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Week in Review: BeiGene's BTK Inhibitor Approved in US and China Approval for PD-1 Expected in Two Months

publication date: Nov 16, 2019
author/source: Richard Daverman, PhD

BeiGene (NSDQ: BGNE; HK: 06160), a Beijing oncology biopharma, announced US approval of its Bruton’s tyrosine kinase candidate, Brukinsa™ (zanubrutinib), as a second-line treatment for adult patients with mantle cell lymphoma (see story). Brukinsa is the first BeiGene-discovered product to be approved. The approval was based on the candidate's overall response rate of 84% and complete response of 59%. BeiGene may be asked to conduct a confirmatory trial of Brukinsa. The company expects its second approval before the end of the year for China use of its PD-1 candidate.

BeiGene's (NSDQ: BGNE; HK: 06160) PD-1 candidate tislelizumab was recommended for approval by China’s Center for Drug Evaluation as a treatment for classical Hodgkin’s lymphoma (see story). The PD-1 candidate is the first BeiGene drug to advance this far and would be the sixth PD-1/PD-L1 to be launched in China. The CDE performed a technical review with a recommendation to approve the immunotherapy and sent tislelizumab to China's National Medical Products Administration for final approval, which BeiGene, a Beijing biopharma, expects before the end of 2019.

Hutchison China MediTech (Chi-Med) (AIM/NSDQ: HCM) said its NDA for surufatinib was accepted for review by China's NMPA as a treatment for advanced non-pancreatic neuroendocrine tumors (see story). If approved, surufatinib would become Chi-Med's second commercialized drug, following fruquintinib one year ago. A novel oral kinase inhibitor, surufatinib works by promoting tumor angiogenesis and limiting immune evasion. In a Phase III trial, which was stopped early because surufatinib met its endpoints, surufatinib increased median progression free survival from 3.8 months in the placebo group to 9.2 months in the active cohort.

Hua Medicine (HK: 2552) of Shanghai reported positive 24-week top-line results from a Phase III trial of its novel oral type 2 diabetes candidate (see story). Dorzagliatin is a first-in-class dual-acting glucokinase (GK) activator that is designed to restore glucose homeostasis in adults with type 2 diabetes. The candidate met its primary efficacy endpoint by producing a statistically significant reduction of 1.07% in HbA1c levels during the first 24 weeks of the trial. According to Hua, it is the first China biotech to achieve its primary efficacy endpoint in a global first-in-class type 2 candidate.

TenNor Therapeutics of Suzhou announced positive top-line results for its anti-bacterial treatment from a US Phase II trial conducted in patients with acute bacterial skin and skin structure infection (see story). After 48-72 hours, TNP-2092 produced a response rate of 76.3% compared to 67.5% for vancomycin. TNP-2092 is a first-in-class drug conjugate that inhibits three drug targets: RNA polymerase, DNAgyrase and topoisomerase IV. TenNor is developing the candidate as a treatment for bacterial biofilm infections associated with implanted medical devices.

Akeso Biopharma of Zhongshan presented results from an Australian Phase I trial of a novel immunotherapy, AK104, a tetrameric bispecific antibody targeting both PD-1 and CTLA-4 (see story). The trial enrolled patients with advanced solid tumors. In 25 patients, AK104 produced an overall response rate of 24% and an acceptable safety profile. The company has expanded Phase Ib/II trials of AK104 to include China and the US. Last week, Akeso announced a $150 million Series D funding to advance its portfolio of 18 mAbs.

Everest Medicines, a New York biopharma that develops novel drugs for Greater China and Asia, dosed the first patient in a China Phase III trial of etrasimod, a novel treatment for ulcerative colitis (see story). In 2017, Everest in-licensed greater China rights to etrasimod from Arena Pharma (NSDQ: ARNA) of San Diego in a $224 million two-drug agreement. Everest was backed with $50 million in initial financing led by China's C-Bridge Capital and set up as a C-Bridge incubator platform for bringing novel drugs to China.

Aslan Pharma (NSDQ: ASLN, TPEx: 6497) of Singapore announced that its lead drug, varlitinib, did not meet its endpoints in a Phase III trial that enrolled patients with biliary tract cancer (BTC) (see story). Varlitinib, a small molecule pan-HER inhibitor, did not provide a significant improvement in progression free survival. The global trial enrolled 127 patients with biliary tract cancer who had failed first-line therapy. Aslan is analyzing a sub-group of the patients in which varlitinib did seem to provide a meaningful PFS improvement.

Deals and Financings

Jiangsu Hengrui Medicine (SHA: 600276) entered a $165 million agreement to in-license China rights for two dry eye treatments from Germany's Novaliq (see story). Hengrui, which will pay $9 million upfront and up to $156 million in milestones, will develop, manufacture and commercialize the innovative, water-free drugs NOV03 and CyclASol® for greater China. Both drugs are in late stage US clinical trials. Novaliq says they have shown superior efficacy, with an early onset of action, excellent tolerability and better benefit-risk profiles than existing dry eye treatments.

Shanghai Anovent Pharma closed a new funding led by Sequoia China to support its portfolio of next-gen, high-quality, efficient, safe and affordable inhalation medicines that include generic and innovative pharmaceuticals (see story). The amount of the financing was not disclosed. The company has applied for several patents to protect its soft mist inhalation technology, which has been recognized for its innovation. Founded in 2014, Anovent plans to offer inhalation products that will serve markets with $20 billion of annual revenues globally.

Denmark's Leo Pharma will exercise an option to develop and market a novel class of oral dermatology drugs discovered by HitGen of Chengdu (see story). The compounds were identified by scanning HitGen’s DNA encoded libraries (DELs) to discover several novel small molecule leads for an undisclosed target specified by Leo Pharma. HitGen will be eligible for preclinical and clinical milestone payments from Leo in addition to an option exercise fee. The discovery operations were part of an ongoing collaboration between the two companies that began in 2015.

Industry Insights

In China, 67% of biotech companies focus on oncology, and most of them are developing a PD-1/PD-L1 candidate (see story). There are 45 companies working on PD-1/PD-L1 antibodies with more than 100 clinical trials underway as of March this year, according to Frank Jiang, CEO of CStone Pharma (HK: 2616). Dr. Jiang spoke as a panelist at the Chinatrials 12 Summit held in Shanghai recently. In the panel discussion, written up in BioWorld, participants were asked how China biotech companies with PD-1/PD-L1 candidates could differentiate their products with so many PD-1/PD-L1 candidates in development.

Disclosure: none.



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