media – Page 19 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What key matters should be focused on when upgrading the quality system of in vitro diagnostic (IVDR) in the European Union?

Drugdu.com expert’s response: When upgrading the quality system under the EU In Vitro Diagnostic Medical Device Regulation (IVDR), the following key aspects require particular attention: I. Regulatory Understanding and Compliance In-depth Understanding of IVDR Regulations: The IVDR imposes stricter and more specific requirements on the quality management system for in vitro diagnostic devices, covering aspects such as product classification, technical documentation, performance evaluation, and post-market surveillance. Manufacturers must thoroughly comprehend the regulatory content to ensure their quality systems align with these requirements. Ensuring Compliance Strategies: Manufacturers should develop compliance assessment procedures to clarify the compliance of significant changes to devices covered by the system, determine applicable General Safety and Performance Requirements (GSPR), and explore processes that meet these requirements. II. Establishment and Optimization of the Quality Management System Building a Quality Management System Based on ISO 13485: Although IVDR does not directly mandate ISO 13485 certification, its quality management system ...
- Source: drugdu
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- November 3, 2025
Novartis transferred the exclusive import, commercial promotion, and distribution rights in China for two ophthalmic drugs to Kangzhe Pharmaceutical.

　　On October 27, Jiemian News learned from Novartis that Novartis and Kangzhe Pharmaceutical’s wholly-owned subsidiary, Kangzhe Weisheng, officially signed a strategic cooperation agreement. Effective November 1, 2025, Novartis will transfer the exclusive import, commercial promotion, and distribution rights in China for two of its ophthalmic products, NoxD (ranibizumab injection) and Beyotime (buxizumab injection), to Kangzhe Weisheng for a period of five years. 　　Novartis stated that this strategic agreement signifies a further step in implementing its global “focus” strategy, concentrating on four core therapeutic areas—cardiovascular, renal and metabolic, oncology, and immunology and neuroscience—to more efficiently integrate resources and provide patients with innovative medicines with high clinical value.thing. https://finance.eastmoney.com/a/202510273545245535.html
- Source: drugdu
- 96
- November 2, 2025
Breakthrough in Innovative Drug Development – Hepatitis B siRNA Therapy HECN30227 Approved for Clinical Trials

　China Securities Journal (Wang Luo) – Recently, information released by the National Medical Products Administration (NMPA) shows that Dongyangguang Pharmaceutical ‘s independently developed Class 1 new drug, small interfering RNA (siRNA) HECN30227 injection, has been approved for clinical research in the treatment of chronic hepatitis B. This is another significant advancement in nucleic acid drug development in China’s biopharmaceutical field, marking a significant step forward for domestic companies in innovative drug development.The development of the track continues to accelerate. 　　In recent years, guided by policies and driven by the market, China’s biopharmaceutical industry has gradually built a complete ecosystem covering basic research, clinical translation, and industrialization. HECN30227, which has now been approved, is a product of Dongyangguang Pharmaceutical based on its independent intellectual property rights.The development of the innovative small interfering RNA (siRNA) drug demonstrates China’s research strength and technological accumulation in the field of nucleic acid drugs. This drug participates in the regulation of the ...
- Source: drugdu
- 70
- November 2, 2025
ALK-N001/QHL-1618 for injection received the drug clinical trial approval notice in April 2025.

　　SecuritiesDaily News Network – AnglikangOn October 30, the company issued an announcement stating that, in response to inquiries from researchers, it received approval for clinical trials of its injectable ALK-N001/QHL-1618 in April 2025. As of now, it is in the dose escalation phase of Phase I clinical trials, and the research and development process is progressing according to the original plan. Regarding the ALK-N002/IMD-1005 project, Yafei Bio and Affinity are still carrying out internal approval procedures. Once the approval is completed, the company will fulfill its information disclosure obligations in a timely manner. https://finance.eastmoney.com/a/202510303550388416.html
- Source: drugdu
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- November 1, 2025
The world’s first EGFR ADC drug, MRG003, developed by Lepu Biopharma, has been approved for marketing.

Shanghai Securities News China Securities(Reporter Zhang Xue) According to the official website of the National Medical Products Administration (NMPA), on October 30, Lepu Biopharma’s MRG003 (verbicotutomab) received conditional approval for marketing, for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. The brand name is Meiyouheng. This indication had previously been included in the priority review list by the NMPA’s Center for Drug Evaluation. 　　Data shows that MRG003 is the world’s first approved EGFR (epidermal growth factor receptor) ADC (antibody-drug conjugate) drug, marking another newmonument. 　　This drug is composed of a humanized EGFR monoclonal antibody and a potent microtubule-inhibiting payload—methylaurestatin E (MMAE)—conjugated via a valine-citrulline linker. It binds specifically and with high affinity to EGFR on the surface of tumor cells, releasing the potent payload through endocytosis and lysosomal protease cleavage, thereby leading to tumor cell death. EGFR is ...
- Source: drugdu
- 146
- November 1, 2025
Zhifei Biological Products delivers its worst third-quarter report in ten years

Zhifei BiologicalIt delivered its worst third-quarter report in the past decade. 　　According to its third-quarter report, in the first three quarters of 2025, Zhifei Biological Products achieved revenue of 7.627 billion yuan, a year-on-year decrease of 66.53%, and net profit of -1.206 billion yuan, a year-on-year decrease of 156.86%. 　　The reason for the poor performance is straightforward—market sales fell short of expectations. On October 30th, Jiemian News sent an interview request to Zhifei Biological Products Co., Ltd. , but had not received a response by the time of publication. 　　In the first three quarters of 2025, Zhifei Biological’s accounts receivable and inventory remained high. During the period, these two figures were RMB 12.814 billion and RMB 20.246 billion, respectively, accounting for 27.62% and 43.64% of total assets. 　　High accounts receivable indicate that Zhifei Biological Products Co., Ltd. has not been able to receive payments from ...
- Source: drugdu
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- October 31, 2025
Borui Pharmaceuticals officially launched its Hong Kong IPO process, further strengthening its global innovative drug R&D layout.

Shanghai Securities News China SecuritiesOn the evening of October 30th, Borui Pharmaceutical…The company has officially announced the submission of its application for a Hong Kong IPO, aiming for a dual listing in both Hong Kong and mainland China (A-shares and H-shares). Huatai International is the sole sponsor for this offering. The company stated that this listing is an important step in its globalization strategy and will help further expand its overseas markets and strengthen its international business foundation. 　　Borui Pharmaceutical plans to use the proceeds from this H-share issuance primarily for three purposes: supporting the research and development of existing and future innovative drug candidates in China and overseas; constructing or upgrading production and R&D facilities in China and abroad to improve automation levels; and supplementing working capital and other general corporate purposes. 　　Financial data shows that Borui Pharmaceutical has maintained steady growth in recent years. From 2022 to 2024, the company’s revenue was RMB ...
- Source: drugdu
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- October 31, 2025
Novo Nordisk outbids Pfizer for $4.9 billion to acquire US company Metsera

①Novo Nordisk,　　the Danish pharmaceutical giant① Novo Nordisk made an all-cash offer of $56.50 per share to acquire the U.S. biopharmaceutical company Metsera, valuing the company at approximately $6 billion; ② A successful acquisition of Metsera by Novo Nordisk would solidify its position in the weight-loss drug market.Market leadership, and potentially impacting PfizerThis constitutes a major blow. 　　Danish pharmaceutical giant Novo Nordisk said on Thursday that it has made a takeover offer for U.S. biopharmaceutical company Metsera, following Pfizer’s offer last week. 　　In early trading on the US stock market, Metsera’s stock price surged more than 21%. As of press time, Metsera’s stock price has risen 250% year-to-date to $63.445, with a market capitalization of approximately $6.67 billion. 　　Novo Nordisk claims it has made an all-cash offer of $56.50 per share, valuing the company at approximately $6 billion; while Pfizer previously offered $47.50 per share in cash, valuing the company at approximately $4.9 billion. 　　In addition, both Novo Nordisk and Metera ...
- Source: drugdu
- 109
- October 31, 2025
Dropping US Vaccine Rates Cause Delay in CSL’s Plans to Spin Off Vaccine Division

CSL delayed plans to spin off CSL Seqirus as its own listed entity on the Australian Securities Exchange due to a drop in US vaccinations rates that the company described as “bigger than expected.”1 The company originally announced plans to spin off the influenza vaccine provider by next June. According to CSL, this would have involved cutting about 3,000 jobs. How else will dropping vaccination rates impact CSL’s business? The company also announced a reduction in its expected full-year revenue growth from 4-5% to just 2-3%. Following these announcements, company shares reportedly dropped 16%. However, the company still plans to perform the spin off, but only at a time when it believes that the market has stabilized. While the US market may not have good news for the company, it is seeing positive headlines from other parts of the world. On Thursday, CSL announced that CSL Seqirus and Vaccine Industrial ...
- Source: drugdu
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- October 31, 2025
How A Brain Pressure Disorder Causes Vision Loss — And Who Might Be Affected

By Dennis Thompson HealthDay ReporterTHURSDAY, Oct. 30, 2025 (HealthDay News) — Doctors think they’ve figured out a way to predict who might lose vision due to a high brain pressure disorder. Idiopathic intracranial hypertension (IIH) occurs when there’s unexplained pressure buildup in the fluid that cushions the brain in the skull, researchers explain in the journal Neurology. If untreated, IIH can lead to blindness, researchers said. It mainly affects women of childbearing age who are obese. Researchers found that changes in the optic disc – the place inside the eye where the optic nerve connects to the retina – can predict who will develop blind spots in their vision or lose sharpness of vision. “The number of cases of idiopathic intracranial hypertension has been increasing, and it mainly affects young women, so we need more information about who is more likely to develop vision problems and how that process works,” ...
- Source: drugdu
- 77
- October 31, 2025

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