Recent Articles in News & Analysis

South Korea’s Samsung Bioepis announced that its Soliris biosimilar, Epysqli, is approved in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Samsung acquired Epysqli as part of its $39 billion takeover of Alexion in 2020. In 2023, Soliris produced $3.15 billion in 2023 global revenues for AstraZeneca, which was 14% lower than the previous year because Soliris had gone off-patent in Europe. Samsung’s Epysqli is the lead biosimilar in Europe to replace Soliris, where it is also approved for the same two rare diseases, PNH and aHUS. More details....

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okyo’s Renalys Pharma raised $38.5 million in a Series A round to develop its lead drug, sparsentan, as a treatment for IbA nephropathy in Japan. The company plans to use the funds to complete a Japanese Phase III trial of sparsentan. The A round was led by Catalys Pacific and SR One. In January, Renalys acquired rights to sparsentan, a dual endothelin angiotensin receptor antagonist, from San Diego’s Travere Therapeutics in a $120 million deal with rights for Japan and other countries in Asia. Travere also received a minority stake in Renalys. More detail....

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San Diego’s Artiva Bio raised $167 million in a NASDAQ IPO to support clinical trials of its cell therapy portfolio. Artiva was spun out of South Korea’s GC Cell and has global rights (ex-Asia, Australia and New Zeeland) to GC Cell’s portfolio. The IPO was priced at $12 per share, lower than the expected $14-$16 range, but Artiva upped the number of shares in the IPO. Founded in 2019, Artiva develops natural killer (NK) cells that are developed from cord blood, making them allogeneic, unlike CAR-T therapies that are derived from a patient’s own cells. More details....

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Suzhou Innovent announced positive data from another Phase III clinical trial of mazdutide, its dual agonist for type 2 diabetes. This trial showed mazdutide met its endpoint of lowering glycated hemoglobin (HbA1c) at week 24 while also producing an average weight loss of 9.6% at week 48. Innovent has already filed for mazdutide approval in China as a weight loss drug based on an earlier trial. Mazdutide combines a glucagon-like peptide-1 receptor (GLP-1R) with a glucagon receptor (GCGR). Innovent acquired China rights to the candidate from its long-time US partner, Lilly. More details....

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Deals and Financings

• South Korea’s SK Biopharma in-licensed global rights to a radiopharmaceutical compound developed by Full-Life Technologies of Shanghai in a $571 million deal;
• Beijing Biocytogen will use its RenLite® platform to discover novel antibody therapeutics for SOTIO Biotech of Prague in a $325 agreement;
• Beijing’s Sino Biological, a biological research reagents/CRO company, completed a $48 million takeover of Vancouver’s SignalChem, a company that offers bioactive enzymes;
• AusperBio, a Hangzhou-San Francisco biotech, booked $37 million in a Series A financing for its novel oligonucleotide and targeted delivery technologies;
• Shanghai’s Rona Therapeutics, a nucleic acid drug R&D company, completed a $35 million Series A+ financing to advance its pipeline of RNA candidates;
• Shanghai's Elpiscience has filed for a Hong Kong IPO to develop drugs for tumor microenvironments that are aimed at improving the efficacy of immunotherapies;
• Legend Biotech, a Nanjing-New Jersey cell therapy company, was rumored to have received a takeover bid, though its parent, GenScript, claims not to know anything about the offer;

Trials and Approvals

• Shanghai’s Everest reported China's NMPA accepted the filing of a supplemental NDA for full approval of Nefecon®, a first-in-disease IgA nephropathy therapy;
• Fujirebio Diagnostics, a global medical diagnostics company, will have access to samples from Alzheimer’s patients in a Phase III trial of an AirBio therapy for AD.
  
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