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【EXPERT Q&A】Which laws, regulations and system standards must medical devices comply with?

Drugdu.com expert’s response: The medical device industry is subject to a multi-tiered regulatory framework of laws and regulations and standards at both domestic and international levels, covering the entire product lifecycle management. The following provides an explanation from four perspectives: legal framework, international standards, domestic regulations, and key compliance considerations. I. Legal Framework: Global and Regional Core Regulations China’s Regulations on the Supervision and Administration of Medical Devices Core Positioning: The “basic law” for medical device supervision, clarifying classification management, registration/filing, production/operation/usage requirements, and legal liabilities. Key Provisions: Classification Rules: Products are categorized into Class I, II, and III based on risk levels, with differentiated regulatory oversight (e.g., stringent approval for Class III). Registration and Filing: Class I devices undergo filing management, while Class II and III devices require technical evaluation and system verification, along with submission of clinical evaluation data (some Class II devices may be exempted). Unique Device Identification ...
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- November 7, 2025
Contezolomide tablets approved for contract manufacturing by Jiangsu Xuantai Pharmaceutical; MRX-5 tablets expanded clinical trial specifications.

On November 5, MICO Pharmaceutical (688373) issued an announcement stating that the company recently received the “Approval Notice for Supplementary Application for Drug” and the “Approval Notice for Supplementary Application for Drug Clinical Trial” issued by the National Medical Products Administration. The announcement stated that Jiangsu Xuantai Pharmaceutical Co., Ltd. has been approved as a new contract manufacturer for continazolamide tablets, while Chongqing Boteng Pharmaceutical Technology Co., Ltd. will serve as its active pharmaceutical ingredient supplier. Continazolamide tablets are a new generation of oxazolidinone antibacterial drug used to treat complicated skin and soft tissue infections. The product was approved for marketing in China in June 2021. In addition, the announcement also mentioned that the supplemental application for clinical trials of MRX-5 tablets has been approved, allowing for the addition of a 200mg dosage for clinical trials. MRX-5 is a novel benzoborazole antibiotic intended for the treatment of infections caused by ...
- Source: drugdu
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- November 6, 2025
Merck receives $700 million investment from Blackstone to accelerate the development of Luchakzatuzumab.

　　Beijing News (Reporter Wang Kala) November 4, Merck…The company announced a $700 million R&D funding agreement with Blackstone, which will be used for the global development of its core ADC asset, sacubitril-TMT (sac-TMT). At a time when the ADC field is becoming a global focus of pharmaceutical innovation , this collaboration between a multinational pharmaceutical company and a capital giant not only demonstrates a high level of recognition of the commercial value of sacubitril-TMT, but also signifies a major milestone for innovative drugs in China.Driven by a dual approach of “global R&D + capital empowerment,” it is accelerating its entry into the ranks of global blockbuster drugs. 　　Under the terms of the agreement, Blackstone will pay Merck $700 million specifically to fund a portion of the development costs for SAC-TMT projected to be incurred in 2026. Merck stated that this agreement will help the company fully realize the potential of ...
- Source: drugdu
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- November 6, 2025
Taienkang’s Class 1.1 innovative drug CKBA achieves new progress, with breakthroughs in Alzheimer’s disease research.

　　On November 5th, ” Tainkang”Class 1.1 innovative drugsA press conference was held in Ma’anshan City, Anhui Province, to announce the publication of innovative research findings on CKBA for the treatment of Alzheimer’s disease in the top international journal “Nature Aging”. Taiencon announced the official launch of its preclinical research on CKBA for Alzheimer’s disease. 　　”With the aging population, the number of Alzheimer’s disease (AD) patients in China is continuing to grow, and there is an urgent need for a new theoretical system and drug solutions.” When talking about the initial motivation for entering the Alzheimer’s disease field, Zheng Hanjie, Chairman and General Manager of Taincon , said that CKBA has shown excellent potential in the AD field, and the company is full of confidence in developing CKBA products. 　　Accelerating the development of the Alzheimer’s disease sector 　　Data shows that Alzheimer’s disease, as the most common neurodegenerative disease in the world, ...
- Source: drugdu
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- November 6, 2025
Sanofi’s innovative targeted nanobody drug, Kebeli, has been approved in China.

On November 5th, SanofiAnnouncement of its innovative drugCablivi (caracizumab for injection) has been officially approved by the National Medical Products Administration (NMPA) for use in combination with plasma exchange and immunosuppressive therapy.Acquired thrombotic thrombocytopenic purpura (aTTP, also known as immune-mediated thrombotic thrombocytopenic purpura) in adults and adolescents aged 12 years and older weighing at least 40 kg. https://finance.eastmoney.com/a/202511053556137255.html
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- November 6, 2025
FDA Approves Kygevvi Becoming the First Treatment for Thymidine Kinase 2 Deficiency

UCB has announced FDA’s approval of Kygevvi (doxecitine and doxribtimine) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d) and is the first and only approved treatment for these patients living with TK2d.1 “The approval of doxecitine and doxribtimine represents a pivotal moment for the TK2d community who previously had no FDA-approved treatment options for this rare genetic mitochondrial disease beyond supportive [palliative] care,” said Donatello Crocetta, chief medical officer at UCB. “We extend heartfelt thanks to the patients, families and friends, advocates, healthcare providers and dedicated clinical trial teams who have partnered with us on this important journey.” Why did FDA approve Kygevvi? Kygevvi’s approval is based on safety and efficacy data collected from a Phase II clinical study, two retrospective chart review studies, and an expanded access use program.1 In total, the studies included 82 various patients treated with Kygevvi or pyrimidine ...
- Source: drugdu
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- November 6, 2025
Pfizer COVID-19 Vaccine Sales Tumble After Government Guidance on the Shots Narrows

The fall COVID-19 vaccine season is starting slowly for Pfizer, with U.S. sales of its Comirnaty shots sinking 25% after federal regulators narrowed recommendations on who should get them. Approval of updated shots also came several weeks later than usual, and Pfizer said Tuesday that hurt sales as well. Many Americans get vaccinations in the fall, to protect against any disease surges in the coming winter. Experts say interest in COVID-19 shots has been declining, and that trend could pick up this fall due to anti-vaccine sentiment and confusion about whether the shots are necessary. The Centers for Disease Control and Prevention last month stopped recommending COVID-19 shots for anyone, instead leaving the choice up to patients. The government agency said it was adopting recommendations made by advisers picked by U.S. Health Secretary Robert F. Kennedy Jr. Before this year, U.S. health officials — following the advice of infectious disease ...
- Source: drugdu
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- November 6, 2025
PMEC India 2025

Organiser：Informa Markets Time：November 25 – November 27, 2025 Address：Gautam Buddha Nagar District, Uttar Pradesh, India Exhibition hall：Greater Noida Product range: Pharmaceutical Machinery and Packaging Equipment Zone Laboratory Instruments and Equipment Zone Packaging and Drug Delivery Systems Zone Cleanroom Equipment and Engineering Zone Environmental Protection and Energy-saving Equipment Zone About PMEC India 2025： The Pharmaceutical Machinery & Packaging Equipment Expo India (PMEC) in New Delhi is a vital global platform for product trade and information exchange in the pharmaceutical industry. This exhibition attracts professionals from the global pharmaceutical sector, including manufacturers, suppliers, contractors, distributors, and dealers. PMEC is held concurrently with CPhI India (India World Pharmaceutical Ingredients Exhibition), covering various fields within the pharmaceutical industry such as pharmaceutical ingredients, intermediates, compounds, pharmaceutical packaging, equipment, and technologies. Exhibitors have the opportunity to showcase their latest pharmaceutical ingredients, technologies, and services, demonstrating their company’s capabilities and technological expertise to professionals from ...
- Source: drugdu
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- November 6, 2025
Baiyang Pharmaceuticals and Jeterbeline join hands to expand the human serum albumin market

On November 4th, a reporter learned from Baiyang Pharmaceuticals…It has been learned that the company signed a deepened cooperation agreement with CSL, a leading global blood products company, on the same day. According to the agreement, Baiyang Pharmaceutical will acquire Ambow, a human serum albumin product from CSL.Exclusive promotion, sales and distribution rights for MI® in specific markets in China. It is understood that this collaboration represents a further strengthening of the partnership between the two parties, building upon their cooperation in the retail market in 2018. Public information shows that human serum albumin can be used for emergency treatment of hypovolemia, treatment of significant hypoalbuminemia, treatment of neonatal hyperbilirubinemia, and as an adjunct therapy for acute respiratory distress syndrome, cardiopulmonary bypass, and plasma exchange in special types of hemodialysis. It is a commonly used drug in clinical emergency and critical care. According to data from Moshang Consulting, the Chinese market for human serum ...
- Source: drugdu
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- November 5, 2025
Plans to Advance Multiple Phase III Lung Cancer Phase II Clinical Trials. (This is part of a larger effort to validate the efficacy of PD-L1 ADC.)

Science and Technology Innovation Board Daily, November 3 (Reporter Xu Hong) – “When the HLX43 project was first launched, not many people were optimistic about this direction. But drug development cannot follow the crowd; we must see what others cannot. Why do so many cancer patients still respond when they use PD-1 again after having previously used it? It was based on this observation that I pushed the team to follow up on this direction.” During a media exchange on November 2, Dr. Zhu Jun, Executive Director and CEO of Henlius Biotech (02696.HK), reviewed the starting point of HLX43’s research and development. Today, this project, which started more as a “trial and error” experiment, is beginning to validate its initial scientific assumptions step by step as clinical research progresses. HLX43 is an antibody-drug conjugate (ADC) that targets PD-L1. Its mechanism of action combines the dual functions of immune checkpoint inhibition ...
- Source: drugdu
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- November 5, 2025

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