Week In Review: $1.5 Billion Total In Week's China Deals

Covid-19 Pandemic

  • Junshi Bio (HK: 1877) of Shanghai and Lilly (LLY) released positive interim data on their paired antibody treatment for COVID-19 (see story). In early results from a Phase II trial, the combination reduced viral load, symptoms, and COVID-related hospitalization and ER visits. Detailed data will be released later in a journal article. Lilly plans to file for Emergency Use Authorization of the combination therapy for patients with mild-to-moderate COVID-19 in November 2020, followed by a BLA filing as early as Q2 2021.
  • Fosun Pharma (HK: 02196) was granted US FDA approval to begin clinical tests of an investigational COVID-19 antibody treatment, HLX70 (see story). The trial will be conducted by Hengenix Biotech, the California arm of Fosun's biologics subsidiary, Henlius (HK: 2696). Hengenix co-developed the molecule with Sanyou Biopharma, a CRO, and Shanghai ZJ Bio-Tech. It is aimed at treating the acute respiratory distress syndrome and multiple organ failure that is associated with COVID-19.  

Trials and Approvals 

  • Harbour BioMed, a China-US biopharma, has begun a China Phase II trial of HL161 (batoclimab) to treat two autoimmune diseases: myasthenia gravis and adult immune thrombocytopenia (ITP) (see story). HL161 is a novel mAb that inhibits FcRn to increase the half-life of immunoglobulin G antibodies. In 2017, Harbour in-licensed China rights to the candidate from HanAll Biopharma of Korea in a two-drug deal worth up to $81 million.  
  • Zai Lab (ZLAB) of Shanghai has dosed the first patient in a China Phase III trial of retifanlimab, an anti-PD-1 antibody, as a first line treatment for metastatic non-small-cell-lung cancer (NSCLC) (see story). In 2019, Zai in-licensed China rights to the candidate from Incyte in a $77.5 million agreement. Zai will be in charge of the China arm of Incyte's global Phase III trial of retifanlimab, which will be administered in combination with platinum-based chemotherapy.
  • Shanghai's CARsgen Therapeutics was granted orphan drug designation in the US for its anti-claudin18.2 autologous CAR-T candidate in patients with gastric and gastroesophageal junction adenocarcinoma (see story). Previously, CARsgen was awarded orphan drug status in China. CT041 is the first claudin18.2-targeted CAR T-cell approved to start trials in the US and the first in China, as well. A Phase Ib trial of the candidate is underway for patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma.
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