China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
Triastek Inc., of Nanjing, China, scored a potential $1.2 billion collaboration and platform technology license deal with Biontech SE to manufacture oral RNA therapeutics with 3D printing technology.
The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
Three Chinese biopharmaceuticals have filed for IPOs on the Hong Kong exchange in July alone, highlighting a potential “newfound positivity” to strengthen the HKEX IPO market in the second half of 2024.
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
Sotio Biotech AS and Biocytogen Pharmaceuticals Co. Ltd. are partnering to discover antibody-drug conjugates (ADCs) via an option and license agreement worth up to $325.5 million plus sales royalties. The deal grants Sotio of Prague, Czech Republic, the option to license multiple fully human bispecific antibodies generated with Biocytogen’s Renlite platform, which Sotio will use to develop next-generation ADCs targeting solid tumors.
As the “most concrete achievement” since its entry into the radiopharmaceutical therapy space last year, SK Biopharmaceuticals Co. Ltd. picked up rights to Full-Life Technologies Ltd.’s RPT asset, FL-091, in a deal fetching up to $571.5 million.
The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies.
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