PharmaFocus Today – Page 58 – media

Another new Alzheimer’s drug approved for home treatment

Recently, the U.S. FDA approved the marketing of lecanemab-irmb subcutaneous injection (U.S. trade name: LEQEMBI IQLIK™), jointly developed by Biogen and Eisai, for the maintenance treatment of early Alzheimer’s disease (AD). It is worth mentioning that this injection is the first Alzheimer’s disease treatment drug that patients can inject themselves at home. The entire injection process takes only 15 seconds, compared to the traditional intravenous injection of 1 hour, which greatly shortens the time and improves efficiency, freeing patients from tedious hospital treatment and enjoying a more free and flexible treatment experience. The price of this subcutaneous injection has not been released yet, but referring to the price of its intravenous formulation, lencanicarbozumab, the annual treatment cost of the intravenous formulation of lencanicarbozumab is approximately US$26,500 (approximately RMB 190,000) in the United States; and approximately RMB 180,000 per year in China. 01 Achieve home treatment According to data, Lecanemab was ...
- Source: drugdu
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- September 11, 2025
Prasugrel Hydrochloride Tablets Receive Clinical Trial Approval

An announcement was made on the evening of September 10th that the company’s holding subsidiary, Chongqing Pharmaceutical (Group) Co., Ltd., received the “Notice of Approval for Drug Clinical Trials” issued by the State Food and Drug Administration. After review, its applied “Prasugrel Hydrochloride Tablets” met the relevant requirements for drug registration and it was approved to conduct clinical trials. According to information, prasugrel hydrochloride tablets, originally developed by Daiichi Sankyo Co., Ltd., are a third-generation drug that inhibits ADP-activated platelet aggregation. They are indicated for preventing thrombosis in patients with acute coronary syndrome, stable angina, and previous myocardial infarction after percutaneous coronary intervention. They are currently available in over 70 countries and regions worldwide (though not in China). The company invested in and acquired the prasugrel hydrochloride tablet technology and exclusive patent license from Daiichi Sankyo Co., Ltd. It submitted its marketing registration application in August 2021 and was accepted. ...
- Source: drugdu
- 146
- September 11, 2025
Huisheng Bio’s self-developed GLP-1R/GCGR dual-target innovative drug P052 injection has been approved for clinical trials

Sihuan Pharmaceutical announced on the Hong Kong Stock Exchange on September 9 that its non-wholly owned subsidiary Huisheng Biopharmaceutical Co., Ltd. independently developed an innovative dual-target agonist drug for the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR).The clinical trial application for P052 Injection, a new drug, has received implicit approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the treatment of type 2 diabetes, overweight, or obesity. P052 Injection not only stimulates the GLP-1 receptor to promote insulin secretion, lower blood sugar, and reduce weight, but also stimulates the GCGR to increase energy expenditure, enhance weight loss efficacy, and improve liver fat metabolism. Preclinical data show that P052 Injection, an innovative dual-target GLP-1R/GCGR drug , has similar glucose-lowering effects as the single-target GLP-1 drug semaglutide injection, and significantly superior weight loss efficacy to semaglutide injection. Source: https://finance.eastmoney.com/a/202509093508169355.html
- Source: drugdu
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- September 11, 2025
9,000 layoffs worldwide

According to ABC News, Danish biopharmaceutical company Novo NordiskOn the 10th, it announced that it would lay off 9,000 employees in a new round of global restructuring, accounting for about 11% of the company’s total employees. As competition in the weight loss drug market intensifies, Novo Nordisk ‘s move aims to streamline its organizational structure and speed up decision-making. Through the new restructuring plan, Novo Nordisk expects to save 8 billion Danish kroner (about 8.9 billion yuan) in expenses by the end of 2026. The savings will be used for its diabetes and obesity business, including research and development. Novo Nordisk currently has approximately 78,400 employees worldwide, of which approximately 5,000 are located in Denmark. The company said the layoffs will begin immediately and affected employees will be notified in the coming months in accordance with local labor laws. Source：https://finance.eastmoney.com/a/202509113510238567.html
- Source: drugdu
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- September 11, 2025
Infant neurodevelopment not affected by brief inhaled anesthesia during surgery

Preliminary findings from a new clinical trial show no adverse neurodevelopmental effects after brief inhaled anesthesia and surgery in infants and young children, reports the Online First edition of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists (ASA). A “balanced” strategy using a lower dose of the inhaled anesthetic sevoflurane did not lead to meaningful short-term differences in IQ or child behavior problems, according to the study by Ji-Hyun Lee, M.D., Ph.D., of Seoul National University Hospital, Republic of Korea, and colleagues. “These findings support existing evidence suggesting that brief anesthetic exposure is unlikely to result in clinically significant neurodevelopmental impairment,” the researchers wrote. Animal studies have raised concerns about possible neurotoxic effects of general anesthetic or sedative drugs in young children. In response, the U.S. Food and Drug Administration issued warnings in 2017 that long-lasting or repeated exposure to these drugs “may negatively affect brain development ...
- Source: drugdu
- 147
- September 10, 2025
New Hampshire Man Doing Well After Experimental Pig Kidney Transplant

Bill Stewart, an athletic trainer from Dover, underwent the procedure June 14 at Massachusetts General Hospital (Mass General) in Boston. “I really wanted to contribute to the science of it,” Stewart told The Associated Press. Stewart’s case marks another step forward for the Mass General team, which is also following the progress of Tim Andrews, a New Hampshire man who has now lived seven months with a transplanted pig kidney — the longest known survival time for a gene-edited pig organ to date. The previous record was 130 days. Based on lessons from these early cases, the U.S. Food and Drug Administration (FDA) has granted approval to biotech company eGenesis to launch a clinical trial that will transplant gene-edited pig kidneys into 30 patients who are 50 or older and on dialysis while awaiting a human kidney, The Associated Press said. “Right now we have a bottleneck,” said Dr. Leonardo ...
- Source: drugdu
- 138
- September 10, 2025
Akeso Biopharma Updates HARMONi Study Data

Recently, Summit Therapeutics, a partner of Kangfang Biopharma, announced updated data from the first global multicenter Phase III clinical HARMONi study of Ivoside at the World Lung Cancer Conference (WCLC 2025): OS HR = 0.78 (P = 0.0332), an improvement compared to the previous analysis results in May (HR = 0.79, p = 0.057); The OS benefit was more significant in the North American population, with OS HR=0.70. Ivoside (AK112) is a world-first PD-1/VEGF dual antibody developed by Kangfang Biopharmaceuticals. Previously, the China National Medical Products Administration (NMPA) approved Ivoside for the treatment of EGFR-mutated nsq-NSCLC that progressed on EGFR-TKI treatment based on the HARMONi-A study, and approved Ivoside for the first-line treatment of PDL1-positive NSCLC based on the HARMONi-2 study. The results of the HARMONi-A study showed that Ivoside therapy achieved the OS clinical endpoint and achieved clinically meaningful and statistically significant OS benefits. The HARMONi study was an ...
- Source: drugdu
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- September 10, 2025
Henlius’ biosimilar HLX17 receives FDA approval for clinical trials, entering the over $30 billion market

On September 8, Henlius Biosciences (02696) announced that it received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of its independently developed pembrolizumab biosimilar, HLX17, in patients with various resected solid tumors. The company plans to conduct this international, multicenter clinical trial in the United States once conditions permit. The potential indications of HLX17 include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair gene-deficient tumors and gastric cancer. According to relevant information, in 2024, the global sales of pembrolizumab will be approximately US$32.056 billion. Source：https://finance.eastmoney.com/a/202509083507721654.html
- Source: drugdu
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- September 10, 2025
Samsung Biopharma signs $1.29 billion contract with US pharmaceutical company

Samsung Biologics announced on September 9th that it had signed a contract manufacturing organization (CMO) contract worth US$1.29464 billion (approximately 1.8001 trillion won) with a US pharmaceutical company. This contract, the second-largest order in the company’s history, runs until December 31, 2029. The client and product names are not being disclosed due to confidentiality clauses. Source：https://finance.eastmoney.com/a/202509093508399792.html
- Source: drugdu
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- September 10, 2025
Beike Biopharma initiates Phase I clinical trial of HSV-2 mRNA vaccine

According to People’s Finance News on September 9, ” Bai Ke BioAccording to a WeChat official account, on September 9th, Beike Bio successfully held a kickoff meeting for the “Phase I Dose-Escalation Trial of the Safety, Tolerability, and Immunogenicity of an HSV-2 mRNA Vaccine in Subjects Aged 18 to 55 with Different Serological Infections” at Beijing Jishuitan Hospital. The kickoff meeting provided systematic training and work deployment on core topics such as genital herpes disease and vaccine development background, GCP standards, clinical trial protocols, investigator brochures, sample management, and on-site procedures. Subsequently, all work preparations were in place, and subject enrollment was about to begin in full swing. Source：https://finance.eastmoney.com/a/202509093508939621.html
- Source: drugdu
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- September 10, 2025

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