Innovent Announces Second New Drug Application of DOVBLERON ® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) was Approved by China's National Medical Products Administration

Rhea-AI Summary

Innovent Biologics (HKEX: 01801) has received approval from China's NMPA for the second New Drug Application of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor. This approval is for treating adult patients with locally advanced or metastatic ROS1-positive NSCLC.

The approval is based on the Phase 2 TRUST-I trial results, which showed impressive efficacy: 91% confirmed objective response rate in ROS1 TKI-naïve patients and 88% intracranial response rate. After a median follow-up of 23.5 months, the median duration of response and progression-free survival were not reached.

This follows DOVBLERON®'s first approval in December 2024 for previously treated ROS1-positive NSCLC patients. It becomes Innovent's 13th commercial product, strengthening their TKI franchise alongside RETSEMOV®, PEMAZYRE®, and DUPERT®.

Positive

• 91% confirmed objective response rate in ROS1 TKI-naïve patients
• 88% intracranial confirmed objective response rate
• Median duration of response and progression-free survival not reached after 23.5 months
• Expanded market opportunity with approval across treatment lines
• 13th commercial product addition strengthening oncology portfolio

Negative

• None.

Insights

Medical Research Analyst

<p>The NMPA approval of DOVBLERON® for first-line treatment of ROS1-positive NSCLC represents a <b>significant therapeutic advancement</b>. The TRUST-I trial data is remarkably robust, with a <percent>91%</percent> confirmed objective response rate in TKI-naïve patients and <percent>88%</percent> intracranial response rate. These efficacy metrics substantially exceed historical benchmarks for first-generation ROS1 inhibitors.</p><p>The durability of response is particularly noteworthy - after <b>23.5 months</b> of follow-up, median duration of response and progression-free survival were not yet reached, suggesting exceptional sustained efficacy. For context, first-generation ROS1 inhibitors typically show median PFS of 15-19 months.</p><p>In simpler terms: This drug works better than existing treatments for this type of lung cancer, especially in treating cancer that has spread to the brain. Patients are responding well to the treatment and staying healthy for longer periods without their cancer getting worse.</p>

Financial Analyst

<p>This regulatory milestone materially strengthens Innovent's commercial oncology portfolio and market position. With DOVBLERON® now approved across treatment lines, the addressable market expands significantly. ROS1-positive NSCLC represents approximately <percent>1-2%</percent> of all NSCLC cases in China - while a niche population, the superior efficacy profile positions DOVBLERON® for rapid market penetration and premium pricing.</p><p>The quick succession of approvals (second NDA just weeks after first approval) and immediate commercial launch demonstrates strong execution capabilities. This adds to Innovent's growing precision oncology franchise alongside RETSEMOV®, PEMAZYRE® and DUPERT®, creating portfolio synergies and operational leverage.</p><p>In simple terms: This new drug approval allows Innovent to treat more lung cancer patients and potentially generate significant revenue. The company is showing it can quickly bring new drugs to market, which is important for growth.</p>

SAN FRANCISCO and SUZHOU, China, Jan. 2, 2025 /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 the second 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 NSCLC.

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 the safety, tolerability and efficiency of 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 that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions. In ROS1 TKI-naïve (n=106) patients, confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached as high as 91% and 88%, respectively. After 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. [Link]

In December 2024, DOVBLERON® was approved by the NMPA 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® is 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.

Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "We are glad to see that DOVBLERON® has been approved for ROS1-positive NSCLC across treatment lines at a fast pace. DOVBLERON® demonstrated superior efficacy compared to the first-generation TKIs. These TRUST-I results reinforce taletrectinib's high overall response and prolonged PFS. The efficacy and safety profile of DOVBLERON® offers a more effective first-line treatment option 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 two NDAs approval of DOVBLERON® is a reflection of its potential best-in-class efficacy to fulfill the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON® to market, rapidly bringing 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^[i]. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options. In patients with metastatic ROS1-positive NSCLC that progressed following initial treatment, many have tumors spread to their brain (up to 55%) or acquired resistance mutations, including G2032R. Next-generation ROS1 TKIs demonstrated robust intracranial and G2032R activity. In the clinical management of ROS1-positive NSCLC patients, the first-line application of the new generation ROS1 TKIs can bring a prolonged progression-free survival and provide patients with greater survival benefits.

About DOVBLERON ® (Taletrectinib Adipate Capsule)

DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1inhibitor. 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.

DOVBLERON® was approved by China's National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs; 2) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

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). This NDA was accepted by the U.S. FDA for priority review in December 2024.

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 are the key efficacy results of DOVBLERON® in the TRUST-I trial for ROS1-positive NSCLC?

In the TRUST-I trial, DOVBLERON® showed a 91% confirmed objective response rate in ROS1 TKI-naïve patients and 88% intracranial response rate, with median duration of response and progression-free survival not reached after 23.5 months follow-up.

When did DOVBLERON® receive its first NMPA approval for ROS1-positive NSCLC?

DOVBLERON® received its first NMPA approval in December 2024 for previously treated ROS1-positive NSCLC patients.

What patient populations are now approved for DOVBLERON® treatment in China?

DOVBLERON® is approved for adult patients with locally advanced or metastatic ROS1-positive NSCLC, both as first-line treatment and for patients previously treated with ROS1 TKIs.

How many commercial products does Innovent now have with DOVBLERON®'s approval?

With DOVBLERON®'s approval, Innovent now has 13 commercial products in its portfolio.