China Approves Innovent's Second NDA for Taletrectinib Adipate Capsule

SAN FRANCISCO and SUZHOU, China, Jan. 2, 2025 – Innovent Biologics, Inc., a prominent biopharmaceutical enterprise, has announced a significant development concerning the treatment of non-small cell lung cancer (NSCLC). China's National Medical Products Administration (NMPA) has sanctioned the second New Drug Application for DOVBLERON® (taletrectinib adipate capsule), a cutting-edge ROS1 tyrosine kinase inhibitor. This approval is aimed at adult patients dealing with locally advanced or metastatic ROS1-positive NSCLC.

The decision followed compelling outcomes from the pivotal Phase 2 TRUST-I trial, an extensive study that delved into the safety and efficacy of taletrectinib among Chinese patients with advanced ROS1-positive NSCLC. The research findings, disclosed at the 2024 American Society of Clinical Oncology Annual Meeting, were also documented in the Journal of Clinical Oncology. The data highlighted taletrectinib's sustained positive response and potent action against brain lesions in patients. In a subset of patients who had not previously been treated with ROS1 TKIs, the confirmed objective response rate was an impressive 91%, with intracranial response rates at 88%. With a median follow-up of 23.5 months, these patients showed significant progression-free survival, and the median duration of response was yet to be determined.

In December 2024, the NMPA had already approved DOVBLERON® for patients with previously treated ROS1-positive NSCLC. This approval marks DOVBLERON® as the 13th product in Innovent's commercial lineup, reflecting its innovative approach to precision therapy and its anticipated impact on lung cancer treatment.

Dr. Caicun Zhou, Director of the Department of Oncology at Shanghai East Hospital, Tongji University, expressed enthusiasm about the rapid approval of DOVBLERON® for ROS1-positive NSCLC treatment across multiple lines. He remarked on the drug's superior efficacy when compared to first-generation TKIs, noting its impressive overall response and prolonged progression-free survival. Dr. Zhou is optimistic about the benefits DOVBLERON® will bring to patients in China.

Dr. Hui Zhou, Senior Vice President of Innovent, highlighted the significance of the dual NDA approvals, describing it as a testament to DOVBLERON®'s potential as a leading treatment option for ROS1-positive NSCLC patients. The recent market launch of DOVBLERON® underscores Innovent's commitment to providing innovative treatment options. The company's diverse TKI product line, which includes RETSEMOV®, PEMAZYRE®, DUPERT®, and DOVBLERON®, showcases its leadership and collaborative strengths in precision oncology, aiming to improve patient quality of life.

Lung cancer remains a leading cause of cancer-related mortality worldwide, with NSCLC constituting about 85% of cases. In China, roughly 2.6% of NSCLC patients are ROS1-positive. Despite advancements, there is a continuous need for more effective and tolerable treatments. The emergence of next-generation ROS1 TKIs has shown substantial activity against brain metastases and mutations like G2032R, offering the potential for extended progression-free survival and improved patient outcomes.

DOVBLERON® is a highly potent, selective ROS1 inhibitor designed for oral administration. It is being evaluated in Phase 2 pivotal studies—TRUST-I in China and TRUST-II, a global study. The drug received approval from the NMPA for patients with locally advanced or metastatic ROS1-positive NSCLC, regardless of prior ROS1 TKI treatment. Taletrectinib, the active component of DOVBLERON®, has been granted Orphan Drug Designation by the U.S. FDA and Breakthrough Therapy Designations by both the U.S. and Chinese regulatory bodies for ROS1-positive NSCLC.

In June 2021, Innovent and AnHeart Therapeutics entered an exclusive agreement to co-develop and market taletrectinib in Greater China. Innovent Biologics, established in 2011, is dedicated to making high-quality biopharmaceuticals accessible globally, with a focus on treating challenging diseases such as cancer and autoimmune disorders.