TOT BIOPHARM INTERNA

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Tot Biopharm International Company Limited Announces Drug Registration Approval for Temozolomide Capsule Obtained from the National Medical Products Administration

05/31/2021 | 12:16am
TOT BIOPHARM International Company Limited announced that the Company's self-developed Temozolomide Capsule (TOZ309, with the proposed brand name (Tazian ®)") (the "Product") has been granted drug registration approval by the National Medical Products Administration ("NMPA"). The Product is deemed to be a generic drug that has passed the consistency of quality and efficacy evaluation and can be marketed in mainland China (i.e. excluding Hong Kong, Macau and Taiwan regions) for the treatment of: (1) newly diagnosed glioblastoma multiforme, initially combined with radiotherapy, and then as maintenance therapy; and (2) glioblastoma multiforme or anaplastic astrocytoma that recurs or progresses after conventional treatment. TOZ309 Tazian ® is the generic drug of Temozolomide Capsule "TEMODAR. Temozolomide is an alkylating agent of imidazotetrazine with anti-tumor activity, which can kill cancer cells by damaging their DNA. With improved efficacy and fewer side effects compared to conventional chemotherapy, Temozolomide Capsules are used as a first-line medication for both newly diagnosed and recurrent glioma. Only three Temozolomide Capsules products have been marketed in mainland China, including the original drug "TEMODAR® which was approved by the United States Food and Drug Administration (FDA) in 1999, and was approved by NMPA to enter the China's market in 2007. The sales of Temozolomide Capsules reached approximately RMB 1.8 billion in 2018 and is expected to grow to approximately RMB 2.5 billion by 2023 in mainland China's market, according to Frost & Sullivan.
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