Innovent and AnHeart Therapeutics Announce the NMPA of China Has Accepted Second NDA for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer

Rhea-AI Summary

Innovent Biologics and AnHeart Therapeutics announce the acceptance of a second New Drug Application for taletrectinib as a first-line treatment for ROS1-positive non-small cell lung cancer in China. The NDA is based on positive Phase 2 trial results, with additional data expected in 2024.

ROCKVILLE, Md. and SUZHOU, China, March 5, 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, 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, announce that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted a second New Drug Application (NDA) for taletrectinib adipate capsule (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI). This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs.

In November 2023, the NMPA accepted taletrectinib's first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs. Both NDAs in China are based on positive results from the Phase 2 TRUST-I (NCT04395677) trial. Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 and additional data from TRUST-I is planned to be presented at an upcoming medical meeting in 2024.

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, stated:" I am pleased this second NDA for taletrectinib has been accepted in China. We need additional options for our patients who are newly diagnosed with advanced or metastatic ROS1-positive NSCLC that may improve upon the first-generation medicines"

Dr. Hui Zhou, Senior Vice President of Innovent, stated:"Given the clinically demonstrated benefits of taletrectinib in the TRUST-I trial, we are pleased to see the second NDA accepted by the NMPA of China. We will continue close communications with our partner AnHeart Therapeutics and regulatory authorities in China, hoping to bring this new generation of targeted therapy to all appropriate patients with ROS1-positive NSCLC as a standard initial treatment option."

Bing Yan, MD, President of AnHeart China, stated: "The acceptance of this NDA in China supports our belief in taletrectinib as a first-line treatment for people with advanced or metastatic ROS1-positive NSCLC, and we are excited by the opportunity to bring a potentially transformative medicine to people earlier in their treatment journey. We plan to work closely with our partner Innovent and regulatory authorities in China to continue progressing taletrectinib as part of our mission to improve the lives of people with cancer. "

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 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), the number increases to approximately 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 was evaluated in ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial. Positive interim results from TRUST-I trial were reported at the ELCC 2023, and positive interim results from TRUST-II trial were reported at the European Society of Medical Oncology Congress 2023.[Link] 

In 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 are ROS1 TKI naïve as well as those who have previously been treated with ROS1 TKIs.

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 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

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 19 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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.

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

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.

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 (NMPA). China's NMPA has accepted and is reviewing New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not been previously been treated with ROS1 TKIs. AnHeart's second investigational therapy, safusidenib, is a mIDH1-inhibitor being evaluated in a Phase 2 trial 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.

View original content:https://www.prnewswire.com/news-releases/innovent-and-anheart-therapeutics-announce-the-nmpa-of-china-has-accepted-second-nda-for-taletrectinib-for-first-line-treatment-of-ros1-positive-lung-cancer-302079359.html

SOURCE Innovent Biologics

FAQ

What is the significance of the second New Drug Application (NDA) for taletrectinib by Innovent Biologics and AnHeart Therapeutics?

The NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer in China.

What is taletrectinib?

Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) developed by Innovent Biologics and AnHeart Therapeutics.

What are the key details of the Phase 2 TRUST-I trial for taletrectinib?

The NDA in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), with data from an interim analysis presented at the European Lung Cancer Congress (ELCC) 2023.

Who is Professor Caicun Zhou and what is their role in the development of taletrectinib?

Professor Caicun Zhou is the Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, and they expressed satisfaction with the acceptance of the second NDA for taletrectinib in China.

What is the role of Dr. Hui Zhou in the taletrectinib development process?

Dr. Hui Zhou is the Senior Vice President of Innovent, and they highlighted the clinical benefits of taletrectinib in the TRUST-I trial.

Who is Bing Yan and what is their involvement in the taletrectinib project?

Bing Yan is the President of AnHeart China, and they emphasized the potential of taletrectinib as a first-line treatment for ROS1-positive NSCLC in China.