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Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention…
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Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for its BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), has been accepted for review by the European Medicine Agency (EMA). This marks a significant step forward in the global development and…
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CSPC’s Generic Xofluza Gains NMPA Approval Amid Roche Patent Dispute
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has obtained market approval from the National Medical Products Administration (NMPA) for its generic version of Roche’s (SWX: ROG) Xofluza (baloxavir marboxil) on October 11, 2022. This approval marks a significant development in the availability of generic influenza treatments in China. However,…
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Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
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Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient…
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Roche Boosts China Investment with Additional RMB 250 Million
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Swiss pharmaceutical giant Roche (SWX: ROG) has pledged to invest an additional RMB 250 million (USD 35.1 million) in China, underscoring its commitment to the market despite challenges posed by the COVID-19 pandemic. The announcement was made during the 34th International Business Leaders’ Advisory Council for the Mayor of Shanghai.…
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Ascletis Pharma and Roche Terminate Promotion Agreement for Pegasys
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced a supplementary agreement with Swiss pharmaceutical giant Roche, terminating the promotion services previously provided by Ascletis for Roche’s Pegasys (peginterferon alfa-2a) as of December 31, 2022. The initial partnership, established in November 2018, granted Ascletis exclusive marketing and promotion rights to the…
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Shanghai Pharma’s CD20 Antibody Advances to Primary Nephropathy Trial After NMPA Approval
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China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options. Study DetailsThe drug, developed by Shanghai Jiaolian Drug R&D Co.,…
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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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Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indication is hepatocellular carcinoma (HCC). Drug BackgroundHanBeiTai is also awaiting a regulatory decision…
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Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
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Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug BackgroundEntrectinib, the first ROS1 inhibitor with…
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NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review
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The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status. About PNHPNH is a rare and fatal blood system disease with an incidence of approximately 1 to…
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Roche’s Rozlytrek Wins NMPA Approval for NTRK Fusion Gene-Positive Tumors
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Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tumor-agnostic therapy Rozlytrek (entrectinib). The drug is approved for treating solid tumors in patients aged 12 and older who carry a neurotrophic tyrosine receptor kinase (NTRK) fusion gene and have…
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Henlius Biotech’s HanBeiTai Biosimilar of Avastin Accepted for CDE Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Center for Drug Evaluation (CDE) has accepted a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), for review. The application is intended for the treatment of recurrent glioblastoma (GBM). Drug ProfileHanBeiTai was first approved in…
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Roche’s Chugai Launches Edirol in China for Postmenopausal Osteoporosis
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Swiss pharma giant Roche’s subsidiary Chugai Pharmaceutical Co Ltd has officially launched Edirol (eldecalcitol), an active Vitamin D3 derivative, in China. The drug, approved in December 2020 for treating osteoporosis in postmenopausal women, will be promoted by Chugai Pharma China Co., Ltd and Roche’s local unit. Drug ProfileEdirol, first approved…
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CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
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The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou Ascentage Pharma’s olverembatinib and Roche’s crovalimab. The designations aim to accelerate regulatory timelines for these therapies targeting unmet medical needs. Ascentage’s Olerembatinib Roche’s Crovalimab
