China Securities Intelligent Finance Changchun High & New Technology Industries Group(000661) announced on November 14 that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., recently received written notification from the U.S. Food and Drug Administration (FDA) that its clinical trial application for its independently developed injectable GenSci143 has been approved. GenSci143 is a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, with dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy, and is intended for the treatment of various advanced solid tumors such as prostate cancer and lung cancer. According to the announcement, the drug binds to B7-H3 or PSMA, internalizes into lysosomes to release TOPO-I inhibitor toxins, and kills tumor cells. Its dual-target synergistic effect can overcome tumor heterogeneity and drug resistance, cover more patients and produce a more durable anti-tumor effect. Previously, GenSci143 had been approved in China to conduct clinical trials for advanced solid tumors. The announcement stated ...
According to NBD AI News, on November 13th, Leadman…(300289.SZ) disclosed a draft report on a major asset purchase, proposing to acquire 70% of the shares of Xiansheng Xiangrui from Shanghai Baijiahui Investment Management Co., Ltd., Nanjing Baijiarui Enterprise Management Consulting Partnership (Limited Partnership), and Hainan Xiansheng Baijiahui Technology Development Co., Ltd. for RMB 1.733 billion in cash. The target company is mainly engaged in biological products.(In vivo diagnostic reagents, vaccines) and in vitro diagnosticsThe company focuses on the research, development, production, and sales of reagents, with its core products being TB-PPD, BCG-PPD, and IGRA, all concentrated in the field of tuberculosis screening and diagnosis. On the other hand, Simcere is one of the few companies in China holding a vaccine production license, focusing on innovative human vaccines that do not yet meet clinical needs. Simcere’s Xs03 project, applied to the field of meningitis, has submitted a pre-IND application, and several ...
Southern Finance reported on November 13th that the company recently received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration, approving a clinical trial of ZG006 for injection in combination with etoposide and cisplatin for advanced neuroendocrine carcinoma. This clinical trial approval will not have a significant impact on the company’s recent performance. However, given the long development cycle, numerous approval processes, and substantial R&D investment required for pharmaceuticals, they are susceptible to uncertainties. Investors are advised to exercise caution and be aware of investment risks. https://finance.eastmoney.com/a/202511133563656229.html
Shanghai Kaibao(300039) announced on November 11 that the company recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration. The drug name is KBZ24020. The approval conclusion is that the clinical trial application of KBZ24020 meets the relevant requirements for drug registration. Based on further improvement of the clinical trial protocol, the company agrees to conduct clinical trials for acute ischemic stroke. https://finance.eastmoney.com/a/202511113561164176.html
Beijing Business Daily (Reporter Ding Ning) – On the evening of November 13th, Borui Pharmaceutical…(688166) issued an announcement stating that its wholly-owned subsidiary, Borui Pharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as “Borui Pharmaceutical”), recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, agreeing to conduct clinical trials of Borui Pharmaceutical’s BGM1812 injection for overweight or obese patients. Borui Pharmaceuticals stated that, as of the date of this announcement, its BGM1812 injection for weight loss has received FDA approval for clinical trials in the United States, and the first clinical enrollment has been completed. As of the date of this announcement, no similar targeted formulations for weight loss have been approved for marketing globally. https://finance.eastmoney.com/a/202511133563845375.html
Hengrui MedicineOn November 3, (600276) announced that it had received a drug clinical trial approval notice from the National Medical Products Administration (NMPA) for Revelumid tablets, agreeing to conduct a Phase III clinical trial for prostate cancer. The company’s Revelumid tablets were approved for marketing in 2022 for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with a high tumor burden. https://finance.eastmoney.com/a/202511133563619583.html
People’s Finance News, November 13th – CanSino Biologics(688185) announced on November 13 that its inhaled tuberculosis vaccine (adenovirus type 5 vector) (hereinafter referred to as “inhaled tuberculosis booster vaccine”) recently started Phase I clinical trials in Indonesia and completed the enrollment of the first subject in Phase I clinical trials. https://finance.eastmoney.com/a/202511133563746120.html
Latest news indicates that US pharmaceutical giant Pfizer…Pfizer Inc. plans to sell its remaining stake in BioNTech SE, a COVID-19 vaccine partner. Sources familiar with the matter revealed that Pfizer plans to sell approximately 4.55 million BioNTech American Depositary Receipts (ADRs) via overnight block trade, with a price range of $108 to $111.70 per share. Based on the upper limit of the range, Pfizer could potentially raise approximately $508 million from this share sale. If this news is true, it would mark the “formal separation” of these two partners who were among the most profitable during the COVID-19 pandemic. Following the news, BioNTech SE shares fell nearly 4.4% in pre-market trading, currently trading at $106.82 per share; Pfizer shares fell slightly by 0.4% to $25.75. BioNTech was founded in 2008 and is headquartered in Mainz, Germany. It went public on Nasdaq in 2019.Going public. In 2020, Pfizer partnered with BioNTech ...
WeightWatchers intends to offer Novo Nordisk’s pill version of Wegovy if it makes its US debut next year following potential FDA approval, Reuters reported.1 Amid a field of telehealth companies selling versions of weight management drugs in microdoses, WeightWatchers aims to stand out among the pack in a market that continues to increase in competitiveness. “We have been working with Novo Nordisk ahead of time to support the launch of oral weight-loss medication,” Tara Comonte, the company’s CEO, commented to Reuters. “A lot of people don’t want an injection. And the convenience of a pill is going to be huge,” she said. FDA expands priority review for weight-loss therapies This comes during a time when when Eli Lilly and Novo Nordisk have been garnering momentum—last week, the FDA added Orforglipron and Wegovy to the Commissioner’s National Priority Voucher (CNPV) program, growing the initiative to a total of 15 products that ...
Antibiotic resistance is widely recognized as one of the most urgent public health challenges of the twenty first century. Now, a new study shows that even very small amounts of antibiotics that commonly appear in soil, rivers, wastewater, and agricultural runoff may significantly accelerate the spread of antibiotic resistance genes among bacteria. The research, published in Biocontaminant, investigates how four typical antibiotics found in the environment influence both vertical and horizontal gene transfer, the two major pathways through which bacteria pass on resistance. The team examined tetracycline, ampicillin, kanamycin, and streptomycin at concentrations ranging from extremely low environmental levels to sub inhibitory levels. These concentrations are commonly detected in rivers, farmland soil, livestock operations, and hospital wastewater. The scientists established three experimental models to capture how resistance spreads. The first model focused on vertical gene transfer, which refers to the passage of genes from parent cells to their progeny. The ...
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