Ensartinib Hydrochloride

HANGZHOU, China, July 8, 2026 /PRNewswire/ -- On July 8, the study of Betta's ensartinib as postoperative adjuvant therapy for patients with stage IB–IIIB (T3N2M0) ALK-positive non-small cell lung cancer (NSCLC), known as the ELEVATE study, was published online in full in The New England Journal of Medicine (NEJM; Impact Factor 84.5), a world-leading medical journal. The study provides important evidence for adjuvant therapy of ALK-positive NSCLC worldwide and has the potential to change current clinical practice. Continue Reading Lung cancer is the most common and deadliest malignancy both globally and in China. According to the statistical report issued by the National Cancer Center, in 2022, there were an estimated 1.06 million new cases of lung cancer and 733,300 related deaths in China. Of patients with lung cancer, NSCLC accounts for up to 85%. Approximately 5-7% of patients with NSCLC have ALK-positive disease. Although some patients with ALK-positive NSCLC are diagnosed at an early or intermediate stage amenable to surgical resection, they still face high risks of recurrence and death, and traditional postoperative adjuvant chemotherapy offers modest benefits. Therefore, reducing the risk of recurrence and prolonging survival after surgery remains an urgent unmet clinical need. The ELEVATE study directly addresses this unmet need. In the ELEVATE study, a total of 274 patients from 56 medical centers across China were randomly assigned at a 1:1 ratio to receive oral ensartinib or placebo following complete surgical resection and any planned adjuvant chemotherapy. It is a phase 3, multicenter, randomized, placebo-controlled, double-blind registration study in the field of ALK-TKI adjuvant therapy for ALK-positive lung cancer. The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37). Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, with the potential to change postoperative adjuvant treatment strategies for patients with ALK-positive lung cancer. The marketing application for the adjuvant indication of ensartinib has already been accepted in China. Moving forward, we will continue to focus on unmet clinical needs, deepen independent innovation, and accelerate the development of more innovative products with core competitiveness and global impact, benefiting more patients." It is known that ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. It is an innovative drug developed independently and wholly owned by Betta Pharmaceuticals and its subsidiary Xcovery. Its first-line and second-line indications have already been approved in China, offering good accessibility and a favorable safety profile, and it has received the First Prize for Scientific and Technological Progress in Zhejiang Province. In December 2024, ensartinib was approved for marketing in the United States and subsequently included in the NCCN Guidelines for Non-Small Cell Lung Cancer. Marketing authorization applications in other overseas markets, including the European Union, are progressing. SOURCE Betta Pharmaceuticals 21% more press release views with Request a Demo

Dr. Selvaggi, a veteran immuno-oncology executive brings more than 30 years of oncology experience and a proven track record of advancing global clinical programs, with novel cancer therapies to registration, strengthening Biond's efforts to advance the clinical development of BND-67 and BND-22 MISGAV, Israel, June 22, 2026 /PRNewswire/ -- Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing first-in-class immunotherapies for cancer and immune-mediated diseases, today announced the appointment of Giovanni Selvaggi, M.D. CMO. Dr. Selvaggi is a physician-scientist and oncology drug development executive with extensive experience spanning academic medicine, global pharmaceutical companies, and biotechnology organizations. Over the course of his career, he has led the clinical development of multiple oncology programs from early-stage research through regulatory submissions, including immuno-oncology therapies, targeted therapies, cancer vaccines, and oncolytic viruses. Dr. Selvaggi most recently served as CMO of Xcovery Holdings, where he led the clinical development and regulatory strategy for ensartinib, including its global Phase 3 program and regulatory interactions with the U.S. Food and Drug Administration. He also held senior leadership positions at Bristol Myers Squibb, where he led immuno-oncology clinical development programs in small cell lung cancer, mesothelioma, and non-small cell lung cancer, contributing to the regulatory filing of nivolumab in small cell lung cancer. Earlier in his career, Dr. Selvaggi held senior development roles at Novartis Oncology, GlaxoSmithKline, Oncolytics Biotech, and Imugene. He is a board-certified pulmonologist and thoracic oncology specialist who spent more than a decade treating patients and conducting clinical research in lung cancer and mesothelioma at the University of Turin and San Luigi Hospital in Italy. "We are delighted to welcome Giovanni to Biond at a transformative stage in the Company's growth," said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond Biologics. "Biond now has two highly differentiated clinical-stage immunotherapy programs, including BND-22, currently advancing in Phase 2 studies, and BND-67, which recently entered a first-in-human study to evaluate BND-67. Giovanni brings a unique combination of deep oncology expertise, immuno-oncology leadership, and hands-on experience advancing innovative therapies from early clinical development through regulatory filings. We believe his clinical leadership and experience will further strengthen our ability to execute our clinical strategy and unlock the full potential of our first-in-class pipeline." "I am excited to join Biond at a crucial development stage and contribute to the advancement of its innovative immunotherapy portfolio," said Giovanni Selvaggi, M.D. "Biond has built a compelling pipeline based on novel biological insights and differentiated mechanisms of action. BND-67 represents a particularly exciting opportunity to unlock the full potential of T-cell immunity through a completely new approach to restoring physiological CD28 signaling. I look forward to working with the talented team at Biond to improve outcomes for patients with cancer." About Biond Biologics Biond Biologics is a private, clinical-stage biotechnology company developing first-in-class immunotherapies targeting novel pathways across both the innate and adaptive immune systems. The company's pipeline includes clinical-stage programs in oncology, alongside a growing portfolio of discovery and preclinical programs in immune-mediated diseases. Biond's clinical pipeline includes BND-22, a first-in-class antibody that acts as a multi-cell checkpoint inhibitor targeting the ILT2 receptor advancing in a phase 2 study. BND-22 enhances the anti-tumor activity of both innate and adaptive immune cells by blocking the interaction between ILT2 and HLA-G, for the treatment of solid tumors. In addition, Biond is developing BND-67, a next-generation immunotherapy and a first-in-class asset targeting CD28 shedding, a novel immune evasion mechanism with the potential to redefine T-cell modulation in cancer. Given the central role of CD28 in T-cell activation, BND-67 introduces a fundamentally new approach to restoring immune responsiveness. By preserving CD28 signaling, it enhances effector T-cell activity while selectively inhibiting regulatory T-cell function, driving a potent and sustained anti-tumor response. The program is IND-ready, with a Phase 1 trial planned for Q2 2026 Biond was founded in 2016, by Tehila Ben Moshe, Ph.D., Ori Shilo, and a team of accomplished scientists and drug developers from the Israel biopharmaceutical industry. . Company contact: Tal Sines VP of Business Development Biond Biologics Ltd. +972-4 884 4337 [email protected] SOURCE Biond Biologics Ltd. 21% more press release views with Request a Demo