let the industry know about Kelenbor's self-developed TROP2 ADC - sac-TMT has the potential to become a global star product, then the collective appearance of TROP2 ADC, HER2 ADC, and CLDN18.2 ADC at the October ESMO conference signifies the deep release of Kelenbor's proprietary ADC and novel DC technology platform OptiDC. At this year's ESMO conference, TROP2 ADC sac-TMT had two phase III clinical studies selected for LBA and oral presentation, both providing crucial clinical data to support new indications. One of them, the study supporting the treatment of EGFR mutant non-small cell lung cancer (NSCLC) in the second line (OptiTROP-Lung04), was presented at the prestigious Presidential Symposium, demonstrating high international academic recognition. OptiTROP-Lung04 aimed to evaluate the efficacy and safety of sac-TMT monotherapy compared to pemigusumab in combination with platinum-based drugs for EGFR mutant NSCLC patients who failed EGFR-TKI treatment. The study showed that compared to the current standard chemotherapy regimens, sac-TMT monotherapy achieved significant statistical and clinical improvements in PFS and OS, effectively enhancing overall survival benefits for patients. This positive result makes it the world's first ADC drug for second-line EGFR mutant NSCLC patients to achieve both PFS and OS dual benefits, filling a long-standing gap in this treatment area. Currently, the core focus of oncology drug development is shifting - not only focusing on PFS benefits but also on long-term OS benefits. From a regulatory perspective, the FDA's requirements for OS data are also becoming increasingly stringent. However, the existing second-line EGFR mutant NSCLC treatments show varying OS performances, none of which can achieve significant OS benefits compared to standard chemotherapy. In this context, the progress of sac-TMT is undoubtedly a historic breakthrough in the field of cancer treatment. Previously, sac-TMT for the third-line treatment of EGFR mutant NSCLC had been approved for market, and with the approval for second-line treatment, it will further fill the treatment gap for EGFR-TKI-resistant patients. In addition to the lung cancer field, sac-TMT also brought good news in the field of breast cancer: its random, multicenter phase III study OptiTROP-Breast 02 for the second-line and above treatment of HR+/HER2- breast cancer was selected for LBA and oral presentation. The first approved indication for sac-TMT is triple-negative breast cancer. If approved for HR+/HER2- breast cancer as well, the product will cover the two major subtypes of breast cancer and has the potential to become a "cornerstone drug" in the field of breast cancer treatment. Another phase III study supporting the approval of the HER2 ADC bodecruzumab (A166) (KL166-III-06) was selected for LBA and oral presentation, aimed at evaluating the efficacy and safety of A166 monotherapy compared to T-DM1 for the second-line and above treatment of HER2-positive breast cancer. The data showed that A166 had a significant and clinically meaningful improvement in PFS compared to T-DM1, and OS also showed a trend of benefit - this result supports it as the first domestically produced HER2 ADC that comprehensively covers the second-line and above HER2-positive breast cancer population. In addition to being selected for LBA, Kelenbor also had 6 studies presented in poster form. Among them, the CLDN18.2 ADC product SKB315 made its debut at ESMO. It aims at another large indication outside of lung and breast cancer - gastric cancer. Gastric cancer is the fifth most common cancer globally and the fourth in terms of mortality, with China being a high-risk country for gastric cancer. At the ESMO conference, Kelenbor first released clinical data on SKB315 (for advanced solid tumors who failed standard treatment), and the preliminary results were impressive. The data showed that SKB315's overall efficacy ranks among the top tier of similar products. In terms of safety, SKB315 uses new TOPO1 inhibitors and a high drug-to-antibody ratio (DAR) design, making the linker-payload system more stable in the bloodstream, reducing toxicity to normal gastric tissue. Therefore, with its excellent balance of "efficacy-safety," broad cancer coverage, and potential for combination therapy, SKB315 has a differentiated advantage in the competitive domestic CLDN18.2 ADC market. In addition, 5 other studies were presented in poster form, including indications for cancer types that had previously faced challenges - such as prostate cancer. The combination strategy of sac-TMT and K drug is gradually becoming a key variable in solving this problem. A phase II study presented at ESMO showed that the sac-TMT + K drug combination had good anti-tumor activity and manageable safety in the corresponding population, with median rPFS and DCR significantly better than the current recommended second-line therapy for mCRPC. Transition Logic from ADC to Novel DC Currently, the advancement of ADC is facing three major realities. Firstly, breakthroughs on mature targets are still key to creating blockbuster varieties, but homogeneous competition has intensified. Only true leaders can seize opportunities to realize global commercial value further. Secondly, the platform value of ADC technology surpasses the value of a single product; the value of a single product will decrease as target homogenization increases. The way to break through is to become one of the top three on the same track or to have a technical foundation to create scarce targets and technologically leading blue ocean varieties based on clinical demands. Thirdly, ADC's research and development strategy cannot be separated from the systematic capabilities of biological engineering technology, clinical, production and quality management, and commercialization. Innovative Capabilities Advancement from the Inside Out Focused on the present, most companies in the Biopharma camp have experienced the previous cycle's tempering, established their own basic models, but the paths and challenges vary. Kelenbor has already proven its market's confidence in its innovative capabilities with a market value of hundreds of billions, but it has also become a pressure test for continuous evolution: can it continue to expand diversified pipeline reserves, accelerate product iteration processes? Can it compete for essential positions on the international stage? Facing these questions, Kelenbor is answering with actions: Firstly, while ensuring the competitiveness of existing flagship products, Kelenbor is also enhancing the diversity and anti-cyclicality of its product portfolio, creating more innovative assets with "global discourse power." From a research and development perspective, Kelenbor is not only achieving "three new" in anti-tumor drugs - new targets, new technologies, new combinations but is also venturing into a vast world beyond tumors, targeting diseases with lower ecological nurturing cycles and more decentralized markets. For example, developing targeted therapies for non-tumor diseases, including monoclonal antibodies that have entered the clinical stage and ADCs with non-cytotoxic payloads currently in development. In terms of product layout, the company is not only solidifying its position in the DC field but also maintaining a steady pace in non-DC products - the anti-PD-L1 monoclonal antibody Tacrolimus monotherapy (A166) and the domestic biopharmaceutical N01 injection (A140) have been commercialized; the new generation RET inhibitor A400 also recently received NDA acceptance. Secondly, it is bridging a sustainable profit ecosystem driven by innovation to provide long-term stable funding and strategic support for the research pipeline. This year's half-year report shows that Kelenbor is no longer dependent on a single BD for revenue but is leveraging both "BD + independent commercialization" tracks to improve profitability. The impressive sales curve in the first half of the year is a reflection of the systematic configuration of its commercialization team, efficient coordination of funds and channels. The establishment of this capability means that Kelenbor is now equipped with the basic conditions to transform innovative results into stable cash flows, which, in turn, provide "hard support" for higher intensity research and development investments and international expansion. Thirdly, accelerating towards the global market. Through BD and self-built commercialization systems, Kelenbor is laying a solid path towards the global market. Currently, Merck is intensively advancing 15 global phase III trials of sac-TMT, while Kelenbor is leading nearly 10 registration clinical trials, and the two are interacting with each other's global clinical progress; at the same time, they are conducting several global basket studies together. This deep interaction in the multinational clinical trial network clearly outlines the evolutionary path of a global blockbuster drug. Looking further into the future, Kelenbor's global goals extend beyond "product globalization" to shaping products with global competitiveness, opening up long-term ceilings with continuous innovation iterations and deepening international paths. It can be seen that Kelenbor, through the three-fold progression of "diversification of the product pipeline, sustainable profitability model, and global market layout," is approaching the operational logic of mature Biopharma on a global scale. This systemic upgrade from "inside to outside" not only solidifies its position in the current innovative drug industry adjustment cycle but also positions it to seize opportunities in global competition - when product strength, profitability, and globalization combine forces, Kelenbor will undoubtedly achieve a substantial leap from the "Chinese innovation leader" to "global Biopharma." This article is reprinted from the WeChat public account "E Pharmaceutical Manager," edited by Xu Wenqiang by GMTEight.