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Mar 19,2024
Medicilon assists Biotime obtain approval for its first dual-filing innovative drug in China and the United States
Shanghai Medicilon Inc. (Medicilon) provides one-stop preclinical R&D services from target to IND application for the research and development of BIOT-001, and fully empowers BIOT-001 tablets to obtain the approval in China and United States.
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Medicilon assists Biotime obtain approval for its first dual-filing innovative drug in China and the United States
Mar 11,2024
Medicilon assists Shanghai Institute of Biological Products' innovative ADC drug obtain clinical approval
On February 19, SIBP-A17, the second class I innovative antibody drug conjugate (ADC) independently developed by China National Pharmaceutical Group's Shanghai Institute of Biological Products, received a clinical trial approval notice from the National Medical Products Administration (NMPA).
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Medicilon assists Shanghai Institute of Biological Products' innovative ADC drug obtain clinical approval
Feb 28,2024
Medicilon assists Shijiazhuang No.4 Pharmaceutical's Class 1 new chemical drug SYN045 tablets obtain clinical approval
​On January 26, SYN045, a Class I new drug developed by Shijiazhuang No.4 Pharmaceutical, received a clinical trial approval notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
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Medicilon assists Shijiazhuang No.4 Pharmaceutical's Class 1 new chemical drug SYN045 tablets obtain clinical approval
Jan 22,2024
Medicilon Assists Hebei Changshan Biochemical Pharmaceutical Co obtain approval for clinical research on Class 1 new drug CSCJC3456 tablets
Changshan Kaijiejian Biopharmaceutical Research and Development (Hebei) Co., Ltd. recently received the approval of the National Medical Products Administration (NMPA) to issue a "Drug Clinical Trial Approval Notice" for the new Class 1 chemical drug CSCJC3456 tablets. Medicilon has efficiently completed most of the preclinical research work of CSCJC3456, including drug efficacy, pharmacokinetics and safety evaluation promoting the project to quickly complete the preclinical research and development process.
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Medicilon Assists Hebei Changshan Biochemical Pharmaceutical Co obtain approval for clinical research on Class 1 new drug CSCJC3456 tablets
Dec 12,2023
Medicilon Assists Zhigen Pharmaceutical's new antidepressant drug ZG-001 to get approval for clinical trials
ZG-001 developed by Zhigen Pharmaceutical has received the "Drug Clinical Trial Approval Notice" approved and issued by NMPA. Medicilon provided ZG-001 with one-stop R&D services such as pharmaceutical research, preclinical research, and IND filing application.
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Medicilon Assists Zhigen Pharmaceutical's new antidepressant drug ZG-001 to get approval for clinical trials
Dec 08,2023
Medicilon Assists Longsee Biomedical's live bacteria preparation LF01 capsules approved for clinical use
On November 20, LF01, an innovative anti-tumor drug independently developed by Longsee Biomedical Co. Ltd. (Longsee Biomedical), received the NMPA drug clinical trial approval notice. Medicilon provided non-clinical safety evaluation and filing application services for the research and development of LF01.
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Medicilon Assists Longsee Biomedical's live bacteria preparation LF01 capsules approved for clinical use
Dec 08,2023
Medicilon Assists Yuyao Biotech's STAT3 dual phosphorylation site inhibitor YY201 successfully completed dual submissions in China and US
Medicilon provided YY201 with pharmaceutical research services (including APIs and preparations), preclinical research services (including efficacy, pharmacokinetics, safety evaluation), and IND application services, which helped YY201 successfully complete dual submissions in China and US.
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Medicilon Assists Yuyao Biotech's STAT3 dual phosphorylation site inhibitor YY201 successfully completed dual submissions in China and US
Nov 22,2023
Medicilon Assists Huaota's CD73-targeting ADC approved for clinical use in US
Recently, Shanghai Huaota Biopharmaceutical Co., Ltd. (Huaota) received a notification from the US FDA, agreeing that the third-generation antibody drug conjugate (ADC) project HB0052 developed by the company targeting the CD73 antigen will enter clinical trials. This is the first antibody conjugate drug project approved by Huaota Biotech to enter clinical trials by the FDA.
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Medicilon Assists Huaota's CD73-targeting ADC approved for clinical use in US
Nov 13,2023
Medicilon Assists Gluetacs Therapeutics' second molecular rubber pipeline line GT929 achieves dual filing and batching in China and US
​On October 27, Gluetacs Therapeutics' second Class 1 new drug, GT929 capsule, in its molecular glue degrader pipeline, was approved by the U.S. Food and Drug Administration (FDA) to enter clinical trials for the treatment of malignant hematological tumors.
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Medicilon Assists Gluetacs Therapeutics' second molecular rubber pipeline line GT929 achieves dual filing and batching in China and US
Nov 01,2023
Medicilon assists LX-132 capsule, a new-targeted anti-tumor drug developed by Salustier Biosciences, successfully obtained clinical approval for a Class I new drug
Recently, LX-132 capsules, a new generation of irreversible kinase inhibitor independently developed by Salustier Biosciences, received a drug clinical trial approval notice from the NMPA. Medicilon has provided a full set of preclinical research services for the research and development of LX-132.
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Medicilon assists LX-132 capsule, a new-targeted anti-tumor drug developed by Salustier Biosciences, successfully obtained clinical approval for a Class I new drug