Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration

Rhea-AI Summary

Innovent Biologics (HKEX: 01801) has received NMPA approval for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor, for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.

The approval is based on the Phase 2 TRUST-I trial results, which demonstrated significant therapeutic effects on brain lesions and efficacy in crizotinib-resistant patients. DOVBLERON® becomes Innovent's 13th commercial product, addressing a critical need as approximately 2.6% of NSCLC patients in China are ROS1-positive, with up to 55% developing brain metastases after initial treatment.

A second NDA for DOVBLERON® was accepted and granted Priority Review Designation in March 2024 for first-line treatment of ROS1-positive NSCLC patients.

Positive

• Received NMPA approval for DOVBLERON®, expanding commercial portfolio to 13 products
• Demonstrated efficacy in treating brain metastases and crizotinib-resistant patients
• Second NDA granted Priority Review Designation for first-line treatment
• Favorable safety profile with low rates of dose reduction and treatment discontinuation

Negative

• None.

Insights

Oncology Research Analyst

The NMPA approval of DOVBLERON® represents a significant advancement in ROS1-positive NSCLC treatment. The drug addresses critical unmet needs, particularly for patients who have developed resistance to first-line ROS1 TKIs and those with brain metastases. Clinical data showing efficacy in crizotinib-resistant patients and against brain lesions positions this as a potentially superior second-line treatment option.

The market opportunity is substantial - with 2.6% of NSCLC patients being ROS1-positive in China and up to 55% developing brain metastases after initial treatment. This translates to thousands of potential patients annually. The pending first-line indication, if approved, would further expand the addressable market significantly.

For investors, this approval strengthens Innovent's oncology portfolio and competitive position in the precision medicine space. The company now has 13 commercialized products, with DOVBLERON® complementing existing TKI offerings like RETSEMOV®, PEMAZYRE® and DUPERT®.

Market Research Analyst

This regulatory milestone enhances Innovent's commercial prospects in China's targeted therapy market. The approval timing and Priority Review status for first-line treatment indicate strong clinical data and regulatory confidence. The drug's differentiated profile in addressing resistance mutations and brain metastases could drive rapid market adoption and potentially command premium pricing.

Innovent's expanding TKI franchise demonstrates successful execution of its precision oncology strategy. The company's market cap of $7.9B could see upward revaluation as DOVBLERON® commercialization progresses and if the first-line indication receives approval. The positive endorsement from key opinion leaders like Dr. Caicun Zhou suggests favorable reception among prescribing physicians.

SAN FRANCISCO and SUZHOU, China, Dec. 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON ® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® marks the 13^th addition to Innovent's commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise.

Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive^[i]. Furthermore, brain metastases are a common challenge, affecting up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC, and increasing to as much as 55% of patients whose cancer has progressed following initial treatment. In addition, patients treated with approved ROS1 TKIs often develop resistance mutations to these therapies, representing a major limitation for patients in terms of duration of response. The approval of DOVBLERON® provides a new and effective treatment option for patients who are no longer responding to previously approved therapies.

The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON® to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies. [Link]

In addition, a second NDA for DOVBLERON® was accepted and granted Priority Review Designation by China's NMPA in March 2024 for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs.

Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "The treatment landscape for advanced ROS1-positive NSCLC remains challenging, especially for patients with brain metastases, who account for more than half of patients who have progressed following initial treatment with a ROS1 TKI, as well as those patients who develop resistance mutations. DOVBLERON® demonstrated significant therapeutic effects on brain lesions, as well as efficacy in crizotinib-resistant patients. Moreover, DOVBLERON® has a favorable safety profile and tolerability with low rates of dose reduction and treatment discontinuation due to adverse events. The efficacy and safety profile of DOVBLERON® offers a new hope for patients and I look forward to its benefit in the ROS1-positive NSCLC patients in China ."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of DOVBLERON® is a reflection of its potential best-in-class efficacy and safety profile, as demonstrated in the TRUST-I trial. We are delighted about the approval of DOVBLERON® and will bring this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life."

About ROS1-positive Non-small Cell Lung Cancer

Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive Up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing to as much as 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options.

About DOVBLERON® (Taletrectinib Adipate Capsule)

DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib, the active ingredient in DOVBLERON® is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II(NCT04919811), a global study.

In December 2024, DOVBLERON® was approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs. In addition, a second NDA for taletrectinib was accepted and granted Priority Review Designation by China's NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs.

Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China's NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval).

In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

References

[i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53.

 

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SOURCE Innovent Biologics

FAQ

What is the approved indication for DOVBLERON® in China?

DOVBLERON® is approved for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.

What percentage of NSCLC patients in China are ROS1-positive?

Approximately 2.6% of NSCLC patients in China are ROS1-positive.

What clinical trial supported DOVBLERON's approval?

The Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial in Chinese patients with advanced ROS1-positive NSCLC.

What is the rate of brain metastases in ROS1-positive NSCLC patients?

Up to 35% of newly diagnosed metastatic ROS1-positive NSCLC patients have brain metastases, increasing to 55% after initial treatment.

When was DOVBLERON's second NDA accepted for review in China?

A second NDA for DOVBLERON® was accepted and granted Priority Review Designation by China's NMPA in March 2024 for first-line treatment.