Recent Articles in Trials & Approvals

Sperogenix Therapeutics of Shanghai announced its NDA for Agamree (vamorolone), a treatment for Duchenne muscular dystrophy (DMD), has been accepted for review by China’s Center for Drug Evaluation (CDE). Two years ago, Sperogenix in-licensed greater China rights to the drug from Santhera Therapeutics of Switzerland in a $124 million agreement. A novel drug, Agamree binds to the same receptor as glucocorticoids but modifies its downstream activity for better safety. Sperogenix is a China rare disease company. More details....

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Shanghai GenFleet announced a clinical trial collaboration to test a combination of GFH009 (a CDK9 inhibitor) and BioGene’s Brukinsa® (a BTK inhibitor) in patients with diffuse large B cell lymphoma (DLBCL). GenFleet will conduct an open-label, single-arm and multi-center (10 hospitals in China) study of the combination to evaluate its safety and efficacy. BeiGene will provide clinical drug supplies of Brukinsa®(zanubrutinib) for the Phase Ib/II trial. The first patient has been dosed in the trial, which is led by Henan Cancer Hospital and Fudan University Shanghai Cancer Center. More details....

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Guangzhou Bio-Thera was cleared to start a US Phase II trial for BAT8006, an ADC targeting Folate Receptor α (FRα). The study will enroll patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. BAT8006 was developed using Bio-Thera's proprietary anti-FRα antibody and proprietary ADC linker-payload combination inhibitor. In preclinical studies, the candidate showed potential for good stability and safety along with strong anti-tumor activity. The company said BAT8006 showed a strong bystander effect in a Phase I trial. Bio-Thera is developing a portfolio of 24 novel and biosimilar candidates. More details....

Stock Symbol: (SHA: 688177)

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Suzhou NeuExcell Therapeutics, a company focused on in vivo neural regenerative therapies, dosed the first patient with a first-in-class NeuroD1 gene therapy product NXL-004. The company explains that neural tissues contain two major types of cells: neurons and supportive glial cells such as astrocytes. Although neurons cannot divide or replenish themselves, glial cells can.  Because both are derived from neural stem cells, neurons and astrocytes have many similar traits. NeuExcell applies its astrocyte-to-neuron (AtN) conversion technology to replace dead neurons in diseased or injured tissues. The investigator trial will evaluate NXL-004 in patients with glioblastoma. More details....

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Suzhou Alphamab Oncology reported positive data from a Phase II trial of KN046, its anti-PD-L1/CTLA-4 bispecific antibody plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC). The bispecific candidate is engineered to target the tumor microenvironment with high PD-L1 expression and clearing of Treg cells. Alphamab is conducting about 20 clinical trials of KN046 for over 10 indications, including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC. The trial results were published online in Cell Reports Medicine. More details....

Stock Symbol: (HK: 9966)

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