Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation

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Innovent Biologics, Inc. (HKEX: 01801) and AnHeart Therapeutics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted Priority Review Designation for the New Drug Application of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have been previously treated with ROS1 TKIs.

ROCKVILLE, Md. and SUZHOU, China, Dec. 18, 2023 /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, metabolic, autoimmune, ophthalmology and other major diseases, and AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review Designation[1] for the New Drug Application (NDA) of taletrectinib, 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. The CDE accepted the NDA in November 2023.

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Taletrectinib's potential as a best-in-class precision therapy is further underscored by the Priority Review Designation. We will continue to work with the regulatory authorities to support the review of taletrectinib with the goal of bringing this next-generation option to address unmet needs for ROS1-positive NSCLC patients in China."

Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Taletrectinib's Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China and the significant clinical advance that taletrectinib may represent for these patients. We look forward to working with the regulatory authorities as they conduct their review of taletrectinib to hopefully bring this breakthrough investigational therapy to patients as soon as possible."

The NDA and Priority Review Designation in China are based on data from the Phase 2 TRUST-I trial (NCT04395677). Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023.[Link]

About ROS1-positive Non-small Cell Lung Cancer

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 3% of people with NSCLC in China are ROS1-positive. There are two approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLC and no approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment.

About Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor.

Taletrectinib is being evaluated in ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

In March 2022, taletrectinib was granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs as well as those who have not previously been treated by ROS1 TKIs (TKI-naïve). 

Taletrectinib has also been granted Breakthrough Therapy Designation in the United States for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration (FDA).

In June 2021, Innovent and AnHeart 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

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules ), FUCASO® (Equecabtagene  Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 2 NDAs under NMPA review, 6 assets in Phase III or pivotal clinical trials, and 19 more molecules in early clinical stage.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.
CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.
Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: Innovent does not recommend any off-label usage.

About AnHeart Therapeutics

AnHeart Therapeutics ("AnHeart'') is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer. Our lead investigational therapy, taletrectinib, is a next-generation ROS1-inhibitor currently in pivotal Phase 2 trials for ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration and the China National Medical Products Administration. AnHeart's second investigational therapy, safusidenib, is a mIDH1-inhibitor being evaluated in Phase 2 trials for IDH1-mutant glioma.

Our mission is to improve the lives of people with cancer. We are supported by leading life sciences investors and have built an organization with deep oncology drug discovery and development expertise, with offices in New York and Shanghai. For more information, visit https://www.anhearttherapeutics.com/ or follow us on LinkedIn at https://www.linkedin.com/company/anheart-therapeutics-official/.

Innovent's 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.

[1] Priority Review Designation was established in China to accelerate the research and development of innovative drugs that have significant clinical advantages and for diseases where there is urgent clinical need. Priority Review Designation allows the CDE to prioritize the review process and evaluation resources for NDAs, which helps accelerate the market access of innovative drugs.

 

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SOURCE Innovent Biologics

FAQ

What is the significance of the Priority Review Designation for taletrectinib by the Center for Drug Evaluation of China's National Medical Products Administration?

The Priority Review Designation highlights the urgent need for patients with ROS1-positive non-small cell lung cancer in China and the potential clinical advance that taletrectinib may represent for these patients.

What trial data is the NDA and Priority Review Designation in China based on?

The NDA and Priority Review Designation in China are based on data from the Phase 2 TRUST-I trial (NCT04395677). Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023.

What is the goal of Innovent and AnHeart in relation to the review of taletrectinib?

Innovent and AnHeart aim to work with the regulatory authorities to support the review of taletrectinib with the goal of bringing this next-generation option to address unmet needs for ROS1-positive non-small cell lung cancer patients in China.