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On September 9, Roche's two new drugs were approved clinically in China, namely CD3/CD20 dual anti-RO7082859 (diffuse large B-cell lymphoma) and C5 single-resistant RO7112689 (diffuse sleep hemoglobinuria patients).
CD3/CD20 dual resistance RO7082859 RO7082859 (glofitamab, CD20-TCB) is a new "2:1" dual resistance developed by Roche, containing 2 Combined with the FAB of cd20 and the Fab of 1 combination of CD3, this "2:1" CD20 TCB is 10-1000 times more active than the traditional "1:1" dual resistance.
the results of roche's phase I/Ib dose increase NP30179, presented at the ASH 2019 Conference, showed that the orR of the 0.6 mg to 16 mg dose range was 54% (n-15/28) and the CR was 46% (n-13/28) for patients treated with R/R B cell NHL.
ORR and CR were 66.7% (n=4/6) and 50.0% (n=11/22) respectively in patients with fig lymphoma, and ORR and CR in invasive NHL patients were 40.9% (n=9/22) and 50.0% (n=11/22), respectively.
the most common adverse events in all therapeutic doses were CRS, with a rate of 67.9% (n-19/28), most of which were grades 1-2.
addition to glofitamab, Roche has developed a CD3/CD20 dual anti-mosunetuzumab, which is currently in the clinical phase I of the world but has not yet been declared in China.
addition, the CD3/CD20 dual anti-REGEN1979 injection introduced by Reding Pharmaceuticals at a cost of US$190 million has also been approved clinically in China.
C5 monoantibodies RO7112689 hairy sleep hemoglobinuria (PNH) is a non-malignant cloning disease caused by pig-A mutations, which is mainly clinically manifested as chronic intracvascular hemolysis, hema production failure and repeated thrombosis.
the disease has been included in China's First List of Rare Diseases.
currently, FDA-approved PNH treatments include Alexion Inc.'s supplement C5 monoantigen Soliris (Ikuzhu monoantigen) and long-acting C5 monoantitor Ultomuis (ravulizumab), both of which will bring in more than $4 billion in revenue for Alexion in 2019.
RO7112689 (crovalimab) is a new type of recirculation antibody that can medium C5 over a longer period of time than conventional antibodies.
addition to SKY59 inhibits R885H mutants, while Ikuzhu monoantitors have a poor effect on patients with this mutation.
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