Mobocertinib Succinate

Sichuan Kelun-Biotech Biopharmaceutical Co. (HKEx: 6990.HK) announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan met the primary endpoint of progression-free survival in a Phase III trial for first-line advanced triple-negative breast cancer. The result positions the drug candidate for a potential regulatory filing in China and adds to a growing body of evidence for the ADC class in a disease where treatment options remain constrained. The OptiTROP-Breast03 trial is a randomized, open-label, multicenter Phase III study evaluating sac-TMT monotherapy against investigator’s choice of chemotherapy in patients with unresectable locally recurrent or metastatic TNBC who had not received prior systemic therapy for advanced disease. The enrolled population includes both PD-L1-negative patients and PD-L1-positive patients who relapsed after prior anti-PD-(L)1 therapy in early-stage disease — two subgroups for whom current approved options are limited. At a prespecified interim analysis, the Independent Data Monitoring Committee concluded that sac-TMT demonstrated a statistically significant and clinically meaningful improvement in PFS progression-free survival breast cancer endpoint versus chemotherapy. The company described the improvement as meeting both the statistical and clinical thresholds, though specific numerical data — median PFS, hazard ratio, and confidence intervals — were not disclosed in the announcement. Overall survival data remain immature at this stage, with the company noting a positive directional trend; follow-up will continue per protocol with OS to be evaluated at subsequent prespecified analyses. The safety profile was consistent with prior studies, and no new safety signals were identified. Full data are expected to be presented at a future medical conference. Nevertheless, the IDMC’s conclusion that both statistical significance and clinical meaningfulness were achieved carries weight, particularly given the trial’s focus on a patient population that includes those ineligible for or refractory to checkpoint inhibition. Sacituzumab tirumotecan TNBC development context Sac-TMT is a next-generation TROP2-directed ADC in which the anti-TROP2 antibody sacituzumab is conjugated to a topoisomerase I inhibitor via a bifunctional linker with a drug-to-antibody ratio of 7.4. The construct is designed to release the payload intracellularly and can act on adjacent tumor cells through a bystander effect. This mechanistic profile distinguishes sac-TMT from the first-generation TROP2 ADC in the class, Gilead Sciences’ Trodelvy (sacituzumab govitecan), which uses a different payload and carries a lower drug-to-antibody ratio. The Kelun-Biotech Phase III trial result in first-line TNBC builds on the drug’s existing approval in China for the second-line-plus setting, which was granted based on the OptiTROP-Breast01 study in patients who had received at least two prior systemic therapies. OptiTROP-Breast03 represents the first registrational Phase III study of sac-TMT to achieve a positive result in the first-line TNBC setting, extending the drug’s potential clinical utility to an earlier and larger patient population. Kelun-Biotech licensed exclusive rights to develop, manufacture, and commercialize sac-TMT outside Greater China to Merck & Co. in May 2022, under which the drug is also known as MK-2870. MSD has since initiated 17 ongoing global Phase III studies of the molecule as monotherapy or in combination with Merck’s Keytruda (pembrolizumab) across multiple tumor types. Merck is also assessing sac-TMT in TNBC in the ongoing global Phase III TroFuse-011 study (NCT06841354). Where sac-TMT fits in first-line TNBC landscape The first-line metastatic TNBC setting is defined by a narrow set of approved options and a substantial unmet need in biomarker-unselected patients. Merck’s Keytruda combined with chemotherapy is the established standard of care for patients with PD-L1 CPS ≥10, based on the KEYNOTE-355 data, but this biomarker restriction excludes approximately 60% of patients with metastatic TNBC who are PD-L1-negative. For those patients, and for patients who relapsed on prior checkpoint inhibitor therapy in the early-stage setting, the first-line standard of care remains cytotoxic chemotherapy alone. The OptiTROP-Breast03 trial was specifically designed to enroll both of these underserved subgroups, which gives the positive PFS result particular clinical relevance if it holds across the full enrolled population. The TROP2 ADC class has demonstrated consistent activity in TNBC across lines of therapy. Trodelvy, approved in the US for the ≥ 2L TNBC setting since 2021, established the class benchmark with meaningful but modest PFS benefit in pretreated patients. A positive first-line result for sac-TMT, if confirmed with mature data, would represent a meaningful extension of the ADC class into earlier disease. AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan, a Trop-2-directed ADC with a different payload, is currently under Priority Review at the US FDA for first-line TNBC. The competitive dynamics in this space are evolving rapidly, with multiple ADCs targeting TROP2 or related pathways advancing through late-stage development. Following the interim analysis, Kelun-Biotech said it plans to engage with China’s Center for Drug Evaluation of the National Medical Products Administration regarding the regulatory pathway for sac-TMT in the first-line TNBC indication. The company has previously received six Breakthrough Therapy Designations from the NMPA for sac-TMT across indications, and two of its approved indications — second-line-plus TNBC and EGFR-mutant NSCLC following EGFR-TKI and platinum-based chemotherapy — are included in China’s National Reimbursement Drug List. Globally, the Phase III TroFuse-011 study (NCT06841354), sponsored by MSD, is evaluating sac-TMT monotherapy or in combination with pembrolizumab as first-line treatment for patients with PD-L1 CPS \< 10 TNBC, a population that maps closely to the unmet need identified in OptiTROP-Breast03. Results from that global registrational study will be critical to any potential regulatory filing outside China. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. 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SHANGHAI, May 21, 2026—Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the Group’s self-developed fourth-generation Epidermal Growth Factor Receptor (“EGFR”) Tyrosine Kinase Inhibitor (“TKI”) HS-10504 tablets has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR C797S mutation after prior EGFR-TKI therapy failure. HS-10504 tablets is a novel, potent, highly selective, fourth-generation EGFR-TKI under clinical development for NSCLC patients. At AACR 2026 (held from April 17-22 in San Diego, California.), the encouraging results of HS-10504 tablets for the treatment of advanced NSCLC post EGFR- TKI therapy were presented in an oral session. The study results indicated, HS-10504 tablets has demonstrated a promising anti-tumor activity in advanced NSCLC harboring EGFR C797S mutation with the ORR 52.9% and mPFS 9.6 months at the RP2D of 400 mg QD. Given its quick and durable response, HS-10504 tablets is expected to provide a novel, effective, precise, and convenient treatment option for these patients, who currently have a poor prognosis and no available targeted therapy. The NMPA's Breakthrough Therapy Designation for HS-10504 tablets marks a significant step towards its availability to patients, as Hansoh Pharma continues to focus on unmet medical needs, and prioritize developing differentiated, high-quality innovative therapies to benefit more patients worldwide. References 1、AACR 2026 | Hansoh Pharma Presented Results of HS-10504 (A Novel, Potent, Highly Selective, Fourth-Generation EGFR TKI) from a First in Human Phase 1 Study in Patients with Advanced NSCLC-Press Releases-Hansoh Pharmaceutical Group Co., Ltd. https://www.hspharm.com/news/news-detail-513449.htm About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK). Statements 1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. 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