media – Page 22 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Autoimmune bispecific antibody product CS2015 selected for exhibition at the ACAAI Annual Meeting in the United States

On the morning of September 15th, CStone Pharmaceuticals (02616), a subsidiary of Zhongzheng Intelligent Finance , announced that its autoimmune and inflammatory drug candidate, CS2015 (OX40L/TSLP bispecific antibody), has been selected for presentation at the 2025 American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting. The meeting will be held in Orlando, USA, from November 6th to 10th.　　CS2015 is a potential first-in-class/best-in-class bispecific antibody that simultaneously targets OX40L and TSLP. By dually inhibiting key regulators of Th2-mediated inflammatory responses, it provides a new treatment strategy for type 2 inflammatory diseases such as atopic dermatitis, asthma, and chronic obstructive pulmonary disease. CStone Pharmaceuticals is an innovation-driven biopharmaceutical company focused on drug research and development in key disease areas such as oncology, autoimmunity, and inflammation. Since its establishment, it has successfully launched four innovative drugs., and obtained approval for 16 new drug applications. The current R&D pipeline includes 16 drug ...
- Source: drugdu
- 74
- September 15, 2025
【EXPERT Q&A】What certifications are required for the export of medical devices and pharmaceutical products?

Drugdu.com expert’s response: Medical devices and pharmaceutical products require multiple certifications for export based on the requirements of target markets, covering international standards, regional regulations, and special product specifications. Below is a detailed explanation: I. International General Certifications ISO Certifications ISO 13485: An international standard for the quality management system of medical devices, serving as a foundational certification for exports. It proves that a company’s production processes comply with international norms. ISO 9001: A general quality management system certification. While not mandatory, it enhances corporate credibility. GMP Certification Good Manufacturing Practice certification ensures that production processes meet international standards, particularly for pharmaceutical-grade medical devices (e.g., vaccines, injectables). II. Regional Mandatory Certifications EU Market CE Certification: The “passport” for entering the EU market, classified by risk level: Class I low-risk products (e.g., surgical scalpels): Require a CE Declaration of Conformity. Class I*, IIa, IIb, and III high-risk products (e.g., implantable devices, pacemakers): Require ...
- Source: drugdu
- 110
- September 15, 2025
ICER Releases Cost Analysis Report on Obesity Treatments Semaglutide, Tirzepatide

The Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report evaluating the comparative clinical effectiveness and value of Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide) for obesity management, including their impact on other obesity-related outcomes. ICER stated that the preliminary draft represents the midpoint of its eight-month assessment process and should not be interpreted as the organization’s final conclusions.1 How Effective and Cost-Efficient are the Newest Obesity Treatments? Key Clinical Findings The initial draft found that both agents, when added to lifestyle modification, produced significant weight loss, improvements in obesity-related comorbidities, and reductions in cardiovascular risk factors. Zepbound demonstrated the greatest weight loss benefits, with average weight loss ranging from 17.8% to 20.8%, and a head-to-head trial showing 20.2% loss versus 13.7% with injectable Wegovy. Early topline results in diabetes populations also suggest promising cardiovascular benefits, including an 8% reduction in major adverse cardiovascular ...
- Source: drugdu
- 88
- September 12, 2025
FDA Releases Guidance to Promote Nonopioid Alternatives for Chronic Pain

By Stephanie Brown HealthDay ReporterWEDNESDAY, Sept. 10, 2025 (HealthDay News) — The U.S. Food and Drug Administration released draft guidance to advance safe and effective nonopioid treatment options and reduce risks tied to prescription opioid misuse. “America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain.” According to the FDA, opioids are commonly prescribed to about one in five U.S. adults living with chronic pain. This is mainly due to a lack of effective alternatives. The agency’s draft guidance underscores more efficient pathways for ...
- Source: drugdu
- 115
- September 12, 2025
Multiple favorable factors resonate, highlighting investment opportunities in the brain computer interface industry chain

Against the backdrop of strong policy support and continuous technological breakthroughs at home and abroad, the application scenarios of the brain computer interface industry have gradually become clear in recent years and have received increasing market attention. According to Wind data, the Wande Brain Computer Interface Concept Index rose by 0.32% on September 10th, indicating a clear upward trend in recent times. Among the constituent stocks of the index, Meihao Medical rose 6.98%, Kunlun Wanwei rose 4.71%, and Innovation Medical, Sino Medical, and others followed suit. Analysts believe that brain computer interface technology has become one of the strategic highlands for global technological competition. Neurorehabilitation and motor function reconstruction are expected to become the first batch of invasive brain computer interface application scenarios to move towards industrialization and commercialization. Currently, China’s brain computer interface industry is expected to usher in a golden period of development. Industry catalysis continues On September ...
- Source: drugdu
- 134
- September 12, 2025
Novo Nordisk announced plans to lay off approximately 9000 employees; Pailin Biotechnology’s controlling shareholder plans to change to China Biologics | Pharmaceutical Early Reference

Novo Nordisk announces plans to lay off approximately 9000 employees Novo Nordisk announced that the company will undergo internal restructuring and lay off approximately 9000 employees to save 8 billion Danish kroner (approximately 1.26 billion US dollars) in expenses annually. Novo Nordisk pointed out in a statement that it will carry out a comprehensive reform of the company to simplify the organizational structure, speed up decision-making, and reallocate resources to business growth opportunities in the field of diabetes and obesity. Comment: Since the beginning of this year, Novo Nordisk has lowered its performance guidance several times due to increasing sales pressure on its core product, semaglutide. This layoff plan is also an adjustment made by the company under profit pressure. NO.2 Pailin Biotechnology’s controlling shareholder plans to change to China Biology Pailin Biotechnology announced that its controlling shareholder, Gongqingcheng Shengbang Yinghao Investment Partnership Enterprise (Limited Partnership), has signed a “Share ...
- Source: drugdu
- 129
- September 12, 2025
【EXPERT Q&A】What are the advantages and disadvantages of oncolytic virus therapy compared with other immunotherapies (such as CAR-T, PD-1 inhibitors)?

Drugdu.com expert’s response: Oncolytic virus (OV) therapy demonstrates outstanding performance in terms of broad-spectrum efficacy, cost-effectiveness, and the ability to reverse the tumor immune microenvironment. However, it faces limitations in administration methods and infection efficiency, necessitating combination with other therapies to overcome single-agent constraints. CAR-T therapy exhibits remarkable efficacy in hematological malignancies but is associated with high costs, limited effectiveness in solid tumors, and elevated risks of side effects. PD-1 inhibitors offer convenience and maturity in application but suffer from low response rates and are constrained by tumor immune phenotypes. Below is a detailed comparison of oncolytic virus therapy with other immunotherapies, such as CAR-T and PD-1 inhibitors: Advantages of Oncolytic Virus Therapy Broad-Spectrum Efficacy and Tumor Microenvironment Remodeling: Oncolytic viruses can target a variety of solid tumors, including liver cancer, melanoma, and ovarian cancer, and are particularly adept at transforming “cold tumors” (with low immune cell infiltration) into “hot tumors.” By ...
- Source: drugdu
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- September 12, 2025
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
- 110
- 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
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- 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
- 108
- September 11, 2025

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