China's urinary skin cancer (UC) the first PD-(L)1 treatment! Baiji Shenzhou Baize an ® (for Reli Zuma mono-resistance) was approved the 2nd indication!

April 11, 2020 /
PRNewswire
BIOON/ -- BeiGene, a commercial biotech company focused on the development and commercialization of innovative molecular targeting and immuno
-oncology drugs for cancer treatment Recently, the company announced that the anti-PD-1 antibody drug Baczean ® (generic name: Tirelli-Zandu monoantigen) was approved by the National Drug Administration (NMPA) for the treatment of patients receiving advanced localized or metastatic urinary disease (UC) with a high level of advanced topical or metastatic PD-L1 within 12 months of treatment of platinum-containing chemotherapy failures, including new or auxiliary chemotherapy Global, 10 PD-(L)1 treatments have been approved, eight of which have been approved in China Of the 10 treatments, six have been approved for URric disease (UC) indications It is worth mentioning that the ® is the first anti-PD-(L)1 treatment approved for UC (click on the picture for a larger view) Baczean ® received NMPA approval for the treatment of classic Hodgkin lymphoma patients for the first time in December 2019, the UC is the second indication approved by the Baczean ® and the first approved meta-tumor indication Previously, the application for a new indication (NDA) had been included in the priority review by the Drug Review Centre (CDE) of the National Drug Administration "Baiji Shenzhou has always been committed to bringing influential, high-quality, innovative drugs to patients around the world," said Dr Wu Xiaobin, General Manager and President of Baiji Shenzhou China, This is the third listing approval we have received in the past five months for our own research and development, a huge achievement for a young biotech company like Baiji Shenzhou and a recognition of the hard work of our team The company's long-term strategic plan for the ® of Baczean is to obtain broad indicationapproval to help patients fighting different cancers This is the first approved meta-tumor indication ®, and we are excited about the prospect of this immuno
tumor drug Professor Ye Dingwei, Vice Dean of the Hospital of Oncology affiliated with Fudan University in , commented: "For patients with advanced urinary tract cancer in China, the existing treatment options are very limited As a new immuno-oncology treatment drug, Terrey Pearl mono-injects has gained welcome clinical effectiveness and safety, with an objective remission rate of 24.8%, and we expect it to bring more far-reaching clinical benefits to patients with tumor in China "
, Senior Vice President of Baiji Shenzhou, Global Pharmaceutical Affairs, Ms Zou Xiaojun, said: "We are pleased to see that Baizean ®'s application for the listing of UC Indications has been approved." Today's results cannot be achieved by the clinical experts involved in this trial, the patients who entrust their cancer treatments to our team Currently, the broad range of development projects in babesan ® include 15 potential registered clinical trial , covering a wide range of cancers, including lung cancer, liver cancer
, esophageal cancer, stomach cancer, nasopharyngeal cancer, and high satellite instability (MSI-H) or mismatched repair of defective (dMMR) solid tumors, in addition to the approved classic Hodgkin's lymphoma and UC We hope that the ® will continue to do so to bring good news to more patients "
this ® obtained NMPA approval is based on a single arm, multicenter, critical Phase 2 clinical trial (clinicaltrial.gov registration number: NCT04004221; drug
clinical trial registration number: CRT2017071) conducted in China and South Korea for the treatment of patients who have received platinum-containing chemotherapy and pD-L1 high expression In patients who met the efficacy assessment, the objective remission rate (ORR) assessed by the Independent Review Committee (IRC) based on reCIST solid tumor effectiveness assessment criteria 1.1 was 24.8% , with a total remission (CR) rate of 9.9% safety data in the ® specification of Baczean came from 934 patients involved in four per® single-drug clinical trials, including the previously mentioned critical Phase 2 clinical trial for UC The most common adverse reactions (up to 10%) were increased rashes, fatigue, and acetaminophen transferase adverse reactions of level 3 or above in at least 1% of patients include elevated gamma-glutamine transferase, anemia , elevated acetaminopheniaminopheniactosis, elevated acetaminophen tomography, pneumonia (non-infectious), severe skin reactions, and hypokalemia Bacazean ® similar to similar products, may occur immunorelated adverse reactions, including pneumonia, diarrhea and colitis, hepatitis, endocrine diseases (thyroid dysfunction, hyperthyroidism and thyroiditis, adrenal cortex dysfunction, hyperglycemia and type I diabetes ) and adverse skin reactions, in addition to nephritis, pancreatitis, myocarditis, myositis and other immune-related adverse reactions are also occasionally occurred Baczean ® intravenous infusion of the method of administration, the recommended dose of 200 mg, every 3 weeks Medication until the disease progresses or becomes intolerant of toxicity urinary malcy (UC): , also known as metastasis cell carcinoma (TCC), is currently the most common type of bladder cancer, accounting for more than 90% of all bladder cancer cases Bladder cancer is the world's 10th most common cancer, with about 550,000 new cases in 2018 Bladder cancer is the eighth most common cancer among men in China, with about 62,000 new cases in 2019 Although UC is most commonly found in the bladder, it can also occur in other parts of the urinary system Baczean ® (Treli-Z) (Treli-Z) is a human-derived lgG4 anti-procedural death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to fc-R receptors in macrophages Preclinical data show that the binding of the Fc'r receptor in macrophages activates antibody-dependent cell-mediated killer T cells, thereby reducing anti-tumor activity of PD-1 antibodies TreliZuma, the first drug developed by Baiji Shenzhou's immuno-oncology bioplatform, is currently undergoing clinical trials for single-drug and combination therapy to develop a range of awidey indications for solid tumors and blood tumor . The ® has been approved by the State Drug Administration (NMPA) for the treatment of patients with recurrent or incurable classic Hodgkin's lymphoma with at least second-line system chemotherapy, as well as platinum-containing chemotherapy failures for the treatment of PD-L1 high expression, including localized advanced or metastatic urinary tract cancer patients within 12 months of advances in new or assisted chemotherapy. (biovalleybioon.com) original source: Baiji Shenzhou, U.S FDA new drug database