media – Page 85 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Another rare disease drug has entered China. A similar product for systemic myasthenia gravis has passed the preliminary review catalog of this year’s national negotiation.

　　On October 11, multinational pharmaceutical company UCB announced that the China National Medical Products Administration (NMPA) has approved the marketing authorization of Zelukeblen sodium (trade name: Zobequel), which can be used in combination with conventional treatment drugs to treat adult patients with generalized myasthenia gravis (GMG) who are positive for anti-acetylcholine receptor (AChR) antibodies. 　　According to the information, Zelukeblen sodium is the world’s first and only new generation C5 complement inhibitor that can be injected subcutaneously, self-administered and has dual inhibitory effects. It can effectively block complement-mediated neuromuscular junction damage. Patients can complete the subcutaneous injection at home in only 5 to 8 seconds, reducing the burden of traveling to and from the hospital. 　　Generalized myasthenia gravis is a rare, chronic, and heterogeneous autoimmune disease with approximately 220,000 patients in China. Common pathogenic antibodies include AChR antibodies and muscle-specific receptor tyrosine kinase (MuSK) antibodies. Among them, AChR antibodies are the ...
- Source: drugdu
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- October 13, 2025
【Company Recommendation】Shaanxi Cuikang Pharmaceutical Technology Co., Ltd

Company Introduction Shaanxi Cuikang Pharmaceutical Technology Co., Ltd. is an enterprise integrating the research and development, production, sales and technical services of natural products, fine chemicals, biological fermentation and innovative materials. The company has built a 2,700-square-meter R&D center and two production lines (enzyme preparation production line + fine chemical production line) in Hanzhong, Shaanxi Province. We can provide global customers with proportionate plant extracts, content plant extracts, synthetic chemical building blocks, synthetic pharmaceutical intermediates, active API molecules, fermentation pharmaceutical intermediates and raw materials for active pharmaceutical products, health foods, functional foods, veterinary drug raw materials, innovative pharmaceutical materials, and laboratory equipment. One-stop services and products for pharmaceutical machinery and equipment series, ranging from small-scale trial research and development to industrial-scale production. The company conducts over 50 R&D and technical service projects annually, applies for more than 10 patents, and many of its scientific research achievements have now been industrially ...
- Source: drugdu
- 141
- October 13, 2025
Tianguangshi’s new drug marketing authorization application for MIL62 for the treatment of primary membranous nephropathy has been accepted

　　According to a report from People’s Finance on October 12th, Beijing Yizhuang WeChat account, Beijing Tianguangshi Biotechnology Co., Ltd. (hereinafter referred to as “Tianguangshi”), a company in Beijing Economic and Technological Development Zone (Beijing Yizhuang), recently announced that its independently developed innovative third-generation CD20 antibody MIL62 for the treatment of primary membranous nephropathy (PMN) has been accepted by the National Medical Products Administration. It is reported that this is the world’s first drug to be approved for the treatment of PMN. Its breakthrough not only provides a better treatment option for PMN, but also demonstrates China’s innovative drug development.Leading advantages in drug research and development and industrialization. https://finance.eastmoney.com/a/202510123531477277.html
- Source: drugdu
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- October 13, 2025
Its subsidiary’s core product, TROP2 ADC Lukangsatuzumab, has been approved by the National Medical Products Administration for a third indication.

　　Kelun PharmaceuticalThe announcement stated that Kelun Biotech’s controlled subsidiary, sac-TMT, an antibody-drug conjugate (ADC) targeting human trophoblast cell surface antigen 2 (TROP2), has been approved by the National Medical Products Administration for a third indication: the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation-positive disease who have progressed after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). sac-TMT is the first and only ADC in the world to date to demonstrate a significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy and has been approved for advanced NSCLC that has progressed after prior TKI therapy (2L). https://finance.eastmoney.com/a/202510123531499855.html
- Source: drugdu
- 196
- October 13, 2025
Fentanyl-stimulant overdose deaths surge among older adults

Overdose deaths in adults age 65 and older from fentanyl mixed with stimulants, such as cocaine and methamphetamines, have surged 9,000% in the past eight years, matching rates found among younger adults, according to research presented at the ANESTHESIOLOGY® 2025 annual meeting. The study is among the first to use Centers for Disease Control and Prevention (CDC) data to show that older adults, a group often overlooked in overdose research, are part of the broader rise in fentanyl-stimulant overdose deaths. Adults 65 years and older are especially vulnerable to overdoses because many live with chronic health conditions, take several medications and process drugs more slowly due to age. The opioid epidemic has unfolded in four waves, each characterized by a different type of opioid driving the increase in overdose deaths: prescription opioids in the 1990s; heroin starting in 2010; fentanyl starting in 2013; and a mix of fentanyl and stimulants ...
- Source: drugdu
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- October 13, 2025
Study reveals distinct links between depression subtypes and metabolic diseases

It is known that depression is linked to increased incidence of metabolic diseases; now scientists have discovered that different types of depression are linked to different cardiometabolic diseases. This work is presented at the ECNP Congress in Amsterdam. Over seven years, researchers tracked 5,794 adults, enrolled in the Netherlands Epidemiology of Obesity (NEO) Study, all of whom were free of diabetes and cardiovascular disease at the study’s start. At the start of the study each participant completed a comprehensive questionnaire to assess depressive symptoms. The team identified two distinct depressive profiles: one typified by “melancholic” symptoms (such as early morning awakening and reduced appetite), and another by “atypical/energy-related” symptoms (such as fatigue, increased sleep, and increased appetite). Around 8% of the participants developed a cardiometabolic condition during the follow-up period, but the type of condition they developed depended on the type of depression they had. Those with atypical/energy-related” symptoms were ...
- Source: drugdu
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- October 13, 2025
【EXPERT Q&A】What processes do medical devices need to go through before they can be produced?

Drugdu.com expert’s response: Key Processes for Medical Devices from R&D to Production Medical devices must undergo several critical processes, including infrastructure establishment, quality management system (QMS) development, product design and development, registration testing, clinical evaluation, product registration application, on-site QMS verification, production license application, and market launch. The specifics are as follows: Infrastructure Establishment Business Registration: Determine the business scope based on corporate development plans and product positioning, then complete registration under the current registered capital subscription system and the “three-in-one” registration system (merging business licenses, organization code certificates, and tax registration certificates). Hardware Preparation: Construct facilities compliant with the Medical Device Production Quality Management Standardsaccording to the category and process requirements of the intended medical devices. If the product requires a sterile environment, a qualified cleanroom must be built. Additionally, acquire production equipment and inspection instruments necessary for manufacturing and testing. If a company faces challenges in hardware investment or ...
- Source: drugdu
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- October 13, 2025
Sanofi achieves a major victory in Phase II clinical trials, challenging its dominance as the “number one nuclear medicine company”!

Sanofi announced that its targeted alpha nuclide therapy AlphaMedix achieved all primary efficacy endpoints in the Phase II clinical trial ALPHAMEDIX-02, demonstrating significant clinically meaningful efficacy in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement not only further confirms the potential of targeted α therapy to provide precise treatment for GEP-NETs, but also marks Sanofi’s challenge to Novartis, the “No. 1 nuclear medicine company.” 01 New Force Alpha Nuclide AlphaMedix is a targeted alpha therapy based on lead-212. It consists of a peptide complex that binds to somatostatin receptors and is coupled to a radionuclide. It serves as an in vivo generator of alpha particles. Due to their high energy and short range, alpha particles can precisely kill cancer cells while minimizing damage to surrounding healthy tissue, presenting potential therapeutic advantages. AlphaMedix wasn’t developed independently by Sanofi, but rather a key move in rapidly expanding its nuclear medicine portfolio ...
- Source: drugdu
- 390
- October 11, 2025
Paclitaxel for Injection Obtains Marketing Authorization in Multiple Countries

　　Shanghai Securities News China SecuritiesNetxun Huiyu Pharmaceutical announced on the evening of the 9th that its subsidiary Seacross Pharma (Europe) Ltd. recently received marketing authorization for the company’s product paclitaxel for injection (albumin-bound) approved and issued by the Netherlands Medicines Evaluation Committee, the Irish Health Products Regulatory Authority, the Finnish Medicines Agency, and the Swedish Medicines Agency. 　　Paclitaxel (albumin-bound) for injection is primarily indicated as monotherapy for the treatment of adult patients with metastatic breast cancer whose disease has not improved after first-line treatment of metastatic disease and for whom standard anthracycline-containing regimens are not appropriate; in combination with gemcitabine, it is indicated for the first treatment of adult patients with metastatic pancreatic adenocarcinoma; and in combination with carboplatin, it is indicated for the initial treatment of adult patients with non-small cell lung cancer who are not suitable for potentially curative surgery or radiotherapy. 　　Huiyu Pharmaceuticals stated that following its ...
- Source: drugdu
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- October 11, 2025
Sinovac’s quadrivalent influenza vaccine has been approved to cover people aged 6 months and above

　　Shanghai Securities News China SecuritiesNet News (Reporter Zhang Xue) The reporter learned from Sinovac Holdings on October 10 that recently, Beijing Sinovac BiotechQuadrivalent influenza virusThe National Medical Products Administration (NMPA) has approved an expanded age range for the Sinovac quadrivalent influenza vaccine, expanding its coverage to include individuals aged 6-35 months, in addition to those aged 3 years and above. With this expanded age range, the Sinovac quadrivalent influenza vaccine now covers all ages 6 months and older and is currently in use in nearly 20 countries and regions worldwide. 　　Infants and young children aged 6-35 months are at high risk for influenza- related complications. Flu vaccination is the most effective and economical way to prevent influenza and reduce the risk of complications. Furthermore, families are a key venue for influenza transmission. Studies have shown that 26% of influenza infections can be attributed to transmission within the family, and the ...
- Source: drugdu
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- October 11, 2025

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