Search Results for “immune” – Page 16 – media

Antibody therapy receives FDA approval again

biopharmaceutical era Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 11th, Johnson&Johnson announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual acting mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. In the critical QUASAR project, the drug demonstrated a highly statistically significant endoscopic response rate. The approval of Tremfya this time is supported by data from the ongoing Phase 2b/3 QUASAR study, which evaluates the efficacy and safety of Tremfya in adult patients with moderate to severe ...
- Source: drugdu
- 65
- September 16, 2024
The light of domestic production! Kangnuo’s IL-4R α antibody drug has been approved for market by NMPA

On September 12th, Konya announced that the company’s independently developed Class 1 new drug, Kangyueda ® (Sipuximab Injection) has been officially approved for marketing by the National Medical Products Administration for the treatment of moderate to severe atopic dermatitis in adults. As the first domestic and second globally approved IL-4R alpha antibody drug, Kangyueda ® The launch of Sipuqibai monoclonal antibody not only fills the gap in the field of domestic atopic dermatitis biologics, but also brings new hope for patients with moderate to severe atopic dermatitis to achieve higher treatment goals. Kangyueda ® (Sprucubizumab) Kangyueda ® The Phase III clinical trial of (Sipuximab) is the largest randomized controlled trial of dermatological subjects completed in China to date. The research results show that, The first dose takes effect quickly: Kangyueda ® The first dose of single agent treatment with (Sipuximab) can quickly relieve itching symptoms within one day; After 2 ...
- Source: drugdu
- 91
- September 14, 2024
A Chinese innovative pharmaceutical company “died”

On September 5, Connect (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company headquartered in the United States, announced its financial results for the six months ended June 30, 2024 and announced plans to large-scale attrition. In addition, as part of Connect’s transformation into a U.S.-focused company, the company plans to significantly reduce the scale of its operations in China. Just a few months ago, Connect was an innovative pharmaceutical company in China. All these changes are rooted in the clinical setbacks of Connect’s core pipeline product, Rademikibart (CBP-201). This is a fully human monoclonal antibody targeting IL-4Rα, which is a common subunit of IL-4Rα and IL-13 receptors. It directly targets Sanofi’s new autoimmune drug Duprilumab. anti. In the CBP-201 clinical data previously announced by Connect, although some connotations of long-term efficacy data were seen, the improvement in the 16-week data was weaker than that of dupilumab; in addition, because it was ...
- Source: drugdu
- 55
- September 13, 2024
Yingsi Intelligence has discovered an AI driven WRN inhibitor that targets highly microsatellite unstable cancer

WRN has been identified as a synthetic lethal target in highly microsatellite unstable (MSI-H) cancer cells, with therapeutic potential for MSI-H tumor patients who do not respond to existing therapies. The innovative module Alchemisty under Yingsi Intelligent Chemistry42 utilizes non-equilibrium switching method to accurately and quickly estimate the binding free energy of protein ligand complexes, simplifying and accelerating the optimization process of ISM2196. In preclinical studies, ISM2196 has demonstrated strong in vivo anti-tumor efficacy in various MSI-H cancer models, with good selectivity, safety, and ADMET (absorption, distribution, metabolism, excretion, and toxicity) characteristics. Yingsi Intelligent, a clinical stage biopharmaceutical technology company driven by generative artificial intelligence (AI), announced the nomination of preclinical candidate drug ISM2196, a potential “best in class” WRN inhibitor discovered by AI, aimed at treating advanced metastatic microsatellite instability (MSI) cancer through synthetic lethal strategies. The DNA helicase Werner (WRN) is a member of the RecQ helicase family ...
- Source: drugdu
- 60
- September 13, 2024
Great earthquake! AlphaProteo breaks doubts! Will become a cancer killer! Leading the way in brand new protein design!

Heavy weight! DeepMind is scaling up again! AlphaFold dominates the field of protein prediction, and AlphaFold 3 breaks through its limitations by predicting all living molecules. When it was released, there were voices claiming that AlphaFold 3’s structured prediction and generation would accelerate the development of AI driven drug design. Now, DeepMind has scaled up its strategy by releasing AlphaProteo for the design of new proteins. AlphaProteo is the first AI system designed specifically for designing novel high-intensity protein conjugates, capable of generating conjugates of multiple target proteins. This system significantly improves the success rate, even 3 to 300 times stronger than existing methods. Especially for the VEGF-A protein related to cancer and diabetes complications, AlphaProteo is the first AI tool to design successful conjugates. In addition, it can effectively bind to various proteins related to infection, cancer, inflammation, and autoimmune diseases, such as BHRF1, SARS-CoV-2 spike protein, IL-7R α, ...
- Source: drugdu
- 85
- September 12, 2024
635 million US dollars! Anmai Biological BCMA × CD3 Double Antibody Successfully Goes to Sea

Anmai Biotechnology announced that it has reached a licensing agreement with Vignette Bio for the T cell conjugation (TCE) molecule EMB-06 targeting BCMA. According to the agreement, Amway Bio will grant Vignette the exclusive right to develop and commercialize EMB-06 outside the Greater China region (including Chinese Mainland, Hong Kong, Macao and Taiwan), and Amway Bio will reserve the right of EMB-06 in the Greater China region. Anmai Biotechnology will receive a total down payment of $60 million in cash and Vignette equity, and will have the right to receive up to $575 million in milestone payments for development, listing, and commercialization, as well as revenue sharing based on net sales. EMB-06 is the first TCE molecule developed under the T cell conjugation platform of Anmai Biotechnology, which combines Anmai Biotechnology’s self-developed FIT Ig bispecific antibody platform and CD3 binding domain library, as well as Anmai Biotechnology’s internal new drug ...
- Source: drugdu
- 67
- September 11, 2024
The first domestic new drug for alopecia areata is about to be launched

Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China. This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market. Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above. Referring to the progress of Pfizer’s application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the ...
- Source: https://mp.weixin.qq.com/
- 82
- September 11, 2024
Vaxcyte’s stock price soared after achieving a ‘stunning’ victory in the competition against Pfizer’s 31 valent pneumococcal conjugate vaccine (PCV)

Editor’s Bio Products Circle Vaxcyte has released Phase 1/2 data for its 31 valent pneumococcal vaccine candidate, which analysts have described as “astonishing”. If these data can be replicated in large-scale critical studies, it could pose a serious threat to Pfizer’s Prevnar 20. Vaxcyte’s half period data for VAX-31 in adults aged 50 and above against Prevnar 20 is “extraordinary” and suggests a “killer product in the pneumococcal conjugate vaccine category,” said analysts at Leerink Partners in a report on Tuesday. Leerink analyst said, “We believe that these data support VAX-31’s potential to gain a significant market share in the pneumococcal conjugate vaccine market expected to exceed $10 billion by 2030+ Due to this positive reading, Mizuho analysts referred to it as the “best case scenario,” and Vaxcyte’s stock price jumped about 44% at the release time on Tuesday morning.Today, we are opening a new chapter for Vaxcyte as we ...
- Source: drugdu
- 81
- September 9, 2024
635 million US dollars! Anmai Biological BCMA × CD3 Double Antibody Successfully Goes to Sea

On September 4th, Anmai Biotechnology announced that it has reached a licensing agreement with Vignette Bio for the T cell conjugation (TCE) molecule EMB-06 targeting BCMA. picture According to the agreement, Amway Bio will grant Vignette the exclusive right to develop and commercialize EMB-06 outside the Greater China region (including Chinese Mainland, Hong Kong, Macao and Taiwan), and Amway Bio will reserve the right of EMB-06 in the Greater China region. Anmai Biotechnology will receive a total down payment of $60 million in cash and Vignette equity, and will have the right to receive up to $575 million in milestone payments for development, listing, and commercialization, as well as revenue sharing based on net sales. EMB-06 is the first TCE molecule developed under the T cell conjugation platform of Anmai Biotechnology, which combines Anmai Biotechnology’s self-developed FIT Ig bispecific antibody platform and CD3 binding domain library, as well as Anmai ...
- Source: drugdu
- 62
- September 6, 2024
Two innovative medical devices have been approved for market launch

On September 3rd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the “Navigation Positioning Microwave Ablation System” of True Health (Zhuhai) Medical Technology Co., Ltd. (hereinafter referred to as “True Health Medical”) and the “Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)” of Fuji Ruibiou Co., Ltd. (hereinafter referred to as “Fuji Ruibiou”). True Health Medical: International First Product Founded in 2018, True Health Medical is a national high-tech enterprise specializing in the research and production services of surgical robots. Based on artificial intelligence technology, it integrates intelligent robot systems into the diagnosis and treatment process through the close integration of industry, academia, research, and medicine, achieving a comprehensive medical technology system with precise puncture of soft tissue lesions throughout the body as a diagnostic and treatment method. Precise puncture is a means to deliver minimally invasive treatment ...
- Source: drugdu
- 87
- September 6, 2024

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