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Merck KGaA Partners with Roche to Commercialize Tepmetko in China
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Germany-based pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a partnership with Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) to commercialize its lung cancer targeted drug Tepmetko (tepotinib) in mainland China. This collaboration aims to leverage the strengths of both companies to bring Tepmetko to more patients in need.…
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Jiangsu Hengrui Pharmaceuticals Inks Global License Deal with Merck for HRS-5346
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced a license agreement with US-based giant Merck & Co., Inc. (NYSE: MRK). Under the terms, Merck gains exclusive global development, manufacturing, and commercialization rights to Hengrui’s HRS-5346, excluding the Greater China region. Financial TermsMerck will provide an upfront payment of USD 200…
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Chongqing Zhifei Acquires 51% Stake in Chenan Bio for RMB593 Million
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122), the distribution partner for US giant Merck’s Gardasil in China, has announced the acquisition of a 51% stake in compatriot firm Chongqing Chenan Biopharmaceutical Co., Ltd. for RMB 593 million (USD 82 million). This strategic move aims to expand Zhifei’s presence in the…
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Merck & Co.’s Winrevair Approved for Pulmonary Arterial Hypertension in Hainan
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US-based giant Merck & Co., Inc. (NYSE: MRK) announced receiving approval from the Hainan Medical Products Administration for its Winrevair (sotatercept-csrk) to be imported by Shanghai Ruijin Hospital’s Hainan subsidiary. This approval is significant as it provides a new treatment option for patients with pulmonary arterial hypertension (PAH) in China.…
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Adagene Starts Phase II Trial of Muzastotug for Colorectal Cancer
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China-based Adagene Inc. (NASDAQ: ADAG) announced the initiation of an Investigator-Initiated (IIT) Phase II trial for muzastotug (ADG126) as a neoadjuvant therapy for patients with stage II or stage III colorectal cancer. Drug ProfileMuzastotug is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells…
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Epitopea and Merck Partner to Identify Cryptigen Tumor Antigens
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UK-based RNA immunotherapy developer Epitopea announced a licensing and research cooperation agreement with US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK). The partnership aims to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. These antigens, derived from non-coding regions of the genome, are shared, non-mutated, and…
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Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric…
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Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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Eli Lilly and Merck Launch Consortium for Innovative Drug Manufacturing
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US-based Eli Lilly and Company (NYSE: LLY) and Merck & Co. Inc. (NYSE: MRK) have announced the launch of the Young Institute Pharmaceutical Manufacturing Consortium in collaboration with Purdue University. The initiative aims to develop new methods of drug manufacturing, driving technological innovation in the pharmaceutical industry. Consortium Focus and…
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Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or…
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Mirror Biologics and Merck KGaA Collaborate on Phase II Trial for Colorectal Cancer Immunotherapy
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US-based Mirror Biologics, Inc., an off-the-shelf immunotherapy developer, has announced a clinical trial collaboration and supply agreement with German major Merck KGaA (ETR: MRK). The collaboration aims to jointly conduct a Phase II clinical study assessing the efficacy and safety of Mirror’s immunotherapy AlloStim combined with Merck’s Bavencio (avelumab), an…
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MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
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US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
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Merck KGaA Adopts Quris AI’s Bio-AI Platform for Drug Development Pipeline
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Quris AI, an artificial intelligence (AI) pharmaceutical company based in Boston and Tel-Aviv, has announced that Merck KGaA (ETR: MRK) has adopted its Bio-AI clinical prediction platform as part of the German major’s drug development pipeline. This means that selected preclinical small molecule candidates will now be tested through the…
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Merck KGaA Completes Acquisition of HUB Organoids, Expanding Cell Culture Portfolio
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German major Merck KGaA (ETR: MRK) announced the completion of its acquisition of Holland-based HUB Organoids Holding B.V. (HUB) last month, following regulatory approval and the fulfillment of other customary transaction conditions. The deal was initially revealed on December 17, 2024. Significance of the AcquisitionHUB is a pioneer in the…
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WuXi Biologics to Sell Irish Vaccine Assets to MSD for USD 500 Million
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) is poised to sell its assets related to vaccine facilities in Ireland to US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) for a consideration of USD 500 million. This strategic move reflects WuXi Biologics’ ongoing efforts…
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MSD’s Clesrovimab for Infant RSV Protection: FDA Accepts BLA for Review
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first…
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Merck to Acquire HUB Organoids Holding B.V., Advancing Organoid Technology in Drug Development
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Merck (NYSE: MRK) has announced a definitive agreement with the intention to acquire HUB Organoids Holding B.V. (HUB), a company specializing in organoid technology. Organoids, which are cell culture models that functionally resemble organs, hold the potential to revolutionize drug development by accelerating processes, enhancing disease treatment understanding across diverse…
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Hansoh Pharmaceutical Secures Global Licensing Deal with Merck for HS-10535
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China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a significant global license deal with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) concerning its investigational oral molecule, HS-10535, a GLP-1 receptor agonist. Terms of the Agreement and Financial ImplicationsAccording to the agreement, Merck will secure exclusive…
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Evopoint Biosciences Submits Pre-NDA for Funobactam, Imipenem, and Cilastatin to NMPA
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Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application) for its Category 1 product, a combination of funobactam, imipenem, and cilastatin, to the National Medical Products Administration (NMPA). This product, once approved, is poised to become the world’s first β-lactam/β-lactamase inhibitor (BL/BLI) with a…
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Xtalpi Inc. Partners with Gnosis Neurodynamics to Develop Neural Drug Screening Platform
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Shenzhen-based QuantumPharm Inc., trading as Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with Gnosis Neurodynamics, a leading brain science artificial intelligence (AI) company in China. This collaboration aims to harness AI algorithms and EEG BioMarker recognition models to develop a state-of-the-art neural drug screening platform. The platform will…
