SHANG HAI, March 2, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) today announced that it has entered into an exclusive Out-License Agreement (the "Agreement" hereafter) with Shanghai Allist Pharmaceuticals Co., Ltd., ("Allist" hereafter) for the further development, manufacture, use, and sales of (EGFR-TKI) ABK3376 in China (Mainland China, Hong Kong, Macau, and Taiwan). Abbisko Therapeutics also grants Allist a time-limited option to expand the licensed Territory worldwide in accordance with the terms and conditions agreed upon by both parties.

Under the terms of the Agreement, Abbisko Therapeutics will receive an upfront payment, potential development and commercial milestones for US$ 187.9 million, and tiered royalty payments.

The licensed small-molecule antagonist of EGFR ABK3376 is a pre-clinical candidate developed by Abbisko Therapeutics' proprietary drug discovery platform, which is a novel, highly potent, selective, and brain-penetrating (Epidermal growth factor receptor, EGFR) new-generation EGFR inhibitor. It can inhibit L858R activating mutation or exon 19 deletion mutation with acquired C797S mutation, which is at pre-clinical development stage.

The third-generation EGFR-TKI has become a routine clinical drug and has gradually become the first-line standard therapy. 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 common target resistance mechanism in targeted therapy. In addition, the research has shown that in patients with EGFR-mutant NSCLC with baseline brain metastases, up to 40% of disease progression involves central nervous system (CNS) metastases. At present, there is no new generation of targeted therapy drugs that are effective for non-small cell lung cancer carrying EGFR-C797S drug-resistant mutations in the world.

Preclinical research results show that ABK3376 has strong tumor cell inhibitory and killing activity, and has shown the ability to inhibit and shrink tumors in tumor-bearing experimental model animals. ABK3376 also showed higher selectivity to wild-type EGFR (WT selectivity) and will have better safety. Not only ABK3376 has the property of efficiently penetrating the blood-brain barrier, can obtain effective drug exposure in the central nervous system, and will be used for the treatment or prevention of central nervous system metastasis of non-small cell lung cancer.

The preclinical studies of ABK3376 have shown positive results whether used as a single drug or in combination with Allist's third-generation EGFR inhibitor Furmonertinib, which is expected to become a new generation of targeted therapy drug for precise treatment of non-small cell lung cancer with EGFR-C797S drug resistance mutation.

"During the past seven years, Abbisko Therapeutics has established a world-class discovery engine with a proprietary platform that has delivered 15 drug candidates including 7 already in clinical trials. It is great to see that our strength in drug development is recognized by more and more domestic and foreign companies," said Dr. Yao-Chang Xu, Chairman of Abbisko Therapeutics. "Abbisko Therapeutics will continue to devote itself to discovering and developing innovative medicines to treat unmet medical needs in China and around the world, and try its best to benefit patients." Allist Pharmaceuticals is an innovative pharmaceutical company with R&D focusing on oncology, manufacturing, and commercialization. It has great and successful experience in the development and commercialization of new drug. We believe that this collaboration will enhance the development of ABK3376 and to provide a novel and better treatment for the patients."

Mr. Jinhao, Du, the chairman of Allist said, "I'm very glad that Allist and Abbisko Therapeutics have reached this cooperation. Furmonertinib has the best-in-class potential in 3rd generation of EGFR TKI due to its strong brain penetration, better efficacy, and considerably well safety. Currently, Furmonertinib is granted as the 1st line and 2nd line treatment for NSCLC with EGFR mutations in the National Drug Reimbursement List (NRDL) in China. Our collaboration with ArriVent in Furmonertinib also provides a door way for the asset to go internationally. As an innovative pharmaceutical company, Allist always insists in self-developing and advancing our innovations, CMC, clinical development and registration, and commercialization. We are active in the collaborations with domestic and international companies to expand our pipeline and to meet the medical unmet. The new generation of EGFR inhibitor licensed from Abbisko Therapeutics will further enhance Allist's competitiveness in the EGFR inhibitor field. This collaboration will provide more treatment options for the unmet clinical needs in the market. Abbisko is an outstanding innovative-driven pharmaceutical company with multiple clinical assets and experience. We look forward to more collaboration possibilities between Allist and Abbisko Therapeutics in future."

About Furmonertinib

Furmonertinib is a self-developed 3^rd generation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with an independent intellectual property right in China. Furmonertinib is approved and commercialized for the treatment of adult patients of locally advanced or metastatic non-small cell lung cancer (NSCLC) who experience progression during or following prior therapy with a EGFR TKI therapy with confirmed EGFR T790M positive mutations. Besides that, Furmonertinib is again approved by the National Medical Products Administration (NMPA) of China for the use in the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations on June 29^th, 2022. Both 1^st line and 2^nd line of treatments are now included in the National Reimbursement Drug List (NRDL) for the benefits of patients in China.

Currently, Allist is still in registered clinical development of the adjuvant treatment for NSCLC in EGFR mutations, that of the treatment in NSCLC with EGFR exon20 insertion and uncommon EGFR mutations.

About Abbisko Therapeutics

Abbisko Therapeutics (StockCode: 02256) is an oncology-focused biopharmaceutical company founded in Shanghai, dedicated to discovering and developing innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich R&D and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of 15 innovative small molecule programs focused on precision oncology and immuno-oncology, and received 17 IND or clinical trial approvals in multiple countries and regions.

Please visit www.abbisko.com for more information.

About Allist

Shanghai Allist Pharmaceuticals Co., Ltd is co-founded by Mr. Du Jinhao, a renowned entrepreneur, and Dr. Guo Jianhui, tenured scientist of The United States National Institutes of Health (NIH) in. Headquartered in Zhangjiang Hi-Tech Park since its founding in March 2004, Allist has built itself into an innovative pharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines.

Under the development concept of "advancing long life with innovation of science and technology", it is oriented by the unmet clinical demands in the global pharmaceutical market, with special focus on tumor treatment. Allist seeks to develop first-in-class and best-in-class medicines with uncompromised devotion to produce safe, effective, and inclusive innovative drugs with independent intellectual property rights.

After the A and A+ rounds of financing in 2019, Allist was formally listed on the Sci-Tech Innovation Board (STAR) market via the Shanghai Stock Exchange on December 2, 2020 (Stock code: 688578).