On March 1, 2023 Allist Pharmaceuticals and Abbisko Therapeutics jointly reported the signing of a license agreement (Press release, Allist Pharmaceuticals, MAR 1, 2023, https://www.allist.com.cn/newsd/101/2063.html [SID1234642123]). According to the agreement, Heyu Pharmaceutical has granted Ellis the regional research, development, and development of ABK3376, a new generation of small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in China (Mainland China, Hong Kong, Macau and Taiwan). An exclusive license to manufacture, use and sell, and Ellis has the right to choose to exercise overseas rights and interests when the exercise conditions are met, expanding the authorized area to a global scale.
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According to the terms of the agreement, the company will pay Heyu Pharmaceutical an upfront payment of up to US$187.9 million, development and sales milestone payments, and a corresponding proportion of net sales license royalties for this authorization.
The third-generation EGFR TKI has become a routine clinical drug and has gradually become the standard therapy for first-line treatment. Although targeted therapy has improved the treatment of patients with EGFR-driven non-small cell lung cancer, drug resistance is still inevitable. C797S is an extremely important factor in targeted therapy. Common targeted resistance mechanisms. Furthermore, studies have shown that up to 40% of disease progression in patients with EGFR-mutant NSCLC with baseline brain metastases involves central nervous system (CNS) metastases. At present, there is no effective new generation targeted therapy drug on the market for non-small cell lung cancer carrying EGFR-C797S resistance mutation.
The ABK3376 introduced this time is a new generation of EGFR oral small molecule inhibitor that is independently developed by Heyu Pharmaceutical and has independent intellectual property rights. It is highly selective and can enter the brain. It can effectively inhibit the C797S mutation that occurs after resistance to third-generation EGFR TKIs. Currently, In preclinical development stage.
Preclinical research results show that ABK3376 has powerful tumor cell inhibitory and killing activities, and has shown the ability to inhibit and shrink tumors in tumor-bearing experimental model animals. ABK3376 also shows high selectivity for wild-type EGFR (WT selectivity), suggesting that it has good safety. Not only that, ABK3376 has the property of efficiently penetrating the blood-brain barrier and can obtain effective drug exposure in the central nervous system, and will be used to treat or prevent central nervous system metastasis of non-small cell lung cancer.
Preclinical studies have also shown that ABK3376 has achieved positive results both as a single agent and in combination with fumetinib, the third-generation EGFR TKI already on the market. It is expected to become a precision treatment for patients with EGFR-C797S drug-resistant mutations. A new generation of targeted therapeutic drugs for small cell lung cancer.
Du Jinhao, Chairman of Ellis, said, "I am very pleased to reach this cooperation with Heyu Pharmaceutical. Ellis is deeply involved in the field of lung cancer, and its core product Aifusa ( foumetinib mesylate) has "strong brain-transforming and curative effect". The clinical advantages of "excellent, good safety and wide therapeutic window" have shown the best-in-class potential. Currently, both first-line and second-line indications for lung cancer have been included in the national medical insurance catalog, benefiting Chinese patients. ArriVent and ArriVent Reaching the exclusive overseas authorization of Fumetinib, Aifusha begins its globalization process. As an innovative pharmaceutical company, Ailes insists on independent research and development and gives full play to its advantages in scientific research and innovation, CMC, clinical, registration and commercialization. , actively cooperate with outstanding innovative drug companies at home and abroad to expand pipelines and provide solutions for treatment areas that have unmet clinical needs. The new generation of EGFR inhibitors introduced from Heyu Pharmaceutical are in line with the development strategy of Ellis and will further enrich it. Ellis’s product pipeline will strengthen its competitiveness in the field of lung cancer treatment. As an excellent R&D-driven biopharmaceutical company, several products have entered clinical trials and have achieved fruitful results. We are very much looking forward to working with Harmony Pharmaceuticals. development. I wish the cooperation a complete success and the products will be launched as soon as possible."
"Over the past seven years, Heyu Pharmaceutical has built a world-class R&D engine. This proprietary technology platform has successfully developed 15 drug candidate molecules, including 7 drugs that have entered clinical trials. It is great to see that Our independently developed drugs have been recognized by more and more domestic and foreign companies," said Xu Yaochang, Chairman of Heyu Medicine. "Heyu Medicine will continue to focus on the research and development of new small molecule drugs for tumor and non-tumor diseases, and deeply explore the unmet needs of patients. clinical needs and make every effort to benefit patients. Ellis is an innovative pharmaceutical company that is deeply involved in the oncology industry and integrates R&D, production and marketing. It has successful experience in the development and commercialization of new drugs. It is believed that this cooperation can accelerate the development of ABK3376. , providing the latest and best treatment options to the majority of patients."