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【EXPERT Q&A】How to apply for and obtain the production and operation license for Class III medical devices?

Drugdu.com expert’s response: Class III Medical Device Production License → Apply to the Provincial Drug Administration Class III Medical Device Operation License → Apply to the Municipal Drug Administration Both require compliant premises, qualified personnel, a quality management system, and a traceability system. Statutory approval period: 20 working days. Validity: 5 years. I. Production License (Provincial Drug Administration) 1. Application Requirements Corporate Qualification: Legal corporate entity; business scope must cover the corresponding production category. Premises & Environment: Production facilities and cleanroom environment must match the product standards. Personnel: Production, Quality, and Technical Directors must hold a relevant major, a college degree or above, and at least 3 years of experience. Inspection personnel and equipment must be fully staffed. Equipment & Documentation: Production and inspection equipment must be complete. Quality manual, procedure documents, and process flowcharts must be fully prepared. Product Registration: The Medical Device Registration Certificate must already be obtained. 2. Required Materials Medical Device ...
- Source: drugdu
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- May 13, 2026
CanSino Biologics’ Td5cp for adolescents and adults has been included in the priority review process, accelerating its deployment of DPT protection throughout the entire life cycle.

May 11, 2026 – CanSino Biologics Inc. (hereinafter referred to as “ CanSino Biologics ” , 688185.SH , 06185.HK ) announced that its independently developed adsorbed acellular diphtheria-tetanus-diphtheria-tetanus combined vaccine ( for individuals aged 6 years and older) (hereinafter referred to as “ Td5cp for adolescents and adults ” ) has been officially included in the priority review list by the National Medical Products Administration ( NMPA ). With the accelerated review and approval process, this product, as an important part of the company’s comprehensive DPT protection system throughout the entire life cycle, is expected to fill the gap in DPT booster immunization products for individuals aged 6 years and older in China, helping to build a broader and stronger immune barrier. Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, and it is highly contagious . <sup> 1 </sup> In recent years, pertussis has shown a resurgence ...
- Source: drugdu
- 54
- May 12, 2026
Industry News | Harbour BioMed Announces FDA Approval of HBM7004 for the Treatment of Advanced Solid Tumors

Harbour BioMed (“the Company”; HKEX code 02142), a global biopharmaceutical company dedicated to the discovery and development of novel antibody therapeutics in the fields of immunology, oncology, and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HBM7004, thereby initiating a first-in-human (FIH) Phase I clinical trial. This study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM7004 in subjects with advanced solid tumors. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the company’s HBICE® platform . This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy, potentially improving efficacy and safety. The development of HBM7004 further demonstrates the versatility and plug-and-play advantages of the HBICE® platform . In preclinical studies, HBM7004 exhibited a tumor-dependent B7H4-dependent T-cell activation pathway. In multiple animal models, HBM7004 demonstrated strong antitumor efficacy, significant in vivo stability, ...
- Source: drugdu
- 55
- May 12, 2026
The world’s first! GSK’s blockbuster hepatitis B drug licensed to Chia Tai Tianqing Pharmaceutical Group.

China Biopharmaceutical has acquired the world’s first blockbuster drug with the potential to achieve a functional cure for hepatitis B in the fastest possible time. On May 11, China Biopharmaceutical (01177.HK) officially announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group, has entered into an exclusive strategic collaboration with multinational pharmaceutical company GlaxoSmithKline (LSE/NYSE: GSK) to accelerate the latter’s first-in-class innovative drug for chronic hepatitis B , Bepirovirsen (code name: GSK836), in China. This promising drug, which is highly anticipated by the industry, has received “breakthrough therapy” designation in China and has been included in the priority review and approval process. Its launch will bring a revolutionary breakthrough to the treatment of hepatitis B in China. Under the terms of the agreement, Chia Tai Tianqing Pharmaceutical Group will be responsible for the import, distribution, hospital access, and promotional and non-promotional activities of bepirovirsen in mainland China. All sales revenue ...
- Source: drugdu
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- May 12, 2026
The Two Sides of RMC-6236

Following Revolution’s announcement on April 13th of positive results from the Phase III clinical trial RASolute302 of its pan-RAS inhibitor RMC-6236 in previously treated metastatic pancreatic cancer patients, the drug has now announced the latest research progress in first-line treatment. In terms of efficacy, RMC-6236 continues to surprise the market, demonstrating impressive remission rates whether used as a monotherapy or in combination therapy, and bringing new expectations to the industry. However, the potential toxicity of RMC-6236 continues to emerge. In particular, in the RMC-GI-102 study of first-line combination chemotherapy, grade ≥3 adverse reactions accounted for as high as 73%. Currently, the impact of this safety hazard on the subsequent R&D layout of RMC-6236 is still unclear, but it has pointed out a clear direction for differentiated breakthroughs for subsequent competitors in the same field. 01 The Two Sides of RMC-6236 RMC-6236 is a two-sided unit. In terms of efficacy, it ...
- Source: drugdu
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- May 12, 2026
A rare disease company was acquired for $4.1 billion.

Italian pharmaceutical company Angelini Pharma recently announced its acquisition of Catalyst, a US-based rare disease specialist, for $4.1 billion, aiming to capitalize on the lucrative US market. The two companies expect to close the deal in the third quarter. According to publicly available information, Catalyst was founded in 2002 and went public on NASDAQ in 2006. The company is patient-centric, focusing on the introduction, development, and commercialization of novel medicines for rare and intractable diseases. In 2025, Catalyst’s revenue reached $589 million, a 20% increase, and this year’s revenue is projected to be between $615 million and $645 million. It has three products already on the market: Firdapse (amifampridine) is the company’s flagship product. It is the only evidence-based treatment approved by the FDA for Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 and older. Sales of this drug are projected to reach $358 million in 2025, a 17% year-on-year ...
- Source: drugdu
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- May 12, 2026
BIO

Organiser：BIO Convention Time：June 22 – June 25, 2026 Address：111 W. Harbor Dr., San Diego, CA 92101 Exhibition hall：San Diego Convention Center Product range: Biotechnology and products, biopharmaceutical R&D achievements, biotechnology parks and industrial base development, applications of biotechnology in healthcare, food, agriculture, energy, environmental protection, as well as international marketing and academic promotion of biotech products, intellectual property protection, clinical research and trials, investment and financing, technology transfer, and more. About BIO： The BIO International Convention (commonly known as BIO) was founded in 1993 and serves as the annual conference of the Biotechnology Innovation Organization (BIO). It is the largest, most professional, and most influential biotechnology event in the world. BIO aims to support the development of the global biotechnology industry. Through sponsoring biotechnology projects and initiatives, the profits from the convention are reinvested back into the biotechnology sector. The event is not primarily trade-oriented; instead, it emphasizes a ...
- Source: drugdu
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- May 12, 2026
Revenue Soars 34% — Why BeiGene Decisively Cut 6 Pipeline Programs?

On May 8, BeiGene officially released its Q1 2026 financial results. Against the backdrop of overall pressure on China’s innovative drug industry and increasingly intense competition in R&D and commercialization, the company’s revenue performance bucked the trend and exceeded market expectations. Even more striking and industry-shaking, the company simultaneously announced a major pipeline strategy adjustment — terminating six investigational programs at once, covering five hot oncology targets and one autoimmune disease pipeline, signaling a clear strategic retrenchment. This “amputation-style” strategic adjustment marks the official end of China’s innovative drug leader’s past “land-grab” expansion model, fully transitioning to a new stage of high-quality development centered on “precision focus, efficient investment, and quality first,” setting a benchmark for industry transformation. I. Core Products Continue to Drive Growth, Commercialization Capabilities Re-validated Key financial data shows that in Q1 2026, BeiGene’s global product revenue reached US$1.5 billion, a substantial 34% year-over-year increase, demonstrating strong ...
- Source: drugdu
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- May 11, 2026
InxMed Bio Partners with Fosun Pharma — Deal Worth RMB 1.115 Billion

On May 8, 2026, InxMed Biotechnology (Nanjing) Co., Ltd. announced a strategic partnership with Fosun Pharma. Under the agreement, InxMed Bio will grant Fosun Pharma the exclusive rights for sales, promotion, and full-channel commercialization of its two self-developed innovative FAK inhibitors, IN10018 (Ifebemtinib) and IN10028, in mainland China (excluding Hong Kong, Macau, and Taiwan). As consideration, InxMed Bio will receive an upfront payment of RMB 100 million, plus milestone payments of up to RMB 1.015 billion tied to R&D registration and sales performance. As consideration, InxMed Bio will receive an upfront payment of RMB 100 million, plus milestone payments of up to RMB 1.015 billion tied to R&D registration and sales performance. IN10018 is an innovative small-molecule FAK inhibitor with dual regulatory functions — kinase catalytic and protein scaffold — that exerts anti-tumor effects through multiple mechanisms including oncogenic pathway modulation and inhibition of tumor proliferation and invasion. The product ...
- Source: drugdu
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- May 11, 2026
【EXPERT Q&A】What factors should be focused on when analyzing the benefits and risks of medical devices?

Drugdu.com expert’s response: The benefit-risk analysis of medical devices is a core component in ensuring their safety and effectiveness, requiring a comprehensive consideration of multidimensional factors encompassing science, clinical practice, ethics, and society. The following are the key factors that should be prioritized during the analysis: I. Intended Use and Performance of Medical Devices Target Patient Population Clearly define the age, gender, disease stage, or health status of patients for whom the device is suitable (e.g., children, pregnant women, elderly individuals, or patients with specific diseases). Evaluate differences in benefits and potential risks among different patient groups (e.g., children’s higher sensitivity to certain materials). Core Functions and Performance Indicators The primary therapeutic or diagnostic functions of the device (e.g., surgical robots, implantable cardiac pacemakers, in vitro diagnostic reagents). Accuracy, sensitivity, and specificity of performance parameters (e.g., false-positive/false-negative rates of diagnostic reagents). Reliability (e.g., mechanical failure rate, software stability) and durability ...
- Source: drugdu
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- May 11, 2026

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