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Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
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Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
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Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of…
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Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
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China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
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InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
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China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
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CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
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China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
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Roche’s Q3 2023 Report Shows 1% Global Growth Amid Lower COVID-19 Product Demand
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2023 report, indicating that a reduced demand for COVID-19 products impacted global growth, resulting in a 1% year-on-year (YOY) increase at constant exchange rates over the first nine months, with total sales amounting to CHF 44.1 billion (USD 49.4 billion). Excluding…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
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MSD Collaborates with Daiichi Sankyo on Development of Innovative ADC Candidates
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based Daiichi Sankyo (TYO: 4568) focused on the development and commercialization of three potential first-in-class deruxtecan-based antibody-drug conjugate (ADC) candidates. This partnership aims to advance innovative treatments for various types of cancer. ADC Candidates and Development…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
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BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
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Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
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China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to…
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MSD Partners with Phanes Therapeutics for Innovative Cancer Combo Therapy
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Global pharmaceutical leader Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic partnership with US-based biotechnology firm Phanes Therapeutics to develop a novel combination therapy. The collaboration will see MSD’s anti-PD-1 blockbuster Keytruda (pembrolizumab) paired with Phanes’s first-in-class CD47×claudin 18.2 drug PT886, targeting claudin 18.2-positive gastric or gastroesophageal…
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Jiangsu Hengrui Licenses Camrelizumab-Apatinib Combo to Elevar Therapeutics
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China-based pharmaceutical giant Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has signed a significant licensing agreement with US-headquartered Elevar Therapeutics. The deal grants Elevar global exclusive development and commercialization rights to Hengrui’s programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab in combination with apatinib for the treatment of hepatocellular carcinoma (HCC),…
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Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
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China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HYP2090PTSA. This small molecule KRAS G12C/PI3K inhibitor is intended for the treatment of advanced solid tumors with KRAS G12C…
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J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and…
