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Henlius Biotech Gains NMPA Approval for Phase I Trial of HLX60 in Solid Tumors and Lymphomas
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. This marks a significant step forward in the development of innovative treatments for these challenging…
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PureID Medical Technology Secures RMB 100M Series B Funding
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PureID Medical Technology Co., Ltd, a medical device compliance service provider based in Guangzhou, has reportedly raised over RMB 100 million (USD 13.89 million) in a Series B financing round. The round was led by Legend Capital, with a contribution from existing investor Bayland Capital. The proceeds will be used…
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Sinocelltech’s COVID-19 Vaccines SCTV01C and SCTV01E Show Promising Phase III Results
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced the preliminary interim analysis results of a Phase III clinical study for its in-house developed recombinant COVID-19 vaccines. The study evaluated the bivalent (Alpha + Beta variants) S trimer protein vaccine SCTV01C and the quadrivalent (Alpha + Beta + Delta + Omicron…
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Jemincare’s Sonidegib Receives First Prescriptions in China for Basal Cell Carcinoma
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China-based Jiangxi Jemincare Group has announced the first prescriptions in China for its sonidegib, a smoothened (Smo) inhibitor used to treat basal cell carcinoma (BCC). The initial batch of prescriptions covers more than 50 special drug pharmacies and online platforms across the country. This marks a significant milestone in the…
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Salus Biomed Raises Over RMB 100M in Pre-Series A Financing
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Salus Biomed, a sequencing and spatial omics platform provider based in Guangdong, has reportedly raised over RMB 100 million (USD 13.89 million) in a Pre-Series A financing round. The funding will support regulatory filings and ongoing research and development of its gene sequencing platform and super-resolution spatial omics products, as…
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Haisco Pharma’s Ciprofol Injection Gains NMPA Approval for Gynecology Use
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving another marketing approval from the National Medical Products Administration (NMPA) for its Category 1 product, ciprofol injection, for use in gynecology outpatient sedation/anesthesia. This approval expands the indications for ciprofol, further solidifying its position in the anesthetic market. Drug…
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ScienCare Pharma’s Naltrexone Implant Prioritized for Review by CDE
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The Center for Drug Evaluation (CDE) website indicates that the market filing by China-based Shenzhen ScienCare Pharmaceutical Co., Ltd for its naltrexone implant has been prioritized for review. The drug, used to prevent relapse among opioid-dependent patients after detoxification, was awarded priority status as a “breakthrough therapy.” This marks a…
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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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Kunshi Biotechnology Raises Angel Funding for Engineered Macrophage Platform
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China-based Kunshi Biotechnology (Shenzhen) Co., Ltd, a company specializing in gene editing, biomaterials, and synthetic biology-driven platforms for engineered macrophages to treat solid tumors, has reportedly raised “tens of millions” of renminbi in an angel financing round. The funding was led by ASB Ventures, Riemann Hypothesis, and other investors. The…
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Akeso Biopharma’s Cadonilimab Recommended as First-Line Treatment for Cervical Cancer
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China-based biotech Akeso Biopharma (HKG: 9926) has revealed that its cadonilimab (AK104) has been included as the first recommended treatment for second-line recurrent or metastatic cervical cancer in the Chinese Society of Clinical Oncology’s (CSCO) cervical cancer diagnosis and treatment guidelines (2022). This marks a significant milestone in the recognition…
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Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, has revealed that Yescarta (axicabtagene ciloleucel) has obtained priority review status for adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has…
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Genor Biopharma Initiates First Patient Dosing for GB263T in China
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May…
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Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
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China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for…
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Innovent Biologics Publishes Mazdutide Phase Ib Study Results for Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the results of the higher-dose cohorts in a Phase Ib study for mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in overweight or obese Chinese participants have been published online at eClinicalMedicine. Licensing Deal and Drug ProfileInnovent struck…
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Sihuan Pharma to Acquire Additional Stake in Heilongjiang Duoduo Pharma
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China-based Sihuan Pharmaceutical Holdings Group Ltd’s subsidiary, Beijing Centergate Technologies (Holding) Co., Ltd (SHE: 000931), has announced that Sihuan Pharma is set to acquire an additional 9.56% stake in Heilongjiang Duoduo Pharmaceutical Co., Ltd. Upon the deal’s closure, Sihuan will own a 78.82% stake in Duoduo Pharma, maintaining its position…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is…
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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…
