Week In Review: VistaGen Out-Licenses China/Asia Rights For Novel Anxiety Drug To EverInsight In $177 Million Deal

COVID-19 Pandemic

  • Another China-discovered COVID-19 vaccine has started Phase II trials. The latest candidate, based on an inactivated virus, was discovered by Beijing's Institute of Medical Biology at Chinese Academy of Medical Sciences (IMBCAMS) (see story). In May, the institute started a China Phase I trial that plans to enroll 942 healthy volunteers to assess efficacy and safety. So far, the ongoing trial has administered the candidate to 200 individuals. 
  • The Taiwan Food and Drug Administration (TFDA) granted conditional approval for the use of remdesivir in patients with severe COVID-19 disease (see story). The maker of the drug, Gilead Sciences (GILD), will be required to implement a risk management plan that ensures the drug's safety as it is used. Last month, scientists reported remdesivir shortened the treatment times and reduced the chance of death in patients whose COVID-19 infections had reached the lower respiratory tract.

Trials and Approvals

  • Shanghai Henlius Biotech (HK: 2696) has been approved to launch its denosumab biosimilar (HLX14) in China as a treatment for postmenopausal osteoporosis (see story). Henlius, a subsidiary of Fosun Pharma (SHA: 600196; HK: 2196), is in charge of Fosun's biologic drug operations, including both novel drugs and biosimilars. The company staged a $410 million IPO on the Hong Kong Exchange last year and it scored its first China approval in 2019 for its first biosimilar, a Rituxan® (rituximab) equivalent.
  • Merck/MSD (MRK) reported China approval of Keytruda, its anti-PD-1 drug, as a second-line treatment for esophageal squamous cell carcinoma (ESCC) (see story). Merck noted that Keytruda is now approved in China for five indications in three different types of cancer, including first-line use in advanced non-small cell lung cancer and second-line treatment for advanced melanoma.
  • InxMed (Shanghai), a clinical stage biotech. reported early research data showing its focal adhesion kinase (FAK) small molecule inhibitor was effective in overcoming drug resistance (see story). InxMed's IN10018, a FAK inhibitor, was administered together with a KRAS G12C inhibitor. InxMed believes IN10018 has the potential to boost the KRAS inhibitor's effect and make other oncology therapies more effective, as well.
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