Search Results for “antibody” – media

Over 5.7 billion! China’s dual antibody ADC goes global+1

On November 18th, VelaVigo Cayman Limited announced a global strategic partnership agreement with Avenzo Therapeutics, Inc. (Avenzo). According to the agreement, Orange Sail Pharmaceuticals will grant Avenzo the development, production, and commercialization of Nectin4/TROP2 bispecific antibody conjugates worldwide (excluding Greater China), while retaining relevant rights in Greater China. Both parties will jointly promote the development and clinical application of the project on a global scale. The project plans to submit an IND to the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) of China by 2025. According to the terms of the agreement, Orange Sail Pharmaceuticals will receive a down payment of up to $50 million and recent milestone payments. After achieving key milestones in development, regulatory approval, and sales, the company is expected to receive up to $750 million in follow-up milestone payments and tiered royalty payments based on sales in the Avenzo region. ...
- Source: drugdu
- 32
- November 21, 2024
Domestic dual antibody makes another breakthrough

Introduction: Has the best potential in its class Recently, Weili Zhibo announced that its independently developed Class 1 new drug LBL-034, which has global intellectual property rights, has been granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). LBL-034 is a new generation of humanized bispecific T cell linker antibody targeting GPRC5D and CD3, developed using LeadsBody TM, a CD3 bispecific technology platform independently developed by Weili Libo with intellectual property rights. It is the third CD3 T cell linker targeting GPRC5D to enter the clinical stage worldwide. Figure 1: GPRC5D/CD3 dual antibody under global research Image source: Pharmaceutical Intelligence Data Multiple myeloma (MM) is a malignant plasma cell disease caused by abnormal proliferation of clonal plasma cells, accounting for approximately 10% of hematological malignancies and 1% of all tumor diseases. MM is still an incurable malignant tumor. With ...
- Source: drugdu
- 58
- November 9, 2024
Cytokines

Preface B cells are the only cell type capable of differentiating into antibody secreting cells (plasma cells), and they can also present antigens to T cells and produce cytokines. By producing cytokines, B cells affect multiple aspects of immunity: cytokines derived from B cells, including lymphotoxins, are crucial for the individual development, homeostasis, and activation of secondary lymphoid organs, as well as the development of tertiary lymphoid tissue in ectopic sites; Other cytokines derived from B cells, such as interleukin-6 (IL-6), interferon – γ, and tumor necrosis factor, can affect the development of effector cells and memory CD4+T cell responses; Finally, B cells can regulate inflammatory immune responses by secreting IL-10 and IL-35, and “regulatory B cells” are the main source of inhibitory cytokines derived from these B cells in the body. The role of B cells in tissue development and repair Lymphatic organogenesis is mainly regulated by lymphoid tissue ...
- Source: drugdu
- 65
- November 7, 2024
Victory! FDA approves Pfizer’s hemophilia A or B monoclonal antibody drug Marstacimab

Pfizer – after starting a showdown with a radical investor, being betrayed by two former executives, reuniting with two former executives, and ending work on an RSV drug – finally has some good news, straightforward. On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity ...
- Source: drugdu
- 74
- October 15, 2024
FDA Approves Pfizer’s Hemophilia A or B Monoclonal Antibody Drug Marstacimab

On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity of factor replacement and the moderate improvement of Mastacrolizumab compared to conventional prevention, Pfizer will have to rely to some extent on the argument of convenience to gain traction, “TD Cowen analyst wrote in a ...
- Source: drugdu
- 62
- October 15, 2024
Over $440 million! Jiahe Biologics’ new dual-antibody drug goes overseas

On August 5, Hong Kong-listed innovative pharmaceutical company Jiahe Biologics (06998.HK) announced that the group entered into a licensing agreement and equity agreement with TRC2004, Inc. on August 2. Pursuant to the License Agreement, the Group has agreed, among other things, to grant TRC2004 an exclusive global license (excluding Mainland China, Hong Kong, Macau and Taiwan) to develop, use, manufacture, commercialize and otherwise exploit GB261. According to the terms of the license agreement and equity agreement, as consideration for the license, the Group will receive a considerable amount of equity in TRC2004, an down payment of tens of millions of US dollars, milestone payments of up to US$443 million, and a single-digit to double-digit share of net sales. percentage tiered royalties. CD3/CD20 inhibitor potential stocks. GB261 is a new type of differentiated CD20/CD3 bispecific T cell engager (TCE) and the first T cell engager (T-cell Engager) that binds to CD3 ...
- Source: drugdu
- 66
- October 11, 2024
PCSK9 antibody marketing application received notification

On September 29, 2024, two acceptance numbers for Junshi Biosciences’s PCSK9 antibody marketing application were notified, indicating that they have not been approved (possibly due to voluntary withdrawal or pending approval). In April 2023, Junshi Biosciences received 4 acceptance numbers for its PCSK9 antibody market application, of which 2 were notified this time, and the other 2 have not yet received results. Four acceptance numbers involve two specifications (pre filled syringes, pre filled automatic syringes) and two indications. This two notifications indicate that a certain specification or indication has not been approved. The competition for PCSK9 targets is particularly fierce. In addition to antibodies from Amgen and Sanofi, PCSK9 antibodies from Sinovac Biotech and PCSK9 siRNA from Novartis have already been approved for marketing. Among them, Novartis’ PCSK9 siRNA only needs to be administered once every six months. For this target, there are more differentiated products under development, including Merck’s ...
- Source: drugdu
- 72
- October 9, 2024
Global Leader! Qilu Pharmaceutical’s ATO Combination Antibody Approved for Second-line Treatment of Cervical Cancer

Recently, the combination antibody of apalutamide toripalimab (QL1706, trade name: Qilu’an, hereinafter referred to as “etuo combination antibody”) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of recurrent or metastatic (R/M) cervical cancer patients who have failed platinum-based therapy. This milestone development not only signifies a major breakthrough in the treatment of advanced cervical cancer in China, but also heralds a new stage of development for cancer immunotherapy.It is reported that the Etu combination antibody is the first dual-function combination antibody targeting PD-1 and CTLA-4 designed and produced by Qilu Pharmaceutical through its self-developed MabPair®️ technology platform. It has shown great potential in the treatment of solid tumors such as cervical cancer, lung cancer, and liver cancer, demonstrating both efficacy and safety. With its unique mechanism, it is at the forefront of the journey of tumor dual immunotherapy strategy!Cervical cancer is the ...
- Source: https://mp.weixin.qq.com
- 101
- October 2, 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
- 120
- 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
- 63
- September 16, 2024

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