Abnova & Nippon Kayaku Signed Exclusive ACTN4 Supply and Commercialization Agreement for Lung Cancer IVD Market in Japan

Neihu, Taiwan (January 28, 2019)

Abnova announced today signing of an exclusive ACTN4 supply and commercialization agreement with Nippon Kayaku Co. for the lung cancer market in Japan. Abnova is developing ACTN4 FISH (Fluorescence In Situ Hybridization) probe as predictive biomarker for Tegafur/Uracil, also called UFT (Uracil and 5-FU) adjuvant therapy for stage 1 non-small cell lung adenocarcinoma (NSCLC). Currently three hospitals, Nippon Medical School Hospital, National Cancer Center, and Tokyo Medical University Hospital, are contributing lung specimens for the ACTN4 clinical trial performed by GeneticLab Co. Japan CRO. Once cleared for Stage 1 non-small cell lung adenocarcinoma, Abnova plans to run a follow-on ACTN4 trials for Stage 2 and 3 lung adenocarcinoma patients as an risk index to assess lung cancer recurrence/relapse. This insight will be highly informative for physicians whose patients have failed traditional chemotherapy but could be potential candidates for the new PD1/PD-L1 immunotherapy.

As a regulatory requirement for completing the clinical trial and before commercialization, Abnova has entered into an exclusive partnership with Nippon Kayaku as the official designated marketing authorization (dMAH) holder for the Japan market. Under this arrangement, Abnova is responsible for ACTN4 FISH probe GMP production in Taiwan and Nippon Kayaku is responsible for packaging, labeling, and product marketing under PMDA guidance, sales, distribution, and product monitoring in Japan. Abnova will also be subjected to regular audits of its facility and ACNT4 manufacturing process by the PMDA or its third party assignee. Nippon Kayaku is a publicly traded company in Japan specializing in functional chemicals, pharmaceuticals, safety systems and agrochemicals.

ACTN4 will be a monumental predictive biomarker for the traditional chemotherapies such as uracil and 5-FU, because such biomarker has been very difficult to come by and develop in the clinical setting. Moreover, under Japan’s national health coverage, low dose spiral CT scan for lung cancer screening has identified more lung adenocarcinoma with smaller size at an earlier stage. This is an market opportunity for ACTN4. Beyond Japan, Abnova aims to out-license its technology to diagnostic companies in China, US, Europe, and other Asian Pacific countries to further expand its markets. Abnova has also gained ACTN4 intellectual property (IP) patent issuance and coverage in the major countries. This out-licensing process will gain additional momentum by the approval of ACTN4 IVD in Japan.