相关临床试验
56
39 进行中
药物批准
136
批准总数
监管机构
6
监管机构数
成立时间
N/A
进行中（未招募）
38
67.9%
已完成
11
19.6%
尚未招募
1
1.8%
招募中
5
8.9%
Unknown
1
1.8%
- The EMA's CHMP recommended 12 new medicines for approval at its September 14-17, 2026 meeting, alongside 11 therapeutic indication extensions and two biosimilars. - Povofortay (povorcitinib) became the first oral daily treatment recommended for adults with moderate to severe hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. - Johnson & Johnson's Tecvayli (teclistamab) won support for earlier-line multiple myeloma use, with MajesTEC-3 data showing a 71% reduction in progression risk versus standard of care. - Two initial marketing applications were withdrawn, for apitegromab in 5q spinal muscular atrophy and trilaciclib in extensive-stage small-cell lung cancer, while three negative opinions entered re-examination.
- The FDA approved Accord's Osvyrti/Jubereq (denosumab-desu) on November 20, 2025, marking the eighth biosimilar approval for Amgen's blockbuster osteoporosis drugs Prolia and Xgeva. - Amgen reached a confidential settlement with Hikma and Gedeon Richter on November 24, 2025, preventing commercial launch of their denosumab biosimilars until January 1, 2026. - Multiple denosumab biosimilar applications remain pending at FDA, including products from Teva, Amneal, and Alvotech/Dr. Reddy's, with ongoing patent litigation cases. - Amgen reported combined U.S. sales of $4.392 billion for Prolia ($2.885 billion) and Xgeva ($1.507 billion) in fiscal year 2024.
- Amgen filed three new BPCIA lawsuits in November 2025 against multiple companies developing biosimilars of its blockbuster denosumab products Prolia® and Xgeva®. - The litigation targets Dr. Reddy's/Alvotech's AVT03, Amneal's MB09, and Alkem's ENZ215 biosimilars, asserting 31-35 patents per case covering manufacturing and composition claims. - These cases represent Amgen's eighth through tenth denosumab biosimilar litigations, with five previous cases having settled and several others ongoing. - Amgen reported combined FY24 U.S. sales of $4.392 billion for Prolia® and Xgeva®, highlighting the significant commercial stakes in these patent disputes.
- AbbVie's VRAYLAR (cariprazine) has gained public reimbursement in Alberta, completing coverage across all Canadian provinces and federal programs for schizophrenia treatment. - The approval addresses a critical access gap, as up to 90% of Canadians with serious mental illness are unemployed and rely on public coverage to manage their symptoms. - VRAYLAR is an atypical antipsychotic that improves both positive and negative symptoms of schizophrenia and is also indicated for bipolar mania and depression. - Mental health experts and advocacy groups praised the decision as an important milestone for expanding equitable access to tailored schizophrenia treatments nationwide.
- Gedeon Richter UK has launched Nalvee (10mg dydrogesterone), marking the return of a dydrogesterone-only hormone replacement therapy formulation after more than 17 years of absence from the UK market. - The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen therapy, with clinical studies showing 97% success in endometrial protection. - Dydrogesterone closely mimics natural progesterone with high bioavailability and specificity for progesterone receptors, allowing efficacy at doses 10 to 20 times lower than micronised progesterone. - The treatment addresses a significant gap in HRT options by providing predictable, lighter bleeding patterns that may enhance patient satisfaction and reduce discontinuation rates.
- Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon. - The lawsuits allege infringement of 26-34 patents each and claim the defendants failed to comply with BPCIA "patent dance" requirements by withholding key manufacturing information. - These cases represent the sixth, seventh, and eighth denosumab biosimilar litigations by Amgen, following previous suits against Sandoz, Celltrion, Samsung Bioepis, Fresenius, and Accord Biopharma. - The targeted biosimilars include RGB-14-P/RGB-14-X (Hikma/Richter), HLX14 (Shanghai Henlius/Organon), and an unnamed Biocon product, all seeking to compete with Amgen's Prolia and Xgeva brands.
- The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara. - The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis patients. - Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval. - USYMRO targets IL-12 and IL-23 pathways involved in chronic inflammatory conditions including psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
• Gedeon Richter has submitted a marketing authorization application to the European Medicines Agency for its tocilizumab biosimilar (RGB-19), developed jointly with Mochida Pharmaceutical. • The application includes comprehensive data from Phase I PK/PD studies in healthy volunteers and Phase III efficacy trials in rheumatoid arthritis patients, demonstrating similarity to RoActemra® across all parameters. • If approved, the biosimilar will expand access to this IL-6 inhibitor for treating rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and COVID-19 across Europe.
• A first-of-its-kind daily pill for endometriosis, relugolix combination therapy (Ryeqo), has been approved for NHS use in England after initially being rejected by Nice. • The breakthrough treatment works by blocking hormones that contribute to endometriosis while providing hormone replacement, offering a more convenient alternative to injectable treatments for approximately 1,000 patients annually. • Endometriosis affects 1.5 million women in the UK, causing debilitating pain and fertility issues, with diagnosis typically taking nine years from symptom onset.
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions. • Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector. • Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
