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Grand Pharma’s TLX591-CDx Approved for Prostate Cancer Diagnosis in China
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Investigational New Drug (IND) filing for TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the National Medical Products Administration (NMPA). This approval marks a significant step forward…
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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
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RemeGen’s Telitacicept Gains EU, China Approvals for Global Phase III Study
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China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative…
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Zelgen’s Jacktinib Shows Strong Efficacy in Phase III Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has published major data from a Phase III clinical study for its Janus kinase (JAK) inhibitor, jacktinib, in patients with medium- to high-risk myelofibrosis (MF). The results indicate an excellent efficacy and safety profile for the drug. A New Drug Application (NDA) for…
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Ningbo Menovo to Sell Zhejiang Liaoyuan Pharma Stake to Jemincare for RMB 512.58M
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China-based Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has announced plans to transfer all of its ownership in Zhejiang Liaoyuan Pharmaceutical Co., Ltd (23,771,218 shares, or 84.5661% of the target company’s total shares) to Jiangxi Jemincare Group for a consideration of RMB 512.58 million (USD 71.2 million). The deal is…
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Sirnaomics Initiates Phase I Study of STP705 for Abdominal Fat Reduction
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the first subject dosing in a Phase I clinical study for its STP705, targeting adult abdominal fat reduction. The study, expected to report results during the first half of 2023, marks a significant step forward in the development of non-invasive…
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Gritgen Therapeutics Secures Hundreds of Millions in A-Round Financing for Gene Therapy Pipeline
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Gritgen Therapeutics, a leading gene therapy drug developer based in Suzhou, has announced the successful completion of a A-round financing round worth several hundred million yuan. The financing was led by Sequoia China, with participation from Sunlight Insurance, Qingsong Capital, and Beijing Life Science Park Venture Fund. Existing shareholders including…
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Shenzhen-Based Pregbio Raises Funds for Non-Invasive Prenatal Gene Detection
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Pregbio, a Shenzhen-based non-invasive prenatal gene detection company, has reportedly raised an undisclosed amount of money in an angel financing round. The sole contributor to the round was ASB Ventures. The proceeds will be used to promote early screening and diagnosis of preterm labor and pre-eclampsia, non-invasive prenatal screening, and…
