Recent Articles in Trials & Approvals

Nanjing Simcere Zaiming, an oncology subsidiary of Simcere Pharma, announced China’s NMPA approved Enlituo® in combination with FOLFIRI as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). Enlituo® (cetuximab beta injection) is an anti-EGFR antibody drug developed by Taizhou’s Mabpharm. It is the first novel EGFR monoclonal antibody drug developed in China and approved as a first-line treatment of mCRC. One year ago, Simcere Zaiming acquired the China distribution rights to the drug from Mabpharm. More details....

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Beijing Gan & Lee, a diabetes drug specialist, reported that its glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18 Injection, showed impressive weight loss results among obese/overweight subjects in a China Phase Ib/IIa trial. The 36 subjects were treated on either a once-weekly (QW) or bi-weekly (Q2W) dosing schedule. After 35 weeks of treatment, the mean weight change from baseline in the QW group was a loss of 16.5 kg, a mean percentage reduction from baseline of 18.6%. The results were better than currently available GLP-1 products, Gan & Lee said. More details....

Stock Symbol: (SHA: 603087)

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Wuhan iRegene was approved to begin US trials of its novel chemically induced allogeneic cell therapy product as a treatment for Parkinson's Disease. iRegene’s technology is based on “AI + chemical induction" to modify cells. Using its platform, that company has developed a pipeline of universal iPSC derived cell products aimed at treating currently incurable diseases, including neurodegenerative disorders such as Parkinson's disease and blindness. In a similar Phase I trial conducted in China, iRegene’s NouvNeu001 produced favorable safety and efficacy data. The US trial will enroll Parkinson patients with mid-to-late state disease. More details....

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Clover Biopharma, a commercial-stage vaccine biotech, reported positive data from a Phase I trial of its bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. SCB-1019 produced early immunogenicity and safety data in older adult & elderly subjects, similar to results from younger adults (aged 18-59) announced earlier this year. The Australian Phase Ⅰ clinical trial is a randomized, placebo-controlled study designed to assess the safety, reactogenicity and immunogenicity of SCB-1019 at multiple dose levels and in different formulations in young and older adults. More details....

Stock Symbol: (HK: 02197)

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Shanghai Asieris Pharma announced its collaboration with ReviR Therapeutics has identified a novel lead series of small molecules that modulate the expression of an oncogenic driver gene. The molecules, which were part of ReviR's proprietary compound library, can drive inclusion of a cryptic exon into the mRNA of a novel target gene, reducing the disease protein. ReviR, a San Francisco area biotech, develops small molecule RNA splicing modulators for neurogenetic and oncology indications. Asieris develops novel drugs for genitourinary tumors and related diseases. More details....

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