AnHeart Therapeutics (Hangzhou) Co., Ltd.

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 or follow us on LinkedIn at . 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. SOURCE Innovent Biologics

Aug. 3, 2022 12:00 UTC FDA Breakthrough Designation Reinforces Significant Unmet Need in the Treatment of This Highly Aggressive Cancer NEW YORK--(BUSINESS WIRE)-- AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib. The FDA decision was supported by the preliminary clinical data of taletrectinib from an ongoing Phase 2 trial (TRUST) in Chinese ROS1-positive NSCLC patients and two completed Phase 1 clinical trials conducted in the United States and Japan. The preliminary clinical data from the ongoing TRUST Phase 2 trial was recently presented at the 2022 American Society of Clinical Oncology (ASCO) meeting. In 67 evaluable ROS1 TKI-naïve patients with ROS1 fusion-positive NSCLC, the confirmed objective response rate (cORR) and disease control rate (DCR) was 92.5% and 95.5%, respectively. In 38 evaluable crizotinib-pretreated patients, the cORR and DCR were 50% and 78.9%, respectively. In 12 patients with brain metastasis and measurable brain lesions at baseline, the intracranial cORR and intracranial DCR were 91.7% and 100%, respectively. In five patients with ROS1 G2032R resistant mutation, 4/5 achieved confirmed partial response (cPR), and 1/5 achieved stable disease (SD). Taletrectinib was generally well tolerated. Low incidence of neurological adverse events (AEs) was observed, likely reflecting taletrectinib’s selective inhibition of ROS1 over tropomyosin receptor kinase B (TRKB). "There is a high unmet need for this specific patient population in lung cancer, where very few treatment options are available," said Lian Li, M.D. Ph.D., Chief Medical Officer (US) of AnHeart. "In the TRUST Phase 2 trial, taletrectinib showed promising antitumor activity against ROS1-fusion and resistant mutations in adult patients with ROS1-positive NSCLC, with a favorable safety profile. Taletrectinib also showed better brain penetration and intracranial antitumor activity in comparison to other ROS1 inhibitors. Patients with ROS1-positive NSCLC desperately need new therapeutic options, and we look forward to our ongoing dialogue with the FDA to accelerate the development of taletrectinib for patients in the US.” The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A Breakthrough Therapy Designation conveys all the fast-track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. ABOUT TALETRECTINIB Taletrectinib is a novel potential best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at . For questions about the ongoing trials, please contact trials@anhearttherapeutics.com. ABOUT ANHEART THERAPEUTICS AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical group company developing a broad pipeline of novel precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a potential best-in-class next-generation ROS1 inhibitor currently in Phase 2 trials for ROS1 TKI-naïve and TKI-pretreated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The Company’s pipeline also includes AB-218, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, please visit .

Sept. 27, 2021 12:00 UTC In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21). In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16). HANGZHOU, China & NEW YORK--(BUSINESS WIRE)-- AnHeart Therapeutics Co., Ltd (“AnHeart”), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, together with Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced today interim clinical data from a Phase Ⅱ trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021. The scientific presentation entitled: “Taletrectinib (AB-106): Preliminary results from TRUST, Phase Ⅱ trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC),” summarized preliminary data from an ongoing Phase Ⅱ trial of taletrectinib (NCT04395677). As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows: In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21). In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16). Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD). In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6). Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased. “We are pleased with the interim Phase Ⅱ data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer,” said Dr. Caicun Zhou, Director of the Department of Oncology, Shanghai Pulmonary Hospital. “Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug.” “Our team is focused on completing patient enrollment for our Phase Ⅱ TRUST trial,” said Bing Yan, MD, Co-founder and Chief Medical Officer at AnHeart Therapeutics. “The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs.” "We are glad to see the interim Phase Ⅱ data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China," said Dr. Hui Zhou, Senior Vice President of Innovent, "In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC." About Taletrectinib Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at . About AnHeart AnHeart Therapeutics Co., Ltd. (“AnHeart”) is a clinical-stage biopharmaceutical company developing novel first-in-class or best-in-class precision oncology therapeutics. Its lead asset, taletrectinib, is a next-generation ROS1 and NTRK inhibitor currently in Phase Ⅱ trials for the first and second-line non-small cell lung cancer (NSCLC) . AnHeart is developing a broad pipeline of next-generation precision oncology therapeutics with high unmet medical need. For more information, please visit . About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major diseases therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 26 valuable assets in major therapeutic areas, with 5 products - TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) , HALPRYZA® (rituximab biosimilar injection), and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset’s NDA under NMPA review, sintilimab’s Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies. Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China’s biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients’ lives. For more information, please visit: . and . AnHeart Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. 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Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. Innovent 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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