Currently Three Drugs in the Pipeline

DB102: anti-tumor drug Enzastaurin

Lilly conducted many clinical studies with Enzastaurin in a variety of tumor indications, including Phase III clinical trials in diffuse large B cell lymphoma(DLBCL) and glioma(GBM), and has received orphan drug certification in US and Europe. Denovo acquired global rights of Enzastaurin from Lilly, including development, production and commercialization. Denovo has completed the identification of the biomarker, which is significantly correlated with the expected therapeutic effects on DLBCL and GBM patients, and has filed international patent applications.Denovo initiated a pivotal phase 3 global DLBCL clinical trial in 2017 with data readout in mid 2021 following which the drug-biomarker combination will be licensed to a global commercial partner.

DB103: psychiatric drug Pomaglumetad

Currently the drugs used in the clinical treatment of psychosis mainly work on dopamine (DA) D2 receptor in central nervous system. DB103 selectively acts on the glutamic acid mGlu2/3 receptor and has no cross-reaction with other receptors in the central nervous system, and hence can avoid some usual side effects of psychiatric drugs on the market. Lilly completed 37 clinical trials with more than 3,800 subjects. DB103 showed significant efficacy in Phase II clinical trial (p<0.05), but failed to achieve the desired effect in the Phase III clinical trial. March 2015, Denovo licensed DB103 development rights from Lilly. After Phase II clinical trial by Denovo, Lilly has priority repurchase right. Financial terms have been defined in the agreement. If Lilly repurchase DB103, Denovo will receive a success fee, back milestone and sales royalties. Denovo is currently conducting biomarker discovery, progress to date is encouraging. Phase 2 clinical study to initiate in 2018 with possible exit by 2020

DB104: psychiatric drug Liafensine

DB104 (Liafensine) Potential first-in-class drug targeting Treatment Resistant Depression (TRD). AMRI was the first developer of Liafensine. AMRI licensed the drug to Bristol-Myers Squibb (BMS). In a number of phase 2 clinical trials conducted by BMS in the treatment of TRD, Liafensine showed high tolerance in TRD patients. Denovo acquired the global right of Liafensine in April 2017, including global R & D, production and marketing. Liafensine is the third potential First-in-Class drug in Denovo’s pipeline. Technical transfer ongoing and biomarker discovery has been initiated. DB104 has COM IP till 2027 with potential extended biomarker-drug IP protection.