HOT-1010 (bevacizumab biosimilar) / Outlook Therap, Zhejiang Huahai Pharma, Shanghai Junshi Biosci - LARVOL DELTA

H0T-1010-03: A multicenter, randomized, double-blind, parallel-positive control of the efficacy and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection (HOT-1010) versus bevacizumab in combination with carboplatin/paclitaxel in the treatment of advanced, metastatic or recurrent non-squamous cell non-small cell lung cancer (ChiCTR) - P3 | N=512 | Completed | Sponsor: Shanghai Chest Hospital; Shanghai Chest?Hospital

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Huahai Pharmaceutical biosimilar wins EMA Approval (AMN Healthcare) - “SinoCast Zhejiang Huahai Pharmaceutical has been informed by the US partner Oncobiologics that the Avastin, single biosimilar jointly developed, gains minutes of meetings the EMA of the EU agrees on launch of Phase I clinical trials. In terms of an agreement, the two sides will launch follow-up research and development on the biosimilar.”

European regulatory • Biosimilar • Oncology

Oncobiologics raising $50M for Avastin, Humira biosimilars (MedCityNews) - "New Jersey cancer biosimilar developer Oncobiologics is aggressively pursuing cash: It raised $43 million earlier this year, and is looking for $50 million more, according to a regulatory filing. Oncobiologics...is in the midst of clinical trials to get its Avastin biosimilar approved. It’s readying itself for Phase 3 trials for its Avastin-like biologic. The patents on Avastin are set to expire in 2019...Oncobiologics has another mAb in the clinic – a biosimilar for Humira. This should enter Phase 3 trials next year."

Anticipated new P3 trial • Financing • Patent expiry • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

ONS-1045: Initiation of P3 trial in 2019 (Oncobiologics) - Q1 FY 2018 Results: Regulatory submission in US in 2021

BLA • New P3 trial • Biosimilar

Oncobiologics: Cantor Fitzgerald Healthcare Conference (Oncobiologics) - "Safety: Adverse events balanced across all three arms of the study"; "Immunogenicity: One subject had ADA detected in EU-Avastin arm at Day 98 (Last visit), No other ADAs detected, No neutralizing antibodies detected in any arm of the study"

P1 data • Biosimilar