Nuvation Bio Receives Approval from China’s National Medical Products Administration for Taletrectinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) announced the approval of taletrectinib by China's National Medical Products Administration (NMPA) for treating adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The drug, to be marketed as DOVBLERON® by Innovent Biologics in China, was launched in January 2025.

The approval was based on the Phase 2 TRUST-I study results, which demonstrated the drug's efficacy in patients who have or haven't been previously treated with ROS1 tyrosine kinase inhibitors. The drug previously received Breakthrough Therapy Designation and Priority Review in China.

Additionally, the U.S. FDA has accepted Nuvation Bio's New Drug Application for taletrectinib with Priority Review, setting a PDUFA date of June 23, 2025. The U.S. application is supported by pooled results from the TRUST-I and TRUST-II studies presented at ESMO Congress in September 2024.

Positive

• Received NMPA approval for taletrectinib in China
• Secured commercial partnership with Innovent Biologics for Chinese market
• FDA granted Priority Review for U.S. application with PDUFA date of June 23, 2025
• Only ROS1 TKI in development with FDA Breakthrough Therapy Designation

Negative

• None.

Insights

Oncology Research Analyst

The NMPA approval of taletrectinib represents a significant milestone in the treatment landscape for ROS1+ NSCLC. The drug's efficacy data from the TRUST-I study, coupled with its Breakthrough Therapy Designation, positions it as a potentially superior option in a market with treatment alternatives. ROS1+ NSCLC affects approximately 1-2% of NSCLC patients, translating to a substantial market opportunity in China, where lung cancer incidence rates are among the highest globally.

The line-agnostic approval (for both TKI-naive and previously treated patients) significantly expands the addressable patient population. The partnership with Innovent Biologics, which has an established oncology presence in China, should facilitate rapid market penetration. The immediate January 2025 launch indicates strong commercial readiness.

Financial Analyst

This regulatory win in China opens up a crucial revenue stream for Nuvation Bio. The Chinese NSCLC market is projected to reach $8.5 billion by 2026 and ROS1+ patients represent a specialized segment with high unmet needs and potentially premium pricing power. The partnership with Innovent reduces commercialization risks while ensuring revenue through royalties and milestone payments.

The pending FDA approval, with a PDUFA date of June 2025, could create a dual-market opportunity. The Breakthrough Therapy Designation in both regions suggests strong clinical differentiation, which could translate to favorable pricing and reimbursement decisions. For a company with a ~$897 million market cap, successful commercialization in these major markets could significantly impact valuation multiples.

Regulatory Affairs Expert

The synchronized regulatory progress in both China and the US demonstrates exceptional clinical development strategy. The Priority Review status in both regions, coupled with Breakthrough Therapy Designations, indicates robust efficacy data and high unmet medical need. The TRUST-I and TRUST-II studies' data presentation at major oncology conferences (ASCO and ESMO) adds credibility to the clinical package.

The line-agnostic approval in China sets a favorable precedent for the upcoming FDA decision. The June 2025 PDUFA date, combined with the Orphan Drug Designation in the US, suggests potential for expedited market entry and extended market exclusivity, critical factors for long-term commercial success.

Taletrectinib will be marketed in China by Innovent Biologics

Approval is based on the pivotal Phase 2 TRUST-I study, demonstrating taletrectinib's durable responses and prolonged progression-free survival

NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that China’s National Medical Products Administration (NMPA) has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI). As part of an exclusive license agreement, Innovent Biologics will commercialize taletrectinib in China under the brand name DOVBLERON®. The product was officially launched in the territory in January 2025. Taletrectinib was previously granted Breakthrough Therapy Designation and Priority Review by China’s NMPA.

The approval by China’s NMPA was based on data from the pivotal Phase 2 TRUST-I study of taletrectinib in patients in China, which were published in the Journal of Clinical Oncology and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024.

“Taletrectinib’s approval by the NMPA underscores its best-in-class potential, and Nuvation Bio’s commercialization partnership with Innovent Biologics in China brings us closer to our goal of addressing the critical needs of patients with ROS1-positive NSCLC worldwide," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are committed to bringing innovative cancer treatments to patients who need them most, and we look forward to building upon this momentum with the potential FDA approval and launch of taletrectinib in the U.S. in mid-2025.”

As a reminder, in December 2024, the U.S. Food and Drug Administration (FDA) accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1-positive NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs. The NDA in the U.S. is based on the pooled results from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib, which were presented at the European Society of Medical Oncology (ESMO) Congress in September 2024.

About Taletrectinib

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

The U.S. FDA has granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted for Priority Review Nuvation Bio’s NDA for taletrectinib for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval).

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

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. Up to 35% of people newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.

About Nuvation Bio

Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, please visit www.nuvationbio.com or follow us on LinkedIn and X (@nuvationbioinc).

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding the timing of FDA approval and commercial launch, a full NDA approval for taletrectinib for the treatment of advanced ROS1+ NSCLC (line agnostic), and taletrectinib’s best-in-class therapeutic potential in advanced ROS1+ NSCLC. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on November 6, 2024, under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

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Nuvation Bio Investor:

ir@nuvationbio.com

Nuvation Bio Media:

media@nuvationbio.com

Source: Nuvation Bio Inc.

FAQ

When did China's NMPA approve Nuvation Bio's taletrectinib (NUVB) for ROS1+ NSCLC?

Nuvation Bio's taletrectinib was approved by China's NMPA in early 2025 for treating ROS1-positive non-small cell lung cancer patients.

What is the PDUFA date for Nuvation Bio's (NUVB) taletrectinib FDA approval?

The FDA has set a PDUFA goal date of June 23, 2025, for Nuvation Bio's taletrectinib NDA review.

Who will commercialize Nuvation Bio's (NUVB) taletrectinib in China?

Innovent Biologics will commercialize taletrectinib in China under the brand name DOVBLERON® through an exclusive license agreement.

What clinical trials supported Nuvation Bio's (NUVB) taletrectinib approval in China?

The approval was based on the Phase 2 TRUST-I study, which demonstrated taletrectinib's durable responses and prolonged progression-free survival.

What regulatory designations has Nuvation Bio's (NUVB) taletrectinib received?

Taletrectinib has received Breakthrough Therapy Designation and Priority Review in China, and Breakthrough Therapy Designation and Orphan Drug Designation in the U.S.