COVID-19 Pandemic

• Sorrento Therapeutics (SRNE), a San Diego-China biotech, reported that its anti-SARS-CoV-2 antibody, STI-1499, completely inhibited SARS-CoV-2 virus infection from interacting with the ACE2 receptor, after four days of incubation. In pre-clinical studies, the molecule was effective at a very low antibody concentration. Sorrento will include STI-1499 in a three-molecule "protective shield" against SARS-CoV-2 being developed with Mt. Sinai Hospital, and as a stand-alone product.

Deals and Financings

• Nanjing Legend Biotech will stage a $100 million US IPO on the NASDAQ exchange. In 2017, Legend announced its CAR-T therapy produced a 94% overall response rate in pre-treated multiple myeloma patients. Within six months, Janssen Pharma paid $350 million upfront for a 50-50 partnership of the CAR-T candidate. Since then, Janssen has paid $110 million in milestones, and it could make up to another $1.3 billion in remaining payments. 
• Nantong Lianya Pharma and its parent company, Novast Holdings, raised $140 million in private equity led by Legend Capital. Novast is a generic drug company specializing in hard-to-make products, especially extended-release formulations. It has developed more than 180 innovative and generic drugs for global markets. In the US, Novast has FDA permission to market 40 drugs, including more than 30 hormone, and nine extended-release products, many of them with a leading market share.
• Qujing Hengsheng Science and Technology of Beijing, a medical device maker, closed a $14 million Pre-A funding to develop novel cardiovascular and intracavitary imaging technologies. The company's S1 intravascular imaging system combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT). 
• Inmagene Biopharma of Shanghai acquired greater China rights to a bispecific molecule aimed at Interleukin-17A (IL-17) for multiple autoimmune diseases from Sweden's Affibody AB. ABY-035 is currently undergoing a German Phase II trial in patients with psoriasis, where it has shown clear clinical benefits, and a good safety profile. Inmagene will be responsible for commercialization in Greater China and South Korea along with development activities in Asia Pacific region, excluding Japan.
• Nanjing's Simcere Pharma acquired greater China rights to a novel product aimed at treating stroke from Canada's Primary Peptides. In 2014, Primary Peptides was spun out of the University of British Columbia to develop drugs based on preventing protein toxic cascades that kill brain cells due to trauma, stroke, or disease. It out-licensed its first product to Yabao Pharma of Beijing in a $40 million agreement.

Trials and Approvals

• Zai Lab (ZLAB) of Shanghai announced China's NMPA approved Optune, a therapy known as Tumor Treating Fields, to treat glioblastoma (GBM). Optune uses electric fields tuned to specific frequencies to disrupt cell division. In 2018, Zai paid $15 million upfront to in-license greater China rights to the Optune therapy from Novocure (NVCR) of Jersey.
• SciMount Pharmatech, a Chengdu subsidiary of Xiling Lab, has been approved to start US trials of SMP-100 as a treatment for Irritable Bowel Syndrome with diarrhea (IBS-D). Compared to current 5-HT3 IBS drugs, SMP-100 lowers the inhibition of 5-HT3, which is expected to improve the safety effect profile, while it matches the efficacy of available treatments.
• Ascletis Pharma of Hangzhou reported its IND for ASC41, a novel candidate for Non-alcoholic Steatohepatitis (NASH), was approved in China. ASC41 is one of three Ascletis candidates in development. The other two are ASC40, an oral fatty acid synthase (FASN) inhibitor, currently in China Phase II trials, and a pre-clinical molecule. Ascletis expects ASC41 will be administered alone or in combination with one of its other two candidates.
• Shanghai's I-Mab Biopharma dosed the first patient in a China Phase I/II trial of its CD73 antibody, TJD5, in patients with advanced solid tumors. TJD5 will be tested as a monotherapy, and in combination with Junshi Pharma's PD-1, Tuoyi. In the US, I-Mab has started tests of the CD73 candidate with a Roche PD-L1 antibody.
• Invivoscribe, a San Diego precision medicine company, has submitted its FLT3 mutation assay to China's NMPA as part of Astellas' NDA for Xospata (gilteritinib), a treatment for acute myeloid leukemia. Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic, supporting use of gilteritinib to treat adult patients with relapsed/refractory FLT3-mutated AML. The assay is approved in the US, the EU, Australia and Japan.