Ensatinib hydrochloride approved for marketing

On November 19, 2022 Betta Pharmaceutical Co., Ltd. reported that the company received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration (NMPA) (Press release, Betta Pharmaceuticals, NOV 19, 2021, View Source [SID1234610680]). Ensatinib Hydrochloride Capsules (trade name: Bemena ) was officially approved for marketing , becoming the first domestic class 1 new drug for the treatment of ALK-mutated advanced non-small cell lung cancer in China.

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Lung cancer is the malignant tumor with the highest mortality and morbidity in China, of which non-small cell lung cancer (NSCLC) accounts for about 80%-85% of lung cancers. Anaplastic lymphoma kinase (ALK) is one of the important oncogenic drivers of NSCLC, and ALK mutations are found in 5%-7% of NSCLC patients . Because this mutation is more common in young, non-smoking or light-smoking lung adenocarcinoma patients, it is easier to achieve 5-year survival after using targeted drugs than other gene mutations. ALK fusion mutation is also known as "diamond mutation".

△Mechanism of action of Ensatinib

Ensatinib hydrochloride is a new-generation, potent and highly selective new-generation ALK inhibitor. It is a brand-new innovative drug with completely independent intellectual property rights jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery. In December 2018 , the drug registration application of ensatinib for patients with ALK -positive locally advanced or metastatic non-small cell lung cancer who had progressed after receiving crizotinib treatment or who were intolerant to crizotinib received national approval. Accepted by the Food and Drug Administration. In February 2019 , ensatinib was included in the priority review list by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration. Since then, the clinical verification and registration on-site inspection organized by the Center for Food and Drug Inspection and Inspection ( CFDI ) of the State Food and Drug Administration have been completed successively .

The domestic phase II registration clinical study of ensatinib hydrochloride was led by Professor Zhang Zhang from Sun Yat-sen University Cancer Center, and a total of 27 domestic medical centers participated. The results of the study were published in full in the internationally renowned medical academic journal "The Lancet Respiratory Medicine" in October 2019 . Subsequent updated data showed that the overall ORR of crizotinib-resistant patients treated with ensatinib was 52.6% , the disease control rate was 87.8% , the median PFS was 11.2 months, the intracranial ORR was 71.4% , and the intracranial disease was 71.4%. The control rate was 95.2% . Studies have shown that ensatinib has more advantages compared with similar imported drugs in efficacy, especially in patients with intracranial metastasis, it has a higher response rate and has a good and controllable safety.

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△The full text of the ensatinib clinical study was published in The Lancet Respiratory Medicine

International oncology authoritative expert – Professor Ross Camidge from the University of Colorado in the United States commented in the editor’s note of The Lancet Respiratory Medicine that ensatinib is effective and safe, and is the second-line treatment for patients with ALK-mutated advanced non-small cell lung cancer The new option , and as the first-line treatment research progresses, may become the first-line treatment drug. Professor Zhang Li said when ensatinib was awarded the "Top Ten Original Researches in China’s Oncology Field in 2019" for its registered clinical study : " Ensatinib has outstanding efficacy and safety, and it can be said to be the ‘J-20’ in China’s ALK field . We hope to continue to work with Betta to create more new drugs to better meet the needs of patients and contribute to China’s pharmaceutical innovation. "

As the second targeted new drug approved by Betta Pharmaceuticals after icotinib, ensatinib, like icotinib , fills the domestic blank of similar drugs. Promoting international multi-center head-to-head, first-line Phase III clinical research ( eXalt3 ) overseas. In August 2020 , Dr. Leora Horn of Vanderbilt University in the United States released the interim analysis results of the eXalt3 study to the world at the World Conference on Lung Cancer ( WCLC ) Bureau Symposium . Results showed that patients with ALK -positive non-small cell lung cancer ( NSCLC ) treated with ensatinib had significantly longer median progression-free survival ( mPFS ) than patients treated with crizotinib.

Professor Mao Li, Senior Vice President and Chief Medical Officer of Betta Pharmaceuticals and CEO of Xcovery in the United States, said: "I am very pleased to see ensatinib emerge as a dark horse in the field of ALK-TKI . The R&D process is the first step for Betta Pharmaceuticals to "base itself in China and go global". The company is also actively preparing for the listing application for first-line indications in China and the United States. It is believed that after successful listing in the future, it will launch a full-scale attack in the whole process of ALK-positive NSCLC patients. In the management, the patient’s life is fully protected."

Dr. Ding Lieming, Chairman and Chief Executive Officer of Betta Pharmaceuticals, said: " I am delighted that ensatinib has been approved for marketing, providing patients with a new treatment option. Ensatinib is confident that it will be the second icotinib, continued The next story of icotinib , and it is expected to become the first targeted new drug for lung cancer to be simultaneously marketed globally by a Chinese company, benefiting not only Chinese patients, but also patients in other countries in the world. Betta will focus on ‘ becoming a The vision of a multinational pharmaceutical company headquartered in China is to strive to develop more affordable Best-in-class and First-in-class new drugs and good drugs, so that people can live a better life. "