Monday, May 31, 2021
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd. ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, today jointly announce an exclusive license agreement for the co-development and commercialization of AnHeart's lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK - in Greater China, including mainland China, Hong Kong, Macau and Taiwan.
Under the terms of the agreement, Innovent will obtain exclusive rights to co-develop and commercialize taletrectinib in Greater China. AnHeart will continue to be responsible for the development of taletrectinib up to regulatory approval in mainland China and for supplying taletrectinib for both developmental and commercial purposes in Greater China. Innovent has the right to co-develop taletrectinib in Hong Kong, Macau and Taiwan up to regulatory approval.
According to the agreement, AnHeart will receive an upfront payment, R&D fees, and potential milestone payments totaling USD189 million in addition to tiered royalties based on annual net sales of taletrectinib in Greater China.
Taletrectinib is currently undergoing three phase 2 studies, including (i) the phase 2 study for first line treatment of TKI-naive and second line treatment of TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) in China, (ii) the phase 2 study for NTRK-positive solid tumors in China, and (iii) the phase 2 study for first line and second line treatment of ROS1-positive NSCLC globally.
"We are excited to collaborate with Innovent, a leading biopharmaceutical company which has demonstrated outstanding development and commercialization capabilities, to commercialize taletrectinib in greater China," said Jerry Junyuan Wang, PhD, CEO and co-founder of AnHeart. "Following the first commercial partnership in Korea we entered into with NewG Lab in July 2020, our collaboration with Innovent further advances our mission to accelerate global patient access to taletrectinib upon approval."
Dr. Yong Jun Liu, president of Innovent, stated, "We are very pleased to enter a collaboration with AnHeart. We have been impressed with our partner's capability to advance the global development of taletrectinib and we are excited to help bring taletrectinib to patients in Greater China. This collaboration further strengthens our position in oncology by adding a late stage and potential best-in-class targeted therapy into our portfolio. At the same time, it further proves that Innovent is an ideal partner for biopharmaceutical companies in terms of accelerating development and commercialization progress."
Taletrectinib is an investigational next-generation TKI designed to effectively target ROS1 and NTRK with potential to treat TKI-naïve or pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK fusion is estimated to be an oncogenic driver in approximately 0.5 percent of patients across multiple advanced solid tumors. There's very limited approved therapy available for advanced ROS1-positive lung cancer patients and NTRK-positive cancer patients in Greater China. After treatment with existing therapies, most patients eventually acquire resistance for which there are significant unmet medical needs globally.
AnHeart has observed a 100% overall response rate (ORR) by investigator review from 11 ROS1-positive NSCLC patients who were not previously treated with a tyrosine kinase inhibitor (TKI) utilizing a January 15, 2021 data cut-off from the Phase 2 portion of the ongoing taletrectinib TRUST trial. Taletrectinib was also generally well-tolerated. These data demonstrate the potential for taletrectinib to be a best-in-class treatment. Data with more patient from first line (ROS1 TKI naive) and second line (ROS1 TKI pretreated) will be published during the 2021 ASCO.
More information about the ongoing TRUST study of taletrectinib may be found by searching clinical trial identifier NCT04395677 at https://clinicaltrials.gov.
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 and other major diseases. 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. Leveraging the platform, the company has built a robust pipeline of 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 4 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection) – officially approved for marketing in China, sintilimab's Biologics License Application (BLA) acceptance in the U.S. , 6 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor included in the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor included in the NRDL in that year.
Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global 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 many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
AnHeart Therapeutics Co., Ltd. ("AnHeart") is a clinical stage biopharmaceutical company developing novel oncology therapies. AnHeart is headquartered in Hangzhou, China with offices in Beijing, Shanghai and has a subsidiary AnHeart Therapeutics Inc. in New York. Led by a management team with a successful track record of clinical development, AnHeart is developing three clinical stage oncology programs globally. For more information, please visit: https://anhearttherapeutics.com/.
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AnHeart Therapeutics, Co., Ltd Forward-Looking Statements
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