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Roche’s Cosentyx 300mg Dosage Approved by NMPA for Ankylosing Spondylitis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the National Medical Products Administration (NMPA) has approved the 300mg dosage regimen of Cosentyx (secukinumab) for use in treating ankylosing spondylitis (AS). This approval represents a significant advancement in the management of this chronic inflammatory disease. Approval Based on MEASURE 3…
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Roche Partners with China Resource Medicine to Promote Xofluza in China
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Swiss pharmaceutical giant Roche (SWX: ROG) has entered into a partnership with China-based China Resource Medicine Commercial Holdings Ltd to jointly promote the anti-influenza drug Xofluza (baloxavir marboxil) in China. Under the agreement, Roche will continue to handle channel promotion for the drug in major hospitals, while CR Medicine Commercial…
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Roche Returns Global Rights to Blueprint’s RET Inhibitor Gavreto
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US-based biotech Blueprint Medicines has announced that Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has returned ex-Greater China global rights to its RET inhibitor Gavreto (pralsetinib), citing strategic reasons. This decision marks a significant shift in the commercial strategy for the drug, which was previously licensed to Roche for global…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low…
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CARsgen and Roche Partner on Clinical Study for Gastric Cancer Treatment
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation agreement with Swiss pharmaceutical giant Roche. The partnership will focus on a clinical study assessing the combination of CARsgen’s Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 with Roche’s PD-L1 therapy Tecentriq (atezolizumab) alongside standard chemotherapy for…
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Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
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China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co. Ltd has received marketing approval in China for its biosimilar version of Roche Holding AG’s (OTCMKTS: RHHBY) Actemra/RoActemra (tocilizumab). This approval marks a significant milestone in expanding treatment options for…
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Roche and HKSTP Collaborate to Boost Life Sciences in Greater Bay Area
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Swiss pharmaceutical giant Roche (SWX: ROG) has signed a multi-faceted collaboration agreement with the Hong Kong Science and Technology Parks Corporation (HKSTP) to further the development of the life sciences industry in Hong Kong and the Greater Bay Area (GBA), which includes Macau and Guangdong Province. Key Areas of CollaborationThe…
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Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG’s (OTCMKTS: RHHBY) blockbuster Actemra/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche’s originator drug, which has been…
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Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
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Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
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The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab (RO7082859) and China-based Dizal Pharmaceutical Co., Ltd’s sunvozertinib (DZD9008) are set to enter the priority review process. This marks a significant step forward for both drugs, which are poised to address significant unmet needs in…
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Luye Pharma’s Shandong Boan Biotechnology IPOs on Hong Kong Stock Exchange
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd has officially made an initial public offering (IPO) of 10.69 million shares to the Hong Kong Stock Exchange, priced at HKD 19.8 (USD 2.54) per share. This amounts to an HKD 212 million (USD 27.2 million) windfall…
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Adagene Initiates International Study for ADG126 in Hepatocellular Carcinoma
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China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced the initiation of a randomized, international, multi-center clinical study to assess the effects of its anti-CTLA-4 monoclonal antibody (mAb) ADG126, combined with Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), in first-line advanced hepatocellular carcinoma (HCC).…
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Roche and Zhongshan Hospital Collaborate on Clinical Studies and Innovation Center
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Swiss giant Roche’s (SWX: ROG) China unit and Roche Diagnostics’ China unit entered into a cooperation memorandum of understanding (MoU) with Shanghai’s Class 3A Zhongshan Hospital, a major teaching hospital affiliated to China’s National Health Commission. The three entities will collaborate on clinical studies in cancer and other diseases, create…
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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include the treatment of cytomegalovirus retinitis…
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Zhangjiang AI New Drug R&D Alliance Expands with New Members
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The Zhangjiang AI New Drug R&D Alliance has welcomed new participants, including Regor Therapeutics, Roche, Hengrui Pharmaceuticals, Wuxi Biologics, LianBio, Baidu, Ainnocence, Galixir, Nutshell Therapeutics, Infinite Intelligence Pharma, and more. This expansion marks a significant step in enhancing the collaborative research efforts within the alliance. Alliance OverviewThe joint effort, initiated…
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PingAn Good Doctor Partners with Roche and OrigiMed at CIIE
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The 5th China International Import Expo (CIIE) saw China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as PingAn Good Doctor, announce partnerships with Swiss giant Roche and its compatriot firm OrigiMed, a precision medicine company. The collaboration aims to expand the pan-solid tumor payment service mode,…
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Hua Medicine Launches Dorzagliatin, a First-in-Class Diabetes Drug, in China
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China-based Hua Medicine has announced the commercial launch of its Category 1 drug, dorzagliatin, with the first prescription issued in Shanghai. Priced at RMB 420 (USD 59.00) per box, the drug is now available in pharmacies across multiple locations in China. This marks a significant milestone for the company and…
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Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
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Roche Reports Q3 Sales Growth, Hit by COVID-19 Product Decline
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2022 financial report last week, showing group sales up 2% year-on-year (YOY) at constant exchange rates (CER) during the 9-month period to CHF 47.0 billion (USD 46.8 billion). The growth rates for Q1, Q2, and Q3 were +11%, +0%, and -6%…
