Search Results for “ breast cancer” – Page 19 – media

EGFR mutated NSCLC has an ORR of 80%! Zhikang Hongyi CDH3 ADC announces latest clinical results

Insight Database On September 14th, Zhikang Hongyi announced the latest clinical data (NCT05957471) on the safety and efficacy of its globally exclusive antibody conjugated drug BC3195 (CDH3 ADC) in phase I clinical trials for advanced solid tumors at the 2024 ESMO Annual Meeting. The ORR for patients carrying EGFR mutations reaches 80%.Image source: ESMO official website BC3195 uses antibodies with high affinity for CDH3 protein and exhibits good endocytic activity, as well as clinically validated linkers and effective payload vc MMA with bystander effect. The data released this time shows that BC3195 has controllable security and good PK characteristics. BC3195 has shown significant anti-tumor activity in NSCLC patients, with an overall response rate (ORR) of 36.4%, especially for patients carrying EGFR mutations with an ORR of 80%. The data deadline is August 10, 2024. This phase I clinical study enrolled a total of 34 patients, all of whom were late stage ...
- Source: drugdu
- 75
- September 25, 2024
Junshi Biosciences’ PD-1 Approved in the EU, Achieving Market Launch in China, the US, and Europe

As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
- Source: drugdu
- 101
- September 25, 2024
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
Five innovative medical devices enter special review process

Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services. In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease ...
- Source: drugdu
- 78
- September 20, 2024
The highest increase was 103398%! The revenue of these pharmaceutical companies soared

In September, the 2024 semi-annual reports of various companies have basically been disclosed. According to statistics from Cyber Blue, among the 493 A-share listed pharmaceutical companies (according to the industry classification of Tonghuashun, the same below), the number of companies with year-on-year decline and growth is close to “50-50” – 242 pharmaceutical companies have a year-on-year decline in revenue, accounting for 49% of the total; 252 have an increase in revenue, accounting for 51% of the total. Among the 242 pharmaceutical companies whose revenue decreased compared with the same period last year, 40% of them fell by less than 10%; there were 12 companies with a decline of more than 50%, of which the company with the largest decline had a year-on-year revenue decline of more than 97%. Among the 252 pharmaceutical companies with year-on-year revenue growth, 183 had an increase of less than 20%, accounting for ...
- Source: https://mp.weixin.qq.com/
- 55
- September 12, 2024
2024 Chinese Small Molecule Targeted Anti Tumor Drugs White Paper

The current development status of the global and Chinese small molecule anti-tumor targeted drug industry China is a major cancer country in the world. The main types of malignant cancer in China are lung cancer, gastric cancer, colorectal cancer, liver cancer, breast cancer and esophageal cancer. The high incidence and death of cancer patients has created a huge demand for innovative therapeutic drugs and treatment schemes. From the perspective of the overall Chinese market, the market size of small molecule anti-tumor drugs in China will reach 73.4 billion yuan in 2023, and it is expected to further grow to 207.5 billion yuan in 2030. The compound annual growth rate during this period is 16.0%, far exceeding the global level during the same period, demonstrating the strong growth momentum of the Chinese market. Representative enterprise of China’s small molecule anti-tumor targeted drug industry – Zhejiang Tongtongkang Pharmaceutical From the perspective of ...
- Source: drugdu
- 97
- September 3, 2024
Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
- Source: drugdu
- 58
- August 19, 2024
US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 68
- August 15, 2024
Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, ...
- Source: drugdu
- 98
- August 12, 2024
Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
- Source: drugdu
- 91
- August 6, 2024

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