Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)

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Innovent Biologics, Inc. (01801) and AnHeart Therapeutics announce the acceptance of the New Drug Application (NDA) for taletrectinib by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Taletrectinib is 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 NDA acceptance is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.

ROCKVILLE, Md. and SUZHOU, China, Nov. 22, 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, announce that the New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, 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 NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.[Link]

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, stated: "We have extremely limited options for our patients with ROS1-positive NSCLC, especially those with brain metastases who represent more than one-third of patients, and those who go on to develop resistant mutations, which is more than half of patients. Once patients progress on the current options, there are no approved treatments. I hope this NDA represents a step towards making another option available to the ROS1-positive NSCLC patient community in China."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are encouraged by the best-in-class efficacy and safety profile that taletrectinib demonstrated in the TRUST-I trial, and are excited about the NDA acceptance in China. Together with our partner AnHeart, we will work closely with the NMPA to bring this precision therapy to NSCLC patients who are in need of novel treatment options, especially those with acquired resistant mutations or with brain metastases."

Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally. We would like to thank all the doctors and patients who participated in the clinical trials that support this submission. We look forward to working with our partner Innovent and the regulatory authorities in China to hopefully make taletrectinib available to patients in need as soon as possible."

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 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 being evaluated for the treatment of ROS1-positive NSCLC.

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-II 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]

Taletrectinib was granted Breakthrough Therapy Designation (BTD) by the CDE of NMPA in 2022 for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who have previously been treated with a ROS1 TKI as well as those who have not previously been treated by a ROS1 TKI (TKI-naïve). In addition, taletrectinib has also been granted BTD for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration in the United States in 2022.

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 1 NDA 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 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.

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SOURCE Innovent Biologics

FAQ

What is the New Drug Application (NDA) for taletrectinib by Innovent Biologics, Inc. (01801) and AnHeart Therapeutics?

The NDA for taletrectinib is 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. It has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

What trial results led to the NDA acceptance?

The NDA acceptance is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), which evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Who presented the interim analysis of the TRUST-I trial?

Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.

What is the purpose of taletrectinib?

Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of ROS1-positive NSCLC patients.

Who is Professor Caicun Zhou?

Professor Caicun Zhou is the Principal Investigator and Oncologist at Shanghai Pulmonary Hospital.

What did Professor Caicun Zhou state about the NDA acceptance?

Professor Caicun Zhou stated that the NDA represents a step towards making another treatment option available to the ROS1-positive NSCLC patient community in China.

Who is Dr. Hui Zhou?

Dr. Hui Zhou is the Senior Vice President of Innovent.

What did Dr. Hui Zhou say about taletrectinib?

Dr. Hui Zhou stated that they are encouraged by the best-in-class efficacy and safety profile that taletrectinib demonstrated in the TRUST-I trial.