Week In Review: BeiGene's BTK Inhibitor Approved In US And China Approval For PD-1 Expected In Two Months

Trials and Approvals

• Beijing's BeiGene had an outstanding week: its BTK drug, Brukinsa™, was approved for use in the US as a treatment for mantle cell lymphoma, and its PD-1 candidate is poised for China approval before the end of the year to treat classical Hodgkin’s lymphoma; 
• Hutchison China MediTech (Chi-Med) announced its NDA for surufatinib was accepted for review in China for advanced non-pancreatic neuroendocrine tumors; 
• Hua Medicine of Shanghai reported its novel oral type 2 diabetes candidate reduced HbA1c by 1.07% in a China Phase III trial at the 24-week review; 
• TenNor Therapeutics of Suzhou announced positive top-line results for its anti-bacterial treatment in a US Phase II trial for acute bacterial skin and skin structure infections; 
• Zhongshan's Akeso Biopharma said its PD-1/CTLA-4 immunotherapy produced a 24% overall response rate in a Phase I trial among patients with solid tumors; 
• Everest Medicines, a US biopharma that develops novel drugs for Greater China and Asia, started a China Phase III trial of its ulcerative colitis treatment; 
• Aslan Pharma of Singapore announced varlitinib did not meet its endpoints in a Phase III trial for patients with biliary tract cancer;

Deals and Financings

• Jiangsu Hengrui Medicine signed a $165 million agreement to in-license China rights for two dry eye treatments from Germany's Novaliq;
• Shanghai Anovent Pharma closed a new funding led by Sequoia China to support its portfolio of inhalation medicines; 
• Denmark's Leo Pharma will exercise an option to develop and market a novel class of oral dermatology drugs discovered by HitGen of Chengdu;

Industry Insights

• In China, 67% of biotech companies focus on oncology; 45 of these companies are working on PD-1/PD-L1 antibodies with more than 100 clinical trials underway; how do they all expect to develop markets?

Disclosure: None

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