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Written by Richard Daverman, PhD. Coherus Biosciences announced that it will set the US price for its in-licensed PD-1 drug, Loqtorzi, at a “modest” 20% discount to the industry leader, Merck’s Keytruda. In 2021, Coherus in- licensed the drug from China’s Junshi Biosciences. The two partners received FDA approval of the drug last month to treat advanced nasopharyngeal cancers (NPC). Loqtorzi is the first China-developed PD-1 approved in the US. Coherus made the US FDA approval seem almost easy, a stark contrast to the rejection of the Lilly-Innovent PD-1 candidate, Tyvyt, earlier this year. More details.....
Stock Symbol: (NSDQ: CHRS)
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Written by Richard Daverman, PhD. Shanghai GenFleet Therapeutics reported China’s CDE has accepted for review the company’s NDA for a KRAS G12C inhibitor. It was also granted Priority Review. GenFleet said GFH925 is its first NDA-stage product and China's first KRAS G12C inhibitor to start a NDA review. Based on Phase II results, GFH925 (IBI351) is seeking China approval as a second-line treatment for advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. One year ago, GenFleet out-licensed greater China rights for GFH925 to Suzhou’s Innovent in a $312 million agreement that could expand to global rights for the candidate. More details...
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Written by Richard Daverman, PhD. Accutar Biotech, a New Jersey-Shanghai AI drug discovery company, formed a partnership with Palo Alto’s Evommune, to discover novel small molecule drug candidates for immune-mediated inflammatory diseases. The partnership will combine Accutar’s proprietary AI platform with Evommune’s expertise in designing novel oral small molecule treatments for targets that are the root cause of chronic inflammatory diseases. Accutar starts its drug discovery using its AI computational drug design capability followed by wet lab validation to shorten drug discovery timelines. Previously, Accutar corroborated with Evommune on an autoimmune candidate that targets PKCθ. Terms of the agreement were not disclosed. More details....
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Written by Richard Daverman, PhD. Shanghai Everest Medicines was approved for a China launch of Nefecon® to treat primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. A rare disease, IgAN is especially prevalent in China. Patients with the disease are at risk of progressing to end-stage renal disease. Nefecon is a targeted-release formulation of budesonide, a second-generation synthetic corticosteroid. In 2019, Everest acquired greater China rights to the drug from Calliditas Therapeutics of Sweden in a $121 million agreement. Nefecon is already approved in the US and EU. More details....
Stock Symbol: (HK: 1952)
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Written by Richard Daverman, PhD. South Korea’s DxVx plans to in-license China and South Korea rights for a novel anti-cancer vaccine from Oxford Vacmedix (OVM), a spin-out from Oxford University. OVM-200 targets survivin, an apoptosis inhibitor that regulates cell division. The candidate uses OVM’s Recombinant Overlapping Peptide (ROP) technology to enhance immunity and vaccine efficacy. In Phase Ia tests, OVM-200 was safe and induced an immune response. DxVx, which owns 45% of OVM, plans to conduct Ib trials in China and South Korea that will be concurrent with OVM’s Ib trial. OVM and DxVx said negotiations on the in-licensing are at an advanced stage. More details....
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Written by Richard Daverman, PhD.
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