March 1st, 2023, Shanghai Allist Pharmaceuticals Co., Ltd. (“Allist”) and Abbisko Therapeutics Co., Ltd. (“Abbisko”) together announced that they have signed and entered into an exclusive License Agreement (“Agreement”). According to this Agreement, Abbisko not only grants the exclusive rights of ABK3376 in its regional research, development, manufacturing, use, and commercialization in Greater China (including China, Hong Kong, Macau, and Taiwan) to Allist, but also allow a time-limited option for Allist to expand the territory global wise in accordance with the terms and conditions agreed upon by both parties.

According to the Agreement, Allist will pay not only the tiered royalty payments, but also the payments up to 187.9 million USD for the upfront, development, and commercial milestones.

The third generation of EGFR TKI is currently used commonly in clinical wise, and will gradually become the standard treatment for 1st line. Although the targeted therapy has improved the treatment for patients with EGFR-driven non-small cell lung cancer (NSCLC), the drug resistance remains inevitable. C797S is one of the most common mutations in drug resistance after the targeted therapy. Besides, according to numerous studies, patients with baseline in NSCLC with EGFR mutations and brain metastasis have more than 40% of disease progression in metastasis in central nervous system (CNS). Currently, there is no commercialized new generation of therapeutic drugs effective in NSCLC with EGFR-C797S resistant mutations worldwide.

ABK3376, the licensed asset with the independent intellectual property right, is developed solely by Abbisko; It is a new generation of highly selective and brain-penetrating EGFR TKI, which can effectively inhibit the C797S mutation after the drug resistance originated from the 3rd generation of EGFR TKI. It is currently in a preclinical stage.

Preclinical studies have shown that ABK3376 has strong inhibition and activities in tumor cells. In addition, PDX models have shown that ABK3376 has the ability to inhibit and shrink the tumors. It also has a higher WT selectivity, which implies its better safety. Besides the inhibition and selectivity, ABK3376 also has an effective brain-penetrating ability, indicating a greater exposure in CNS. ABK3376 has the potential to become the treatment for NSCLC with CNS metastasis.

The preclinical study of ABK3376 shows that positive results have been achieved both alone and in combination with Furmonertinib, a commercialized third-generation EGFR inhibitor. It is expected to become a new generation of targeted therapy for the precise treatment of NSCLC with EGFR-C797S resistant mutation.

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 unment. 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.”

“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 are 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 the 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.”

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).

About Furmonertinib

Furmonertinib is a self-developed 3rd 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 29th, 2022. Both 1st line and 2nd 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.