COVID-19 Pandemic

Sorrento Therapeutics (NSDQ: 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 (see story). In preclinical studies, the molecule was effective at a very low antibody concentration. The company discovered STI-1499 by screening its proprietary G-MAB™ fully human antibody library. 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 (see story). In 2017, Legend announced its CAR-T therapy produced a 94% overall response rate in pretreated 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. Janssen and Legend expect to file for US and EU approvals of JNJ-4528 in the second half of 2020.

Nantong Lianya Pharma and its parent company, Novast Holdings, raised $140 million in private equity led by Legend Capital (see story). 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. In 2012, Novast partnered with Lilly, building a Nantong manufacturing facility to supply products to China's market.

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 (see story). The company's S1 intravascular imaging system combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Qujing Hengsheng claims each of the two technologies already surpass the performance of foreign-made technologies, while combining the two via a single catheter allows doctors to choose the best modality, reducing risk in percutaneous coronary intervention (PCI) procedures.

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 (see story). 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 (see story). 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. Simcere will have rights to the candidate in mainland China, Hong Kong, Macau and Taiwan. Financial terms were not disclosed.

Trials and Approvals

Zai Lab (NSDQ: ZLAB) of Shanghai announced China's NMPA approved Optune, a therapy known as Tumor Treating Fields, to treat glioblastoma (GBM) (see story). Optune uses electric fields tuned to specific frequencies to disrupt cell division. The therapy is approved in combination with temozolomide to treat patients with newly diagnosed GBM, and as a monotherapy in patients with recurrent GBM. In 2018, Zai paid $15 million upfront to in-license greater China rights to the Optune therapy from Novocure (NSDQ: 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) (see story). SMP-100 is a selective serotonin receptor-3 (5-HT3) partial agonist. 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 (HK: 1672) of Hangzhou reported its IND for ASC41, a novel candidate for Non-alcoholic Steatohepatitis (NASH), was approved in China (see story). Developed in-house, ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist. It 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 (NSDQ: IMAB) dosed the first patient in a China Phase I/II trial of its CD73 antibody, TJD5, in patients with advanced solid tumors (see story). TJD5 will be tested as a monotherapy and in combination with Junshi Pharma's PD-1, Tuoyi®. The trial will enroll patients with advanced or metastatic cancer. In the US, I-Mab has started tests of the CD73 candidate with a Roche PD-L1 antibody. I-Mab expects TJD5 may address the low response rates of PD-1/PD-L1 therapies in solid tumors.

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 (see story). 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. Invivoscribe has also opened a Shanghai lab to provide laboratory testing services for clinical trials and pharmaceutical partners.

Disclosure: none.