The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CFDA) announced that Bayer has received implicit approval for clinical trials for its Category 1 new drug, BAY 3713372 tablets, intended for the treatment of methylthioadenosine phosphorylase-deficient (MTAP-DEL) solid tumors. This is an oral small molecule PRMT5 inhibitor. In March of this year, Bayer and Puhe Pharmaceuticals announced a global licensing agreement, granting them exclusive global rights to develop, manufacture, and commercialize this product. Comment: Bayer’s small molecule PRMT5 inhibitor has received clinical approval in China, which is expected to bring new hope to patients with MTAP-DEL solid tumors.It selectively targets cancer cells, has high safety, and has received technical support through cooperation with Puhe Pharmaceutical. Subsequent clinical data is highly anticipated. https://finance.eastmoney.com/a/202508273495486977.html
Drugdu.com expert’s response: Development Trends in the Complex Formulation Industry I. Complex formulation processes will gain broader development opportunities Formulation innovation can extend the lifecycle of new molecular entities while enhancing the safety, efficacy, and patient compliance of existing products, making it a focal point of pharmaceutical R&D. For instance, conventional leuprolide formulations have gradually been phased out, whereas leuprolide microspheres remain a first-line treatment for prostate cancer and uterine fibroids. In 2022, the market size of leuprolide microspheres in China reached approximately RMB 4.8 billion, with steady year-on-year growth. China’s 14th Five-Year Plan for the Pharmaceutical Industry emphasizes the need to prioritize the development of complex formulation technologies for chemical drugs, including high-selectivity, long-acting controlled-release injectables (e.g., microspheres) and oral formulations such as controlled-release and multi-particulate systems. Enterprises mastering innovative complex formulation processes are poised to stand out and secure greater profit margins. II. Significant potential for import substitution by domestic ...
On the evening of August 27th, Xingqi Eye Medicine released its semi annual report for 2025. During the reporting period, the company achieved a revenue of 1162742877.58 yuan, an increase of 30.38% compared to the same period last year; The net profit attributable to shareholders of the listed company was 334826054.80 yuan, a significant increase of 97.75% compared to the same period last year. As a national high-tech enterprise mainly engaged in the subdivision of ophthalmic drugs, the company continues to focus on the ophthalmic field, adhere to the path of professional development, and continuously enhance its industry status and market competitiveness. During the reporting period, the company’s management team, under the leadership of the board of directors, focused on the company’s development strategy and business goals, consolidated the foundation of early development achievements, deepened resource integration, improved internal management level, actively and orderly promoted and implemented various important work ...
According to the National Healthcare Security Administration, from August 12 to August 18, 2025, the National Healthcare Security Administration publicly announced the list of drugs that have passed the preliminary form review for the adjustment of the 2025 National Basic Medical Insurance, Maternity Insurance, Work Injury Insurance Drug Catalog, and Commercial Insurance Innovative Drug Catalog. During the public announcement period, a total of 75 feedback comments were received. According to the collected opinions, the National Healthcare Security Administration has reviewed and revised the relevant drug review results in accordance with the procedures. A total of 6 drug form review results have changed, all of which are drugs that have applied for the basic medical insurance catalog. The specific situation is: 1. Change the status of injectable risperidone microspheres to not pass the formal review; 2. Change the form review of triptorelin hydrochloride for injection to not pass; 3. Levodopa ...
Bayer Global announced that its New Drug Application (NDA) for Gadoquatrane was accepted for review by the U.S. FDA. Gadoquatrane’s NDA was filed for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other regions of the body in adults, and pediatric patients. Dr. Konstanze Diefenbach, head of radiology research & development at Bayer’s Pharmaceuticals Division touched on the importance of Gadoquatrane’s approval, saying, “Chronic diseases like cancer, neurological disorders like multiple sclerosis and cardiovascular conditions are on the rise, leading to an increase in medical imaging. Patients, especially those who require multiple examinations over the course of their lives, can benefit from a reduced contrast media dosage.”1 What is Gadoquatrane? Gadoquatrane is an investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. A low-dose gadolinium-based contrast agent featuring a distinct tetrameric structure with high stability and high relativity.1 The agent is part ...
By Stephanie Brown HealthDay ReporterWEDNESDAY, Aug. 27, 2025 (HealthDay News) — The U.S. Food and Drug Administration has sent letters to health care providers alerting them to the importance of following manufacturer instructions for the safe use of hyperbaric oxygen therapy (HBOT) devices. HBOT uses a pressurized chamber to deliver 100 percent oxygen, helping the lungs absorb more oxygen to support healing and fight infections, according to the FDA. The agency has recently received reports of fires with HBOT devices causing serious injuries and deaths. Though rare, these events highlight the importance of following manufacturer instructions to reduce risks, the FDA notes. The agency advises health care providers to follow strict fire prevention and safety measures with HBOT devices, including proper grounding. Staff working with HBOT devices should receive ongoing training and always keep in mind that high concentrations of oxygen increase the risk for fire. Patients need to be ...
If the GLP-1 drug battle between Novo Nordisk and Eli Lilly were a football match, then 2021-2025 would be the first half, with Novo Nordisk’s earlier launches giving Eli Lilly’s product a head start. However, the situation seems poised to reverse in the second half, which begins in 2026. In 2026, we will achieve comprehensive transcendence According to Bloomberg’s forecast, Mounjaro and Zepbound will surpass Ozempic and Wegovy in 2026, and the gap will widen significantly in the next three years (Figure 1). Figure 1 Historical sales and future sales forecast trends of Wegovy, Ozempic, Mounjaro, and Zepbound Image source: Bloomberg In 2025, Novo’s semaglutide combination (Ozempic + Wegovy) will have a total revenue of US$33.6 billion, still higher than Lilly’s tirzepatide combination (Mounjaro + Zepbound) of US$31.1 billion; by 2026, the positions will be reversed, with Eli Lilly’s tirzepatide products totaling US$40.8 billion, ahead of Novo Nordisk’s semaglutide of ...
On August 25, Hengrui Medicine (600276/01276) issued an announcement that the company recently received the “Drug Clinical Trial Approval Notice” for HRS-6093 tablets approved and issued by the National Medical Products Administration, and will conduct clinical trials in the near future. This drug is a novel, highly potent, and selective oral KRASG12D inhibitor that specifically binds to the mutant KRASG12D protein, exerting anti-tumor effects. Currently, no similar products have been approved for marketing in China or abroad. To date, the cumulative R&D investment in the HRS-6093 tablet project has reached approximately 29.84 million yuan. According to the relevant laws and regulations on drug registration, after obtaining approval for clinical trials, drugs still need to undergo clinical trials and be reviewed and approved by the National Medical Products Administration before they can be produced and marketed. There is uncertainty in the drug research and development and marketing process. By mid-2025, Hengrui ...
Recently, Wantai BioThe company disclosed its 2025 semi-annual report, showing that its operating income in the first half of the year was 844 million yuan, a year-on-year decrease of 38.25%; its net profit attributable to shareholders of the parent company turned from profit to loss to -144 million yuan, a year-on-year decrease of 155.3%; its non-net profit was as low as -243 million yuan, a year-on-year decrease of 481.93%. Regarding the decline in revenue and net profit, Wantai Biological explained that it was mainly due to the fact that the company’s vaccine segment was affected by market adjustments, government procurement and the expansion of the age limit for the nine-valent HPV vaccine, resulting in sales falling short of expectations and a decline in revenue from the vaccine segment compared with the same period last year. Regarding the company’s sharp decline in first-half performance and subsequent boosting measures, a reporter from ...
On August 25, Lepu Medical(300003) announced that its holding subsidiary, Minwei Bio, independently developed an innovative drugMWN109 injection is currently undergoing Phase II clinical trials for the treatment of overweight or obesity, and the first subject was successfully dosed recently. The drug is a GLP-1/GIP/GCG receptor triple agonist with global intellectual property rights .MWN109 injection is designed to effectively control blood sugar and reduce weight by stimulating pancreatic beta cells to secrete insulin and increase satiety. MWN109 injection received clinical trial approval from the National Medical Products Administration in November 2024. A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial has been initiated, primarily investigating the effectiveness of different doses of MWN109 injection in reducing weight over a 24-week period in non-diabetic overweight or obese participants. The primary endpoint of the study is the percentage change in body weight compared to baseline after 24 weeks of dosing. The company reminds ...
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