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Sirnaomics Initiates Phase I/II Trial for STP705 in Facial Squamous Cell Carcinoma
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the first subject systemic dosing in a Phase I/II clinical study for its therapeutic candidate STP705 in facial squamous cell carcinoma in situ (isSCC). The study is expected to be completed during Q1 2023. Study Design and ObjectivesThe open-label, dosage escalation…
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NHC, NDRC Issue Guidelines to Boost China’s Birth Rates with Reproductive Support Measures
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The National Health Commission (NHC) and National Development and Reform Commission (NDRC), along with multiple other bureaus, have released the “Guiding Opinions on Further Improving and Implementing Active Reproductive Support Measures.” The aim is to enhance prenatal and postnatal care services, develop the universal childcare service system, and improve the…
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Biocytogen Pharmaceuticals Makes HKSE Debut with USD 70 Million IPO
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Sino-US contract research organization (CRO) Biocytogen Pharmaceuticals (Beijing) Co., Ltd has completed an initial public offering (IPO) of 21.76 million shares on the Hong Kong Stock Exchange (HKSE), raising a total of HKD 549 million (USD 69.97 million). Company Overview and Core ProductsFounded in 2009, Biocytogen has a pipeline that…
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CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed…
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Jemincare Licenses Oral Androgen Receptor Degrader to Roche’s Genentech
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China-based Jiangxi Jemincare Group has entered into a licensing agreement with Swiss giant Roche’s Genentech. The deal grants Genentech exclusive global development and commercialization rights to Jemincare’s oral androgen receptor (AR) degrader, JMKX00299, including all related intellectual property rights. Financial TermsUnder the agreement, Genentech will pay a USD60 million upfront…
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Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
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The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research Institute of the Chinese University of Hong Kong jointly released a report titled “Research on the Quality of Life of Chinese SMA Patients.” The report indicates that among patients treated with Biogen’s Spinraza (nusinersen), 76.4%…
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CDE Releases Draft Guidelines for RWE-Backed Drug Registration Applications
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The Center for Drug Evaluation (CDE) has released a notification regarding the “Real-World Evidence (RWE)-backed Drug Registration Application Communication Guidelines” (draft proposal). The draft is open for public feedback for one month. The aim is to provide specific requirements and guiding suggestions for communication between the applicant and the review…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
