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Biokin Pharmaceutical's Unit Gets Nod to Trial Leukemia Drug in US; Shares Up 6%
Polaris Tianheng (688506.SH): BL-M11D1 (CD33-ADC) has obtained FDA approval for the Phase I clinical trial application for the treatment of relapsed or refractory acute myeloid leukemia patients.
Gelonghui October 13th|Balitiane (688506.SH) announced that its wholly-owned subsidiary SystImmune, Inc. has received notification from the Food and Drug Administration (FDA) of the United States that the Phase I clinical trial application for BL-M11D1 (CD33-ADC) for the treatment of relapsed or refractory acute myeloid leukemia patients has been approved by the FDA, including the newly FDA-approved BL-M11D1. As of now, a total of 5 projects have been approved by the FDA to conduct clinical research, with the other 4 projects being
Bai Li Tian Heng (688506.SH): 2 indications of BL-B01D1 for EGFR sensitive mutations and EGFR wild-type non-small cell lung cancer patients are included in the list of breakthrough therapies for injection.
Glory 7th, 10th|Baili Tianheng (688506.SH) announced that the innovative biopharmaceutical BL-B01D1 independently developed by the company is used for locally advanced or metastatic non-squamous non-small cell lung cancer patients with EGFR-sensitive mutations who have failed EGFR-TKI treatment, and is also used for the treatment of locally advanced or metastatic EGFR wild-type non-small cell lung cancer patients who have failed previous anti-PD-1/PD-L1 monoclonal antibody treatment and platinum-containing chemotherapy. Two indications have been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration Drug Evaluation Center (referred to as the "Drug Evaluation Center").
US FDA Allows Trial of Sichuan Biokin Pharma-Bristol-Myers Squibb's Cancer Drug
Bailitianheng (688506.SH): The BL-B01D1 combination therapy project for advanced solid tumors has obtained FDA approval for phase 1/2a clinical trial application.
On September 29, Geelong Hui announced that its partner, Bristol-Myers Squibb (BMS), with the New York Stock Exchange code: BMY, has received a notification from the Food and Drug Administration (FDA) of the United States that the BL-B01D1 combination therapy project for the treatment of advanced solid tumors has obtained FDA approval for a phase 1/2a clinical trial application.
Sichuan Biokin Pharmaceutical Gets Clinical Trial Approval for Tumor Antibody Injection
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