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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
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Global healthcare leaders Merck, Sharp & Dohme Inc.(MSD; NYSE: MRK), known as MSD outside the US and Canada, and Daiichi Sankyo (TYO: 4568) have announced that their jointly developed anti-HER3 antibody drug conjugate (ADC), patritumab deruxtecan, has demonstrated a significant progression-free survival (PFS) benefit in the Phase III HERTHENA-Lung02 trial.…
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III trials evaluating its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) in new indications, due to insufficient efficacy. The decisions to halt the trials were made following recommendations from their respective independent data monitoring committees. The trials…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic acquisition agreement with Shanghai-based biotech firm Curon Biopharmaceutical. Under the terms of the deal, MSD will fully acquire CN201, a cutting-edge CD3 x CD19-targeted T-cell-engager bispecific antibody (BsAb). The transaction includes an upfront payment of USD 700 million, with…
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Daiichi Sankyo (TYO: 4568), a Japanese pharmaceutical company, has announced an expansion of its strategic partnership with U.S.-based Merck, Sharp & Dohme (MSD; NYSE: MRK) to include global co-development of an antibody drug conjugate (ADC). This extension incorporates a new T-cell engager, MK-6079, which MSD acquired as part of its…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has reported its financial results for the second quarter of 2024, with global revenues reaching USD 16.1 billion, marking an 11% increase year-on-year when excluding currency impacts. Despite this growth, the company’s stock price declined by 9.81% as investors reacted to the…
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I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company, has announced significant changes to its leadership structure. Wei Fu, currently the CEO of venture capital fund CBC Group and I-Mab’s founding shareholder, has been appointed as the chairman of the board. Fu succeeds Dr. Pamela M. Klein, who is stepping down from…
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is indicated to prevent invasive disease caused by a range of Streptococcus pneumoniae serotypes in adults,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an equity investment into DELFI Diagnostics, a U.S.-based developer of blood-based cancer tests, without disclosing the financial terms. The investment will enable DELFI to further develop its fragmentomics and artificial intelligence technologies, enhancing early cancer detection and treatment monitoring. DELFI’s proprietary…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that Tang Xiaochun, who served as the head of vaccine business and assistant vice-president at MSD China, has left the company. Tang initially joined MSD China in 2018 as the executive director of the company’s oncology medical affairs department. During his…
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into an agreement to acquire UK-based ophthalmology specialist Eyebiotech Limited for an upfront payment of USD 1.3 billion, plus potential milestone payments of up to USD 1.7 billion. The deal is anticipated to be finalized in the third quarter of 2024,…