media – Page 171 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Application for registration and marketing authorization of quadrivalent influenza vaccine has been accepted

Chengda Bio announced in the evening that the application for registration and marketing authorization of the quadrivalent influenza virus split vaccine (referred to as “quadrivalent influenza vaccine”) developed by its wholly-owned subsidiary Chengda Bio (Benxi) Co., Ltd. in China has recently received the “Acceptance Notice” from the State Food and Drug Administration. https://finance.eastmoney.com/
- Source: drugdu
- 258
- January 30, 2025
Fosun Pharma’s drug registration application for salbutamol hydrochloride has been accepted

On January 24, Fosun Pharma (600196/02196) issued an announcement that the drug registration application for salbutamol hydrochloride nebulized inhalation solution of its holding subsidiary Fosun Pharma (Xuzhou) Co., Ltd. was recently accepted by the State Drug Administration. The drug is a chemical drug independently developed by the company, mainly used to treat or prevent bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old. As of December 2024, the group’s cumulative R&D investment in the drug is approximately 4.54 million yuan. According to data provided by IQVIA, the sales of salbutamol hydrochloride nebulized inhalation solution in China in 2023 will be approximately 1.009 billion yuan. The announcement pointed out that the drug still needs to pass GMP compliance inspection and obtain drug registration approval before commercial production, so the acceptance of the drug registration application will not have a significant impact on the group’s current ...
- Source: drugdu
- 228
- January 30, 2025
encourage and support pharmaceutical operators to strengthen anti-monopoly compliance

On January 24, in order to effectively prevent and stop monopoly behavior in the pharmaceutical sector and safeguard consumer interests and social public interests, the State Council Anti-monopoly and Anti-unfair Competition Committee formulated and issued the “Anti-monopoly Guidelines for the Pharmaceutical Sector” (hereinafter referred to as the “Guidelines”). The “Guidelines” have 7 chapters and 55 articles. Aiming at the prominent monopoly problems in the pharmaceutical sector, they further refine the behavior, law enforcement principles and identification standards of monopoly behavior in the pharmaceutical sector. The “Guidelines” refine the behavior of monopoly agreements in the pharmaceutical sector. First, they list typical horizontal and vertical monopoly agreements in the pharmaceutical sector, and clarify the identification principles and ideas of anti-monopoly law enforcement agencies; Second, they summarize the behavior of new monopoly agreements in the pharmaceutical sector, and summarize the considerations for the application of the “Anti-monopoly Law” to reverse payment agreements; Third, ...
- Source: drugdu
- 308
- January 30, 2025
Johnson & Johnson’s revenue increased by 4.3% to US$88.821 billion last year, and pharmaceutical sales increased by 5.8%

Recently, Johnson & Johnson released its 2024 Q4 and full-year annual results. It was disclosed that the revenue in Q4 last year was US$22.52 billion, a year-on-year increase of 5.26%. Net profit was US$3.431 billion, a year-on-year decrease of 15.26%. In 2024, the company achieved revenue of US$88.821 billion, a year-on-year increase of 4.3%, and a year-on-year increase of 7% excluding the impact of exchange rates. The full-year net profit attributable to ordinary shareholders was US$14.066 billion, a year-on-year decrease of 59.99% compared with US$35.153 billion in the same period last year. Among them, global Johnson & Johnson’s innovative pharmaceutical sales were US$57 billion, a year-on-year increase of 5.8%. Global Johnson & Johnson Medical Technology sales were US$31.9 billion, a year-on-year increase of 4.8%. https://finance.sina.com.cn/
- Source: drugdu
- 261
- January 30, 2025
Oman Health

Organiser：Oman Exhibition Group Time：September 22 – 24, 2025 Address：P.O. Box 117, P.C. 111, Muscat International Airport, Oman. Exhibition hall：Oman International Exhibition Center Product range: Hospital Equipment, Devices & Technology: Hospital equipment and medical devices, surgical instruments and medical-related books, X-ray, CT, MRI, nuclear medicine, imaging, pharmaceutical and herbal products, home medical equipment, physiotherapy, pharmaceutical raw materials, anesthesiology, respiratory equipment, pharmaceutical and packaging equipment, surgical techniques and equipment, healthcare products, sterilization and disinfection equipment, clinical chemistry automation instruments, emergency medical equipment and medications, biotechnology laboratory equipment, surgical instruments and endoscopic equipment, blood bank and refrigeration equipment, general and special diagnostics, dental care and treatment equipment, orthopedic surgical techniques and rehabilitation equipment, oral care, consumables, and equipment (sterilization and technology). About Oman Health： The Oman Health Exhibition is the largest and most influential medical exhibition in Oman. It showcases products such as laboratory equipment, instruments, laboratory supplies, emergency management solutions, ...
- Source: drugdu
- 582
- January 30, 2025
【EXPERT Q&A】Does European GPSR compliance require CE certification?

Drugdu.com expert’s response: Happy Chinese New Year! Detailed Analysis on the Relationship Between GPSR Compliance and CE Certification in Europe I. Concepts and Relationship Between GPSR and CE Certification GPSR (General Product Safety Regulation): It is a regulation of the European Union concerning the general safety of products, aiming to ensure that products placed on the EU market are safe under normal or reasonably foreseeable conditions of use. It covers a wide range of product categories, including toys, electrical appliances, and various consumer goods, requiring products to meet corresponding safety, health, and environmental standards. CE Certification: It constitutes the “essential requirements” of European directives and is considered as the “passport” for manufacturers to enter the European market. It indicates that the product complies with the basic requirements of the EU’s “New Approach to Technical Harmonization and Standardization” directives, involving mechanical safety, electromagnetic compatibility, low-voltage safety, and other aspects. Relationship: Partial ...
- Source: drugdu
- 487
- January 29, 2025
HEALTH EXPO IRAQ

Organiser：IFP IRAQ Time：September 18th – 21st, 2025 Address：Baghdad International Exhibition Center, Baghdad, Iraq Exhibition hall：Baghdad International Exhibition Center, Iraq Product range: Medical equipment, medical engineering, diagnostic equipment, operating room instruments, emergency & rescue equipment, biology, medical manufacturing and control equipment, laboratory instruments and equipment, medical products, new technologies & equipment, equipment needed for hospitals & nursing homes, emergency medical supplies, surgical medical supplies for hospitals, modern information technology for healthcare services About HEALTH EXPO IRAQ： The Health Expo Iraq, held in Baghdad, is a representative and large-scale international exhibition on hospital medical device technology in Iraq.
- Source: drugdu
- 640
- January 28, 2025
Without the consent of independent H-share shareholders, Henlius privatization terminated

On January 22, Fosun Pharma issued an evening announcement stating that the special resolution on the privatization of Henlius by its holding subsidiary Fosun New Drug through absorption merger was not approved at the H-share class shareholders’ meeting. Therefore, the absorption merger will not be implemented and Henlius will retain its H-share listing status. The announcement showed that the proposal was mainly opposed by small and medium-sized shareholders. At the interim shareholders’ meeting of Henlius, it was approved by more than two-thirds (including the number) of shareholders with voting rights who attended the meeting, but at the class shareholders’ meeting where only H-share shareholders had voting rights, the proportion of dissenting votes reached 19.25%, exceeding the 10% upper limit stipulated in the acquisition regulations. Fosun Pharma said that it regretted the failure of the Henlius privatization proposal and fully respected the decision of all shareholders. Fosun Pharma will continue to ...
- Source: drugdu
- 436
- January 27, 2025
Another ADC drug is approved for marketing

Recently, the FDA officially approved Datroway (datopotamab deruxtecan, Dato-DXd), an innovative antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of unresectable or metastatic hormone receptor (HR)-positive, HER2-negative adult breast cancer patients who have received endocrine therapy and chemotherapy. The key basis for the approval of Dato-DXd for breast cancer indications was the positive results of its Phase III clinical study TROPION-Breast01. In the TROPION-Breast01 study, Dato-DXd showed efficacy advantages. Compared with the standard therapy selected by the researchers, the drug successfully reduced the risk of disease progression or death in patients by 37%. This data means that in patients treated with Dato-DXd, the rate of disease deterioration has slowed significantly, giving patients more survival time and treatment opportunities. Specifically, progression-free survival (mPFS) was significantly extended from 4.9 months in the control group to 6.9 months in the trial group. In terms of safety assessment, a key concern ...
- Source: drugdu
- 272
- January 27, 2025
【EXPERT Q&A】How effective is Telitacicept?

Drugdu.com expert’s response: Telitacicept, a novel fusion protein drug for the treatment of autoimmune diseases, has demonstrated its therapeutic efficacy in multiple clinical trials, as detailed below: I. Main Therapeutic Indications and Effects Systemic Lupus Erythematosus (SLE) Telitacicept alleviates SLE symptoms by inhibiting the overactivation of B cells. Clinical trial data indicate that over 60% of patients using Telitacicept experienced significant improvement in their condition, specifically evident in the relief of skin, joint, and kidney symptoms. A multicenter, randomized, double-blind, placebo-controlled pivotal clinical study showed that the 48-week response rate in the high-dose Telitacicept group was 79.2%, significantly higher than the 32.0% in the placebo control group. Another nationwide multicenter, randomized, double-blind, placebo-controlled Phase IIb drug study showed that the Telitacicept 160mg dose group (the standard dose approved for marketing in China) had significantly higher response rates than the placebo group from Week 12 onwards, and the efficacy advantage persisted ...
- Source: drugdu
- 367
- January 27, 2025

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