Search Results for “inhibitor” – media

Ascentage Pharmaceuticals’ Bcl-2 Inhibitor to be Reviewed for Priority

On November 4, according to the official website of CDE, Suzhou Ascentage Pharmaceuticals Co., Ltd. (hereinafter referred to as “Ascentage Pharmaceuticals”) proposed a priority review for the Class 1 new drug APG-2575 tablets, which is intended for patients with refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. APG-2575 is a Bcl-2 selective inhibitor independently developed by Ascentage Pharmaceuticals. It can restore the normal apoptosis process of cancer cells by selectively inhibiting Bcl-2 protein, thereby achieving the purpose of treating tumors. It is understood that APG-2575 is the first locally developed Bcl-2 inhibitor to enter the clinical stage in China. It is also the second in the world and the first in China to see clear efficacy and enter the key registration clinical stage. At present, the drug has broad potential for single-drug and combination therapy in the treatment of various blood tumors and solid tumors. To date, APG-2575 has received ...
- Source: drugdu
- 69
- November 9, 2024
BeiGene PD-1 inhibitor BaiZeAn ® Approved for the 14th indication in China

Beijing, China – October 21, 2024- BeiGene Limited (NASDAQ: BGNE; Hong Kong Stock Exchange code: 06160; Shanghai Stock Exchange code: 688235), a global cancer treatment innovation company, announced today that its PD-1 inhibitor BeiGene An ® Teralizumab has been officially approved by the China National Medical Products Administration (hereinafter referred to as “NMPA”) for use in combination with platinum based chemotherapy as neoadjuvant therapy, and continues to be used as monotherapy for resectable stage II or IIIA non-small cell lung cancer patients after surgery. As the first PD-1 drug approved for neoadjuvant and adjuvant immunotherapy of stage II-III non-small cell lung cancer (NSCLC) in China, Trastuzumab provides a new option for perioperative treatment of operable lung cancer patients, helping them achieve longer survival benefits. This approval is based on clinical trial data of RATIONALE 315 (NCT04379635). This study is a multicenter, randomized, placebo-controlled, double-blind phase 3 study evaluating the efficacy ...
- Source: drugdu
- 65
- October 22, 2024
InnoCare’s “novel TYK2 inhibitor” ushered in progress

Recently, InnoCare announced that the Phase II clinical study of ICP-488, a novel self-developed tyrosine kinase 2 (TYK2) inhibitor, in the treatment of moderate to severe plaque psoriasis, met the primary endpoint. In patients treated for 12 weeks, ICP-488 demonstrated superior efficacy and safety. ICP-488 met multiple efficacy endpoints in the once-in-a-day 6 mg and once-daily 9 mg dose groups, including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (PASI score improvement from baseline ≥75%, ≥90%, and ≥100%), and static Clinician’s Global Assessment (sPGA) 0/1 (i.e., complete or basic clearance of lesions). The response rate of PASI 75 was 77.3% and 78.6%, respectively, in the once-daily 6 mg and 9 mg dose groups, compared with 11.6% in the placebo group (p<0.0001). The response rate of PASI 90 in the two dose groups reached 36.4% and 50.0%, respectively, compared with 0% in the placebo group (p<0.0001); The response ...
- Source: drugdu
- 71
- October 15, 2024
Jacobs’ Pan-KRAS inhibitor approved for clinical trial in the US

September 23, 2024 – The clinical trial application (IND) for Pan-KRAS inhibitor JAB-23E73 independently developed by JACOBIO was approved in the United States, and a Phase I/IIa clinical trial for advanced solid tumors will be conducted in the United States. The IND application for China has been submitted, and clinical trials will be conducted in China simultaneously after approval. KRAS is widely present in a variety of tumor mutations. 23%-25% of cancer patients have KRAS mutations. About 2.7 million new tumor patients with KRAS-related mutations each year are expected to benefit from Pan-KRAS inhibitors. JAB-23E73 can inhibit both active and inactive KRAS, and has no significant inhibition on HRAS and NRAS. As an oral KRAS inhibitor, JAB-23E73’s preclinical data showed good pharmacokinetic properties. JACOBIO is committed to providing patients with breakthrough treatment options. The company’s research projects are based on the six major tumor signaling pathways of KRAS, tumor immunity, ...
- Source: drugdu
- 74
- September 27, 2024
Yingsi Intelligent’s world’s first TNIK inhibitor ISM001-055 has achieved positive results in phase IIa clinical trials

·ISM001-055 is an innovative drug driven by generative artificial intelligence and fully developed independently by Insilicon Intelligence. It targets TNIK (Traf2/NCK interacting kinase) and has completed phase IIa clinical trials for the treatment of patients with idiopathic pulmonary fibrosis (IPF); ·This study lasted for 12 weeks, and its preliminary results showed that ISM001-055 exhibited good safety in IPF patients and showed a dose-dependent pharmacological trend in improving lung function indicators in patients; ·The positive clinical trial results of ISM001-055 also provide the first conceptual validation for AI driven drug development. Hong Kong, China, September 18, 2024- Yingsi Intelligent, a clinical stage biotechnology company driven by generative artificial intelligence (AI), announced that its pipeline ISM001-055 has achieved positive preliminary research results in a phase IIa clinical trial. ISM001-055 is a “first in class” small molecule inhibitor driven by generative AI for drug discovery and design, targeting TNIK (Traf2/NCK interacting kinase) for ...
- Source: drugdu
- 95
- September 23, 2024
Johnson & Johnson’s IL-23 Dual Inhibitor Guselkumab Approved by FDA for Ulcerative Colitis

On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-action inhibitor targeting interleukin 23 (IL-23) approved for the treatment of active ulcerative colitis, further solidifying Johnson & Johnson’s leadership in the field of inflammatory bowel disease. Guselkumab is the first approved interleukin 23 (IL-23) inhibitor in the world, selectively binding to the p19 subunit of IL-23 to inhibit its interaction with the IL-23 receptor. It has shown strong efficacy for various autoimmune diseases; it can block IL-23 while also binding to the CD64 receptors on cells that produce IL-23. It is currently approved for the treatment of plaque psoriasis, active psoriatic arthritis, and UC. Furthermore, in June 2024, Johnson & Johnson submitted a supplemental Biologics ...
- Source: drugdu
- 71
- September 18, 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
- 61
- September 13, 2024
Hengrui Pharmaceutical’s JAK1 inhibitor new indication application for market launch

Medical Guanlan Medical Guanlan September 5, 2024 08:35 Shanghai Reported by WuXi AppTec Content Team Today (September 5th), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) just announced that Hengrui Pharmaceutical’s application for the new indication of imatinib sulfate tablets has been accepted, but the specific indication has not been disclosed yet. Ivarmacitinib tablet is an orally administered highly selective JAK1 inhibitor, which has previously submitted three marketing applications in China for the treatment of ankylosing spondylitis, atopic dermatitis, and rheumatoid arthritis. According to publicly available information from Hengrui Pharmaceutical, imatinib (SHR0302) is a independently developed JAK inhibitor that targets JAK1. It can specifically block the JAK/STAT pathway and reduce adverse reactions such as anemia and thrombotic diseases, while achieving good clinical efficacy. As an oral small molecule targeted drug, the convenient administration method can significantly improve patients’ treatment ...
- Source: drugdu
- 81
- September 7, 2024
Hengrui Medicine’s “JAK1 inhibitor” application for alopecia areata indication has been accepted

Recently, the drug marketing authorization application for the JAK1 inhibitor amaxitinib sulfate tablets (SHR0302 tablets) was accepted by the State Food and Drug Administration. This product is suitable for adult patients with severe alopecia areata. At present, no JAK1 inhibitor self-developed by domestic companies has been approved for marketing. In addition to the indications for alopecia areata, the marketing authorization application for Amaxitinib Sulfate Tablets has been accepted by the State Food and Drug Administration for three indications, namely: moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, and ankylosing spine. inflammation and moderate to severe active rheumatoid arthritis. In June 2024, the main research endpoint of the Phase III clinical trial of Emmaxitinib Sulfate Tablets reached the superiority standard preset in the protocol. This study is a randomized, double-blind, and placebo-controlled Phase III study to evaluate the effectiveness and safety of amaxitinib sulfate tablets ...
- Source: drugdu
- 63
- September 7, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 121
- July 29, 2024

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