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BioWorld - Thursday, February 5, 2026
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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AI-generated image for cancer cells observed under a microscope
Immuno-oncology

CSPC’s SYS-6041 cleared to enter clinic in China

Jan. 13, 2025
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYS-6041, an antibody-drug conjugate, for advanced solid tumors.
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Cancer

Quanta’s multi-KRAS inhibitor QTX-3544 gains IND clearance

Jan. 9, 2025
Quanta Therapeutics Inc. has gained IND clearance from the FDA for QTX-3544, an oral multi-KRAS inhibitor with G12V-preferring activity and dual ON/OFF state.
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Neurology/psychiatric

Solid Biosciences gains IND clearance for Friedreich’s ataxia gene therapy

Jan. 8, 2025
Solid Biosciences Inc. has gained IND clearance from the FDA for SGT-212 for the treatment of Friedreich’s ataxia (FA).
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Heart illustration
Cardiovascular

Cyclarity’s UDP-003 to enter clinic for acute coronary syndrome

Jan. 8, 2025

Cyclarity Therapeutics Inc. has obtained regulatory approval to begin a first-in-human trial of UDP-003. 


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Immuno-oncology

SYS-6045 cleared for clinic in China for advanced solid tumors

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
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Lungs
Respiratory

SYH-2059 to enter trials in China for interstitial lung disease

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
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Immuno-oncology

Simcere Zaiming’s CDH6-binding ADC to enter clinic in US, China

Jan. 7, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
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Cardiovascular

SYH-2062 cleared for clinic in China for hypertension

Dec. 24, 2024
CSPC Pharmaceutical Group Ltd. has gained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2062 injection, a double-stranded small interfering RNA (siRNA) drug to treat hypertension.
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Musculoskeletal

Epirium’s MF-300 cleared to enter clinic for sarcopenia

Dec. 24, 2024
Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
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Monoclonal antibody illustration
Cancer

177Lu-RAD-202 approved for therapeutic phase I in Australia

Dec. 23, 2024
Radiopharm Theranostics Ltd. has been granted Belberry Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human phase I therapeutic study of 177Lu-labeled RAD-202 (177Lu-RAD-202) for the treatment of HER2-expressing solid tumors, including breast and gastric cancers.
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