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Indication Oncology
Status ‒ ODD for treatment of chronic myeloid leukemia on March 17th, 2022.
‒ NDA receipt on September 23th, 2022.
‒ ODD for treatment of acute lymphoblastic leukemia on November 3rd, 2022.
‒ CRL on April 27th, 2023. Handa will supplement deficiencies and submit to FDA ASAP.
Product Advantages Handa is utilizing its ONCORE™ technology to develop improved versions of Oncology drug for reducing the risk associated with sever side effect.。
Potential Market According to the data in 2021 annual report of the brand company, the total sales of the brand drug were US$2.117 billion (US$1.297 billion in the U.S. and US$820 million rest of world).