Innovent's DOVBLERON®: A New Hope for ROS1-Positive NSCLC Patients

Innovent Biologics, Inc. (HKEX: 01801), a world-class biopharmaceutical company, has received a significant boost with the approval of its second New Drug Application (NDA) for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), by China's National Medical Products Administration (NMPA). This approval marks a crucial milestone in the company's ongoing commitment to developing innovative medicines for the treatment of major diseases, including oncology.



DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor, designed to target the guanosine triphosphate/guanosine diphosphate exchange process by covalently and irreversibly modifying the ROS1 G12C protein's cysteine residue. This innovative therapy has demonstrated high selectivity towards G12C, effectively inhibiting downstream signaling pathways and leading to apoptosis (programmed cell death) and cell cycle arrest in tumour cells.

The approval of DOVBLERON® is grounded in the positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that assessed the efficacy and safety of fulzerasib monotherapy in Chinese patients with advanced NSCLC and the ROS1 G12C mutation. As of 13 December 2023, the study had enrolled 116 evaluable subjects, demonstrating that fulzerasib was generally well-tolerated and exhibited promising antitumour activity.

In ROS1 TKI-naïve patients (n=106), the confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) reached as high as 91%, with intracranial cORR reaching 88%. After a median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. These impressive results indicate that DOVBLERON® has the potential to significantly improve the lives of patients with ROS1-positive NSCLC.

The approval of DOVBLERON® by the NMPA is a testament to Innovent's commitment to addressing unmet medical needs and expanding its precision oncology portfolio. With this approval, Innovent now offers a comprehensive range of targeted therapies, including RETSEMOV®, PEMAZYRE®, DUPERT®, and DOVBLERON®, further solidifying its position as a leader in the TKI landscape.

Innovent's robust TKI product pipeline, coupled with its synergistic strengths in precision oncology, enables the company to offer more treatment options to patients and expand its global reach. The approval of DOVBLERON® by the NMPA not only enhances Innovent's market position and competitive advantage in the TKI landscape but also opens up new market opportunities and revenue streams.

As Innovent continues to invest in research and development, it will explore new indications and geographies, further driving market growth and revenue expansion. The company's expertise in precision oncology, combined with its ability to navigate complex regulatory environments, positions it well to succeed in the global biopharmaceutical industry.

In conclusion, the approval of DOVBLERON® by the NMPA is a significant milestone for Innovent Biologics, Inc. This innovative precision therapy offers new hope for patients with ROS1-positive NSCLC and further strengthens Innovent's position in the TKI landscape. With a robust product pipeline and a commitment to addressing unmet medical needs, Innovent is well-positioned to continue its success in the global biopharmaceutical industry.