Merck & Co., Inc.
American multinational pharmaceutical company headquartered in Rahway, New Jersey; ranks fifth among biomedical companies by revenue, driven by oncology (Keytruda), vaccines (Gardasil), and animal health; does business as Merck Sharp & Dohme (MSD) outside the US and Canada.
相关临床试验
270
268 进行中
药物批准
5
批准总数
监管机构
1
监管机构数
成立时间
1891
进行中（未招募）
268
99.3%
已完成
2
0.7%
- Singapore plans to support an mRNA influenza vaccine pilot to build adaptable manufacturing capacity for peacetime production and future pandemic response. - Hilleman Laboratories' Singapore facility is adapting manufacturing know-how from MSD's ERVEBO Zaire Ebola vaccine to accelerate a Bundibugyo Ebola candidate with CEPI support. - The facility will produce material for early clinical trials with a first batch by the end of this year, targeting up to 12 million doses of drug product annually. - Singapore is aligning its Prepvax initiative with CEPI's 100-day mission and exploring an RNA Readiness and Response global biofoundry with Wellcome Leap.
- The CHMP has adopted a positive opinion recommending enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer in the EU. - The opinion rests on Phase 3 EV-304 data showing a 47% reduction in risk of recurrence, progression or death and a 35% reduction in risk of death versus gemcitabine-cisplatin. - If the European Commission approves, the MIBC indication would extend from cisplatin-ineligible patients to all adults with resectable disease regardless of cisplatin eligibility.
- SK Biopharmaceuticals has secured exclusive global rights to 1ST-104, a preclinical oral small-molecule dual inhibitor of LRRK2 and c-Abl for Parkinson's disease, from 1ST Biotherapeutics. - The licensing agreement is valued at up to $314.8 million, including a $1.8 million upfront payment, a $1.8 million candidate-selection milestone, and tiered royalties on global net sales. - SK Biopharmaceuticals separately made a $2.2 million strategic equity investment in 1ST Biotherapeutics to support a long-term partnership between the two South Korean companies. - 1ST-104 is a next-generation Type 2 LRRK2 inhibitor designed to avoid pulmonary findings seen with some Type 1 inhibitors, and has shown target selectivity and blood-brain barrier permeability preclinically.
- Japan's Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX, a fixed-dose combination of pembrolizumab and berahyaluronidase alfa, for subcutaneous use across all 22 approved KEYTRUDA indications. - The product, to be marketed in Japan as KEYJECT, can be given by a healthcare provider in one minute every three weeks or two minutes every six weeks. - Approval was based on the Phase 3 MK-3475A-D77 trial, which showed comparable pembrolizumab exposure and an objective response rate of 45.4% versus 42.1% for intravenous KEYTRUDA. - Merck said KEYJECT is the first and only subcutaneous immune checkpoint inhibitor available in Japan, adding to prior U.S. and European Union approvals of subcutaneous pembrolizumab.
- South Korean and U.S. healthcare experts urged regulatory reforms aligned with global standards to support sustainable growth and improve patient care at an AMCHAM seminar in Seoul. - Local doctors emphasized that precision diagnostics and treatment, including genome testing for advanced lung cancer patients, are urgently needed but currently hindered by regulatory barriers. - Experts called for legislation specifically addressing corneal transplants, noting that access is restricted by regulations treating corneas like other human tissue. - The government pledged to shorten reimbursement approval times for rare disease treatments and strengthen outcomes-based value assessments.
- Manufacturing accounts for roughly 80% of a pharmaceutical company's environmental footprint, making the factory floor the critical intervention point for meaningful change. - Eight leading APAC CDMOs are integrating renewable electricity, water reuse, waste recovery, green chemistry and continuous manufacturing into core production strategy rather than isolated initiatives. - The global sustainable drug manufacturing market is projected to grow from USD 105.8 billion in 2026 to USD 248.2 billion by 2036 at an 8.9% CAGR. - Scope 3 emissions, supplier engagement and internal carbon pricing are emerging as the next frontier, with WuXi AppTec reporting 82.14% of emissions from Scope 3.
- The novel hypercholesterolemia drugs market is projected to grow from USD 17.6 billion in 2026 to USD 42.8 billion by 2036, a 9.3% CAGR. - PCSK9 inhibitors are forecast to hold a 42.0% drug-class share in 2026, spanning monoclonal antibodies, inclisiran-based siRNA, and the new oral enlicitide. - Merck's Lipfendra (enlicitide) gained FDA approval in July 2026 as the first once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia. - Injectable therapies lead with a 57.0% route-of-administration share, while gene-editing programs from Verve, CRISPR Therapeutics, and Eli Lilly advance toward one-time treatment.
- Kazakhstan's Health Ministry granted Promomed a registration certificate for Tirzetta (tirzepatide), making it the country's first officially available drug with that active substance. - Tirzepatide activates both GLP-1 and GIP receptors, a dual incretin mechanism the company says drives weight loss mainly through increased adipose tissue metabolism. - WHO data for 2024 show 56% of Kazakhstan's adult population is overweight, above the global average of 45%, supporting local demand for obesity and diabetes treatments. - Tirzepatide became the world's top-selling drug in Q1 2026 with revenue nearing $9 billion, overtaking MSD's Keytruda, while Russia's patent on the molecule expired in November 2024.
- The Southeast Asia oncology drug access market is projected to grow from USD 3.19 billion in 2026 to USD 4.41 billion by 2031, at a CAGR of 6.7%. - Rising cancer burden, particularly breast, lung, colorectal, liver, and cervical cancers, alongside hematologic malignancies, is fueling demand for affordable oncology therapies. - Biosimilars, generics, patient assistance programs, and precision oncology advances are reshaping treatment accessibility across the region. - Key challenges include high out-of-pocket costs, fragmented regulations, and rural infrastructure limitations, though healthcare reforms present growth opportunities.
- The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded full accreditation to five new entities, including Merck & Co., Inc. and MedStar Health Research Institute. - An additional 21 organizations earned reaccreditation, joining more than 600 entities worldwide committed to AAHRPP's ethical research standards. - AAHRPP President and CEO Elyse I. Summers emphasized that each accreditation strengthens research protections and helps restore public trust in science. - The Uniformed Services University of the Health Sciences, a U.S. government institution, was recognized for sending a "deliberate, powerful message" about its dedication to safe, ethical research.
