The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
The product will be manufactured at Lupin’s facility in Goa, India
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis
Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA
The product will be manufactured at Lupin’s facility in Goa, India
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