Search Results for “arthritis” – Page 4 – media

Yuheng Biotechnology announces the release of APHEXDA (Antifotide) ®, Motixafortide has been approved for marketing by the Macau Drug Administration in China

Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®， Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
- Source: drugdu
- 164
- September 23, 2024
How many drugs does Biotech need to sell to avoid losing money?

Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
- Source: drugdu
- 58
- September 20, 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
- 70
- September 18, 2024
Leading the development of antibody drugs! Zhengda Tianqing Nanjing Shunxin Pharmaceutical was recognized as “Nanjing Engineering Research Center”

The “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” built this time aims at the difficulties and pain points of key technologies and results transformation in the process of antibody drug research and development and industrialization. It will build and improve the two key platforms of “core technology breakthrough” and “innovation results transformation” to conduct independent localization research on materials and consumables required for the production of biological products, including cell culture medium, protein chromatography medium and virus removal nanofiltration membrane, and carry out results transformation and industrialization development for key innovative antibodies, antibody-drug conjugates and recombinant humanized proteins. Next, the “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” will further promote the development of biological products and the joint development of upstream and downstream industrial chains, complete the transformation from biosimilars to innovative biological products, develop new antibody drugs with independent intellectual property rights, and ensure the ...
- Source: drugdu
- 123
- September 18, 2024
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
Milestone! Symptoms completely disappeared, dual-antibody treatment of autoimmune diseases published in the New England Journal of Medicine

Targeting B cells and plasma cells is a key strategy for treating a variety of autoimmune diseases. In recent years, chimeric antigen receptor T cell (CAR-T) therapy has made some progress in autoimmune diseases, and many patients who received CD19-targeted CAR-T therapy have achieved long-term drug-free remission. However, the long production process of this type of therapy, the need for patients to undergo pretreatment in advance, and the inability to flexibly adjust the dose of CAR-T cells after the start of treatment have limited its widespread application. In addition, for some patients, their disease may be caused by long-lived plasma cells that express B cell maturation antigen (BCMA) but not CD19. Therefore, even after receiving CD19-targeted CAR-T therapy, autoimmune antibodies such as antinuclear antibodies and polymyositis-scleroderma-associated antibodies (PM-Scl) still exist in patients. In view of the limitations of CAR-T therapy in the application of autoimmune diseases, researchers have set their ...
- Source: drugdu
- 86
- September 16, 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
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
- 79
- 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
- 60
- September 7, 2024
Chongqing’s first Class 1 innovative biological drug is launched

On August 27, Chongqing’s first Class 1 biological innovative drug, Celici monoclonal antibody injection, was approved for marketing, achieving a “zero” breakthrough in Chongqing’s biological product innovative drug track. According to Zhixiang Jintai’s official microblog, Celici monoclonal antibody injection is its first product approved for marketing and the first fully human IL-17A target drug in China. Indications for the birth of the “king of medicine” Moderate to severe plaque psoriasis as an indication is regarded as the “Gold Coast” in the field of autoimmune indications. The former “king of medicine” Humira was born from it. Due to the complexity of the psoriasis pathway itself, there are also many antigens that can be targeted in the pathway. The more typical one is the previous generation of “king of medicine” Humira. Adalimumab is a monoclonal antibody targeting TNF-α. This target has a wide range of adaptability for autoimmune diseases. Its indications range ...
- Source: drugdu
- 73
- August 31, 2024

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