Coronavirus Pandemic

• Junshi Biosciences out-licensed ex-China rights for a therapeutic antibody aimed at preventing and treating COVID-19 to Eli Lilly (LLY). The antibody research was developed jointly by Junshi and the Institute of Microbiology, Chinese Academy of Science. Lilly plans to file an IND and start trials in the US in Q2 of 2020.
• Sorrento Therapeutics (SRNE), a San Diego-Suzhou biopharma, formed a partnership with Mount Sinai Health System of New York City to develop a triple antibody product designed to provide a protective shield against SARS-COV-2 infection. The antibody is expected to provide up to two months of protection for people returning to work, or as a therapy for infected patients.
• Harbour BioMed, a Rotterdam, US, and China biotech, used its antibody discovery technology to help Dutch researchers identify a mAb that prevents SARS-CoV-2 virus from infecting cultured cells. HBM used its H2L2 transgenic mouse technology to generate the antibody, which has the potential to either treat or prevent the infection.
• Shanghai Fosun Pharma and BioNTech of Germany will start China trials of their partnered mRNA COVID-19 vaccine candidate as soon as China approves the trials. The news came as BioNTech and Pfizer (PFE) began US and EU trials of the vaccine. Fosun made a $50 million investment in BioNTech and agreed to pay up to $85 million in milestones to form a China development partnership for BNT162.
• Ansun Pharma, a San Diego anti-infectives company with ties to China, has added a COVID-19 US arm to its global Phase III trial of DAS181, which was testing the drug in patients with lower respiratory tract parainfluenza virus infection. Ansun said DAS181 was administered to a small number of COVID-19 patients in Wuhan with positive, albeit anecdotal, results.

Deals and Financings

• TargetRx, a Shenzhen company developing small molecules therapeutics for cancer, completed a $21.2 million Series A financing, led by CCB Principal Capital Management. Proceeds from the funding will be used for clinical studies of chronic myeloid leukemia, non-small cell lung cancer treatments, and other R&D.
• Immunophage, a Nanjing biotech, closed a $14 million Pre-A financing, led by Jinfang Hongrui Investment Management, to support its immune-regulating candidates for cancer, and autoimmune and neurodegenerative indications.

Trials and Approvals

• CANbridge Pharma of Beijing announced China's NMPA approved the launch of Nerlynx® (neratinib) as an extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer. In 2018, CANbridge in-licensed greater China rights to Nerlynx from Puma Pharma of the US in a $70 million agreement.
• Suzhou Innovent Bio announced its approved anti-PD-1 drug, Tyvyt® (sintilimab injection), and met its progression-free primary endpoint in a China Phase III trial in patients with non-small cell lung cancer. In January, Innovent released positive results from a similar NSCLC trial testing Tyvyt with ALIMTA® and platinum chemotherapy. The company's China NDA based on the earlier trial has been accepted for review.
• HighTide Therapeutics, a Shenzhen-Maryland biopharma, reported its lead drug, HTD1801, met its primary endpoint in a China Phase IIa trial in patients who have both non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM). The molecule was generally well-tolerated without any unexpected side effects.
• Shanghai's Zai Lab (ZLAB) received word that China's Center for Drug Evaluation will review its NDA for omadacycline, a novel tetracycline designed to overcome resistance, under priority rules. Zai in-licensed greater China rights to the antibiotic in 2017 from Boston-based Paratek (PRTK), which was approved for a US launch of omadacycline in 2019.
• Ascentage Pharma of Suzhou was granted Orphan Drug designation in the US for HQP1351, a third-gen BCR-ABL inhibitor aimed at treating drug-resistant chronic myeloid leukemia (CML). In July 2019, HQP1351 was cleared by the FDA to start a Phase Ib study in the US. It is currently being tested in a China pivotal Phase II trial, and Ascentage plans to submit a China NDA for HQP1351 this year.