Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy.
Cutia Therapeutics Ltd. raised HK$465 million (US$65 million) in a Hong Kong IPO on June 12, with almost half of the proceeds going toward furthering its lead product to treat adipose accumulation. Cutia’s shares moved a little higher on the first day of trading, opening at HK$21.80, rising 0.46% and closing at HK$21.95.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint.
When it comes to CAR T therapies, South Korea is trailing behind the U.S. and China, but the South Korean government sees cell and gene therapies as a space where the country can draw international investors, speakers said during the Bio Korea 2023 conference in Seoul on May 10.
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
Korean biopharmas in the antibody-drug conjugate (ADC) space can leverage the strength of the Korean ecosystem when partnering with global pharma companies, said investors during the BIO Korea 2023 conference in Seoul on May 12.
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