Kelun-Biotech's Novel TROP2 ADC Lusacamtuzumab Approved in China for Metastatic Triple-Negative Breast Cancer

　　【Pharmaceutical Network Industry DynamicsAccording to the information from the National Medical Products Administration, this week, multiple innovative drugs and medical devices have been approved for marketing.
 

In terms of innovative drugs, according to a message published on the website of the National Medical Products Administration on November 28, the injectable drug Lukuoshazhu Monoclonal Antibody (trade name: Jiatilai), submitted by Sichuan Kelun-Biotech Biopharmaceutical Co., LTD, has been approved for marketing. It is intended for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received at least two systemic treatments (at least one of which was for advanced or metastatic stages).
 

Data show that sacituzumab govitecan is an antibody-drug conjugate (ADC) targeting human trophoblast cell surface antigen 2 (TROP2). It specifically recognizes TROP2 on the surface of tumor cells through a recombinant humanized monoclonal antibody against TROP2, and is internalized by tumor cells, releasing small molecule compounds within the cells, thereby inducing cell cycle arrest and apoptosis in tumor cells.
 

Kelun-Biotech stated that the approval of Lukansatuzumab was based on the positive results of the randomized, controlled Phase 3 OptiTROP-Breast01 study, which involved adult patients with unresectable locally advanced or metastatic TNBC who had previously received at least two systemic treatments (with at least one treatment targeting the advanced or metastatic stage). Compared to chemotherapy, Lukansatuzumab demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS).
 

It is reported that breast cancer seriously threatens women's health, with its incidence showing an increasing trend year by year. Data shows that there are 357,000 new cases of breast cancer among Chinese women each year, indicating a huge demand for drug treatments. The successful launch of Kelun-Biotech's Luskansa Monoclonal Antibody has officially opened up a new treatment landscape for second-line and above patients with advanced TNBC, providing them with a new therapeutic option.
 

In addition, according to the summary, in November, Alpha Biopharma's Class 1 innovative drug Zorifertinib Hydrochloride Tablets (brand name: Zerene) was also approved for marketing by the National Medical Products Administration. This drug is suitable for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and are accompanied by central nervous system (CNS) metastases. CHIATAI TIANQING's Class 1 innovative drug Geosotresib Tablets (brand name: Anfangning) was also approved for marketing. This drug is suitable for treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring mouse sarcoma virus oncogene (KRAS) G12C mutations who have received at least one systemic therapy.
 

In terms of innovative medical devices, according to a message on the website of the National Medical Products Administration on November 27, three innovative products have been approved for marketing. These are the ultrasound diagnostic system from Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and two innovative products from Hangzhou Ruidi Biotechnology Co., Ltd.: the pulse ablation device and the disposable pulse ablation needle.
 

Among them, the Ruidi Bio steep pulse treatment device is used in conjunction with disposable steep pulse ablation needles and connecting cables. The steep pulse treatment device employs a nanosecond high-voltage pulse electric field generator that utilizes linear modulation technology to store energy and form pulses through a pulse-shaping network, characterized by high electric field intensity and short pulse width. The disposable steep pulse ablation needle uses non-thermal ablation technology, allowing the ablation needle to percutaneously puncture and act on the target area, generating a high-voltage pulse electric field that causes irreversible pore formation and rapid apoptosis in cells, achieving ablation of malignant solid liver tumors. This technology represents a new approach in minimally invasive interventional tumor treatment and is of great significance for improving patients' quality of life and increasing survival rates.
 

Mindray's Bio-Ultrasound Diagnosis System consists of a main unit, probes, and optional accessories. It synchronously emits near-infrared laser based on the linear array probe, causing the tested tissue to thermally expand and generate ultrasound signals at specific frequencies. These signals' intensity and characteristics are then converted into image displays, revealing the blood oxygen distribution in the tested tissue area. It is used for clinical ultrasound and photoacoustic diagnostic examinations. This product is a dual-modality imaging system that integrates ultrasound and photoacoustic imaging technologies, capable of simultaneously displaying ultrasound tissue structure images and photoacoustic images within one imaging cycle, providing doctors with richer information on tissue structure and function for diagnosing patients' conditions.
 

According to the review, apart from the above three innovative medical device products, five domestically produced medical devices were approved for marketing in November. These include "Implantable Cardiac Pacemaker Electrode Leads" by Creater Medical (Shanghai) Co., Ltd., "Zirconia Ceramic Femoral Heads" by Beijing Ensuno Technology Co., Ltd., and brain-related products by HuaKe Precision (Beijing) Medical Technology Co., Ltd.Surgical OperationPlanning software, "Intracranial Aneurysm Embolization Assist Stent" by Shanghai Xinwei Medical Technology Co., Ltd., "Knee Joint Prosthesis System" by Yabone Medical Technology (Suzhou) Co., Ltd., etc.
 

The industry stated that the approval and market launch of innovative drugs and innovative medical device products will meet the needs of patients across China to a greater extent, providing patients with new treatment options.
 

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