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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for the use of fluzoparib alone or in combination with apatinib. This new treatment is aimed at patients with human epidermal growth factor…
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Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the initiation of a Phase III study for SIM0270 (SCR-6852), an oral brain-penetrating selective estrogen receptor down-regulator (SERD) inhibitor. The study includes the first patient dosing and is designed to assess the anti-tumor effect and safety of SIM0270 in…
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China’s National Medical Products Administration (NMPA) has granted approval to Hangzhou Ruidi Biotechnology Co., Ltd for its steep pulse therapy equipment and disposable steep pulse ablation needle, as reported on the bureau’s website. This marks a significant advancement in the field of minimally invasive interventional treatments for tumors in China.…
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational product, KYS202003A. The Chinese company is set to initiate a clinical study assessing this Category 1 biologic product for the treatment of advanced solid tumors.…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
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China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC)…
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Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
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China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is now approved in combination with the multi-target kinase inhibitor anlotinib to treat patients with non-Microsatellite Instability-High (non MSI-H)…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously…
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US pharmaceutical giant Pfizer Inc. (NYSE: PFE) has entered into a strategic agreement with China Resources Pharmaceutical Group Co., Ltd (HKG: 3320) to leverage their respective strengths in promoting the commercial operations of Pfizer’s established oncology drugs in China. The focus will be on drugs Aromasin (exemestane), Ibrance (palbociclib), Pharmorubicin…
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UK-based pharmaceutical giant AstraZeneca Inc., (AZ, NASDAQ: AZN) has announced that its Phase III CAPItello-281 study has successfully met its primary endpoint of radiographic progression-free survival (rPFS). The study evaluated the efficacy of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient de novo…
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Swiss pharmaceutical giant Roche (SWX: ROG) has reported an update on the phase III SKYSCRAPER-01 study, which evaluated the combination of tiragolumab with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 Study Details and ResultsThe global, randomized, double-blind…
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin). GSK is seeking approval for the drug in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex…
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China-based GeneQuantum Healthcare, a leading developer of antibody drug conjugates (ADCs), has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for GQ1011 (AMB302). This FGFR3-targeted ADC was co-developed with South Korea-based biotech Aimed Bio under an agreement established in…