Week In Review: Three $300 Million Deals For China Biopharma

Trials and Approvals 

  • Shanghai Green Valley Pharma announced its global Phase III trial of an algae-derived treatment for Alzheimer's disease has begun enrolling patients (see story). The company intends to enroll 2046 patients with mild to moderate Alzheimer's in the US, China, and Europe. The trial is expected to finish in 2024, even though the longest endpoint is based on 76 weeks of treatment. The US approved the Phase III trial in April, but the COVID-19 pandemic delayed the start of the trial. Green Valley was approved to launch Oligomannate in China one year ago following trials there.  
  • LianBio, a Shanghai-Princeton biotech, has been approved to start a Phase III trial of infigratinib in China (see story). Infigratinib is a potential first-line treatment for locally advanced or metastatic unresectable cholangiocarcinoma (bile cancer) with FGFR2 gene fusions. It is one of two oncology candidates that LianBio in-licensed from BridgeBio three months ago in a $538 million agreement. Last week, LianBio raised $310 million in its first funding round to support China/Asia development of western drugs. 
  • Asieris Pharma has been approved to conduct a China Phase III trial of its MetAP2 inhibitor as a first-line treatment for non-muscle invasive bladder cancer (NMIBC) (see story). The candidate, APL-1202, is already being tested in a Phase III trial in combination with chemotherapy as a second-line therapy in NMIBC patients at risk for recurrence from chemotherapy alone.
  • Everest Medicines (HK:1952) has dosed the first patient in a registrational China Phase IIb trial of TrodelvyTM to treat metastatic triple-negative breast cancer (see story). Trodelvy (sacituzumab govitecan) is a first-in-class antibody-drug conjugate directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Last year, Everest in-licensed Greater China rights to Trodelvy from Immunomedics (IMMU) in an agreement worth up to $835 million. Immunomedics recently released US Phase III data showing significantly improved PFS and OS results for Trodelvy.  
  • Beijing's InnoCare Pharma (HK: 09969) was approved to start a US Phase II trial of orelabrutinib, a Bruton’s tyrosine kinase inhibitor, in patients with multiple sclerosis (see story). The trial will enroll 160 patients with relapsing-remitting MS in the US and several EU countries. Orelabrutinib is already being tested in the US and China as a treatment for B-cell lymphomas and autoimmune indications as a monotherapy or in combination regimens. InnoCare says it has shown efficacy with an ability to cross the blood-brain barrier.  
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