PharmaFocus Today – Page 11 – media

Receives Approval Notice for Drug Clinical Trial

　　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
- Source: drugdu
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- November 14, 2025
//finance.eastmoney.com/a/202511133563845375.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
- Source: drugdu
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- November 14, 2025
Clinical trials of Revelumid tablets approved

　　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
- Source: drugdu
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- November 14, 2025
Inhaled tuberculosis booster vaccine initiates Phase I clinical trial in Indonesia and completes first subject enrollment.

　　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
- Source: drugdu
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- November 14, 2025
Pfizer plans to sell its stake in BioNTech for $500 million.

　　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 ...
- Source: drugdu
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- November 14, 2025
WeightWatchers to Offer Novo Nordisk’s Oral Wegovy, if Approved Next Year

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 ...
- Source: drugdu
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- November 14, 2025
Tiny antibiotic traces found to greatly accelerate resistance spread

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 ...
- Source: drugdu
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- November 14, 2025
its application for marketing authorization of pertuzumab injection has been accepted.

　　On November 12, CSPC Pharmaceutical Group (01093) issued an announcement stating that the marketing application of pertuzumab injection developed by its subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration. This product is a recombinant humanized anti-HER2 monoclonal antibody injection, mainly used to treat HER2-positive breast cancer. The product has good safety and tolerability, comparable to the original reference drug. https://finance.eastmoney.com/a/202511123562408428.html
- Source: drugdu
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- November 13, 2025
The clinical trial application for BaiKe Bio-Adsorbed Cell-Free Two-Component Diphtheria-Tetanus Combined Vaccine has been approved

　　On November 12th, BaiKe Biotechnology(688276) issued an announcement stating that it recently received the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration for its adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine (for adults and adolescents). 　　This vaccine is designed to prevent pertussis, diphtheria, and tetanus, and is intended for individuals aged 10 years and older. The approval notification number is 2025LP02992, the acceptance number is CXSL2500724, and the approval date is November 11, 2025. 　　The announcement also mentioned that there is some uncertainty regarding the conduct of subsequent clinical trials, and there is also uncertainty regarding whether commercial objectives can ultimately be achieved. 　　In the first three quarters of 2025, BaiKe Bio achieved revenue of 474 million yuan and net profit attributable to the parent company of -158 million yuan. https://finance.eastmoney.com/a/202511123562254094.html
- Source: drugdu
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- November 13, 2025
Novo Nordisk’s stock price surged after the company announced a series of major news items, withdrawing from the bidding process and receiving support from Wall Street.

　　On Tuesday (November 11), at the close of US stock trading, Novo Nordisk…U.S. stocks rose nearly 7% to $49.15. 　　Earlier today, data from the Phase II clinical trial of Novo Nordisk ‘s experimental drug coramitug (formerly known as PRX004) were presented at the American Heart Association Scientific Sessions and published in the American Heart Association journal Circulation. 　　PRX004, developed by the biotechnology company Prothena, is a novel monoclonal antibody drug designed to eliminate amyloid protein associated with the pathology of hereditary and wild-type ATTR amyloidosis (hATTR and wtATTR) without affecting the protein’s native, normal tetrameric form. In 2021, Novo Nordisk acquired the drug for $1.23 billion. 　　Phase II data presented at the conference showed that a dose of 60 mg/kg coramitug reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration by 48%. (NT-proBNP is a key indicator for diagnosing ATTR-CM and assessing disease severity and prognosis.) 　　However, the lower dose of 10 ...
- Source: drugdu
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- November 13, 2025

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