科伦药业今日公告，公司近日获悉，控股子公司科伦博泰首款用于既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）成人患者的国产靶向人滋养细胞表面抗原2(TROP2）的抗体偶联药物（ADC）芦康沙妥珠单抗（sac-TMT，前称SKB264/MK-2870）（佳泰莱）获国家药品监督管理局（NMPA）批准在国内上市。Sichuan Kelun Pharmaceutical's subsidiary, Kelunbotai Lutetium Sandutuzumab Monoclonal Antibody, has been approved for marketing domestically. This drug is used to treat unresectable locally advanced or metastatic breast cancer and is the first domestic ADC to be fully approved for marketing domestically. Lutetium Sandutuzumab Monoclonal Antibody has two supplementary new drug applications accepted by the NMPA.
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On November 27, Financial Alliance News (Reporter He Fan), a new stage for domestic ADC drugs, Kelun Pharmaceutical (002422.SZ) controlled subsidiary Kelunbotai-B (06990.HK) core product - TROP2 ADC Lutetium Sandutuzumab Monoclonal Antibody has been approved for marketing domestically. This drug is used to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), and it is the first domestically produced ADC to be fully approved for marketing domestically. In addition, Lutetium Sandutuzumab Monoclonal Antibody has two supplementary new drug applications already accepted by the NMPA.
Today, Kelun Pharmaceutical announced that the company recently learned that its subsidiary Kelunbotai's first domestic anti-TROP2 antibody drug conjugate (ADC) Lutetium Sandutuzumab Monoclonal Antibody (sac-TMT, formerly known as SKB264/MK-2870) (Jiataile) for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults who have previously received at least two systemic treatments (of which at least one treatment was targeted at the advanced or metastatic stage) has been approved by the National Medical Products Administration (NMPA) for domestic marketing.
On the same day, Kelunbotai also announced this news, stating that the approval was based on positive results from the randomized, controlled phase 3 OptiTROP-Breast01 study in adults with unresectable locally advanced or metastatic TNBC who have previously received at least two systemic treatments (of which at least one treatment was targeted at the advanced or metastatic stage). Compared to chemotherapy, sac-TMT showed significantly improved progression-free survival (PFS) and overall survival (OS) with both statistical and clinical significance.
Kelunbotai's CEO Ge Junyou expressed through the company's official WeChat account that as the company's first independently developed TROP2 ADC innovative drug, the smooth market approval of Lutetium Sandutuzumab Monoclonal Antibody officially opens up a new treatment pattern for second-line and above late-stage TNBC patients. The company looks forward to significantly enhancing the clinical benefits for advanced TNBC patients and improving their quality of life with its outstanding clinical efficacy and safety. In the future, we will continue to explore the clinical value of Lutetium Sandutuzumab Monoclonal Antibody in other indications, maximizing its market potential and meeting the clinical needs of patients nationwide.
Lutetium Sandutuzumab Monoclonal Antibody is the first domestically produced ADC to be fully approved for marketing in China. Prior to this, the only domestically produced ADC was Vidisutumab Monoclonal Antibody developed by Remegen, used for the treatment of gastric cancer and uroepithelial carcinoma, conditionally approved for marketing in China in June 2021 and December 2021 respectively.
Reportedly, sac-TMT is the core product of Kelunbotai, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), and gynecological tumors. This drug specifically recognizes tumor cells' surface TROP2 through recombinant anti-TROP2 humanized monoclonal antibody, is internalized by tumor cells, and releases KL610023 intracellularly.
The results of the sac-TMT research were announced at the ASCO (American Society of Clinical Oncology) annual meeting held in May this year. Sichuan Kelun Pharmaceutical had previously disclosed that in TNBC indications, patients receiving sac-TMT treatment in a 1:1 randomization had a 69% lower risk of disease progression or death compared to chemotherapy based on interim analysis.
Industry expert Li Changcheng stated in an interview with Caixin reporter that ADCs, such as targeted antibody drugs, are more precise compared to general targeted therapy. Currently, these drugs are mostly monopolized by foreign countries. From the perspective of indications, triple-negative breast cancer is highly invasive with a high risk of distant metastasis. The approval of Remegen Botai's Lukansatusimab in China signifies a breakthrough in domestic innovative drugs, providing patients with more treatment options.
In May 2022, Remegen Botai granted Merck exclusive rights outside of Greater China for the development, use, manufacturing, and commercialization of Lukansatusimab (sac-TMT).
In addition, the application for Lukansatusimab monotherapy for locally advanced or metastatic EGFR mutation non-small cell lung cancer (NSCLC) patients who progressed after EGFR-TKI treatment or after progression following EGFR-TKI and platinum-containing chemotherapy has been accepted by the NMPA.